Myodine 25 mg/ml Solution for Injection for Dogs and Cats

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: VMD (Veterinary Medicines Directorate)

Wirkstoff:

Nandrolone Laurate

Verfügbar ab:

Le Vet Beheer B.V.

ATC-Code:

QA14AB01

INN (Internationale Bezeichnung):

Nandrolone Laurate

Darreichungsform:

Solution for injection

Verschreibungstyp:

POM-V - Prescription Only Medicine – Veterinarian

Therapiegruppe:

Cats, Dogs

Therapiebereich:

Hormone anabolic steroid

Berechtigungsstatus:

Authorized

Berechtigungsdatum:

2017-06-12

Fachinformation

Revised: June 2022
AN: 01476/2021 & 01478/2021
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Myodine 25 mg/ml solution for injection for dogs and cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Nandrolone laurate
25 mg
(equivalent to nandrolone 15 mg)
EXCIPIENT(S):
Benzyl alcohol (E1519)
104 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear yellowish oily solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Indicated for use in dogs and cats as an adjunctive treatment for
conditions in which
anabolic therapy is considered to be beneficial.
4.3
CONTRAINDICATIONS
Do not use in pregnant animals (see also section 4.7).
Do not use in animals with hypercalcaemia.
Do not use in animals with androgenic dependent tumours.
Do not use in breeding animals.
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Anabolic therapy is to induce an improvement in clinical signs rather
than a cure. The
animal should therefore be carefully examined for potential
pre-existing disease and
the anabolic therapy should be combined with treatment of this
underlying disease, if
present.
Revised: June 2022
AN: 01476/2021 & 01478/2021
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
This product contains benzyl alcohol, which has been documented to
cause adverse
reactions in neonates. For this reason, use of the product is not
recommended in
very young animals.
Special care (particularly in geriatric patients) should be taken when
administering
the product to animals with compromised cardiac or renal function
because of the
potential of anabolic steroids to increase sodium and water retention.
The product should be administered with caution to animals with severe
hepatic
dysfunction. The liver function of treated animals s