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SALBUTAMOL Nebuliser solution (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Salbutamol 2mg/ml nebuliser solution.

Qualitative and quantitative composition

Each nebule contains 5mg/2.5ml salbutamol (as sulphate). For the full list of excipients, see section 6.1.

Pharmaceutical form

Nebuliser solution (for use via a nebuliser). Plastic ampoule containing 2.5 ml of a clear sterile solution containing 5mg salbutamol (as sulphate) in normal saline.

Therapeutic indications

Salbutamol nebuliser solutions are indicated in adults, adolescents and children aged 4 to 11 years. For babies and children under 4 years of age, see Section 4.2. Salbutamol is a selective β<sub>2</sub> ...

Posology and method of administration

Posology Adults (including the elderly) 2.5 mg to 5 mg salbutamol up to four times a day. Up to 40 mg per day can be given under strict medical supervision in hospital. Paediatric Population Children aged ...

Contraindications

Hypersensitivity to salbutamol or to 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.

Special warnings and precautions for use

Salbutamol nebuliser solution must only be used by inhalation, to be breathed in through the mouth, and must not be injected or swallowed. Potentially serious hypokalaemia has been reported in patients ...

Interaction with other medicinal products and other forms of interaction

Salbutamol and non-selective β-blocking medicinal products such as propranolol, should not usually be prescribed together.

Fertility, pregnancy and lactation

Pregnancy Administration of medicinal products 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 medicinal ...

Effects on ability to drive and use machines

None reported.

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 (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), ...

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 ...

Pharmacodynamic properties

Pharmacotherapeutic group: Andrenergics, inhalants. Selective beta-2-andrenoreceptor agonists ATC code: R03AC02 Salbutamol is a selective β<sub>2</sub>-agonist providing short-acting (4-6 hour) bronchodilation ...

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 ...

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, ...

List of excipients

Sodium chloride Sulphuric acid to adjust pH Water for injection

Incompatibilities

Not applicable.

Shelf life

Shelf life: 2 years unopened. 3 months after opening the foil over-wrap.

Special precautions for storage

Store in the original package. The ampoules should be protected from light after removal from the foil over-wrap.

Nature and contents of container

Plastic polyethylene ampoules in strips of 5 ampoules, with a protective foil over-wrap. Available in boxes containing 20 ampoules.

Special precautions for disposal and other handling

Nebulisers should be used in a well ventilated room as it is usual for some nebulised drug to be released into the local environment. Dilution: May be diluted with sterile sodium chloride solution, (normal ...

Marketing authorization holder

Cipla (EU) Limited, Dixcart House, Addlestone Road, Bourne Business Park, Addlestone, Surrey, KT15 2LE, United Kingdom

Marketing authorization number(s)

PL 36390/0036

Date of first authorization / renewal of the authorization

06/06/2011

Date of revision of the text

19/06/2018

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