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SPC: REVATIO Solution for injection (2018)

Αναφορές

Βιβλιογραφική αναφορά

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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

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

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