Gleptoferron Labiana 200 mg/ml Solution for Injection

Composition

Each ml contains:

Active Substance:

Iron (III) 200.0 mg

(as Gleptoferron 532.6 mg)

Excipients:

Dark brown, slightly viscous solution.

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Pharmacological properties

4.1 ATCvet code: QBO3AC

4.2 Pharmacodynamics

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 (is stored in form of ferritin).

4.3 Pharmacokinetics

Absorption of the product has been shown to be rapid. Over 95% of the administered iron (1 ml/200mg iron administered at three days of age) was absorbed by 24 hours after injection.

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Target species

Pig (piglets).

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Indications

For the prevention and treatment of iron deficiency anaemia.

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Dosage

Intramuscular use.

Use only automatic syringe equipment. The veterinary medicinal 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.

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Contraindications

- Do not use in cases of hypersensitivity to the active substance, or to any of the excipients.

- Do not use 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 cases of diarrhoea.

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Adverse reactions

Target species: Pig (piglets)

1 Slight staining of muscle tissue at injection site

2 Associated with maternal dietary deficiency of vitamin E and/or selenium.

3 Attributed to an increased susceptibility to infection due to temporary blocking of the reticuloendothelial system.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

Normal aseptic injection techniques should be practised.

It is advisable to stretch the skin at the injection site to minimise leakage after withdrawal of the needle.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

People with known hypersensitivity to iron dextran, or those with hemochromatosis should avoid contact with the veterinary medicinal product. Care should be taken 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 package leaflet or the label to the physician.

Wash hands after use.

Special precautions for the protection of the environment:

Not applicable.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

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Use during pregnancy, lactation or lay

Not applicable.

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Interactions

Do not mix with other products prior to administration.

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Overdose

Over dosage with the veterinary medicinal product is unlikely to result in signs of intoxication.

In studies carried out in piglets with doses up to 6 times the recommended dose, no clinical signs of intolerance were observed, except for a slight staining of the muscle at the injection site, the intensity of which depends on the dose administered.

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Special warnings

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 veterinary medicinal product is required for use.

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Withdrawal period

Meat and offal: zero days.

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Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

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Immediate packaging

Low-density polyethylene collapsible bottles (LDPE) with a nominal capacity of 100 ml and 200 ml closed with a chlorobutyl rubber closure and an aluminium ring seal. Each bottle is sealed in a sachet. The sachet is a polyester/polyethylene laminate. Do not open the sachet until ready to use the veterinary medicinal product.

High-density polyethylene collapsible bottles (HDPE) with a nominal capacity of 100 ml and 200 ml closed with a chlorobutyl rubber closure and an aluminium ring seal.

Pack sizes:

Carton box with 1 bottle of 100 ml

Carton box with 10 bottles of 100 ml

Carton box with 20 bottles of 100 ml

Carton box with 40 bottles of 100 ml

Carton box with 1 bottle of 200 ml

Carton box with 10 bottles of 200 ml

Carton box with 20 bottles of 200 ml

Not all pack sizes may be marketed.

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Storage

This veterinary medicinal product does not require any special storage conditions.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years

Shelf life after first opening the immediate packaging: 28 days

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Disposal of unused product

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

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Additional information

Vm 32112/4001

8 DATE OF FIRST AUTHORISATION

24 October 2017

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

September 2025

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Approved: 28 October 2025

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Registration holder

Labiana Life Sciences SA

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