GLEPTOFERRON LABIANA 200 MG/ML SOLUTION FOR INJECTION

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

IRON (AS GLEPTOFERRON COMPLEX)

Available from:

Labiana Life Sciences, S.A.

ATC code:

QB03AC91

INN (International Name):

IRON (AS GLEPTOFERRON COMPLEX)

Dosage:

200 Mg/l

Pharmaceutical form:

Solution for Injection

Prescription type:

LM-Licensed Merchant

Therapeutic group:

Porcine

Therapeutic area:

Gleptoferron

Therapeutic indications:

Vitamins & Minerals

Authorization status:

Authorised

Authorization date:

2016-12-23

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Gleptoferron Labiana 200 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Iron
200 mg/ml
(as gleptoferron complex)
EXCIPIENTS:
Phenol
5 mg/ml
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
A dark brown, slightly viscous, sterile, colloidal, aqueous solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Neonatal pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the prevention and treatment of iron deficiency anaemia.
4.3 CONTRAINDICATIONS
Do not use in case of:
-Hypersensitivity to gleptoferron complex or any of the excipients.
-In animals with hepatic and/or renal disease.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The sachet in the low-density polyethylene collapsible bottles with a nominal capacity of 100 ml and 200 ml should not
be opened until the product is required for use.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 23/12/2016_
_CRN 7021405_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Normal aseptic injection techniques should be practised.
Avoid the introduction of contamination during use.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS
Care should be taken to avoid accidental self-injection as well as mucous membrane contact, especially people with
known hypersensitivity to iron dextran.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or label to the
physician.
Wash hands after use.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
There are normally no un