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Vistide (cidofovir) – Package leaflet - J05AB12

Updated on site: 10-Oct-2017

Medication nameVistide
ATC CodeJ05AB12
Substancecidofovir
ManufacturerGilead Sciences International Limited
What is CMV retinitis?

 

PACKAGE LEAFLET: INFORMATION FOR THE USER

 

Vistide 75 mg/ml concentrate for solution for infusion

 

Cidofovir

 

Read all of this leaflet carefully before you start using this medicine.

 

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

 

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

 

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This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even

 

if their symptoms are the same as yours.

 

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If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,

 

please tell your doctor or pharmacist.

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In this leaflet:

1.

What Vistide is and what it is used for

2.

Before you use Vistide

3.

How to use Vistide

4.

Possible side effects

5.

How to store Vistide

6.

Further information

1.

What Vistide is and what it is used for

Vistide is used to treat an eye infection called CMV retilongeritis in patients with AIDS (Acquired

Immunodeficiency Syndrome). Vistide will not cure CMV reti itis but may improve your condition by delaying progression of the disease.

 

 

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The safety and efficacy of Vistide has not been dem nstrated in diseases other than CMV retinitis in

patients with AIDS.

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Vistide must be administered by a health are professional (doctor or nurse) in a hospital setting.

CMV retinitis is an eye infecti n caused by a virus named cytomegalovirus (CMV). CMV attacks the

retina of the eye and may cause loss of vision, and eventually lead to blindness. Patients with AIDS Medicinalare at high risk of deve oping CMV retinitis or other forms of CMV disease such as colitis (an

inflammatory bowel dise se). Treatment for CMV retinitis is necessary to reduce the potential for blindness.

Vistide is an antiviral medicine which blocks the replication of CMV by interfering with viral DNA production.

2. Before you use Vistide Do not use Vistide

If you are allergic (hypersensitive) to cidofovir or any of the other ingredients of Vistide.

If you have ever had kidney disease.

If you cannot take the medicine probenecid because of a serious allergy to probenecid or other sulfa-containing medicines (e.g. sulfamethoxazole).

If any of these apply to you, talk to your doctor. You are not to be given Vistide.

Take special care with Vistide

Kidney damage is the major side effect of Vistide treatment. To reduce the risk of kidney damage, you will receive intravenous fluids (normal saline) before each dose of Vistide and probenecid tablets before and after each dose of Vistide (see section 3 below for more information). Your doctor may also instruct you to drink plenty of fluids. Your doctor will monitor your kidney function before each dose of Vistide. Your treatment with Vistide may be stopped by your doctor if changes in kidney function occur.

Tell your doctor if you have diabetes mellitus. Vistide should be used with caution in

 

diabetic patients due to the potential increased risk of developing low pressure in the eye

 

(ocular hypotony).

 

 

 

During treatment with Vistide you should receive regular follow-up eye examinations for

 

possible eye irritation, inflammation or swelling. If you get pain, redness or itch ng of the eye

 

or changes in your vision, tell your doctor promptly.

 

Vistide caused reduced testes weight and low sperm count (hypospermia) in animals. Although

 

not observed in human studies of Vistide, such changes may occur in h mans and cause

 

infertility. Men should practice barrier birth control methods d ring and for 3 months

 

after treatment with Vistide.

 

 

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Vistide is not used for the treatment of HIV infection. Vistide will not stop you passing HIV

 

infection onto other people so you should continue to take precautions to avoid infecting

 

others.

 

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Use in children

 

 

 

 

 

 

Vistide has not been studied in children. Theref re, this medicine should not be used in children.

Using other medicines

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Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, as these may interact with Vistide or probenecid.

your kidneys.

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It is very important to te

your doctor if you are receiving other medicines that may damage

These include:

 

tenofov r ontaining medicines, used to treat HIV-1 infection and/or chronic hepatitis B infect on

aminoglycosides, pentamidine or vancomycin (for bacterial infections)

amphotericin B (for fungal infection)

foscarnet (for viral infection)

adefovir (for HBV infection)Medicinal

These medicines must be stopped at least 7 days before taking Vistide.

