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Date: Tuesday, May 7, 2024 2:33

Release 4.194
Gleptosil® 200 mg/ml Solution for Injection
 
Species: Pigs
Therapeutic indication: Pharmaceuticals: Dietary supplements and fluid metabolites: Iron preparations
Active ingredient: Gleptoferron
Product:Gleptosil® 200 mg/ml Solution for Injection
Product index: Gleptosil
Pig - meat: Zero days
Incorporating:
Qualitative and quantitative composition
Active Substance:
Iron 200 mg/ml
(as gleptoferron complex) 498 mg/ml
Excipients:
Phenol 5 mg/ml
For a full list of excipients see Pharmaceutical particulars.
Pharmaceutical form
Solution for injection. A dark brown, slightly viscous, sterile, colloidal, aqueous solution
Clinical particulars
Target species
Neonatal pigs
Indications for use, specifying the target species
Neonatal pigs: For the prevention and treatment of iron deficiency anaemia.
Contra-indications
None
Special warnings for each target species
None
Special precautions for use
Special precautions for use in animals
Normal aseptic injection techniques should be practised.
Special precautions for the person administering the veterinary medicinal product to animals
Care should be taken to avoid accidental self injection. In the event of accidental self injection seek medical advice. Wash hands after use.
Other precautions
The sachet should not be opened until the product is required for use. Avoid the introduction of contamination during use.
Adverse reactions (frequency and seriousness)
There are normally no undesirable side effects associated with the use of the product. Its use does not result in permanent staining of the injected muscle tissue.
Use during pregnancy, lactation or lay
Not applicable
Interaction with other medicinal products and other forms of interaction
There are no known interactions between the product and other medicaments. There are no known other forms of interaction. Do not mix with other products prior to administration.
Amounts to be administered and administration route
Use only automatic syringe equipment
Swab the septum before use. The product is administered as a single 1 mL (200 mg iron) dose by deep intramuscular injection into the hind limb midway between the stifle joint and the base of the tail. Injections should be administered as follows:
For the prevention of iron deficiency anaemia: not later than the third day of life.
For the treatment of iron deficiency anaemia: at the onset of clinical anaemia, normally within the first three weeks of life.
For 100 & 250 ml plastic vials: as the vial cannot be broached more than 20 times, use of automatic syringe equipment is recommended.
For 100 ml collapsible vial: as the vial cannot be broached more than 4 times, the use of automatic syringe equipment is recommended.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Overdosage with the product is unlikely to result in signs of intoxication.
Withdrawal periods
Meat and offal: Zero Days
Pharmacological particulars
Pharmacotherapeutic group: Antianaemic preparations, iron preparations, iron trivalent, parenteral preparations. ATCvet code: QB03AC
Pharmacodynamic properties
Injectable iron-carbohydrate complexes are established haematinic agents in veterinary medicine. Following intramuscular injection, the complex is absorbed and metabolised to release the iron for utilisation and/or storage in accordance with the nutritional status of the animal. In iron deficient states, the iron is utilised for the synthesis of haemoglobin and other iron-containing molecules. Excess iron is stored principally in the liver.
Pharmacokinetic properties
Absorption of the product has been shown to be rapid. Over 95% of the administered iron (1mL/200 mg iron administered at three days of age) was absorbed by 24 hours after injection. Use of the product does not result in permanent staining of the injected muscle tissue.
Environmental properties
Not applicable
Pharmaceutical particulars
List of excipients
Phenol, Sodium chloride, Water for injections
Major incompatibilities
None known
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale in 100ml collapsible vial: 2 years.
Shelf life after opening the immediate packaging: 28 days.
Shelf-life of the veterinary medicinal product as packaged for sale in 100 & 250 ml multilayer plastic vials: 3 years.
Special precautions for storage
Do not store above 25°C. Protect from light.
Nature and composition of immediate packaging
100 mL clear colourless low-density polyethylene collapsible bottles with grey chlorbutyl rubber bung with aluminium overseal.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
UK: Vm 15052/4079
Significant changes
Date of the first authorisation or date of renewal
30 August 1995
Date of revision of the text
October 2022
Any other information
Nil
Legal category
Legal category: POM-VPS
GTIN
GTIN description:Gleptosil 200mg/ml Solution 250ml
GTIN:03411113021139