国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Gleptoferron
Labiana Life Sciences, S.A.
QB03AC91
Gleptoferron
200 milligram(s)/millilitre
Solution for injection
LR: Licensed Retailer as defined in national legislation
Pigs
ZZZ Gleptoferron
Vitamins and minerals
Authorised
2016-12-23
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 完全なドキュメントを読む