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Optimark (gadoversetamide) – Package leaflet - V08CA06

Updated on site: 09-Oct-2017

Package leaflet: Information for the user

Optimark 500 micromol/ml solution for injection in pre-filled syringe

Gadoversetamide

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you are being given this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor or pharmacist.

-If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.What Optimark is and what it is used for

2.What you need to know before you are given Optimark

3.How Optimark is given

4.Possible side effects

5.How to store Optimark

6.Contents of the pack and other information

1.What Optimark is and what it is used for

Optimark contains the active substance gadoversetamide. Gadoversetamide is used as a ‘contrast agent’ in magnetic resonance imaging.

Optimark is for diagnostic use, only. It is used in adult patients and children of two years and older, who are undergoing magnetic resonance imaging (MRI), a type of scan where images of the internal organs are taken. Optimark is used to obtain a clearer scan in patients who have or are thought to have abnormalities in the brain, spine or liver.

2.What you need to know before you are given Optimark

Do not use Optimark if you are allergic

to the active substance gadoversetamide or

to any of the other ingredients of Optimark (see section 6), or

to other gadolinium contrast agents.

You must not be given Optimark if

you suffer from severe and/or acute kidney impairment, or

if you are a patient who is about to have or has had a liver transplant as use of Optimark in patients with these conditions has been associated with a disease called nephrogenic systemic fibrosis (NSF). NSF is a disease involving thickening of the skin and connective tissues. NSF may result in debilitating joint immobility, muscle weakness or may affect the normal working of internal organs which may potentially be life-threatening.

Optimark must not be used in newborn babies up to the age of 4 weeks.

Before you receive Optimark, you will need to have a blood test to check how well your kidneys are working.

Warnings and precautions

Talk to your doctor before Optimark is used, if:

you suffer from allergies (e.g. medicinal products, seafood, hay fever, hives) or asthma

you had any reactions to previous injections of a contrast agent, including a previous history of reaction to iodine-based contrast agents

your kidneys do not work properly

you have recently had, or soon expect to have, a liver transplant

you are feeling thirsty and/or if you have only had small quantities or nothing to drink before the examination

you are taking a special kind of antihypertensive medicine, i.e. a beta-blocker

you have heart disease

you suffer from epilepsy or brain lesions

you are on a controlled sodium diet

If any of these apply to you, your doctor will decide whether the intended examination is possible or not.

Children and adolescents

Optimark is not recommended in children who are below the age of two years.

Other medicines and Optimark

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Optimark should not be used during pregnancy unless strictly necessary. Breast-feeding should be discontinued for at least 24 hours after you receive Optimark.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

If you are an ambulant patient and plan to drive or use tools or machines, take into account that dizziness may incidentally occur after you undergo a procedure involving the injection of Optimark. Up to 1 in 100 people may be affected.

Optimark contains sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per dose of up to 17 ml, i.e. it is essentially ‘sodium-free’.

10 ml vials and 15 ml vials contain less than 1 mmol sodium; i.e. they are essentially ‘sodium free‘. Higher doses contain 1 mmol sodium or more, which should be taken into consideration for patients on a controlled sodium diet.

20 ml of the solution contain 28.75 mg sodium.

30 ml of the solution contain 43.13 mg sodium.

3.How Optimark is given

Diagnostic procedures involving the use of contrast agents should be conducted under supervision of a physician with the prerequisite training and a thorough knowledge of the procedure to be performed.

The usual dose

The usual dose of 0.2 ml/kg body weight is the same in adults and children of 2 years and older. It would account for 14 ml for a 70 kg individual, and this volume would be injected over about 7-14 seconds into a vein, usually a vein in an arm. The injection is then flushed through with a saline injection to make sure none is left in the needle or tube used for the injection. In adults, a second dose may be given within 30 minutes of the first injection. When looking at certain abnormalities in the brain, Optimark may need to be used at three times the usual dose in one injection in adults. The

doctor will decide how much Optimark is needed for your examination. You must tell the doctor or nurse/technologist immediately if you feel pain around the area where the needle is placed.

Dosage in special patient groups

In patients with moderate kidney problems, more than one dose of Optimark should not be used during a scan. Optimark injections should not be repeated unless the interval between injections is at least 7 days.

It is not necessary to adjust your dose if you are 65 years of age or older but you will have a blood test to check how well your kidneys are working.

If you are given more Optimark than you should have been

If too much Optimark was injected it is unlikely that it will do you much harm, as much higher doses did not lead to any problems when some people received them. If your kidneys are working normally it is unlikely you will have any problems. Optimark can be removed using dialysis. If you think you have been injected with too much Optimark, tell the doctor or nurse/technologist immediately.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You must report any of the following symptoms immediately to the doctor or nurse/technologist, and get immediate treatment as they can be or can become very serious:

side effects affecting the heart (fainting, extra heart beats, chest pain) or the respiratory system (shortness of breath, tightening of the airways, swollen or tight throat, itchy or runny nose, sneezing).

