Emdogent 100 mg/ml Oplossing voor injectie
Emdogent 100 mg/ml Oplossing voor injectie
Authorised
- Gentamicin sulfate
Product identification
Medicine name:
Emdogent 100 mg/ml Oplossing voor injectie
Emdogent 100 mg/ml Solution injectable
Emdogent 100 mg/ml Injektionslösung
Active substance:
- Gentamicin sulfate
Target species:
-
Cattle
-
Dog
-
Horse
Route of administration:
-
Intramuscular use
-
Subcutaneous use
-
Intravenous use
Product details
Active substance and strength:
-
Gentamicin sulfate1.00/million international units1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intramuscular use
-
Cattle
-
Meat and offal214dayDue to accumulation of gentamicin in liver, kidneys and injection site, any repeated course of treatment during the withdrawal period must be avoided
-
Milk7day
-
-
-
Intravenous use
-
Cattle
-
Meat and offal214dayDue to accumulation of gentamicin in liver, kidneys and injection site, any repeated course of treatment during the withdrawal period must be avoided
-
Milk7day
-
-
Horse
-
Meat and offalno withdrawal periodDo not use in animals aimed at human consumption
-
Milkno withdrawal periodDo not use in animals producing milk for human consumption
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QJ01GB03
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Available in:
-
Belgium
Package description:
- Emdogent 12 Vials with 100 ml of Solution for injection
- Emdogent 1 Vial with 100 ml of Solution for injection
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
- Emdoka
Marketing authorisation date:
Manufacturing sites for batch release:
- Produlab Pharma B.V.
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V526640
Date of authorisation status change:
Generic of:
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
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Package Leaflet
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Labelling
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