SPC, UK: Vistide
||Gilead Sciences Ltd
||Flowers Building, Granta Park, Abington, Cambridge, Cambridge, CB21 6GT, UK
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Name of the medicinal product
Vistide 75 mg/ml concentrate for solution for infusion.
Qualitative and quantitative composition
Each ml contains 75 mg cidofovir anhydrous. Each vial contains 375 mg/5 ml cidofovir anhydrous as the ...
Concentrate for solution for infusion. Clear solution. The formulation is adjusted to pH 7.4.
Vistide is indicated for the treatment of CMV retinitis in adults with acquired immunodeficiency syndrome ...
Posology and method of administration
The therapy should be prescribed by a physician experienced in the management of HIV infection. Before ...
Hypersensitivity to the active substance or to any of the excipients. Cidofovir administration is contraindicated ...
Special warnings and precautions for use
Vistide is formulated for intravenous infusion only and must not be administered by other methods including ...
Interaction with other medicinal products and other forms of interaction
There is a risk that concomitant treatment of Vistide with products containing tenofovir disoproxil fumarate ...
Fertility, pregnancy and lactation
Women of childbearing potential/Contraception in males and females Women of childbearing potential have ...
Effects on ability to drive and use machines
Cidofovir has negligible influence on the ability to drive and use machines. Adverse reactions such as ...
The table below lists the adverse reactions identified through clinical trials or post-marketing surveillance ...
Two cases of cidofovir overdose have been reported. In both cases, the overdose occurred during the first ...
Pharmacotherapeutic group: Antivirals for systemic use, nucleosides and nucleotides excluding reverse ...
The major route of elimination of cidofovir was by renal excretion of unchanged drug by a combination ...
Preclinical safety data
Preclinical animal studies demonstrated that nephrotoxicity was the major dose-limiting toxicity of cidofovir. ...
List of excipients
Sodium hydroxide Hydrochloric acid Water for injections
This medicinal product must not be mixed with other medicinal products or diluents except those mentioned ...
3 years. From a microbiological point of view, the product must be used immediately. Chemical and physical ...
Special precautions for storage
Do not store above 30°C. Do not refrigerate or freeze. For storage conditions of the diluted medicinal ...
Nature and contents of container
5 ml clear glass vials with a 5 ml nominal fill volume. The container/closure components include: Type ...
Special precautions for disposal and other handling
Method of preparation and administration Vistide vials should be visually inspected for particulate matter ...
Marketing authorization holder
Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom
Marketing authorization number(s)
Date of first authorization / renewal of the authorization
Date of first authorisation: 23 April 1997 Date of last renewal: 23 April 2007
Date of revision of the text
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί
πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.