Most of the side effects observed after the use of Optimark were of mild to moderate intensity and transient in nature. The most common side effects were a strange taste in the mouth, feeling hot, headache and dizziness.

Possible side effects are described in greater detail below.

The frequencies below and the following symptoms are based on clinical trials, and on the experience in using Optimark after it was on the market:

Frequency

Possible side effects

Common (may

headache, strange taste in the mouth, feeling hot

affect up to 1 in

 

10 people)

 

Uncommon

allergic/hypersensitivity reaction, dizziness, tingling sensation, numbness,

(may affect up to

reduced sense of smell, skin red and warm, nasal congestion, sore throat, nausea,

1 in 100 people)

diarrhoea, itching, rash, chest discomfort, chest pain, feeling cold including cold

 

feeling in extremities, administration site reactions, changes in blood calcium

 

levels

Frequency

Possible side effects

Rare

decreased appetite, feeling anxious, sleep disorder, drowsy feeling, burning

(may affect up to

sensation, a sensation of movement or spinning, ringing in the ears, eyelid

1 in 1000 people)

redness, eye pain, vision blurred, bloodshot eyes, awareness of the heartbeat,

 

irregular heartbeats, extra heartbeats, low blood pressure, shortness of breath,

 

hoarseness, runny nose, throat constriction, mouth watering, abdominal pain,

 

constipation, dry mouth, hives, cold sweat, redness, higher blood level of a

 

substance (creatinine) usually eliminated by the kidneys, blood in urine, face

 

swollen, weakness and similar symptoms like fatigue and general feeling of being

 

unwell, fever, swelling in limbs, chill, pain, cold feeling in extremities, liver

 

enzyme increased, urine analysis abnormal, mineral values in urine increased,

 

protein in urine, heart and muscle enzyme increased, decreased haemoglobin,

 

feeling confused and disoriented, shaking, convulsion, pink eye, fast heart beat,

 

high blood pressure, tightening of the airways, swollen throat or voice box, raw

 

throat, cough, itchy nose, sneezing, sweating

Very rare

swelling around the eyes, abnormal ECG heart tracing, fainting, vomiting

(may affect up to

 

1 in 10,000

 

people)

 

Not known

hardening of the skin which may affect also soft tissue and internal organs

(frequency cannot

(nephrogenic systemic fibrosis), feeling unwell

be estimated from

 

the available

 

data)

 

There have been reports of nephrogenic systemic fibrosis (which causes hardening of the skin and may affect also soft tissue and internal organs).

When Optimark was used in children aged 2 or older they had similar side effects as in adults.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5.How to store Optimark

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the syringe label after EXP.

Keep the syringe in the outer carton in order to protect from light.

Do not refrigerate or freeze.

The medicine should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

Do not use the solution if it is discoloured or particulate matter is present.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Optimark contains

The active substance is gadoversetamide.

1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol. Each 10 ml syringe contains 3309 mg gadoversetamide.

Each 15 ml syringe contains 4963.5 mg gadoversetamide. Each 20 ml syringe contains 6618 mg gadoversetamide. Each 30 ml syringe contains 9927 mg gadoversetamide.

The other ingredients are: versetamide, calcium hydroxide, calcium chloride dihydrate, sodium hydroxide and/or hydrochloric acid, water for injections.

What Optimark looks like and contents of the pack

Optimark syringes contain a clear, colourless to pale yellow solution.

Optimark is supplied in pre-filled syringes made of polypropylene. Syringe tip cap and piston are made of bromobutyl rubber.

Optimark pre-filled syringes are supplied in the following package sizes:

1 x 10 ml

10 x 10 ml

1 x 15 ml

10 x 15 ml

1 x 20 ml

10 x 20 ml

1 x 30 ml

10 x 30 ml

Not all package sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Guerbet

15, rue des Vanesses 93420 Villepinte France

For any information about this medicine, please contact the Marketing Authorisation Holder.

Manufacturer

Mallinckrodt Medical Imaging Ireland

Damastown

Mulhuddart, Dublin 15

Ireland

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency (EMA) web site http://www.ema.europa.eu.

The following information is intended for healthcare professionals only:

Therapeutic indications

Optimark is indicated for use with magnetic resonance imaging (MRI) of the central nervous system (CNS) and liver. It provides contrast enhancement and facilitates visualization and helps with characterization of focal lesions and abnormal structures in the CNS and liver in adult patients and in children of two years and older with known or highly suspected pathology.

Contraindications

Hypersensitivity to gadoversetamide or to other gadolinium containing products or to any of the excipients.

Optimark is contraindicated in patients with severe renal impairment (GFR < 30ml/min/1.73 m2) and/or acute kidney injury, in

patients who have had liver transplantation or in

patients in the perioperative liver transplantation period and in

neonates up to 4 weeks of age.

