Hypertonic 72 mg/ml Solution for Infusion for Cattle, Cattle (Calves), Horses, Dogs and Cats
Hypertonic 72 mg/ml Solution for Infusion for Cattle, Cattle (Calves), Horses, Dogs and Cats
Authorised
- Sodium chloride
Product identification
Medicine name:
Hypertonic 72 mg/ml Solution for infusion
Hypertonic 72 mg/ml Solution for Infusion for Cattle, Cattle (Calves), Horses, Dogs and Cats
Active substance:
- Sodium chloride
Target species:
-
Dog
-
Horse
-
Cattle
-
Cat
Route of administration:
-
Intravenous use
Product details
Active substance and strength:
-
Sodium chloride72.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for infusion
Withdrawal period by route of administration:
-
Intravenous use
-
Horse
-
Meat and offalno withdrawal periodZero days
-
Milkno withdrawal periodZero hours
-
-
Cattle
-
Meat and offalno withdrawal periodZero days
-
Milkno withdrawal periodZero hours
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QB05BB01
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
United Kingdom (Northern Ireland)
Package description:
- Hypertonic 72 mg/ml inf. sol. i.v. 2 x 5000 ml
- Hypertonic 72 mg/ml inf. sol. i.v. 4 x 3000 ml
- Hypertonic 72 mg/ml inf. sol. i.v. 20 x 500 ml
- Hypertonic 72 mg/ml inf. sol. i.v. 5000 ml
- Hypertonic 72 mg/ml inf. sol. i.v. 3000 ml
- Hypertonic 72 mg/ml inf. sol. i.v. 500 ml
- Hypertonic 72 mg/ml inf. opl. i.v. 15 x 500 ml
- Hypertonic 72 mg/ml inf. sol. i.v. 3 x 3000 ml
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
- Infomed Fluids S.r.l.
- Industria Farmaceutica Galenica Senese S.r.l.
Responsible authority:
- The Veterinary Medicines Directorate
Authorisation number:
- Vm 50406/3033
Date of authorisation status change:
Reference member state:
-
Belgium
Procedure number:
- BE/V/0043/001
Concerned member states:
-
France
-
Germany
-
Netherlands
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet