FOSCAVIR Solution for infusion (2019)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Foscavir 24 mg/ml Solution for Infusion.
Qualitative and quantitative composition
Foscarnet trisodium hexahydrate 24 mg/ml. For the full list of excipients, see section 6.1.
Pharmaceutical form
Solution for infusion. Clear and colourless solution.
Therapeutic indications
Foscavir is indicated for induction and maintenance therapy of cytomegalovirus (CMV) retinitis in patients with AIDS. Foscavir is also indicated for the treatment of mucocutaneous Herpes Simplex Virus ...
Posology and method of administration
Method of administration: Foscarnet should be administered by the intravenous route only, either by a central venous line or in a peripheral vein. When peripheral veins are used, the solution of foscarnet ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Foscavir should be used with caution in patients with reduced renal function. Since renal function impairment may occur at any time during Foscavir administration, serum creatinine should be monitored ...
Interaction with other medicinal products and other forms of interaction
Since Foscavir can impair renal function, additive toxicity may occur when used in combination with other nephrotoxic drugs such as aminoglycosides, amphotericin B, ciclosporin A, aciclovir, methotrexate ...
Fertility, pregnancy and lactation
Fertility There are no data available regarding the influence of Foscavir on fertility. No effects on fertility were observed in animal studies (see section 5.3). Women of childbearing potential/contraception ...
Effects on ability to drive and use machines
Foscavir has moderate influence on the ability to drive and use machines. Due to the disease itself and possible undesirable effects of Foscavir (such as dizziness and convulsions, see section 4.8), the ...
Undesirable effects
The majority of patients who receive Foscavir are severely immuno-compromised and suffering from serious viral infections. Patients' physical status, the severity of the underlying disease, other infections ...
Overdose
Overdose has been reported during the use of Foscavir, the highest being some 20 times the recommended dose. Some of the cases were relative overdoses, in that the dose of drug used had not been promptly ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antivirals for systemic use; direct acting antivirals; phosphonic acid derivatives ATC code: J05AD01 Foscarnet is an antiviral agent with a broad spectrum inhibiting all known ...
Pharmacokinetic properties
Foscarnet is eliminated by the kidneys mainly through glomerular filtration. The plasma clearance after intravenous administration to man varies between 130–160 ml/min and the renal clearance is about ...
Preclinical safety data
The most pronounced effects noted during general toxicity studies performed with foscarnet are perturbation of some serum electrolytes, and kidney and bone changes. An observed reduction of serum electrolytes ...
List of excipients
Water for injection Hydrochloric acid (E507)
Incompatibilities
This medicinal product must not be mixed with any other medicinal products except those mentioned in section 4.2. Foscarnet is not compatible with dextrose 30% solution, amphotericin B, aciclovir sodium, ...
Shelf life
Shelf life Unopened: 3 years. Once opened: From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the ...
Special precautions for storage
Do not store above 30°C. Do not refrigerate. If refrigerated or exposed to temperatures below freezing point precipitation may occur. By keeping the bottle at room temperature with repeated shaking, the ...
Nature and contents of container
Infusion glass bottles of 250 ml.
Special precautions for disposal and other handling
Individually dispensed doses of foscarnet can be aseptically transferred to plastic infusion bags by the hospital pharmacy. The physico-chemical stability of foscarnet and dilutions thereof in equal parts ...
Marketing authorization holder
Clinigen Healthcare Ltd., Pitcairn House, First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW, UK
Marketing authorization number(s)
PL 31644/0001
Date of first authorization / renewal of the authorization
10/06/2010
Date of revision of the text
20/02/2019
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