Special warnings and precautions for use

As with any paramagnetic contrast agent, enhancement of MRI with Optimark may impair the visualization of existing lesions. Some of these lesions may be seen on unenhanced, non-contrast MRI. Therefore, caution should be exercised when contrast enhanced scan interpretation is made in the absence of a companion unenhanced MRI.

Before the examination, care must be taken that patients are sufficiently hydrated.

Hypersensitivity

Allergoid and other idiosyncratic reactions also may occur with gadoversetamide, which could become manifest in form of cardiovascular, respiratory and skin reactions. Most of these reactions occur within half an hour after administering the contrast medium. As with all other contrast media of the same class, late reactions may occur (after hours or days) in rare cases; however, none were reported in the completed clinical trials.

If hypersensitivity reactions occur, the administration of the contrast medium must be discontinued immediately and intravenous treatment initiated, if necessary.

During the examination, supervision by a physician is necessary and insertion of a flexible in-dwelling catheter is recommended. To enable immediate action in emergencies, the necessary medicinal products (e.g. epinephrine/adrenaline, theophylline, antihistamines, corticosteroids and atropines), endotracheal tube and ventilator must be immediately available.

The risk of hypersensitivity reactions is increased in the following cases:

-patients with allergic predisposition

-patients with bronchial asthma; in these patients it is especially the risk of bronchospasm which is increased

-patients with a history of reactions to contrast agents, including a previous history of reaction to iodine-based contrast agents

Before the injection of contrast media, patients should be asked whether they have any allergies (e.g. allergies to seafood or medicinal products, hay fever, urticaria), whether they are hypersensitive to contrast media and whether they have bronchial asthma. Premedication with antihistamines and/or glucocorticoids may be considered.

Patients taking beta-blockers

It should be noted that patients using beta-blockers do not necessarily respond to the beta-agonists usually used for the treatment of hypersensitivity reactions.

Patients with cardiovascular disease

In this group of patients hypersensitivity reactions may be severe. Especially in patients with serious heart diseases (e.g. severe heart failure, coronary artery disease) cardiovascular reactions may deteriorate. However, these were not evident from clinical trials with Optimark.

Central nervous system disorders

In patients suffering from epilepsy or brain lesions the likelihood of convulsions during the examination may be increased. Precautions are necessary when examining these patients (e.g. monitoring of the patient) and the equipment and medicinal products needed for the rapid treatment of possible convulsions should be available.

Patients with impaired renal function

Prior to administration of Optimark, all patients should be screened for renal dysfunction by obtaining laboratory tests.

There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of Optimark and some gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR < 30ml/min/1.73 m²) and/or acute kidney injury. Optimark is contraindicated in these patients (see section Contraindications). Patients who have had or are undergoing liver transplantation are at particular risk since the incidence of acute renal failure is high in this group. Therefore, Optimark must not be used in patients who have had or are undergoing liver transplantation and in neonates. The risk for development of NSF in patients with moderate renal impairment (GFR 30–59 ml/min/1.73 m²) is unknown; therefore, Optimark should only be used after careful risk-benefit evaluation in patients with moderate renal impairment. Gadoversetamide is dialysable. Haemodialysis shortly after Optimark administration may be useful at removing Optimark from the body. There is no evidence to support the initiation of haemodialysis for prevention or treatment of NSF in patients not already undergoing haemodialysis.

In patients with baseline renal impairment, acute kidney injury requiring dialysis has occurred with the use of Optimark. The risk of acute kidney injury may increase with an increased dose of the contrast agent. Administer the lowest dose possible for adequate imaging.

Children and adolescents

Optimark must not be administered with an autoinjector. The required dose should be administered by hand to children of 2 to 11 years to avoid overdosage by mistake.

Neonates and infants

Optimark should not be used in children below the age of two years. Safety and efficacy have not been studied in this age group.

Elderly

As the renal clearance of gadoversetamide may be impaired in the elderly, it is particularly important to screen patients aged 65 years and older for renal dysfunction.

Sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per dose of up to 17 ml, i.e. it is essentially ‘sodium-free’.

10 ml vials and 15 ml vials contain less than 1 mmol sodium; i.e. they are essentially ‘sodium free‘. Higher doses contain 1 mmol sodium or more, which should be taken into consideration for patients on a controlled sodium diet.

20 ml of the solution contain 28.75 mg sodium.

30 ml of the solution contain 43.13 mg sodium.

Serum iron and zinc

Caution should be exercised because transient decreases in serum iron and zinc parameters have been observed in clinical trials. The clinical significance of this is unknown.

Fertility, pregnancy and lactation

Pregnancy

There are no data from the use of gadoversetamide in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Optimark should not be used during pregnancy unless the clinical condition of the woman requires use of gadoversetamide.

