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Ibandronic acid Accord (ibandronic acid) – Package leaflet - M05BA06

Updated on site: 07-Oct-2017

Medication nameIbandronic acid Accord
ATC CodeM05BA06
Substanceibandronic acid
ManufacturerAccord Healthcare Ltd

Package leaflet: Information for the patient

Ibandronic acid Accord 2 mg concentrate for solution for infusion Ibandronic acid Accord 6 mg concentrate for solution for infusion ibandronic acid

Read all of this leaflet carefully before you start using 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, pharmacist or nurse.

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

What is in this leaflet:

1.What Ibandronic acid Accord is and what it is used for

2.What you need to know before you receive Ibandronic acid Accord

3.How to receive Ibandronic acid Accord

4.Possible side effects

5.How to store Ibandronic acid Accord

6.Contents of the pack and other information

1.What Ibandronic Acid Accord is and what it is used for

Ibandronic acid Accord contains the active substance ibandronic acid. This belongs to a group of medicines called bisphosphonates.

Ibandronic acid Accord is used in adults and prescribed to you if you have breast cancer that has spread to your bones (called ‘bone metastases’).

It helps to prevent your bones from breaking (fractures).

It helps to prevent other bone problems that may need surgery or radiotherapy.

Ibandronic acid Accord can also be prescribed if you have a raised calcium level in your blood due to a tumour.

Ibandronic acid Accord works by reducing the amount of calcium that is lost from your bones. This helps to stop your bones from getting weaker.

2. What you need to know before you receive Ibandronic acid Accord

Do not receive Ibandronic acid Accord

if you are allergic to ibandronic acid or any of the other ingredients of this medicine (listed in section 6)

if you have, or have ever had low levels of calcium in your blood

Do not receive this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before having Ibandronic acid Accord.

Warnings and precautions

A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported very rarely in the post marketing setting in patients receiving ibandronic acid for cancer-related conditions. ONJ can also occur after stopping treatment.

It is important to try and prevent ONJ developing as it is a painful condition that can be difficult to treat. In order to reduce the risk of developing osteonecrosis of the jaw, there are some precautions you should take.

Before receiving treatment, tell your doctor/nurse (health care professional) if:

you have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction

you don’t receive routine dental care or have not had a dental check up for a long time

you are a smoker (as this may increase the risk of dental problems)

you have previously been treated with a bisphosphonate (used to treat or prevent bone disorders)

you are taking medicines called corticosteroids (such as prednisolone or dexamethasone)

you have cancer.

Your doctor may ask you to undergo a dental examination before starting treatment with ibandronic acid.

While being treated, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups. If you wear dentures you should make sure these fit properly. If you are under dental treatment or will undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with ibandronic acid.

Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, non-healing of sores or discharge, as these could be signs of osteonecrosis of the jaw.

Talk to your doctor, pharmacist or nurse before receiving Ibandronic acid Accord:

if you are allergic to any other bisphosphonates.

if you have high or low levels of vitamin D, calcium or any other minerals.

if you have kidney problems.

if you have heart problems and the doctor recommended to limit your daily fluid intake

Cases of serious, sometimes fatal allergic reaction have been reported in patients treated with intravenous ibandronic acid.

If you experience one of the following symptoms, such as shortness of breath/difficulty breathing, tight feeling in throat, swelling of tongue, dizziness, feeling of loss of consciousness, redness or swelling of face, body rash, nausea and vomiting, you should immediately alert your doctor or nurse (see section 4).

Children and adolescents

Ibandronic acid Accord should not be used in children and adolescents below the age of 18 years.

Other medicines and Ibandronic Acid Accord

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Ibandronic acid Accord can affect the way some other medicines work. Also, some other medicines can affect the way Ibandronic acid Accord works.

In particular, tell your doctor or pharmacist if you are receiving a type of antibiotic injection called ‘“aminoglycoside”’ such as gentamicin. This is because aminoglycosides and Ibandronic acid Accord can both lower the amount of calcium in your blood.

Pregnancy and breast-feeding

Do not receive Ibandronic acid Accord if you are pregnant, planning to get pregnant or if you are breast-feeding. Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

You can drive and use machines as it’s expected that Ibandronic acid Accord has no or negligible effect on your ability to drive and use machines. Talk to your doctor first if you want to drive, use machines or tools.