Probenecid may interact with other medicines commonly used in the treatment of AIDS and AIDS-related illnesses, such as zidovudine (AZT). If you are taking zidovudine, you should discuss with your doctor whether to temporarily stop taking zidovudine or decrease the dose of zidovudine by 50% on days when Vistide and probenecid are given.

The potential for interactions between Vistide and anti-HIV protease inhibitors has not been

studied.

Using Vistide with food and drink

Food should be taken before you are given Vistide. Your doctor may instruct you to drink plenty of fluids before receiving Vistide.

Pregnancy and breast-feeding

You should not be given Vistide if you are pregnant. If you become pregnant while

 

receiving this medication, you must inform your doctor immediately. Vistide has been shown

 

to cause damage in unborn animals and should not be used during pregnancy unless the

 

potential benefits justify the risks to the foetus. If you could get pregnant, you must use an

 

effective method of contraception to stop you getting pregnant during treatment with Visti e

 

and for 1 month afterwards.

 

 

You should not be given Vistide if you are breast-feeding. It is not known whether Vistide is

 

passed on to the baby in human milk. Because many medicines are passed thr ugh to human

 

milk, nursing mothers should stop Vistide or stop breast-feeding if they con inue to receive

 

Vistide.

 

 

In general, women with HIV should not breast-feed in order to void passing HIV to their

 

infant through the milk.

 

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Driving and using machines

 

 

Vistide may cause short-term side effects such as fatigue r weak ess. If you drive or operate

 

 

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machinery, discuss this with your doctor to get their advice about stopping these activities based

upon your disease and your tolerance of the medicine.

 

 

Important information about some of the i gredients of Vistide

 

 

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This medicine contains 2.5productmmol (or 57 mg) sodium per vial which should be taken into consideration if you are on a controlled sodium diet.

3.How to use Vistide

MedicinalVistide is given by intr venous infusion (a drip into a vein). It must not be administered by other methods including intr ocular injection (direct injection into the eye) or topically (on the skin).

Vistide must be g ven by a doctor or nurse with appropriate experience in treating people with AIDS.

The doctor or nurse will transfer the appropriate dose of Vistide from the vial to an infusion bag containing 100 ml 0.9% (normal) saline solution. The entire volume of the bag will be infused into your v in at a constant rate over a period of 1 hour using a standard infusion pump. The recommended dose, frequency of use, or rate of infusion must not be exceeded. At the end of this leaflet, there is further information for healthcare professionals on how to administer Vistide.

To lower the risk of kidney damage, probenecid tablets and intravenous fluids (saline solution) must be given on the day of each Vistide infusion. (See sub-sections “How to take probenecid with Vistide” and “How IV fluids are given before Vistide” below.)

Dose in adults

The dose you will need is calculated based on your body weight.

Starting (induction) treatment

The recommended dose of Vistide in patients with normal kidney function is 5 mg per kg of body weight given once weekly for two consecutive weeks.

Maintenance treatment

Beginning two weeks after completion of induction treatment, the recommended maintenance dose of Vistide in patients with normal kidney function is 5 mg per kg of body weight given once every two

weeks.

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Dose adjustment

If you have kidney problems, Vistide may not be appropriate treatment for you. Samples of your urine and/or blood will be taken before each infusion of Vistide and used for testing kidney function. For patients with evidence of decreased kidney function, your Vistide dose may be interrupted or stopped depending on your individual case.

If you have accidentally been given more Vistide than prescribed for you, tell yo r doctor immediately.

How to take probenecid with Vistide

Probenecid tablets are given to lower the risk of kidney dama e. You must take 3 doses of

probenecid tablets orally on the same day as Vistide as sh

wn in the following table:

 

 

 

 

 

Time

 

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Dose

3 hours before start of Vistide infusion

 

 

2 g probenecid

2 hours after end of Vistide infusion

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1 g probenecid

8 hours after end of Vistide infusion

 

 

1 g probenecid

Total

 

 

4 g probenecid

Probenecid is only taken on the same

ay that Vistide is given.

 

How IV fluids are given befo e Vistide

 

 

 

Normal saline is given to productower the risk of kidney damage. You should receive a total of one litre

of 0.9% (normal) s line solution intravenously (as a drip into a vein) before each Vistide dose. The

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saline solution should be infused over a 1 hour period immediately before the Vistide infusion. If you can tolerate the add tional fluid load, your doctor may administer a second litre of fluid. If administered, the second litre of saline should be given either at the start of the Vistide infusion or imme iately afterwards, and infused over a 1 to 3 hour period. Your doctor may also tell you to drink plenty of fluids.

