VISTIDE Concentrate for solution for infusion (2017)
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Περιεχόμενα
Name of the medicinal product
Cidofovir Tillomed 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 active substance. Excipients with known effect: Each vial contains approximately 2.5 mmol (or 57 mg) ...
Pharmaceutical form
Concentrate for solution for infusion. Clear and colourless solution. The concentrate for solution is adjusted to pH 7.4.
Therapeutic indications
Cidofovir is indicated for the treatment of CMV retinitis in adults with acquired immunodeficiency syndrome (AIDS) and without renal dysfunction. It should be used only when other medicinal products are ...
Posology and method of administration
The therapy should be prescribed by a physician experienced in the management of HIV infection. Before each administration of cidofovir, serum creatinine and urine protein levels should be investigated. ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Cidofovir administration is contraindicated in patients unable to receive probenecid or other sulfa containing ...
Special warnings and precautions for use
Cidofovir 75 mg/ml Concentrate for Solution for Infusion is formulated for intravenous infusion only and must not be administered by other methods including intraocular injection or topically. It should ...
Interaction with other medicinal products and other forms of interaction
There is a risk that concomitant treatment of cidofovir with products containing tenofovir disoproxil fumarate may give rise to a pharmacodynamic interaction and increase the risk of Fanconi syndrome (see ...
Fertility, pregnancy and lactation
Women of childbearing potential/Contraception in males and females Women of childbearing potential have to use effective contraception during and after treatment with cidofovir. Men should be advised to ...
Effects on ability to drive and use machines
Cidofovir has negligible influence on the ability to drive and use machines. Adverse reactions such as asthenia may occur during cidofovir therapy. The physician is advised to discuss this issue with the ...
Undesirable effects
The table below lists the adverse reactions identified through clinical trials or post-marketing surveillance by system organ class (SOC) and frequency. Within each frequency grouping, adverse reactions ...
Overdose
Two cases of cidofovir overdose have been reported. In both cases, the overdose occurred during the first induction dose and no additional cidofovir therapy was administered. One patient received a single ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antivirals for systemic use, nucleosides and nucleotides excluding reverse transcriptase inhibitors ATC code: J05AB12 General Cidofovir is a cytidine analogue with in vitro and ...
Pharmacokinetic properties
The major route of elimination of cidofovir was by renal excretion of unchanged drug by a combination of glomerular filtration and tubular secretion. In patients with normal renal function, 80 to 100% ...
Preclinical safety data
Preclinical animal studies demonstrated that nephrotoxicity was the major dose-limiting toxicity of cidofovir. Evidence for a nephroprotective effect for probenecid was shown in a 52-week study conducted ...
List of excipients
Sodium hydroxide (for pH – adjustment) Hydrochloric acid (for pH – adjustment) Water for injections
Incompatibilities
This medicinal product must not be mixed with other medicinal products or diluents except those mentioned in section 6.6.
Shelf life
Shelf life: 2 years. From a microbiological point of view, the product must be used immediately. Chemical and physical in-use stability has been demonstrated for up to 24 hours at 2-8°C when dilution is ...
Special precautions for storage
Do not store above 25°C. Do not refrigerate or freeze. For storage conditions of the diluted medicinal product, see section 6.3.
Nature and contents of container
5 ml clear glass vials with a 5 ml nominal fill volume. The container/closure components include: Type I clear highly resistant borosilicate glass vials, Dark grey bromobutyl rubber stoppers, and aluminium ...
Special precautions for disposal and other handling
Method of preparation and administration Cidofovir 75 mg/ml Concentrate for Solution for Infusion vials should be visually inspected for particulate matter and discolouration prior to administration. ...
Marketing authorization holder
Tillomed Laboratories Limited, 220 Butterfield, Great Marlings, Luton, LU2 8DL, United Kingdom
Marketing authorization number(s)
PL 11311/0587
Date of first authorization / renewal of the authorization
10/06/2016
Date of revision of the text
11/10/2017
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