ANAEMEX 200MG/ML SOLUTION FOR INJECTION

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

IRON DEXTRAN

Available from:

Ark Animal Care Ltd

ATC code:

QB03AC90

INN (International Name):

IRON DEXTRAN

Dosage:

200 Mg/Ml

Pharmaceutical form:

Solution for Injection

Prescription type:

LM-Licensed Merchant

Therapeutic group:

Porcine

Therapeutic area:

Iron dextran

Therapeutic indications:

Vitamins & Minerals

Authorization status:

Authorised

Authorization date:

1989-10-01

Summary of Product characteristics

                                IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA: 10900/010/001
Case No: 7007757
The Irish Medicines Board in exercise of the powers conferred on it by Animal Remedies (No. 2) Regulations (S.I. No. 786 of 2007) hereby
grants to:
ARK ANIMAL CARE LTD
NEWBRIDGE, CO. KILDARE, IRELAND
an authorisation, subject to the provisions of the said Regulations and the general conditions of the attached authorisation, in respect of the
Veterinary Medicinal Product:
ANAEMEX 200MG/ML SOLUTION FOR INJECTION
The particulars of which are set out in Part 1 and Part 2 of the said Schedule. The authorisation is also subject to any special conditions as may
be specified in the said Schedule.
The authorisation,unless revoked, shall continue in force from 27/04/2010.
Signed on behalf of the Irish Medicines Board
________________
A person authorised in that behalf by the said Board.
(NOTE: This authorisation replaces any previous authorisation in respect of this product which is now null and void.)
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 28/04/2010_
_CRN 7007757_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Anaemex 200 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance
Elemental Iron as Iron Dextran Complex
200 mg
Excipients
Phenol
5 mg
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A reddish brown solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Young pigs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For treatment and prevention of iron deficiency anaemia in piglets.
4.3 C
                                
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