Gleptolab 200 mg/ml Solution for Injection for Pigs

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: VMD (Veterinary Medicines Directorate)

Ակտիվ բաղադրիչ:

Iron

Հասանելի է:

Labiana Life Sciences SA

ATC կոդը:

QBO3AC

INN (Միջազգային անվանումը):

Iron

Դեղագործական ձեւ:

Solution for injection

Ռեկվիզորի տեսակը:

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

Թերապեւտիկ խումբ:

Pigs

Թերապեւտիկ տարածք:

Mineral antianaemia

Լիազորման կարգավիճակը:

Authorized

Հաստատման ամսաթիվը:

2023-02-13

Ապրանքի հատկությունները

Amended Pages: September 2023
AN: 00620/2021
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
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 PRODUCt
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.
Amended Pages: September 2023
AN: 00620/2021
Page 2 of 5
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
Targ