Λογότυπο www.galinos.gr Beta
 

Ιατροφαρμακευτική πληροφόρηση για τον επαγγελματία υγείας

Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
Κλαύδιος Γαληνός
Είσοδος χρηστών
Όνομα χρήστη
Συνθηματικό
Εικονίδιο Είσοδος χρήστη
Εικονίδιο Δωρεάν εγγραφή
Εικονίδιο Ανανέωση συνθηματικού

Ακολουθήστε μας Λογότυπο Facebook Λογότυπο Twitter

Αναζήτηση σε 63811 καταχωρήσεις
Εικονίδιο αναζήτησης

Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Vistide (2011)

Εκδότης

Εκδότης Gilead Sciences Ltd
Διεύθυνση Flowers Building, Granta Park, Abington, Cambridge, Cambridge, CB21 6GT, UK
Σφάλμα Για την προβολή της πλήρους καταχώρησης χρειάζεται να έχετε συνδρομή σε ισχύ (αγορά συνδρομής).
Ολοκληρώνοντας τη διαδικασία δωρεάν εγγραφής θα αποκτήσετε, χωρίς καμία δέσμευση εκ μέρους σας, συνδρομή διάρκειας 30 ημερών.

Περιεχόμενα

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 ...

Pharmaceutical form

Concentrate for solution for infusion. Clear solution. The formulation is adjusted to pH 7.4.

Therapeutic indications

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 ...

Contraindications

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 ...

Undesirable effects

The table below lists the adverse reactions identified through clinical trials or post-marketing surveillance ...

Overdose

Two cases of cidofovir overdose have been reported. In both cases, the overdose occurred during the first ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antivirals for systemic use, nucleosides and nucleotides excluding reverse ...

Pharmacokinetic properties

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

Incompatibilities

This medicinal product must not be mixed with other medicinal products or diluents except those mentioned ...

Shelf life

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)

EU/1/97/037/001

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

01/2011
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.