Gleptoferron Labiana 200 mg/ml Solution for Injection

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Gleptoferron

Disponibil de la:

Labiana Life Sciences, S.A.

Codul ATC:

QB03AC91

INN (nume internaţional):

Gleptoferron

Dozare:

200 milligram(s)/millilitre

Forma farmaceutică:

Solution for injection

Tip de prescriptie medicala:

LR: Licensed Retailer as defined in national legislation

Grupul Terapeutică:

Pigs

Zonă Terapeutică:

ZZZ Gleptoferron

Indicații terapeutice:

Vitamins and minerals

Statutul autorizaţiei:

Authorised

Data de autorizare:

2016-12-23

Caracteristicilor produsului

Health Products Regulatory Authority
21 January 2022
CRN00CH24
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Gleptoferron Labiana 200 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
Each ml contains:
​
​
​
Active substance:
​
​
​
Iron (III)
200.00
mg​
(as Gleptoferron 532.6 mg)​
​
​
​
Excipients:
​
​
​
Phenol
​
5.0
​mg
​
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.
- Do not administer to piglets suspected to suffer from deficiency of
vitamin E and/or selenium.
- Do not use in clinically diseased animals, especially not in case of
diarrhoea.
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
21 January 2022
CRN00CH24
Page 2 of 4
4.5 SPECIAL PRECAUTIONS FOR USE
i) Special precautions for use in animals
Normal aseptic injection techniques should be practised.
Avoid the introduction of contamination during use.
It is advisable to stretch the skin at the injection site to minimize
leakage after withdrawal of the needle.
ii) Special precautions to be taken by the person administering the
veterinary medicinal product to animals
People with known hypersensitivity to the active substance
(gleptoferron) or with hemochromatosis should avoid contact with
the veterinary medicinal product.
Take care to avoid accidental self-injection as well as contact with
the eyes, mouth a