VENTOLIN Solution for inhalation via a nebuliser (2019)
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Περιεχόμενα
1. Name of the medicinal product
Ventolin Nebules 2.5mg.
2. Qualitative and quantitative composition
Plastic ampoule containing 2.5 ml of a sterile 0.1% w/v solution of salbutamol (as Salbutamol Sulfate BP) in normal saline.
3. Pharmaceutical form
Solution for inhalation via a nebuliser.
4.1. Therapeutic indications
Salbutamol is a selective β2-agonist providing short-acting (4-6 hour) bronchodilation with a fast onset (within 5 minutes) in reversible airways obstruction. Ventolin Nebules are indicated for use in ...
4.2. Posology and method of administration
Ventolin Nebules are for inhalation use only, to be breathed in through the mouth, under the direction of a physician, using a suitable nebuliser. The solution should not be injected or swallowed. Adults ...
4.3. Contraindications
Hypersensitivity to the active substance or any of the excipients listed in section 6.1. Non-IV formulations of salbutamol must not be used to arrest uncomplicated premature labour or threatened abortion. ...
4.4. Special warnings and precautions for use
Ventolin Nebules must only be used by inhalation, to be breathed in through the mouth, and must not be injected or swallowed. Bronchodilators should not be the only or main treatment in patients with severe ...
4.5. Interaction with other medicinal products and other forms of interaction
Salbutamol and non-selective β-blocking drugs such as propranolol, should not usually be prescribed together.
4.6. Fertility, pregnancy and lactation
Pregnancy Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus. As with the majority of drugs, there is ...
4.7. Effects on ability to drive and use machines
None reported.
4.8. Undesirable effects
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000) ...
4.9. Overdose
The most common signs and symptoms of overdose with salbutamol are transient beta agonist pharmacologically mediated events, including tachycardia, tremor, hyperactivity and metabolic effects including ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Andrenergics, inhalants. Selective beta-2-andrenoreceptor agonists <b>ATC code:</b> R03AC02 Salbutamol is a selective β2-agonist providing short-acting (4-6 hour) bronchodilation ...
5.2. Pharmacokinetic properties
Salbutamol administered intravenously has a half-life of 4 to 6 hours and is cleared partly renally, and partly by metabolism to the inactive 4'-O-sulfate (phenolic sulfate) which is also excreted primarily ...
5.3. Preclinical safety data
In an oral fertility and general reproductive performance study in rats at doses of 2 and 50 mg/kg/day, with the exception of a reduction in number of weanlings surviving to day 21 post partum at 50 mg/kg/day, ...
6.1. List of excipients
Sodium chloride Sulfuric acid if required to adjust pH Purified water
6.2. Incompatibilities
None known.
6.3. Shelf life
3 years if unopened. 3 months after removal from the foil overwrap, (see below).
6.4. Special precautions for storage
Ventolin Nebules should be stored below 30°C. The Nebules should be protected from light after removal from the foil tray.
6.5. Nature and contents of container
Low density polyethylene ampoules available in boxes of 20 in strips of 5.
6.6. Special precautions for disposal and other handling
The nebulised solution may be inhaled through a face mask, T-piece or via an endotracheal tube. Intermittent positive pressure ventilation (IPPV) may be used but is rarely necessary. When there is a risk ...
7. Marketing authorization holder
GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
8. Marketing authorization number(s)
17101
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 27 January 1998 Date of latest renewal: 12 March 2010
10. Date of revision of the text
02/04/2019
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