Palladia
Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Upplýsingar fylgiseðill
(PIL)
30-03-2021
Vara einkenni
(SPC)
30-03-2021
Opinber matsskýrsla
(PAR)
05-06-2013
Virkt innihaldsefni:
toceranib
Fáanlegur frá:
Zoetis Belgium SA
ATC númer:
QL01EX90
INN (Alþjóðlegt nafn):
toceranib
Meðferðarhópur:
Dogs
Lækningarsvæði:
Antineoplastic agents
Ábendingar:
Treatment of non-resectable Patnaik grade-II (intermediate-grade) or -III (high-grade), recurrent, cutaneous mast-cell tumours in dogs.
Vörulýsing:
Revision: 10
Leyfisstaða:
Authorised
Leyfisdagur:
2009-09-23
Upplýsingar fylgiseðill
17
B. PACKAGE LEAFLET
18
PACKAGE LEAFLET:
PALLADIA 10 MG FILM-COATED TABLETS FOR DOGS.
PALLADIA 15 MG FILM-COATED TABLETS FOR DOGS.
PALLADIA 50 MG FILM-COATED 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 the batch release:
Pfizer Italia s.r.l.
Località Marino del Tronto
63100 Ascoli Piceno (AP)
ITALY
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Palladia 10 mg film-coated tablets for dogs.
Palladia 15 mg film-coated tablets for dogs.
Palladia 50 mg film-coated tablets for dogs.
toceranib.
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each film-coated tablet contains toceranib phosphate equivalent to 10
mg, 15 mg or 50 mg of
toceranib as active substance.
Each tablet also contains lactose monohydrate, cellulose
microcrystalline, magnesium stearate, silica
colloidal anhydrous and Crospovidone.
Palladia are round tablets and have a coloured film coat to minimise
risk of exposure and to help
identify the correct tablet strength.
Palladia 10 mg: blue
Palladia 15 mg: orange
Palladia 50 mg: red
4.
INDICATION(S)
Treatment of non-resectable Patnaik grade II (intermediate grade) or
III (high grade), recurrent,
cutaneous mast cell tumours.
19
5.
CONTRAINDICATIONS
Do not use in pregnant or lactating bitches or in dogs intended for
breeding.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
Do not use in dogs less than 2 years of age or less than 3 kg
bodyweight.
Do not use in dogs with evidence of stomach bleeding. Your
veterinarian will advise you if this is the
case for your dog.
6.
ADVERSE REACTIONS
Results from the clinical field study involving 151 treated and
placebo-treated dogs showed that the
clinical signs of the disease (mast cell tumour) and treatment related
adverse reactions are very similar
in nature.
Some
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Vara einkenni
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Palladia 10 mg film-coated tablets for Dogs
Palladia 15 mg film-coated tablets for Dogs
Palladia 50 mg film-coated tablets for Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each film-coated tablet contains toceranib phosphate equivalent to 10
mg, 15 mg or 50 mg of
toceranib.
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
Palladia 10 mg: Round shaped, blue coloured tablets
Palladia 15 mg: Round shaped, orange coloured tablets
Palladia 50 mg: Round shaped, red coloured tablets
Each tablet is marked with the strength (10, 15 or 50) on one side,
the reverse side is blank.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of non-resectable Patnaik grade II (intermediate grade) or
III (high grade), recurrent,
cutaneous mast cell tumours in dogs
.
4.3
CONTRAINDICATIONS
Do not use in pregnant or lactating bitches or in dogs intended for
breeding.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
Do not use in dogs less than 2 years of age or less than 3 kg body
weight.
Do not use in dogs with gastrointestinal bleeding.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
For any mast cell tumour treatable by surgery, surgery should be the
first choice of treatment.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Dogs should be carefully monitored. Dose reductions and/or dose
interruptions may be needed to
manage adverse events. Treatment should be reviewed weekly for the
first six weeks and every six
3
weeks thereafter or at intervals deemed appropriate by the
veterinarian. Evaluations should include
assessment of clinical signs reported by the pet owner.
To appropriately use the dose adjustment table it is advised that a
complete blood cell count, serum
chemistry panel and urinalysis be conducted prior to initiation of
treatment and
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