Trocoxil

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

mavacoxib

MAH:

Zoetis Belgium SA

ATC_code:

QM01AH92

INN:

mavacoxib

therapeutic_group:

Dogs

therapeutic_area:

Anti inflammatory and antirheumatic products

therapeutic_indication:

For the treatment of pain and inflammation associated with degenerative joint disease in dogs in cases where continuous treatment exceeding one month is indicated.

leaflet_short:

Revision: 10

authorization_status:

Authorised

authorization_date:

2008-09-09

PIL

15
B. PACKAGE LEAFLET
16
PACKAGE LEAFLET:
TROCOXIL 6 MG CHEWABLE TABLETS FOR DOGS
TROCOXIL 20 MG CHEWABLE TABLETS FOR DOGS
TROCOXIL 30 MG CHEWABLE TABLETS FOR DOGS
TROCOXIL 75 MG CHEWABLE TABLETS FOR DOGS
TROCOXIL 95 MG CHEWABLE TABLETS FOR DOGS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIUM
Manufacturer responsible for batch release:
Pfizer Italia s.r.l.
Località Marino del Tronto
63100 Ascoli Piceno (AP)
ITALY
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Trocoxil 6 mg chewable tablets for dogs
Trocoxil 20 mg chewable tablets for dogs
Trocoxil 30 mg chewable tablets for dogs
Trocoxil 75 mg chewable tablets for dogs
Trocoxil 95 mg chewable tablets for dogs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
ACTIVE SUBSTANCE:
Mavacoxib
6 mg
Mavacoxib
20 mg
Mavacoxib
30 mg
Mavacoxib
75 mg
Mavacoxib
95 mg
Tablets also contain the following ingredients:
Sucrose
Silicified microcrystalline cellulose
Artificial powdered beef flavour
Croscarmellose sodium
Sodium laurylsulfate
Magnesium stearate
Triangular tablet with mottled brown appearance embossed with the
tablet strength on one side, the
reverse side is blank.
17
4.
INDICATION(S)
Trocoxil chewable tablets are indicated for the treatment of pain and
inflammation associated with
degenerative joint disease in dogs where treatment for more than one
month is needed.
Trocoxil belongs to a group of medicines called Non-steroidal
Anti-inflammatory drugs (NSAIDs)
which are used to treat pain and inflammation.
5.
CONTRAINDICATIONS
Do not use in dogs less than 12 months of age and/or less than 5 kg
body weight.
Do not use in dogs suffering from gastro-intestinal disorders
including ulceration and bleeding.
Do not use where there is evidence of a haemorrhagic disorder.
Do not use in cases of impaired kidney or liver function.
Do not use in cases of heart insufficiency.

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Trocoxil 6 mg chewable tablets for dogs
Trocoxil 20 mg chewable tablets for dogs
Trocoxil 30 mg chewable tablets for dogs
Trocoxil 75 mg chewable tablets for dogs
Trocoxil 95 mg chewable tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains:
ACTIVE SUBSTANCE:
Mavacoxib
6 mg
Mavacoxib
20 mg
Mavacoxib
30 mg
Mavacoxib
75 mg
Mavacoxib
95 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablets
Triangular tablet with mottled brown appearance embossed with the
tablet strength on one side, the
reverse side is blank.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs aged 12 months or more.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of pain and inflammation associated with
degenerative joint disease in dogs in cases
where continuous treatment exceeding one month is indicated.
4.3
CONTRAINDICATIONS
Do not use in dogs less than 12 months of age and/or less than 5 kg
body weight
Do not use in dogs suffering from gastro-intestinal disorders
including ulceration and bleeding.
Do not use where there is evidence of a haemorrhagic disorder.
Do not use in cases of impaired renal or hepatic function
Do not use in cases of cardiac insufficiency
Do not use in pregnant, breeding or lactating dogs.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients
Do not use in case of known hypersensitivity to sulphonamides.
Do not use concomitantly with glucocorticoids or other Non-Steroidal
Anti-Inflammatory Drugs
(NSAIDs), see section 4.8.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as
there is a potential risk of increased
renal toxicity.
3
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Do not administer other NSAIDs or glucocorticoids concurrently or
within 1 month of the last
administration of Trocoxil.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Mavacoxib exhibits an ex