Ibandronic Acid Accord contains less than 1 mmol sodium (23 mg) per vial, i.e. ‘essentially sodium free’.

3. How to receive Ibandronic Acid Accord

Receiving this medicine

Ibandronic acid Accord is normally given by a doctor or other medical staff who have experience with the treatment of cancer.

it is given as an infusion into your vein.

Your doctor may do regular blood tests while you are receiving Ibandronic acid Accord. This is to check that you are being given the right amount of this medicine.

How much to receive

Your doctor will work out how much Ibandronic acid Accord you will be given depending on your illness.

If you have breast cancer that has spread to your bones, then the recommended dose is 6 mg every 3-4 weeks, as an infusion in your vein over at least 15 minutes.

If you have raised calcium level in your blood due to a tumour then the recommended dose is a single administration of 2 mg or 4 mg, depending on the severity of your illness.

The medicine should be administered as an infusion in your vein over two hours. A repeated dose may be considered in case of insufficient response or if your illness reappears.

Your doctor may adjust your dose and duration of intravenous infusion if you have kidney problems.

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.

Talk to a nurse or a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:

Rare (may affect up to 1 in 1,000 people)

persistent eye pain and inflammation

new pain, weakness or discomfort in your thigh, hip or groin. You may have early signs of a possible unusual fracture of the thigh bone.

Very rare (may affect up to 1 in 10,000 people)

pain or sore in your mouth or jaw. You may have early signs of severe jaw problems (necrosis (dead bone tissue) in the jaw bone).

Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection. These could be signs of bone damage in the ear.

itching, swelling of your face, lips, tongue and throat, with difficulty breathing. You may be having a serious, potentially life threatening allergic reaction (see section 2).

severe adverse skin reactions

Not known (frequency cannot be estimated from the available data)

asthma attack

Other possible side effects

Common (may affect upto 1 in 10 people)

flu-like symptoms, including fever, shaking and shivering, feeling of discomfort, fatigue, bone pain and aching muscles and joints. These symptoms usually disappear within a couple of hours

or days. Talk to a nurse or doctor if any effects become troublesome or last more than a couple of days

rise in body temperature.

stomach and tummy pain, indigestion, being sick, vomiting or having diarrhoea (loose bowels)

low calcium or phosphate levels in your blood

changes in blood test results such as Gamma GT or creatinine

a heart rhythm problem called ‘“bundle branch block”’

pain in your bone or muscles

headache, feeling dizzy or feeling weak

feeling thirsty, sore throat, changes in taste

swollen legs or feet

aching joints, arthritis, or other joint problems

problems with your parathyroid gland

bruising

infections

a problem with your eyes called ‘cataracts’

skin problems

tooth problems.

Uncommon (may affect less than 1 in 100 people)

shaking or shivering

your body temperature getting too low (hypothermia)

a condition affecting the blood vessels in your brain called ‘“cerebrovascular disorder”’ (stroke or brain bleeding)

heart and circulatory problems (including palpitations, heart attack, hypertension (high blood pressure) and varicose veins)

changes in your blood cells (‘anaemia’)

a high level of alkaline phosphatase in your blood

fluid build up and swelling (‘“lymphoedema”’)

fluid in your lungs

stomach problems such as ‘“gastroenteritis”’ or ‘“gastritis”’

gallstones

being unable to pass water (urine), cystitis (bladder inflammation)

migraine

pain in your nerves, damaged nerve root

deafness

increased sensitivity of sound, taste or touch or changes in smell

difficulty swallowing

mouth ulcers, swollen lips (‘“cheilitis”’), oral thrush

itching or tingling skin around your mouth

pelvic pain, discharge, itching or pain in the vagina

a skin growth called a ‘“benign skin neoplasm”’

memory loss

sleep problems, feeling anxious, emotional instability, or mood swings

skin rash

hair loss

injury or pain at the injection site

weight loss

kidney cyst(fluid-filled sac in the kidney)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Ibandronic acid Accord

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 label after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

After dilution:

Chemical and physical in-use stability after dilution in 0.9 % sodium chloride or 5% glucose solution has been demonstrated for 36 hours at 25°C and 2 °C to 8 °C.

From a microbiological point of view, the solution for infusion should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2° C to 8°C unless dilution has taken place in controlled and validated aseptic condition.

Do not use this medicine if you notice that the solution is not clear or contains particles.