Breast-feeding

It is unknown whether gadoversetamide is excreted in human milk. There is insufficient information on the excretion of gadoversetamide in animal milk. A risk to the suckling child cannot be excluded. Breast-feeding should be discontinued for at least 24 hours after the administration of Optimark.

Fertility

Nonclinical data did not reveal special hazards for humans based on conventional studies of reproductive toxicity. Clinical studies on fertility have not been performed.

Posology and method of administration

Optimark should only be administered by physicians experienced in clinical MRI practice.

To enable immediate action in emergencies, the necessary medicinal products (e.g. epinephrine/ adrenaline, theophylline, antihistamines, corticosteroids and atropines), endotracheal tube and ventilator must be immediately available.

Posology

The agent should be administered as a bolus peripheral intravenous injection at a dose of 0.2 ml/kg (100 micromol/kg) body weight. To ensure complete injection of the contrast medium, the injection should be followed by a 5 ml flush of sodium chloride 9 mg/ml (0.9 %) solution for injection. The imaging procedure should be completed within 1 hour of administration of the contrast medium.

Repeat dose

In cranial MRI, if a strong clinical suspicion of a lesion persists despite a single dose contrast- enhanced MRI or when more accurate information on the number, size or extent of lesions might influence management or therapy of the patient, in subjects with normal renal function, a second bolus injection of 0.2 ml/kg (100 micromol/kg) may be administered within 30 minutes of the first injection as it may increase the diagnostic yield of the examination.

The safety of repeat doses has not been established in children and adolescents (2 years and older), in patients with renal impairment, or the elderly. The repeat dose is not recommended in these populations.

Limited data with other gadolinium contrast agents suggests that for the exclusion of additional cranial metastases in a patient with a known solitary resectable metastasis, an MR exam with the injection of 300 micromol/kg body weight of Optimark may lead to higher diagnostic confidence.

Paediatric population

No dose adjustment is considered necessary in children more than 2 years of age.

Optimark is contraindicated in neonates up to 4 weeks of age. Use of Optimark is not recommended in children less than 2 years of age because the safety, efficacy, and impact of immature kidney function have not been studied in this age group.

Elderly (aged 65 years and above)

No dosage adjustment is considered necessary. Caution should be exercised in elderly patients.

Renal and hepatic impairment

Optimark is contraindicated in patients with severe renal impairment (GFR < 30 ml/min/1.73 m2) and/or acute renal injury and in patients who have had liver transplantation or in patients in the perioperative liver transplantation period. Optimark should only be used after careful risk/benefit evaluation in patients with moderate renal impairment (GFR 30-59 ml/min/1.73 m2) at a dose not exceeding 100 micromol/kg body weight. More than one dose should not be used during a scan. Because of the lack of information on repeated administration, Optimark injections should not be repeated unless the interval between injections is at least 7 days.

Method of administration

The agent should be administered as a bolus peripheral intravenous injection. To ensure complete injection of the contrast medium, the injection should be followed by a 5 ml flush of sodium chloride 9 mg/ml (0.9 %) solution for injection. Insertion of a flexible in-dwelling venous catheter is recommended.

Optimark must not be administered with an autoinjector to children of 2 to 11 years.

Precautions to be taken before handling or administering the medicinal product

The container and the solution should be inspected prior to use.

Interaction with other medicinal products and other forms of interaction

No formal interaction studies have been performed.

Gadoversetamide has been shown to cause interference in the measurement of serum calcium using the ortho-cresolphthalein complexone (OCP) colorimetric method. However, the administration of gadoversetamide does not cause a true decrease in serum calcium. In the presence of gadoversetamide, the OCP technique produces an erroneous, low value for plasma calcium. The magnitude of this measurement artefact is proportional to the concentration of gadoversetamide in the blood, and in patients with normal renal clearance accurate values can be obtained approximately 90 minutes following injection. In patients with compromised renal function, clearance of gadoversetamide will be slowed and the interference with calcium determination by OCP prolonged. Gadoversetamide does not affect other methods of measuring serum calcium, such as the arsenazo III colorimetric method, atomic absorption spectroscopy, and inductively coupled plasma mass spectroscopy.

Special precautions for disposal and other handling

Optimark is intended for single use only; any unused portions should be discarded.

Do not use the solution if it is discoloured or particulate matter is present. If non-disposable equipment is used, scrupulous care should be taken to prevent residual contamination with traces of cleansing agents.

Pre-filled syringes:

Assembly and Inspection

Inspect the syringe for signs of leakage. Do not use if leakage is observed.

After screwing the push rod into the syringe piston, it is important to turn the push rod an additional ½ turn so that the grey piston rotates freely.

Prior to using the syringe, twist off grey tip cap and discard. Syringe is now ready for needle or infusion tubing attachment.

Discard syringe and unused portion of the solution after use.

