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SPC, UK: BRICANYL Solution for injection or infusion (2017)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Bricanyl Injection, 0.5 mg/ml, solution for injection or infusion.

Qualitative and quantitative composition

1 ml solution for injection contains 0.5mg of terbutaline sulfate. Excipient(s) with known effect: 1 ml also contains sodium (<1 mmol/ml), as sodium chloride. For the full list of excipients, see section ...

Pharmaceutical form

Solution for injection or infusion. A clear aqueous solution.

Therapeutic indications

Bronchodilation Terbutaline is a selective beta2-adrenergic agonist recommended for the relief of bronchospasm in bronchial asthma and other bronchopulmonary disorders in which bronchospasm is a complicating ...

Posology and method of administration

Posology The dosage should be individualised. For bronchodilation When a rapid therapeutic response is required, Bricanyl can be administered by any of the three standard parenteral routes: subcutaneous, ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. In the treatment of premature labour Bricanyl is contraindicated in the following conditions: A gestational age ...

Special warnings and precautions for use

As for all beta<sub>2</sub>-agonists caution should be observed in patients with thyrotoxicosis. Cardiovascular effects may be seen with sympathomimetic drugs, including Bricanyl. There is some evidence ...

Interaction with other medicinal products and other forms of interaction

Beta-blocking agents (including eye drops), especially the non-selective ones such as propranolol, may partially or totally inhibit the effect of beta-stimulants. Therefore, Bricanyl preparations and non-selective ...

Pregnancy and lactation

Bronchospasm Pregnancy Although no teratogenic effects have been observed in animals or in patients, Bricanyl should only be administered with caution during the first trimester of pregnancy. Breast-feeding ...

Effects on ability to drive and use machines

Bricanyl has no or negligible influence on the ability to drive and use machines.

Undesirable effects

The intensity of the adverse reactions depends on dosage and route of administration. An initial dose titration will often reduce the adverse reactions. Most of the adverse reactions are characteristic ...

Overdose

Symptoms Headache, anxiety, tremor, nausea, tonic cramps, palpitations, tachycardia and arrhythmia. A fall in blood pressure sometimes occurs. Laboratory findings: hypokalaemia, hyperglycaemia and lactic ...

Pharmacodynamic properties

Pharmacotherapeutic group: selective beta<sub>2</sub>-agonist, terbutaline ATC code: R03CC03 Terbutaline is a selective beta<sub>2</sub>-adrenergic stimulant, having the following pharmacological effects: ...

Pharmacokinetic properties

Basic parameters have been evaluated in man after i.v. and oral administration of therapeutic doses, e.g. i.v. single dose: Volume of distribution (VSS): 114 L Total body clearance (CL): 213 ml/min Mean ...

Preclinical safety data

The major toxic effect of terbutaline, observed in toxicological studies in rats and dogs at exposures in excess of maximum human exposure, is focal myocardial necrosis. This type of cardiotoxicity is ...

List of excipients

Sodium chloride Hydrochloric acid Water for injection

Incompatibilities

Bricanyl solution for injection should not be mixed with alkaline solutions, i.e. solutions with a pH higher than 7.0.

Shelf life

Shelf life: 2 years.

Special precautions for storage

Do not store above 25°C. Keep in the outer carton.

Nature and contents of container

Packs of 5 1ml glass ampoules. Packs of 10 5ml glass ampoules. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Bronchodilation: the recommended diluent is 5% dextrose, ...

Marketing authorization holder

AstraZeneca UK Ltd., 600 Capability Green, Luton, LU1 3LU, UK

Marketing authorization number(s)

PL 17901/0112

Date of first authorization / renewal of the authorization

7<sup>th</sup> May 2002 / 12<sup>th</sup> May 2007

Date of revision of the text

11<sup>th</sup> April 2017

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