Rycarfa 50 mg/ml solution for injection for dogs and cats

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Carprofen

MAH:

Krka, d.d., Novo mesto

ATC_code:

QM01AE91

INN:

Carprofen

dosage:

50 milligram(s)/millilitre

pharmaceutical_form:

Solution for injection

prescription_type:

POM: Prescription Only Medicine as defined in relevant national legislation

therapeutic_group:

Cats, Dogs

therapeutic_area:

carprofen

therapeutic_indication:

N.S.A.I.D.

authorization_status:

Authorised

authorization_date:

2014-07-11

SPC

Health Products Regulatory Authority
02 November 2018
CRN000YDW
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Rycarfa 50 mg/ml solution for injection for dogs and cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
Each ml contains:
​
​
​
ACTIVE SUBSTANCE:
​
​
​
Carprofen
50​
mg​
​
EXCIPIENT:
​
​
​
Benzyl alcohol (E1519)
10​
mg​
​
For the full list of excipients, see section 6.1.
​
​
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, pale yellow coloured solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Dogs: For the control of post-operative pain and inflammation
following orthopaedic
and soft tissue (including intraocular) surgery.
Cats: For the control of post-operative pain following surgery.
4.3 CONTRAINDICATIONS
Do not use in animals suffering from cardiac, hepatic or renal disease
or
gastrointestinal problems, where there is a possibility of
gastrointestinal ulceration or
bleeding, or hypersensitivity to carprofen or any other NSAIDs or any
excipients of
this product.
Do not administer by intramuscular injection.
Do not use after surgery which was associated with considerable blood
loss.
Do not use in cats on repeated occasions.
Do not use in cats less than 5 months of age.
Do not use in dogs less than 10 weeks of age.
Health Products Regulatory Authority
02 November 2018
CRN000YDW
Page 2 of 6
See also section 4.7.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Do not exceed the recommended dose or duration of treatment.
Due to the longer half life in cats and narrower therapeutic index,
particular care
should be taken not to exceed the recommended dose and the dose should
not be
repeated.
Use in aged dogs and cats may involve additional risk.
If such use cannot be avoided, such animals may require a reduced
dosage and
careful clinical management.
Avoid use in any dehydrated, hypovol