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

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Nandrolone Laurate

Tersedia dari:

Le Vet Beheer B.V.

Kode ATC:

QA14AB01

INN (Nama Internasional):

Nandrolone Laurate

Dosis:

25 milligram(s)/millilitre

Bentuk farmasi:

Solution for injection

Jenis Resep:

POM: Prescription Only Medicine as defined in relevant national legislation

Kelompok Terapi:

Cats, Dogs

Area terapi:

nandrolone

Indikasi Terapi:

Hormone

Status otorisasi:

Authorised

Tanggal Otorisasi:

2017-07-28

Karakteristik produk

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