Gleptoferron Labiana 200 mg/ml Solution for Injection

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: VMD (Veterinary Medicines Directorate)

Aktiivinen ainesosa:

Iron

Saatavilla:

Labiana Life Sciences SA

ATC-koodi:

QBO3AC

INN (Kansainvälinen yleisnimi):

Iron

Lääkemuoto:

Solution for injection

Prescription tyyppi:

POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person

Terapeuttinen ryhmä:

Pigs

Terapeuttinen alue:

Mineral antianaemia

Valtuutuksen tilan:

Authorized

Valtuutus päivämäärä:

2017-10-24

Valmisteyhteenveto

Renewed: March 2022
AN: 00982/2021 & 00983/2021
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Gleptoferron Labiana 200 mg/ml Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active Substance:
Iron (III) 200.0 mg (as Gleptoferron 532.6 mg)
Excipients:
Phenol 5.0 mg
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection.
A dark brown, slightly viscous, sterile, colloidal, aqueous solution
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Neonatal pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the prevention and treatment of iron deficiency anaemia.
4.3 CONTRAINDICATIONS
Do not use in case of:
-
Hypersensitivity to gleptoferron complex or any of the excipients.
-
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 case of
diarrhoea.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
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 product
is required
for use.
Renewed: March 2022
AN: 00982/2021 & 00983/2021
Page 2 of 5
4.5 SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for use in animals
Normal aseptic injection techniques should be practised.
Avoid the introduction of contamination during use.
It is advisable to stretch the skin at the injection site to minimize
leakage after
withdrawal of the needle.
ii)
Special precautions to be taken by the person administering the
veterinary
medicinal product to animals
People with known hypersensitivity to the active substance
(gleptoferron) or with
hemochromatosis should avoid contact with the veterinary medicinal
product.
Take care 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