Gleptoferron Labiana 200 mg/ml Solution for Injection

Dark brown, slightly viscous solution.
3. CLINICAL INFORMATION
3.1 Target species
Pig (piglets).
3.2 Indications for use for each target species
For the prevention and treatment of iron deficiency anaemia.
3.3 Contraindications
-
the excipients.
-
-
and/or selenium.
-
3.4 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.
AN: 00213/2025 & 00275/2025
3.5 Special precautions for use
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.
3.6 Adverse events
Target species: Pig (piglets)
Uncommon
(1 to 10 animals / 1,000
animals treated):
Injection site skin change NOS
1Rare (more than 1 but less
than 10 animals in 10,000
animals treated)
Death
Very rare
(<1 animal / 10,000 animals
treated, including isolated
reports):
Death
Hypersensitivity reaction.
Slight staining of muscle tissue at injection site
Associated with maternal dietary deficiency of vitamin E and/or selenium.
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.
AN: 00213/2025 & 00275/2025
3.7 Use during pregnancy, lactation or lay
Not applicable.
3.8 Interaction with other medicinal products and other forms of
interaction
Do not mix with other products prior to administration.
3.9 Administration routes and 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.
3.10 Symptoms of overdose (and where applicable, emergency procedures
and antidotes)
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.
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.
3.12 Withdrawal periods
Meat and offal: zero days.

4.