REVATIO Solution for injection (2018)
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
Revatio 0.8mg/ml solution for injection.
Qualitative and quantitative composition
Each ml of solution contains 0.8mg of sildenafil (as citrate). Each 20ml vial contains 12.5ml of solution (10mg of sildenafil, as citrate). For the full list of excipients, see section 6.1.
Pharmaceutical form
Solution for injection. Clear, colourless solution.
Therapeutic indications
Revatio solution for injection is for the treatment of adult patients (≥18 years) with pulmonary arterial hypertension who are currently prescribed oral Revatio and who are temporarily unable to take oral ...
Posology and method of administration
Treatment should only be initiated and monitored by a physician experienced in the treatment of pulmonary arterial hypertension. In case of clinical deterioration in spite of Revatio treatment, alternative ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Co-administration with nitric oxide donors (such as amyl nitrite) or nitrates in any form due to the hypotensive ...
Special warnings and precautions for use
No clinical data is available for sildenafil IV administration in patients who are clinically or haemodynamically unstable. Its use is accordingly not recommended in these patients. The efficacy of Revatio ...
Interaction with other medicinal products and other forms of interaction
Unless otherwise specified, drug interaction studies have been performed in healthy adult male subjects using oral sildenafil. These results are relevant to other populations and routes of administration. ...
Fertility, pregnancy and lactation
Women of childbearing potential and contraception in males and females Due to lack of data on effects of Revatio in pregnant women, Revatio is not recommended for women of childbearing potential unless ...
Effects on ability to drive and use machines
Revatio has moderate influence on the ability to drive and use machines. As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be aware of how they might be ...
Undesirable effects
Adverse reactions that resulted from intravenous Revatio use are similar to those associated with oral Revatio use. Since there are limited data for intravenous Revatio use and since pharmacokinetic models ...
Overdose
In single dose volunteer studies of oral doses up to 800mg, adverse reactions were similar to those seen at lower doses, but the incidence rates and severities were increased. At single oral doses of 200mg ...
Pharmacodynamic properties
Pharmacotherapeutic group: Urologicals, Drugs used in erectile dysfunction ATC code: G04BE03 Mechanism of action Sildenafil is a potent and selective inhibitor of cyclic guanosine monophosphate (cGMP) ...
Pharmacokinetic properties
Absorption The mean absolute oral bioavailability for sildenafil is 41% (range 25-63%). In study A1481262 C<sub>max</sub>, CL and AUC<sub>(0-8)</sub> of 248 ng/ml, 30.3 l/h and 330 ng h/ml, were observed ...
Preclinical safety data
Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential, toxicity to reproduction and ...
List of excipients
Glucose Water for injections
Incompatibilities
This medicinal product must not be mixed with other medicinal products or intravenous diluents except those mentioned in section 6.6.
Shelf life
3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Each pack contains one 20ml clear, type I glass vial with a chlorobutyl rubber stopper and an aluminium overseal.
Special precautions for disposal and other handling
This medicinal product does not require dilution or reconstitution before use. One 20ml vial contains 10 mg of sildenafil (as citrate). The recommended dose of 10mg requires a volume of 12.5ml, to be administered ...
Marketing authorization holder
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Marketing authorization number(s)
EU/1/05/318/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 28 October 2005 Date of latest renewal: 23 September 2010
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
