Name of the veterinary medicinal product
Gleptosil® 200 mg/mL Solution for Injection.

Qualitative and quantitative composition
For a full list of excipients see section 6.1.

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.
• Contraindications : None
• Special warnings for each target species : None.

Active Substance
Iron 200 mg/mL (as gleptoferron complex) 498 mg/mL.

Excipients
Phenol 5 mg/mL.

• Special precautions for use

Special precautions for use in animals

Normal aseptic injection techniques should be practised.

Special precautions to be taken by 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, promptly 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.

• Overdose (symptoms, emergency procedures, antidotes if necessary)

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

• Withdrawal Period(s)

Meat and offal: Zero days

Pharmacological or immunological properties

Pharmacotherapeutic group: Anti-anaemic preparations, iron preparations, iron trivalent, parenteral preparations.

ATC vet code: QB03AC91.

• 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 (1 mL/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 injection.

• Incompatibilities

None known.

• Shelf-life

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

Shelf-life after opening the immediate packaging: 28 days

• 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 chlorobutyl rubber bung with aluminium overseal.

• Special precautions for the disposal of unused veterinary medicinal products or waste materials

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

_{From one country to another, product lines are adapted to local demand and regulatory requirements. For further information, please take a look at the CEVA Santé Animale site for your country. Warning: the information provided on the products depends on national registrations. Access to technical information is restricted to authorised persons.}