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

4. Possible side effects

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

These side effects usually disappear when treatment with Vistide is stopped. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist immediately.

The most common side effect observed with Vistide is damage to the kidneys.

Very common side effects

(These can affect more than 1 user in 10)

low white blood cell counts, headache, nausea, vomiting, protein in the urine, increase in blood creatinine (a measure of kidney function), hair loss, rash, weakness/fatigue and fever.

Common side effects

(These can affect 1 to 10 users in 100)

inflammation of the eye, reduced pressure in the eyes, difficult or laboured breathing, shortness of breath, diarrhoea and chills.

(These can affect more than 1 user in 10)

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Any pain, redness or itching of the eye or changes in your vision should be promptly r port to your doctor so that your treatment can be reviewed.

Additional reactions reported from post-marketing experience include kidney failure, damage to kidney tubule cells, inflammation of the pancreas and hearing impairment.

Possible side effects of taking probenecid

Very common side effects possibly related to probenecid

nausea, vomiting, rash and fever.

Common side effects possibly related to probenecid

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(These can affect 1 to 10 users in 100)

 

headache, weakness/fatigue, chills and allergic reacti ns.

To reduce the risk of nausea and/or vomiting assnociated with taking probenecid, you should eat food before each dose. Yourproductdoctor might ins ruct you to take other medicines such as anti-emetics (anti sickness medicines), antihistamines and/or paracetamol to decrease the side effects of probenecid.

Probenecid may also cause other si e effects including loss of appetite, sore gums, flushing, hair loss,

dizziness, reduced red blood cell count and increased frequency of passing water (urinating). Allergic

reactions, with skin inflammati n, itching, hives and, rarely, severe allergic reactions, and serious skin

reaction have occurred. The e have been reports of reduced white blood counts, liver toxicity, kidney

toxicity and destruction of red blood cells. Reductions in blood cell and platelet counts have also occurred.Medicinal

Therefore before g vi g you probenecid your doctor should consult the current prescribing information regarding the safety of probenecid. You should also read the probenecid package leaflet.

5. How to store Vistide

Keep out of the reach and sight of children.

Do not use Vistide after the expiry date which is stated on the label.

Do not store above 30°C. Do not refrigerate or freeze.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Further information What Vistide contains

The active substance of Vistide 75 mg/ml is cidofovir. Each ml contains 75 mg cidofovir anhydrous. Each vial contains 375 mg/5 ml cidofovir anhydrous.
The other ingredients are
• Sodium hydroxide
• Hydrochloric acid
• Water for injections

What Vistide looks like and contents of the pack

Vistide is supplied as a sterile concentrate for solution for infusion in clear, glass vials conta ning 375 mg of the active ingredient, anhydrous cidofovir, formulated in 5 ml water for injecti ns at a concentration of 75 mg/ml. The formulation is pH-adjusted with sodium hydroxide (and hydrochloric acid if needed) and contains no preservatives.

Marketing Authorisation Holder

 

 

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Gilead Sciences International Limited

 

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Cambridge

 

CB21 6GT

 

 

 

United Kingdom

 

 

Manufacturer

 

 

Gilead Sciences Limited

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IDA Business & Technology Park

 

Carrigtohill Co. Cork

 

 

 

Ireland

 

 

 

 

 

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

België/Belgique/Belgien

 

Luxembourg/Luxemburg

Gilead Sciences Belgium BVBA

Gilead Sciences Belgium BVBA

Tél/Tel: + 32 (0) 24 01 35 79

Tél/Tel: + 32 (0) 24 01 35 79

България

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Magyarország

 

Gilead Sciences I ter ational Ltd

Gilead Sciences International Ltd

Тел.: + 44 (0) 20 7136 8820

Tel: + 44 (0) 20 7136 8820

Česká republika

 

Malta

Gil ad Sci nces International Ltd

Gilead Sciences International Ltd

Tel: + 44 (0) 20 7136 8820

Tel: + 44 (0) 20 7136 8820

Danmark

 

Nederland

Medicinal

 

Gilead Sciences Netherlands B.V.