Any unused product or waste material should be disposed of in accordance with local requirements. The peel-off tracking label on the pre-filled syringes should be stuck onto the patients record to enable accurate recording of the gadolinium contrast agent used. The dose used should also be recorded.

If electronic patient records are used, the name of the product, the batch number and the dose should be entered into the patient record.

Package leaflet: Information for the user

Optimark 500 micromol/ml solution for injection in vial

Gadoversetamide

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you are being given this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor or pharmacist.

-If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.What Optimark is and what it is used for

2.What you need to know before you are given Optimark

3.How Optimark is given

4.Possible side effects

5.How to store Optimark

6.Contents of the pack and other information

1. What Optimark is and what it is used for

Optimark contains the active substance gadoversetamide. Gadoversetamide is used as a ‘contrast agent’ in magnetic resonance imaging.

Optimark is for diagnostic use, only. It is used in adult patients and children of two years and older, who are undergoing magnetic resonance imaging (MRI), a type of scan where images of the internal organs are taken. Optimark is used to obtain a clearer scan in patients who have or are thought to have abnormalities in the brain, spine or liver.

2. What you need to know before you are given Optimark

Do not use Optimark if you are allergic

to the active substance gadoversetamide or

to any of the other ingredients of Optimark (see section 6), or

to other gadolinium contrast agents.

You must not be given Optimark if

you suffer from severe and/or acute kidney impairment, or

if you are a patient who is about to have or has had a liver transplant as use of Optimark in patients with these conditions has been associated with a disease called nephrogenic systemic fibrosis (NSF). NSF is a disease involving thickening of the skin and connective tissues. NSF may result in debilitating joint immobility, muscle weakness or may affect the normal working of internal organs which may potentially be life-threatening.

Optimark must not be used in newborn babies up to the age of 4 weeks.

Before you receive Optimark, you will need to have a blood test to check how well your kidneys are working.

Warnings and precautions

Talk to your doctor before Optimark is used, if:

you suffer from allergies (e.g. medicinal products, seafood, hay fever, hives) or asthma

you had any reactions to previous injections of a contrast agent, including a previous history of reaction to iodine-based contrast agents

your kidneys do not work properly

you have recently had, or soon expect to have, a liver transplant

you are feeling thirsty and/or if you have only had small quantities or nothing to drink before the examination

you are taking a special kind of antihypertensive medicine, i.e. a beta-blocker

you have heart disease

you suffer from epilepsy or brain lesions

you are on a controlled sodium diet

If any of these apply to you, your doctor will decide whether the intended examination is possible or not.

Children and adolescents

Optimark is not recommended in children who are below the age of two years.

Other medicines and Optimark

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Optimark should not be used during pregnancy unless strictly necessary. Breast-feeding should be discontinued for at least 24 hours after you receive Optimark.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

If you are an ambulant patient and plan to drive or use tools or machines, take into account that dizziness may incidentally occur after you undergo a procedure involving the injection of Optimark. Up to 1 in 100 people may be affected.

Optimark contains sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per dose of up to 17 ml, i.e. it is essentially ‘sodium-free’.

10 ml vials and 15 ml vials contain less than 1 mmol sodium; i.e. they are essentially ‘sodium free‘. Higher doses contain 1 mmol sodium or more, which should be taken into consideration for patients on a controlled sodium diet.

20 ml of the solution contain 28.75 mg sodium.

3. How Optimark is given

Diagnostic procedures involving the use of contrast agents should be conducted under supervision of a physician with the prerequisite training and a thorough knowledge of the procedure to be performed.

The usual dose

The usual dose of 0.2 ml/kg body weight is the same in adults and children of 2 years and older.

It would account for 14 ml for a 70 kg individual, and this volume would be injected over about 7-14 seconds into a vein, usually a vein in an arm. The injection is then flushed through with a saline injection to make sure none is left in the needle or tube used for the injection.

In adults, a second dose may be given within 30 minutes of the first injection. When looking at certain abnormalities in the brain, Optimark may need to be used at three times the usual dose in one injection in adults. The doctor will decide how much Optimark is needed for your examination. You must tell

the doctor or nurse/technologist immediately if you feel pain around the area where the needle is placed.

Dosage in special patient groups

In patients with moderate kidney problems, more than one dose of Optimark should not be used during a scan. Optimark injections should not be repeated unless the interval between injections is at least 7 days.

It is not necessary to adjust your dose if you are 65 years of age or older but you will have a blood test to check how well your kidneys are working.

If you are given more Optimark than you should have been

If too much Optimark was injected it is unlikely that it will do you much harm, as much higher doses did not lead to any problems when some people received them. If your kidneys are working normally it is unlikely you will have any problems. Optimark can be removed using dialysis. If you think you have been injected with too much Optimark, tell the doctor or nurse/technologist immediately.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You must report any of the following symptoms immediately to the doctor or nurse/technologist, and get immediate treatment as they can be or can become very serious:

side effects affecting the heart (fainting, extra heart beats, chest pain) or the respiratory system (shortness of breath, tightening of the airways, swollen or tight throat, itchy or runny nose, sneezing).

