Myodine 25 mg/ml solution for injection for dogs and cats

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Nandrolone Laurate

Available from:

Le Vet Beheer B.V.

ATC code:

QA14AB01

INN (International Name):

Nandrolone Laurate

Dosage:

25 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cats, Dogs

Therapeutic area:

nandrolone

Therapeutic indications:

Hormone

Authorization status:

Authorised

Authorization date:

2017-07-28

Summary of Product characteristics

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Myodine 25 mg/ml solution for injection for dogs and cats (AT, BE, CY,
CZ, EL, ES, FR, HR, HU,
IE, IT, LU, NL, PT, RO, SI, SK, UK)
Myodine vet 25 mg/ml solution for injection for dogs and cats (DK, EE,
FI, IS, LT, LV, NO, PL, SE)
Nandrosol 25 mg/ml solution for injection for dogs and cats (DE)
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.
2
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.
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 cau