Clevor

Ülke: Avrupa Birliği

Dil: İngilizce

Kaynak: EMA (European Medicines Agency)

Aktif bileşen:

ropinirole hydrochloride

Mevcut itibaren:

Orion Corporation

ATC kodu:

QN04BC04

INN (International Adı):

ropinirole

Terapötik grubu:

Dogs

Terapötik alanı:

Dopaminergic agents, Dopamine agonists

Terapötik endikasyonlar:

Induction of vomiting in dogs.,

Ürün özeti:

Revision: 1

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2018-04-13

Bilgilendirme broşürü

17
B. PACKAGE LEAFLET
18
PACKAGE LEAFLET:
CLEVOR 30 MG/ML EYE DROPS, SOLUTION IN SINGLE-DOSE CONTAINER FOR DOGS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND
OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR
BATCH RELEASE, IF DIFFERENT
Orion Corporation
Orionintie 1
FI-02200 Espoo
FINLAND
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Clevor 30 mg/ml eye drops, solution in single-dose container for dogs
Ropinirole (ropinirol)
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Clevor is a very slightly yellow to yellow clear solution containing
30 mg/ml ropinirole, equivalent to
34.2 mg/ml ropinirole hydrochloride.
4.
INDICATION(S)
For induction of vomiting in dogs.
5.
CONTRAINDICATIONS
Your dog must not be given this medicine if it:
-
has decreased consciousness, seizures or other similar neurologic
symptoms or difficulties in
breathing or swallowing that could make the dog inhale a part of the
vomit potentially causing
aspiration pneumonia
-
has ingested sharp foreign objects, acids or alkalis (e.g. drain or
toilet bowl cleaners, household
detergents, battery fluids), volatile substances (e.g. petroleum
products, essential oils, air
fresheners) or organic solvents (e.g. antifreeze, windshield wiper
fluids, nail polish remover)
-
is hypersensitive to ropinirole or to any of the excipients.
6.
ADVERSE REACTIONS
This veterinary medicinal product may cause the following adverse
reactions:
Very common reactions: temporary mild or moderate redness of the eye,
increased tear production,
increased visibility of the third eyelid and/or squinting; temporary
mild tiredness and/or increased heart
rate.
Common reactions: temporary, mild swelling of the mucous membranes of
the eyelids, itching of the
eyes, rapid breathing, shivering, diarrhoea and/or irregular or
uncoordinated bodily movements.
19
Extended vomiting (for more than 60 minutes) which should be evaluated
by the responsible
veterinarian as it might need appropriate treatment.
In dogs with protracted vomiting (more than 60 minutes)

Ürün özellikleri

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Clevor 30 mg/ml eye drops, solution in single-dose container for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains:
ACTIVE SUBSTANCE:
Ropinirole (ropinirol)
30 mg
(equivalent to 34.2 mg ropinirole hydrochloride)
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops solution in single-dose container.
Very slightly yellow to yellow clear solution.
pH 3.8–4.5 and osmolality 300–400 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Induction of vomiting in dogs.
4.3
CONTRAINDICATIONS
Do not use in dogs with depression of the central nervous system,
seizures or other marked neurologic
impairments that could lead to aspiration pneumonia.
Do not use in dogs which are hypoxic, dyspnoeic or lacking pharyngeal
reflexes.
Do not use in cases of the ingestion of sharp foreign objects,
corrosive agents (acids or alkalis), volatile
substances or organic solvents.
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
The efficacy of the veterinary medicinal product has not been
established in dogs weighing less than
1.8 kg, or in dogs under 4.5 months of age or in elderly dogs. Use
only according to the benefit-risk
assessment by the responsible veterinarian.
Based on the clinical trial results, most dogs are expected to respond
to a single dose of the veterinary
medicinal product; however, a small proportion of dogs will require a
second dose to induce vomiting.
A very small proportion of dogs may fail to respond to the treatment
despite administration of a second
dose. It is not recommended to administer further doses to these dogs.
Please refer to sections 4.9 and
5.1 for further information.
3
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
This veterinary medicinal product may cause a transient in