6.Contents of the pack and other information

What Ibandronic acid Accord contains

The active substance is ibandronic acid.

Ibandronic acid Accord 2 mg concentrate for solution for infusion

One vial with 2 ml of a concentrate for solution for infusion contains 2 mg ibandronic acid (as 2.25 mg ibandronate sodium monohydrate).

Ibandronic acid Accord 6 mg concentrate for solution for infusion

One vial with 6 ml of a concentrate for solution for infusion contains 6 mg ibandronic acid (as

6.75 mg ibandronate sodium monohydrate).

The other ingredients are sodium chloride, sodium acetate trihydrate, glacial acetic acid and water for injections.

What Ibandronic acid Accord looks like and contents of the pack

Ibandronic acid Accord is a colourless, clear solution.

It is supplied in:

Ibandronic acid Accord 2 mg concentrate for solution for infusion

6 ml, glass vial (type I) with fluorotec plus rubber stopper and aluminium seals with lavender flip-off cap.

Ibandronic acid Accord 6 mg concentrate for solution for infusion

6 ml, glass vial (type I) with fluorotec plus rubber stopper and aluminium seals with pink flip-off cap.

Pack size:

Ibandronic acid Accord 2 mg concentrate for solution for infusion

It is supplied as packs containing 1 vial.

Ibandronic acid Accord 6 mg concentrate for solution for infusion

It is supplied as packs containing 1, 5 and 10 vials. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Accord Healthcare Limited

Sage House

319, Pinner Road

North Harrow

Middlesex HA1 4HF

United Kingdom

Manufacturer

Accord Healthcare Limited

Sage House

319, Pinner Road

North Harrow

Middlesex HA1 4HF

United Kingdom

Other sources of information

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

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.

---------------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only:

Dosage: Prevention of Skeletal Events in Patients with Breast Cancer and Bone Metastases

The recommended dose for prevention of skeletal events in patients with breast cancer and bone metastases is 6 mg intravenously given every 3-4 weeks. The dose should be infused over at least 15 minutes.

Patients with renal impairment

For patients with mild renal impairment (CLcr ≥50 and <80 ml/min) no dosage adjustment is necessary. For patients with moderate renal impairment (CLcr ≥30 and <50 ml/min) or severe renal impairment (CLcr <30 ml/min) being treated for the prevention of skeletal events in patients with breast cancer and metastatic bone disease the following dosing recommendations should be followed:

Creatinine Clearance (ml/min)

Dosage

Infusion Volume 1 and Time2

≥50 CLcr <80

6 mg (6 ml of concentrate for

100 ml over 15 minutes

 

 

solution for infusion)

 

 

≥30 CLcr <50

4 mg (4 ml of concentrate for

500 ml over 1 hour

 

solution for infusion)

 

 

<30

2 mg (2 ml of concentrate for

500 ml over 1 hour

 

solution for infusion)

 

 

10.9% sodium chloride solution or 5% glucose solution

2Administration every 3 to 4 week

A 15 minute infusion time has not been studied in cancer patients with CLcr <50 ml/min.

Dosage: Treatment of Tumour-induced hypercalcaemia

Ibandronic acid Accord is usually administered in a hospital setting. The dose is determined by the doctor considering the following factors.

Prior to treatment with Ibandronic acid Accord the patient should be adequately rehydrated with

9 mg/ml (0.9 %) sodium chloride. Consideration should be given to the severity of the hypercalcaemia as well as the tumour type. In most patients with severe hypercalcaemia (albumin-corrected serum calcium* ≥3 mmol/l or ≥12 mg/dl) 4 mg will be an adequate single dosage. In patients with moderate hypercalcaemia (albumin-corrected serum calcium <3 mmol/l or <12 mg/dl) 2 mg is an effective dose. The highest dose used in clinical trials was 6 mg but this dose does not add any further benefit in terms of efficacy.

* Note albumin-corrected serum calcium concentrations are calculated as follows:

Albumin-corrected

=

serum calcium (mmol/l) - [0.02 x albumin (g/l)] + 0.8

serum calcium

 

 

(mmol/l)

 

 

 

Or

 

Albumin-corrected

=

serum calcium (mg/dl) + 0.8 x [4 - albumin (g/dl)]

serum calcium

 

 

(mg/dl)

 

 

To convert the albumin-corrected serum calcium in mmol/l value to mg/dl, multiply by 4.

