Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
IRON (AS GLEPTOFERRON COMPLEX)
Labiana Life Sciences, S.A.
QB03AC91
IRON (AS GLEPTOFERRON COMPLEX)
200 Mg/l
Solution for Injection
LM-Licensed Merchant
Porcine
Gleptoferron
Vitamins & Minerals
Authorised
2016-12-23
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 ________________________________________________________________________________________________________________________ _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 Citiți documentul complet