BRICANYL RESPULES
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-04-2024
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Active ingredient:
TERBUTALINE SULFATE
Available from:
AstraZeneca UK Limited
Dosage:
5mg/2 Millilitre
Pharmaceutical form:
Solution for Inhalation
Authorization date:
1997-09-01
Summary of Product characteristics
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0970/036/004
Case No: 2055163
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
ASTRAZENECA UK LIMITED
600 CAPABILITY GREEN, LUTON, LU1 3LU, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
BRICANYL RESPULES 5 MG/2 ML NEBULISER SOLUTION
The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as
may be specified in the said Regulations as listed on the reverse of this document.
This authorisation, unless previously revoked, shall continue in force from 18/08/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 18/08/2009_
_CRN 2055163_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bricanyl Respules 5 mg/ 2 ml nebuliser solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Terbutaline sulphate 2.5 mg/ml.
Each single dose Respule contains 2 ml (5 mg).
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Nebuliser solution
A clear, aqueous, isotonic solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Terbutaline is a selective beta
2
-adrenergic agonist recommended for the relief of severe bronchospasm in bronchial
asthma and in chronic bronchitis and other bronchopulmonary disorders in which bronchospasm is a complicating
factor.
4.2 POSOLOGY AND METHOD OF ADMINI
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