Apovomin 3 mg/ml solution for injection for dogs

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Apomorphine hydrochloride hemihydrate

Boleh didapati daripada:

Le Vet Beheer B.V.

Kod ATC:

QN04BC07

INN (Nama Antarabangsa):

Apomorphine hydrochloride hemihydrate

Dos:

3 milligram(s)/millilitre

Borang farmaseutikal:

Solution for injection

Jenis preskripsi:

VPO: Veterinary Practitioner Only as defined in relevant national legislation

Kumpulan terapeutik:

Dogs

Kawasan terapeutik:

apomorphine

Tanda-tanda terapeutik:

Neurological Preparations

Status kebenaran:

Authorised

Tarikh kebenaran:

2018-03-16

Ciri produk

Health Products Regulatory Authority
23 March 2018
CRN000TVW
Page 1 of 5
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Apovomin 3 mg/ml solution for injection for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
1 ml contains:
​
ACTIVE SUBSTANCE:
​
​
Apomorphine hydrochloride hemihydrate
​
3 mg
​
(equivalent to apomorphine
​
2.56 mg)
​
EXCIPIENTS:
​
​
Benzyl alcohol (E1519)
​
10 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless aqueous solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Induction of emesis.
4.3 CONTRAINDICATIONS
Do not use in case of depression of the Central Nervous System (CNS).
Use is contra-indicated in cats.
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
Do not exceed the recommended dosage. If emesis is not induced
following a single
injection, repeated injections will also prove ineffective and should
not be given.
Health Products Regulatory Authority
23 March 2018
CRN000TVW
Page 2 of 5
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
None.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
This product may cause hypersensitivity reactions. People with known
hypersensitivity to apomorphine or any of the excipients should avoid
contact with
the veterinary medical product.
Pregnant women should take particular care when handling this product,
as potential
risks associated with exposure during pregnancy are unknown.
Wash hands after use.
Avoid accidental self-injection as this product may cause yawning,
dizziness, nausea,
somnolence or dyskinesia.
In case of accidental self–injection, seek medical advice
immediately and show the
package leaflet or the label to the physician. DO NOT DRIVE, as
sedation may occur
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
At higher doses apomorp