EPIPEN JUNIOR
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
08-05-2024
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Active ingredient:
EPINEPHRINE
Available from:
ALK-Abello A/S
Dosage:
0.15 Mg/Dose
Pharmaceutical form:
Solution for Injection
Authorization date:
2006-09-22
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PA1255/002/001
Case No: 2079103
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
ALK-ABELLO A/S
BOGE ALLE 6-8, DK-2970 HORSHOLM, DENMARK
an authorisation, subject to the provisions of the said Regulations, in respect of the product
EPIPEN JUNIOR 0.15 MG, SOLUTION FOR INJECTION
the particulars of which are set out in 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 06/07/2010 until 24/10/2011.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 06/07/2010_
_CRN 2079103_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
EpiPen Junior 0.15 mg, solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 0.5 mg adrenaline (Epinephrine). A single dose (0.3 ml) contains 0.15 mg (150 microgram) adrenaline
(Epinephrine).
Excipient: Sodium Metabisulphite.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear and colourless solution in a pre-filled pen (Auto-injector).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The Auto-Injectors are indicated in the emergency treatment of a severe anaphylactic shock or allergic reaction to
allergens e.g. insect stings or bites, foods or drugs.
4.2 POSOLOGY
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