NALOXONE HYDROCHLORIDE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
NALOXONE HYDROCHLORIDE
Available from:
HOSPIRA UK Ltd
Dosage:
20 Microgram/ML
Pharmaceutical form:
Solution for Injection
Authorization date:
1991-05-31
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)
PA0437/024/002
Case No: 2045348
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
HOSPIRA UK LTD
QUEENSWAY, ROYAL LEAMINGTON SPA, WARWICKSHIRE CV31 3RW, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
NALOXONE HYDROCHLORIDE 20 MICROGRAM/ML SOLUTION FOR INJECTION
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 20/02/2008.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 06/03/2008_
_CRN 2045348_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Naloxone Hydrochloride 20 micrograms/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2ml ampoule contains 40 micrograms of naloxone hydrochloride (as dihydrate) equivalent to 20 micrograms per
ml. Excipient: sodium 9 mg/ml.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
Clear, colourless, aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
CHILDREN
Overdosage of narcotics: Known or suspected: 10mcg/kg body weight intravenously. If the desired degree of clinical
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