Carprogesic 100 mg Tablets for Dogs

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Carprofen

Disponibil de la:

Norbrook Laboratories (Ireland) Limited

Codul ATC:

QM01AE91

INN (nume internaţional):

Carprofen

Dozare:

100 mg/tablet

Forma farmaceutică:

Tablet

Tip de prescriptie medicala:

POM: Prescription Only Medicine as defined in relevant national legislation

Zonă Terapeutică:

carprofen

Statutul autorizaţiei:

Authorised

Data de autorizare:

2010-11-26

Caracteristicilor produsului

Health Products Regulatory Authority
07 February 2019
CRN008VR5
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Carprogesic 100 mg Tablets for Dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Active Ingredient:
Carprofen
100 mg
Excipients:
Tartrazine (E102)
1.2 mg
For the full list of excipients, see Section 6.1
3 PHARMACEUTICAL FORM
Tablet.
A yellow circular tablet of 8 mm diameter, embossed “100” on one
side and a single
breakline on the other side.
The tablets can be divided into halves.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In the dog:
Reduction of inflammation and pain caused by musculoskeletal disorders
and
degenerative joint disease. As a follow up to parenteral analgesia in
the management
of post operative pain.
4.3 CONTRAINDICATIONS
Do not use in cats.
Do not use in pregnant or lactating bitches.
Do not use in puppies less than 4 months of age.
Health Products Regulatory Authority
07 February 2019
CRN008VR5
Page 2 of 5
Do not use in animals with known hypersensitivity to the active
substance or to any
of the excipients
Do not use in dogs suffering from cardiac, hepatic or renal disease,
where there is a
possibility of gastrointestinal ulceration or bleeding, or where there
is evidence of a
blood dyscrasia.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Refer to Sections 4.3 and 4.5.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Use in aged dogs may involve additional risk.
If such a use cannot be avoided, such dogs may require a reduced
dosage and
careful clinical management.
Avoid use in any dehydrated, hypoproteinemic, hypovolaemic or
hypotensive dog, as
there is a potential risk of increased renal toxicity.
NSAIDs can cause inhibition of phagocytosis and hence in the treatment
of
inflammatory conditions associated with bacterial infection,
appropriate concurrent
antimicrobial therapy should be instigated.
Refer to section 4.8.
SPECIAL PRECAUTIONS TO