VENTOLIN Syrup (2020)

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Περιεχόμενα

1. Name of the medicinal product

Ventolin Syrup.

2. Qualitative and quantitative composition

Each 5 ml contains 2 mg Salbutamol (as Salbutamol Sulfate BP). Excipient with known effect: Sodium. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Syrup. A clear, colourless to pale yellow viscous liquid with an odour of orange.

4.1. Therapeutic indications

Ventolin Syrup is indicated in adults, adolescents and children aged 2 to 12 years. Salbutamol is a selective beta-2 adrenoceptor agonist providing short-acting (4-6 hour) bronchodilation in reversible ...

4.2. Posology and method of administration

Route of administration: oral. Adults The minimum starting dose is 2 mg three times a day given as 5 ml syrup. The usual effective dose is 4 mg (10 ml syrup) three or four times a day, which may be increased ...

4.3. Contraindications

Hypersensitivity to the active substance or any of the excipients listed in section 6.1. Non-i.v. formulations of salbutamol must not be used to arrest uncomplicated premature labour or threatened abortion. ...

4.4. Special warnings and precautions for use

Bronchodilators should not be the only or main treatment in patients with severe or unstable asthma. Severe asthma requires regular medical assessment including lung function testing as patients are at ...

4.5. Interaction with other medicinal products and other forms of interaction

Ventolin syrup and non-selective beta-blocking drugs, such as propranolol, should not usually be prescribed together.

4.6. 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 foetus. As with the majority of drugs, there ...

4.7. Effects on ability to drive and use machines

None known.

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 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <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

Pharmacotherapeutic group: Selective beta-2-adrenoreceptor agonists ATC Code: R03CC02 Salbutamol is a selective beta-2 adrenoceptor agonist. At therapeutic doses it acts on the beta-2 adrenoceptors ...

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 common with other potent selective β2-agonists, salbutamol has been shown to be teratogenic in mice when given subcutaneously. In a reproductive study, 9.3% of fetuses were found to have cleft palate ...

6.1. List of excipients

Sodium citrate Citric acid monohydrate Hydroxypropyl methylcellulose Sodium benzoate Saccharin sodium Sodium chloride Orange flavour IFF 17.42.8187 Purified water

6.2. Incompatibilities

None known. Ventolin syrup is sugar free. Dilution of Ventolin syrup with syrup BP or sorbitol solution is not recommended as this may result in the precipitation of the cellulose thickening agent. If ...

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Store at a temperature not exceeding 30°C. Protect from light. Ventolin syrup may be diluted with freshly Purified Water BP. The diluted mixture must be protected from light and stored below 25°C. Discard ...

6.5. Nature and contents of container

Type III amber glass bottle with plastic, child resistant, pilfer-proof caps with low density polyethylene polyvinylidene chloride low density polyethylene (LDPE-PVDC-LDPE) faced liners. Pack size: ...

6.6. Special precautions for disposal and other handling

Ventolin syrup may be diluted with Purified Water BP (50% v/v). The resulting mixture should be protected from light and used within 28 days. A 50% v/v dilution of Ventolin syrup has been shown to be adequately ...

7. Marketing authorization holder

GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

8. Marketing authorization number(s)

19628

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 29 April 2004 Date of latest renewal: 17 July 2009

10. Date of revision of the text

5/10/2020

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