Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Gleptoferron
Laboratorios Hipra S.A.
QB03AC
Gleptoferron
200 milligram(s)/millilitre
Solution for injection
LR: Licensed Retailer as defined in national legislation
Pigs
Iron, parenteral preparations
Vitamins and minerals
Authorised
2016-11-04
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 Preberite celoten dokument