Gilead Sciences Sweden AB

Tlf: + 46 (0) 8 5057 1849

 

Tel: + 31 (0) 20 718 3698

Deutschland

 

Norge

Gilead Sciences GmbH

 

Gilead Sciences Sweden AB

 

Tlf: + 46 (0) 8 5057 1849

Eesti

 

Österreich

 

Gilead Sciences Sweden AB

Gilead Sciences GesmbH

Tel: + 46 (0) 8 5057 1849

 

Tel: + 43 1 260 830

 

Ελλάδα

 

Polska

 

Gilead Sciences Ελλάς Μ.ΕΠΕ.

Gilead Sciences Poland Sp. z o. o.

Τηλ: + 30 210 8930 100

 

Tel: + 48 22 262 8702

España

 

Portugal

 

Gilead Sciences, S.L.

 

Gilead Sciences, Lda.

Tel: + 34 91 378 98 30

 

Tel: + 351 21 7928790

France

 

România

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Gilead Sciences

 

Gilead Sciences International Ltd

Tél: + 33 (0) 1 46 09 41 00

Tel: + 44 (0) 20 7136 8820

Ireland

 

Slovenija

 

Gilead Sciences Ltd

 

Gilead Sciences International Ltd

Tel: + 44 (0) 1223 897555

 

Tel: + 44 (0) 20 7136 8820

Ísland

 

Slovenská republika

Gilead Sciences Sweden AB

 

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Gilead Sciences Inte national Ltd

Sími: + 46 (0) 8 5057 1849

Tel: + 44 (0) 20 7136 8820

Italia

 

Suomi/Fi land

 

Gilead Sciences S.r.l.

 

Gilead Scie ces Sweden AB

Tel: + 39 02 439201

 

Puh/Tel: + 46 (0) 8 5057 1849

Κύπρος

 

no

 

 

 

Sverige

 

Gilead Sciences Ελλάς Μ.ΕΠΕ.

Gilead Sciences Sweden AB

Τηλ: + 30 210 8930 100

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Tel: + 46 (0) 8 5057 1849

 

Latvija

 

United Kingdom

 

Gilead Sciences Sweden AB

Gilead Sciences Ltd

 

Tel: + 46 (0) 8 5057 1849

 

Tel: + 44 (0) 1223 897555

Lietuva

 

 

 

 

Medicinal

 

 

 

 

Gilead Sciences Sweden AB

 

 

 

Tel: + 46 (0) 8 5057 1849

This leaflet was last approved in

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

The following information is intended for medical or healthcare professionals only:

Vistide vials should be inspected visually prior to use. If visible particles or discolouration are observed, the vial should not be used.

Adequate precautions including the use of appropriate safety equipment are recommended for the preparation, administration and disposal of Vistide. The preparation of Vistide diluted solution should be done in a laminar flow biological safety cabinet. Personnel preparing the solution should wear

surgical gloves, safety glasses and a closed front surgical-type gown with knit cuffs. If Vistide contacts the skin, wash membranes and flush thoroughly with water.

The appropriate dose of Vistide should be transferred from the vial to an infusion bag containing 100 ml 0.9% (normal) saline solution. The entire volume of the bag should be infused into the patient’s vein at a constant rate over a period of 1 hour using a standard infusion pump. The recommended dose, frequency of use, or rate of infusion must not be exceeded.

The chemical stability of Vistide mixed in saline solution has been demonstrated in glass bottles, in infusion bags composed of either polyvinyl chloride (PVC) composition or ethylene/propylene copolymer, and in PVC based vented IV administration sets. Other types of IV set tubing and infusion bags have not been studied.

Compatibility of Vistide with Ringer’s Solution, Lactated Ringer’s Solution or bacteriostatic infusion

fluids has not been evaluated.

 

From a microbiological point of view, the product must be used immediately.

 

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Chemical and physical in-use stability has been demonstrated for up to 24 ours at 2 - 8ºC when dilution is performed under controlled and validated aseptic conditions. Storage beyond 24 hours or freezing is not recommended. Refrigerated infusion bags should be llowed to warm to room

temperature prior to use.

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Vistide is supplied in single-use vials. Partially used vials must be discarded.

 

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