Most of the side effects observed after the use of Optimark were of mild to moderate intensity and transient in nature. The most common side effects were a strange taste in the mouth, feeling hot, headache and dizziness.

Possible side effects are described in greater detail below.

The frequencies below and the following symptoms are based on clinical trials, and on the experience in using Optimark after it was on the market:

Frequency

Possible side effects

Common

headache, strange taste in the mouth, feeling hot

(may affect up to 1

 

in 10 people)

 

Uncommon

allergic/hypersensitivity reaction, dizziness, tingling sensation, numbness,

(may affect up to 1

reduced sense of smell, skin red and warm, nasal congestion, sore throat, nausea,

in 100 people)

diarrhoea, itching, rash, chest discomfort, chest pain, feeling cold including cold

 

feeling in extremities, administration site reactions, changes in blood calcium

 

levels

Frequency

Possible side effects

Rare

decreased appetite, feeling anxious, sleep disorder, drowsy feeling, burning

(may affect up to 1

sensation, a sensation of movement or spinning, ringing in the ears, eyelid

in 1000 people)

redness, eye pain, vision blurred, bloodshot eyes, awareness of the heartbeat,

 

irregular heartbeats, extra heartbeats, low blood pressure, shortness of breath,

 

hoarseness, runny nose, throat constriction, mouth watering, abdominal pain,

 

constipation, dry mouth, hives, cold sweat, redness, higher blood level of a

 

substance (creatinine) usually eliminated by the kidneys, blood in urine, face

 

swollen, weakness and similar symptoms like fatigue and general feeling of

 

being unwell, fever, swelling in limbs, chill, pain, cold feeling in extremities,

 

liver enzyme increased, urine analysis abnormal, mineral values in urine

 

increased, protein in urine, heart and muscle enzyme increased, decreased

 

haemoglobin, feeling confused and disoriented, shaking, convulsion, pink eye,

 

fast heart beat, high blood pressure, tightening of the airways, swollen throat or

 

voice box, raw throat, cough, itchy nose, sneezing, sweating

Very rare

swelling around the eyes, abnormal ECG heart tracing, fainting, vomiting

(may affect up to 1

 

in 10,000 people)

 

Not known

hardening of the skin which may affect also soft tissue and internal organs

(frequency cannot

(nephrogenic systemic fibrosis), feeling unwell

be estimated from

 

the available data)

 

There have been reports of nephrogenic systemic fibrosis (which causes hardening of the skin and may affect also soft tissue and internal organs).

When Optimark was used in children aged 2 or older they had similar side effects as in adults.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Optimark

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the vial label after EXP.

Keep the vial in the outer carton in order to protect from light.

Do not refrigerate or freeze.

The medicine should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

Do not use the solution if it is discoloured or particulate matter is present.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Optimark contains

The active substance is gadoversetamide.

1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol. Each 10 ml vial contains 3309 mg gadoversetamide.

Each 15 ml vial contains 4963.5 mg gadoversetamide. Each 20 ml vial contains 6618 mg gadoversetamide.

The other ingredients are: versetamide, calcium hydroxide, calcium chloride dihydrate, sodium hydroxide and/or hydrochloric acid, water for injections.

What Optimark looks like and contents of the pack

Optimark vials contain a clear, colourless to pale yellow solution.

Optimark is supplied in vials, fitted with bromobutyl rubber closures and aluminium cap seals.

Optimark vials are supplied in the following package sizes:

1 x 10 ml

10 x 10 ml

1 x 15 ml

10 x 15 ml

1 x 20 ml

10 x 20 ml

Not all package sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Guerbet

15, rue des Vanesses 93420 Villepinte France

For any information about this medicine, please contact the Marketing Authorisation Holder.

Manufacturer

Mallinckrodt Medical Imaging Ireland

Damastown

Mulhuddart, Dublin 15

Ireland

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency (EMA) web site http://www.ema.europa.eu.

The following information is intended for healthcare professionals only:

Therapeutic indications

Optimark is indicated for use with magnetic resonance imaging (MRI) of the central nervous system (CNS) and liver. It provides contrast enhancement and facilitates visualization and helps with characterization of focal lesions and abnormal structures in the CNS and liver in adult patients and in children of two years and older with known or highly suspected pathology.

Contraindications

Hypersensitivity to gadoversetamide or to other gadolinium containing products or to any of the excipients.

Optimark is contraindicated in patients with severe renal impairment (GFR < 30ml/min/1.73 m²) and/or acute kidney injury, in

patients who have had liver transplantation or in

patients in the perioperative liver transplantation period and in

neonates up to 4 weeks of age.