In most cases a raised serum calcium level can be reduced to the normal range within 7 days. The median time to relapse (re-increase of serum albumin-corrected serum calcium above 3 mmol/l) was 18-19 days for the 2 mg and 4 mg doses. The median time to relapse was 26 days with a dose of 6 mg.

Method and route of administration

Ibandronic acid Accord concentrate for solution for infusion should be administered as an intravenous infusion.

For this purpose the contents of the vial are to be used as follows:

-Prevention of Skeletal Events in patients with breast cancer and bone metastases - added to 100 ml isotonic sodium chloride solution or 100 ml 5 % dextrose solution and infused over at least

15 minutes. See also dosage section above for patients with renal impairment

-Treatment of tumour-induced hypercalcaemia - added to 500 ml isotonic sodium chloride solution or 500 ml 5% dextrose solution and infused over 2 hours

Note:

In order to avoid potential incompatibilities, Ibandronic acid Accord concentrate for solution for infusion should only be mixed with isotonic sodium chloride solution or with 5% dextrose solution. Calcium containing solutions should not be mixed with Ibandronic acid Accord concentrate for solution for infusion.

Diluted solutions are for single use. Only clear solutions without particles should be used.

It is recommended that the product once diluted be used immediately (see point 5 of this leaflet ‘How to store Ibandronic Acid Accord’).

Ibandronic acid Accord concentrate for solution for infusion should be administered as an intravenous infusion.Care must be taken not to administer Ibandronic acid Accord concentrate for solution for infusion via intra-arterial or paravenous administration, as this could lead to tissue damage.

Frequency of administration

For treatment of tumour induced hypercalcaemia, Ibandronic acid Accord concentrate for solution for infusion is generally given as a single infusion.

For the prevention of skeletal events in patients with breast cancer and bone metastases, the Ibandronic acid Accord infusion is repeated at 3-4 week intervals.

Duration of treatment

A limited number of patients (50 patients) have received a second infusion for hypercalcaemia. Repeated treatment may be considered in case of recurrent hypercalcaemia or insufficient efficacy.

For patients with breast cancer and bone metastases, Ibandronic acid Accord infusion should be administered every 3-4 weeks. In clinical trials, therapy has continued for up to 96 weeks.

Overdose

Up to now there is no experience of acute poisoning with Ibandronic acid Accord concentrate for solution for infusion. Since both the kidney and the liver were found to be target organs for toxicity in preclinical studies with high doses, kidney and liver function should be monitored.

Clinically relevant hypocalcaemia (very low serum calcium levels) should be corrected by intravenous administration of calcium gluconate.

Package leaflet: Information for the user

Ibandronic acid Accord 3 mg solution for injection in pre-filled syringe ibandronic acid

Read all of this leaflet carefully before you start using 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, pharmacist or nurse.

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

What is in this leaflet

1.What Ibandronic acid Accord is and what it is used for

2.What you need to know before you receive Ibandronic acid Accord

3.How to use Ibandronic acid Accord

4.Possible side effects

5.How to store Ibandronic acid Accord

6.Contents of the pack and other information

1.What Ibandronic acid Accord is and what it is used for

Ibandronic acid Accord belongs to a group of medicines called bisphosphonates. It contains the active substance ibandronic acid.

Ibandronic acid Accord may reverse bone loss by stopping more loss of bone and increasing bone mass in most women who take it, even though they won’t be able to see or feel a difference. Ibandronic acid Accord may help lower the chances of breaking bones (fractures). This reduction in fractures was shown for the spine but not for the hip.

Ibandronic acid Accord is prescribed to you to treat postmenopausal osteoporosis because you have an increased risk of fractures. Osteoporosis is a thinning and weakening of the bones, which is common in women after the menopause. At the menopause, a woman’s ovaries stop producing the female hormone, oestrogen, which helps to keep her skeleton healthy. The earlier a woman reaches the menopause, the greater her risk of fractures in osteoporosis.

Other things that can increase the risk of fractures include:

not enough calcium and vitamin D in the diet

smoking cigarettes, or drinking too much alcohol

not enough walking or other weight-bearing exercise

a family history of osteoporosis

A healthy lifestyle will also help you to get the most benefit from your treatment. This includes:

eating a balanced diet rich in calcium and vitamin D

walking or other weight-bearing exercise

not smoking and not drinking too much alcohol

2. What you need to know before you receive Ibandronic acid Accord Do not use Ibandronic acid Accord

if you have, or had in the past, low blood calcium. Please consult your doctor

if you are allergic to ibandronic acid or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported very rarely in the post marketing setting in patients receiving ibandronic acid for osteoporosis. ONJ can also occur after stopping treatment.

