Gleptolab 200 mg/ml Solution for Injection for pigs

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Iron (as gleptoferron)

Dostupné z:

Labiana Life Sciences, S.A.

ATC kód:

QB03AC

INN (Medzinárodný Name):

Iron (as gleptoferron)

Forma lieku:

Solution for injection

Typ predpisu:

LR: Licensed Retailer as defined in national legislation

Terapeutické oblasti:

Iron, parenteral preparations

Dátum Autorizácia:

2023-08-14

Súhrn charakteristických

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Gleptolab 200 mg/ml Solution for Injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Iron (III)
200.0 mg
(as Gleptoferron
532.6 mg)
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS
AND OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT INFORMATION
IS ESSENTIAL FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUC
t
Phenol
5.0 mg
Water for injections
Dark brown, solution and slightly viscous. Free of visible sediment
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
- 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.
3.4.
SPECIAL WARNINGS
None.
3.5.
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe 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
haemochromatosis should avoid
contact with the product.
Care should be taken to avoid accidental self-injection, as well as
contact with the eyes and
mouth.
In case of accidental injection, seek medical advice immediately and
show the package leaflet or
label to the physician.
Wash hands after use.
Special precautions for the protection of the environment:
Not applicable.
3.6.
ADVERSE EVENTS
Target species: Pigs (piglets)
Uncommon
(1 to 10 animals / 1,000 animals
treated):
Slight staining of muscle tissue at injection site
Deaths
1
Very rare
(<