Special warnings and precautions for use

As with any paramagnetic contrast agent, enhancement of MRI with Optimark may impair the visualization of existing lesions. Some of these lesions may be seen on unenhanced, non-contrast MRI. Therefore, caution should be exercised when contrast enhanced scan interpretation is made in the absence of a companion unenhanced MRI.

Before the examination, care must be taken that patients are sufficiently hydrated.

Hypersensitivity

Allergoid and other idiosyncratic reactions also may occur with gadoversetamide, which could become manifest in form of cardiovascular, respiratory and skin reactions. Most of these reactions occur within half an hour after administering the contrast medium. As with all other contrast media of the same class, late reactions may occur (after hours or days) in rare cases; however, none were reported in the completed clinical trials.

If hypersensitivity reactions occur, the administration of the contrast medium must be discontinued immediately and intravenous treatment initiated, if necessary.

During the examination, supervision by a physician is necessary and insertion of a flexible in-dwelling catheter is recommended. To enable immediate action in emergencies, the necessary medicinal products (e.g. epinephrine/adrenaline, theophylline, antihistamines, corticosteroids and atropines), endotracheal tube and ventilator must be immediately available.

The risk of hypersensitivity reactions is increased in the following cases:

-patients with allergic predisposition

-patients with bronchial asthma; in these patients it is especially the risk of bronchospasm which is increased

-patients with a history of reactions to contrast agents, including a previous history of reaction to iodine-based contrast agents

Before the injection of contrast media, patients should be asked whether they have any allergies (e.g. allergies to seafood or medicinal products, hay fever, urticaria), whether they are hypersensitive to contrast media and whether they have bronchial asthma. Premedication with antihistamines and/or glucocorticoids may be considered.

Patients taking beta-blockers

It should be noted that patients using beta-blockers do not necessarily respond to the beta-agonists usually used for the treatment of hypersensitivity reactions.

Patients with cardiovascular disease

In this group of patients hypersensitivity reactions may be severe. Especially in patients with serious heart diseases (e.g. severe heart failure, coronary artery disease) cardiovascular reactions may deteriorate. However, these were not evident from clinical trials with Optimark.

Central nervous system disorders

In patients suffering from epilepsy or brain lesions the likelihood of convulsions during the examination may be increased. Precautions are necessary when examining these patients (e.g. monitoring of the patient) and the equipment and medicinal products needed for the rapid treatment of possible convulsions should be available.

Patients with impaired renal function

Prior to administration of Optimark, all patients should be screened for renal dysfunction by obtaining laboratory tests.

There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of Optimark and some gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR < 30ml/min/1.73 m²) and/or acute kidney injury. Optimark is contraindicated in these patients (see section Contraindications). Patients who have had or are undergoing liver transplantation are at particular risk since the incidence of acute renal failure is high in this group. Therefore, Optimark must not be used in patients who have had or are undergoing liver transplantation and in neonates. The risk for development of NSF in patients with moderate renal impairment (GFR 30–59 ml/min/1.73 m2) is unknown; therefore, Optimark should only be used after careful risk-benefit evaluation in patients with moderate renal impairment. Gadoversetamide is dialysable. Haemodialysis shortly after Optimark administration may be useful at removing Optimark from the body. There is no evidence to support the initiation of haemodialysis for prevention or treatment of NSF in patients not already undergoing haemodialysis.

In patients with baseline renal impairment, acute kidney injury requiring dialysis has occurred with the use of Optimark. The risk of acute kidney injury may increase with an increased dose of the contrast agent. Administer the lowest dose possible for adequate imaging.

Children and adolescents

Optimark must not be administered with an autoinjector. The required dose should be administered by hand to children of 2 to 11 years to avoid overdosage by mistake.

Neonates and infants

Optimark should not be used in children below the age of two years. Safety and efficacy have not been studied in this age group.

Elderly

As the renal clearance of gadoversetamide may be impaired in the elderly, it is particularly important to screen patients aged 65 years and older for renal dysfunction.

Sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per dose of up to 17 ml, i.e. it is essentially ‘sodium-free’.

10 ml vials and 15 ml vials contain less than 1 mmol sodium; i.e. they are essentially ‘sodium free‘. Higher doses contain 1 mmol sodium or more, which should be taken into consideration for patients on a controlled sodium diet.

20 ml of the solution contain 28.75 mg sodium.

Serum iron and zinc

Caution should be exercised because transient decreases in serum iron and zinc parameters have been observed in clinical trials. The clinical significance of this is unknown.

Fertility, pregnancy and lactation

Pregnancy

There are no data from the use of gadoversetamide in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Optimark should not be used during pregnancy unless the clinical condition of the woman requires use of gadoversetamide.