It is important to try and prevent ONJ developing as it is a painful condition that can be difficult to treat. In order to reduce the risk of developing osteonecrosis of the jaw, there are some precautions you should take.

Before receiving treatment, tell your doctor/nurse (health care professional) if:

you have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction

you don’t receive routine dental care or have not had a dental check up for a long time

you are a smoker (as this may increase the risk of dental problems)

you have previously been treated with a bisphosphonate (used to treat or prevent bone disorders)

you are taking medicines called corticosteroids (such as prednisolone or dexamethasone)

you have cancer

Your doctor may ask you to undergo a dental examination before starting treatment with ibandronic acid.

While being treated, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups. If you wear dentures you should make sure these fit properly. If you are under dental treatment or will undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with ibandronic acid.

Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, or non-healing of sores or discharge, as these could be signs of osteonecrosis of the jaw.

Some patients need to be especially careful when using Ibandronic acid Accord. Talk to your doctor before receiving Ibandronic acid Accord:

If you have or have ever had kidney problems, kidney failure or have needed dialysis, or if you have any other disease that may affect your kidneys

If you have any disturbance of mineral metabolism (such as vitamin D deficiency)

You should take calcium and vitamin-D supplements while receiving Ibandronic acid Accord. If you are unable to do so, you should inform your doctor

If you have heart problems and the doctor recommended to limit your daily fluid intake.

Cases of serious, sometimes fatal allergic reaction have been reported in patients treated with intravenous ibandronic acid. If you experience one of the following symptoms, such as shortness of breath/difficulty breathing, tight feeling in throat, swelling of tongue, dizziness, feeling of loss of consciousness, redness or swelling of face, body rash, nausea and vomiting, you should immediately alert your doctor or nurse (see section 4).

Children and adolescents

Ibandronic acid Accord must not be used in children or adolescents below 18 years.

Other medicines and Ibandronic acid Accord

Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding

Ibandronic acid Accord is for use only by postmenopausal women and must not be taken by women who could still have a baby.

Do not take Ibandronic acid Accord if you are pregnant or breast-feeding.

Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

You can drive and use machines as it’s expected that Ibandronic acid Accord has no or negligible effect on your ability to drive and use machines.

Ibandronic acid Accord contains less than 1 mmol sodium (23 mg) per dose (3 ml), i.e. essentially “sodium-free”.

3.How to use Ibandronic acid Accord

The recommended dose of Ibandronic acid Accord for the intravenous injection is 3 mg (1 pre-filled syringe) once every 3 months.

The injection should be given into the vein by a physician or qualified/trained health care worker. Do not administer the injection to yourself.

The solution for injection must be administered into a vein only, and not anywhere else in the body.

Continuing to receive Ibandronic acid Accord

To get the most benefit from the treatment it is important to continue receiving the injections every 3 months for as long as your doctor prescribes it for you. Ibandronic acid Accord can treat osteoporosis only for as long as you keep receiving the treatment, even though you will not be able to see or feel a difference. After 5 years of receiving Ibandronic acid Accord, please consult with your doctor whether you should continue to receive Ibandronic acid Accord.

You should also take calcium and vitamin-D supplements, as recommended by your doctor.

If you use more Ibandronic acid Accord than you should

You may develop low levels of calcium, phosphorus or magnesium in the blood. Your doctor may take steps to correct such changes and may give you an injection containing these minerals.

If you forget to use Ibandronic acid Accord

You should arrange an appointment to get the next injection as soon as possible. After that, go back to getting the injections every 3 months from the date of the most recent injection.

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

4. Possible side effects

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

Talk to a nurse or a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:

Rare (may affect up to 1 in 1000 people):

itching, swelling of your face, lips, tongue and throat, with difficulty breathing.

persistent eye pain and inflammation (if prolonged)

new pain, weakness or discomfort in your thigh, hip or groin. You may have early signs of a possible unusual fracture of the thigh bone.

Very rare (may affect up to 1 in 10000 people):

• pain or sore in your mouth or jaw .You may have early signs of severe jaw problems ( necrosis (dead bone tissue) in the jaw bone).

Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection. These could be signs of bone damage in the ear.

serious, potentially life-threatening allergic reaction (see section 2).

severe adverse skin reactions

Other possible side effects

Common (may affect up to 1 in 10 people):

headache

stomach pain (such as gastritis) or tummy pain, , indigestion, nausea, having diarrhoea (loose bowels) or constipation

pain in your muscles, joints, or back

feeling tired and exhausted

flu-like symptoms, including fever, shaking and shivering, feeling of discomfort, bone pain and aching muscles and joints. Talk to a nurse or doctor if any effects become troublesome or last more than a couple of days

rash

Uncommon (may affect up to 1 in 100 people)

inflammation of a vein

pain or injury at the injection site

bone pain

feeling weak

asthma attacks

Rare (may affect up to 1 in 1000 people):

hives

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 Ibandronic acid Accord

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

This medicinal product does not require any special storage conditions.

Do not use Ibandronic acid Accord this medicine after the expiry date which is stated on the carton and on the syringe after “EXP”. The expiry date refers to the last day of that month.

The person giving the injection should throw away any unused solution and put the used syringe and injection needle into an appropriate disposal container.

6. Contents of the pack and other information

What Ibandronic acid Accord contains

The active substance is ibandronic acid. One pre-filled syringe contains 3 mg of ibandronic acid in 3 ml of solution (as sodium monohydrate).

The other ingredients are sodium chloride, acetic acid, sodium acetate trihydrate and water for injections.

What Ibandronic acid Accord looks like and contents of the pack

Ibandronic acid Accord 3 mg solution for injection in pre-filled syringes is a clear colourless solution. Each pre-filled syringe contains 3 ml of solution. Ibandronic acid Accord is available in packs of 1 pre-filled syringe and 1 injection needle or 4 pre-filled syringes and 4 injection needles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Accord Healthcare Limited

Sage House

319, Pinner Road. North Harrow

Middlesex HA1 4HF

United Kingdom

Manufacturer

Accord Healthcare Limited

Sage House

319, Pinner Road, North Harrow

Middlesex HA1 4HF

United Kingdom

This leaflet was last revised in {date}.

Other sources of information

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

This information is intended for healthcare professionals only:

INFORMATION FOR THE HEALTHCARE PROFESSIONALS Please see the summary of product characteristics for more information.

Administration of Ibandronic acid Accord 3 mg solution for injection in pre-filled syringe:

Ibandronic acid Accord 3 mg solution for injection in pre-filled syringe should be injected intravenously over a period of 15 - 30 seconds.

The solution is irritant, therefore strict adherence to the intravenous route of administration is important. If you inadvertently inject into the tissues around the vein, patients may experience local irritation, pain and inflammation at the injection site.

Ibandronic acid Accord 3 mg solution for injection in pre-filled syringe must not be mixed with calcium-containing solutions (such as Ringer-Lactate solution, calcium heparin) or other intravenously administered medicinal products. Where Ibandronic acid Accord is administered via an existing intravenous infusion line, the intravenous infusate should be restricted to either isotonic saline or 50 mg/ml (5 %) glucose solution.

Missed dose:

If a dose is missed, the injection should be administered as soon as convenient. Thereafter, injections should be scheduled every 3 months from the date of the last injection.

Overdose:

No specific information is available on the treatment of overdosage with Ibandronic acid Accord.

Based on knowledge of this class of compounds, intravenous overdosage may result in hypocalcaemia, hypophosphataemia, and hypomagnesaemia, which can cause paraesthesia. In severe cases intravenous infusion of appropriate doses of calcium gluconate, potassium or sodium phosphate, and magnesium sulfate, may be needed.

General advice:

Ibandronic acid Accord 3 mg solution for injection in pre-filled syringe like other bisphosphonates administered intravenously, may cause a transient decrease in serum calcium values.

Hypocalcaemia and other disturbances of bone and mineral metabolism should be assessed and effectively treated before starting Ibandronic acid Accord injection therapy. Adequate intake of calcium and vitamin D is important in all patients. All patients must receive supplemental calcium and vitamin D.

Patients with concomitant diseases, or who use medicinal products which have a potential for undesirable effects on the kidney, should be reviewed regularly in line with good medical practice during treatment.

Any unused solution for injection, syringe and injection needle should be disposed of in accordance with local requirements.

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