Previron 200 mg/ml solution for injection for pigs

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Gleptoferron

Verfügbar ab:

Laboratorios Hipra S.A.

ATC-Code:

QB03AC

INN (Internationale Bezeichnung):

Gleptoferron

Dosierung:

200 milligram(s)/millilitre

Darreichungsform:

Solution for injection

Verschreibungstyp:

LR: Licensed Retailer as defined in national legislation

Therapiegruppe:

Pigs

Therapiebereich:

Iron, parenteral preparations

Anwendungsgebiete:

Vitamins and minerals

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2016-11-04

Fachinformation

Health Products Regulatory Authority
15 October 2021
CRN00C7WG
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Previron 200 mg/ml solution for injection for pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Iron (III)
………............................................................
200.0 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.
Dark brown, slightly viscous solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs (piglets)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the prevention of iron deficiency anaemia in piglets.
4.3 CONTRAINDICATIONS
Do not use in piglets suspected to suffer from deficiency of vitamin E
and/or selenium.
Do not use in cases of hypersensitivity to the active substance.
Do not use in clinically diseased animals, especially not in case of
diarrhoea.
Do not administer intravenously.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Health Products Regulatory Authority
15 October 2021
CRN00C7WG
Page 2 of 4
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
It is advisable to stretch the skin at the injection site to minimise
leakage after withdrawal of the needle. 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
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 and contact with mucous
membranes.
In case of accidental self-injection, seek medical advice immediately
and show the package leaflet or the label to the physician.
Wash hands after use.
4.6 ADVERSE REAC