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VENTAVIS Nebuliser solution (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Ventavis 10 microgram/ml nebuliser solution. Ventavis 20 microgram/ml nebuliser solution.

Qualitative and quantitative composition

Ventavis 10 microgram/ml nebuliser solution 1 ml solution contains 10 microgram iloprost (as iloprost trometamol). Each ampoule with 1 ml solution contains 10 microgram iloprost. Each ampoule with 2 ml ...

Pharmaceutical form

Nebuliser solution. Ventavis 10 microgram/ml nebuliser solution: Clear, colourless solution. Ventavis 20 microgram/ml nebuliser solution: Clear, colourless to slightly yellowish solution.

Therapeutic indications

Treatment of adult patients with primary pulmonary hypertension, classified as NYHA functional class III, to improve exercise capacity and symptoms.

Posology and method of administration

Drug product Suitable inhalation device (nebuliser) to be used Ventavis 10 microgram/ml Breelib I-Neb AAD Venta-Neb Ventavis 20 microgram/ml Breelib I-Neb AAD   Ventavis should only be initiated ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Conditions where the effects of Ventavis on platelets might increase the risk of haemorrhage (e.g. active peptic ...

Special warnings and precautions for use

The use of Ventavis is not recommended in patients with unstable pulmonary hypertension, with advanced right heart failure. In case of deterioration or worsening of right heart failure transfer to other ...

Interaction with other medicinal products and other forms of interaction

Iloprost may increase the effects of vasodilatators and antihypertensive agents and then favour the risk of hypotension (see section 4.4). Caution is recommended in case of co-administration of Ventavis ...

Fertility, pregnancy and lactation

Women of childbearing potential Women of childbearing potential should use effective contraceptive measures during treatment with Ventavis. Pregnancy Women with pulmonary hypertension (PH) should avoid ...

Effects on ability to drive and use machines

Ventavis has major influence on the ability to drive and use machines for patients experiencing hypotensive symptoms such as dizziness. Care should be exercised during initiation of therapy until any effects ...

Undesirable effects

Summary of the safety profile In addition to local effects resulting from administration of iloprost by inhalation such as cough, adverse reactions with iloprost are related to the pharmacological properties ...

Overdose

Symptoms Cases of overdose were reported. Symptoms of overdoses are mainly related to the vasodilatory effect of iloprost. Frequently observed symptoms following overdose are dizziness, headache, flushing, ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excluding heparin ATC code: B01AC11 Iloprost, the active substance of Ventavis, is a synthetic prostacyclin analogue. The ...

Pharmacokinetic properties

Absorption When iloprost at the concentration of 10 microgram/ml is administered via inhalation in patients with pulmonary hypertension or healthy volunteers (iloprost dose at the mouthpiece: 5 microgram: ...

Preclinical safety data

Systemic toxicity In acute toxicity studies, single intravenous and oral doses of iloprost caused severe symptoms of intoxication or death (intravenous) at doses about two orders of magnitude above the ...

List of excipients

Trometamol Ethanol 96% Sodium chloride Hydrochloric acid (for pH adjustment) Water for injections

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Shelf life

Ventavis 10 microgram/ml nebuliser solution: 4 years. Ventavis 20 microgram/ml nebuliser solution: 5 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

Ventavis 10 microgram/ml nebuliser solution 1 ml ampoules, colourless, glass type I, containing 1 ml nebuliser solution, ring coded with two coloured rings (white yellow). 3 ml ampoules, colourless, glass ...

Special precautions for disposal and other handling

For each inhalation session the content of one opened ampoule of Ventavis has to be transferred completely into the medication chamber immediately before use. After each inhalation session, any solution ...

Marketing authorization holder

Bayer AG, 51368, Leverkusen, Germany

Marketing authorization number(s)

Ventavis 10 microgram/ml nebuliser solution: EU/1/03/255/001 EU/1/03/255/002 EU/1/03/255/003 EU/1/03/255/004 EU/1/03/255/005 EU/1/03/255/006 EU/1/03/255/007 EU/1/03/255/008 EU/1/03/255/011 EU/1/03/255/013 ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 16 September 2003 Date of latest renewal: 26 August 2013

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