SUMMARY OF PRODUCTS CHARACTERISTICS

Gleptosil 200mg/ml solution for injection

Active Substance: Iron (as gleptoferron complex). Excipients: Phenol For a full list of excipients see Section 6.1

200 mg/ml 498 mg/ml) 5 mg/ml

Solution for injection.

A dark brown, slightly viscous, sterile, colloidal, aqueous solution

Neonatal pigs

Neonatal pigs:

For the prevention and treatment of iron deficiency anaemia.

None

None

Normal aseptic injection techniques should be practised.

Care should be taken to avoid accidental self injection.In the event of accidental self injection seek medical advice. Wash hands after use.

The sachet should not be opened until the product is required for use.

Avoid the introduction of contamination during use.

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.

Not applicable

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.

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.

Overdosage with the product is unlikely to result in signs of intoxication.

MEAT AND OFFAL: ZERO DAYS.

Pharmacotherapeutic group: Antianaemic preparations, Iron preparations, Iron trivalent, parenteral preparations

ATCVet Code: QBO3AC91

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.

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.

Not applicable

Phenol

Sodium chloride

Water for injections

None known

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after opening the immediate packaging: 28 days

Do not store above 25°C. Protect from light.

100 mL clear colourless low-density polyethylene collapsible bottles with grey chlorbutyl rubber bung with aluminium overseal.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Ceva Animal Health Ltd

Unit 3, Anglo Office Park

White Lion Road

Amersham

Buckinghamshire

HP7 9FB

Vm 15052/4079

Date:30 August 1995

Date:June 2015

Approved: 02 June 2015