Страна: Велика Британія
мова: англійська
Джерело: VMD (Veterinary Medicines Directorate)
Iron
Labiana Life Sciences SA
QBO3AC
Iron
Solution for injection
POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person
Pigs
Mineral antianaemia
Authorized
2017-10-24
Renewed: March 2022 AN: 00982/2021 & 00983/2021 Page 1 of 5 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) 200.0 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. 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. Renewed: March 2022 AN: 00982/2021 & 00983/2021 Page 2 of 5 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 and mucous membranes. In case of accidental self-injection, seek medical advice immediately and show the Прочитайте повний документ