Laurabolin 25 mg/ml solution for injection

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Nandrolone laurate

Disponible depuis:

Intervet Ireland Limited

Code ATC:

QA14AB01

DCI (Dénomination commune internationale):

Nandrolone laurate

Dosage:

25 milligram(s)/millilitre

forme pharmaceutique:

Solution for injection

Type d'ordonnance:

POM: Prescription Only Medicine as defined in relevant national legislation

Groupe thérapeutique:

Cats, Dogs

Domaine thérapeutique:

nandrolone

indications thérapeutiques:

Hormone

Statut de autorisation:

Authorised

Date de l'autorisation:

1987-10-01

Résumé des caractéristiques du produit

Health Products Regulatory Authority
17 February 2021
CRN00C174
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Laurabolin 25 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains
Active substance
Nandrolone laurate
25
mg
Excipients
Benzyl alcohol (E1516)
104
mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
Light yellow 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 to treat conditions in which
anabolic therapy is considered to be beneficial, e.g. chronic renal
failure, debility, weight loss and inappetence in ageing animals,
cachexia, conditions in which healing is delayed e.g. non-union
of bone fractures, supportive therapy in orthopaedic conditions and to
counter the catabolic effects of prolonged
corticosteroid therapy.
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 known cases of hypersensitivity to the active substance
or any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Prolonged administration may cause signs of the androgenic activity to
appear, especially in entire female animals.
The product contains benzyl alcohol, which has been documented to
cause adverse reactions in neonates. For this reason, do
not use in very young animals.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
In the event of accidental self-injection, transient painful, local
reactions may occur. Avoid accidental self-injection. In the case
of accidental self-injection, seek medical advice and show the package
leaflet or the label to the physician.
Health Products Regulatory Authority
17 February 2021
CRN00C174
Page 2 of 4
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