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

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Nandrolone laurate

可用日期:

Le Vet Beheer B.V.

ATC代码:

QA14AB01

INN（国际名称）:

Nandrolone laurate

剂量:

25 milligram(s)/millilitre

药物剂型:

Solution for injection

处方类型:

POM: Prescription Only Medicine as defined in relevant national legislation

治疗领域:

nandrolone

授权状态:

Authorised

授权日期:

2021-06-11

产品特点

Health Products Regulatory Authority
11 June 2021
CRN009SWJ
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Myolone 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.
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.
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
an