Breast-feeding

It is unknown whether gadoversetamide is excreted in human milk. There is insufficient information on the excretion of gadoversetamide in animal milk. A risk to the suckling child cannot be excluded. Breast-feeding should be discontinued for at least 24 hours after the administration of Optimark.

Fertility

Nonclinical data did not reveal special hazards for humans based on conventional studies of reproductive toxicity. Clinical studies on fertility have not been performed.

Posology and method of administration

Optimark should only be administered by physicians experienced in clinical MRI practice.

To enable immediate action in emergencies, the necessary medicinal products (e.g. epinephrine/ adrenaline, theophylline, antihistamines, corticosteroids and atropines), endotracheal tube and ventilator must be immediately available.

Posology

The agent should be administered as a bolus peripheral intravenous injection at a dose of 0.2 ml/kg (100 micromol/kg) body weight. To ensure complete injection of the contrast medium, the injection should be followed by a 5 ml flush of sodium chloride 9 mg/ml (0.9 %) solution for injection. The imaging procedure should be completed within 1 hour of administration of the contrast medium.

Repeat dose

In cranial MRI, if a strong clinical suspicion of a lesion persists despite a single dose contrast- enhanced MRI or when more accurate information on the number, size or extent of lesions might influence management or therapy of the patient, in subjects with normal renal function, a second bolus injection of 0.2 ml/kg (100 micromol/kg) may be administered within 30 minutes of the first injection as it may increase the diagnostic yield of the examination.

The safety of repeat doses has not been established in children and adolescents (2 years and older), in patients with renal impairment, or the elderly. The repeat dose is not recommended in these populations.

Limited data with other gadolinium contrast agents suggests that for the exclusion of additional cranial metastases in a patient with a known solitary resectable metastasis, an MR exam with the injection of 300 micromol/kg body weight of Optimark may lead to higher diagnostic confidence.

Paediatric population

No dose adjustment is considered necessary in children more than 2 years of age.

Optimark is contraindicated in neonates up to 4 weeks of age. Use of Optimark is not recommended in children less than 2 years of age because the safety, efficacy, and impact of immature kidney function have not been studied in this age group.

Elderly (aged 65 years and above)

No dosage adjustment is considered necessary. Caution should be exercised in elderly patients.

Renal and hepatic impairment

Optimark is contraindicated in patients with severe renal impairment (GFR < 30 ml/min/1.73 m²) and/or acute renal injury and in patients who have had liver transplantation or in patients in the perioperative liver transplantation period. Optimark should only be used after careful risk/benefit evaluation in patients with moderate renal impairment (GFR 30-59 ml/min/1.73 m2) at a dose not exceeding 100 micromol/kg body weight. More than one dose should not be used during a scan. Because of the lack of information on repeated administration, Optimark injections should not be repeated unless the interval between injections is at least 7 days.

Method of administration

The agent should be administered as a bolus peripheral intravenous injection. To ensure complete injection of the contrast medium, the injection should be followed by a 5 ml flush of sodium chloride 9 mg/ml (0.9 %) solution for injection. Insertion of a flexible in-dwelling venous catheter is recommended.

Optimark must not be administered with an autoinjector to children of 2 to 11 years.

Precautions to be taken before handling or administering the medicinal product

The container and the solution should be inspected prior to use.

Interaction with other medicinal products and other forms of interaction

No formal interaction studies have been performed.

Gadoversetamide has been shown to cause interference in the measurement of serum calcium using the ortho-cresolphthalein complexone (OCP) colorimetric method. However, the administration of gadoversetamide does not cause a true decrease in serum calcium. In the presence of gadoversetamide, the OCP technique produces an erroneous, low value for plasma calcium. The magnitude of this measurement artefact is proportional to the concentration of gadoversetamide in the blood, and in patients with normal renal clearance accurate values can be obtained approximately 90 minutes following injection. In patients with compromised renal function, clearance of gadoversetamide will be slowed and the interference with calcium determination by OCP prolonged. Gadoversetamide does not affect other methods of measuring serum calcium, such as the arsenazo III colorimetric method, atomic absorption spectroscopy, and inductively coupled plasma mass spectroscopy.

Special precautions for disposal and other handling

Optimark is intended for single use only; any unused portions should be discarded.

Optimark should be drawn into the syringe and used immediately.

Do not use the solution if it is discoloured or particulate matter is present. If non-disposable equipment is used, scrupulous care should be taken to prevent residual contamination with traces of cleansing agents.

The product must be examined before use to confirm that all solids are dissolved and that the container and closure are un-damaged. If solids remain, the vial must be discarded.

Discard syringe and unused portion of the solution after use.

Any unused product or waste material should be disposed of in accordance with local requirements. The peel-off tracking label on the vials should be stuck onto the patients record to enable accurate recording of the gadolinium contrast agent used. The dose used should also be recorded. If electronic patient records are used, the name of the product, the batch number and the dose should be entered into the patient record.

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