Zubrin
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
08-05-2012
Charakterystyka produktu
(SPC)
08-05-2012
Sprawozdanie z oceny publicznego
(PAR)
08-05-2012
Składnik aktywny:
tepoxalin
Dostępny od:
Intervet International B. V.
Kod ATC:
QM01AE92
INN (International Nazwa):
tepoxalin
Grupa terapeutyczna:
Dogs
Dziedzina terapeutyczna:
Musculo-skeletal system
Wskazania:
Reduction of inflammation and relief of pain caused by acute and chronic musculoskeletal disorders.
Podsumowanie produktu:
Revision: 13
Status autoryzacji:
Withdrawn
Data autoryzacji:
2001-03-13
Ulotka dla pacjenta
17
B. PACKAGE LEAFLET
Medicinal product no longer authorised
18
PACKAGE LEAFLET
Zubrin oral lyophilisates 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:
Intervet International B. V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
MANUFACTURER FOR THE BATCH RELEASE:
S-P Veterinary Ltd
Breakspear Road South
Harefield
Uxbridge UB9 6LS
United Kingdom
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Zubrin 50 mg oral lyophilisates for dogs
Zubrin 100 mg oral lyophilisates for dogs
Zubrin 200 mg oral lyophilisates for dogs
3.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
ACTIVE SUBSTANCE
Tepoxalin
50 mg / oral lyophilisate
Tepoxalin
100 mg / oral lyophilisate
Tepoxalin
200 mg / oral lyophilisate
4.
INDICATIONS
Reduction of inflammation and relief of pain caused by acute and
chronic musculoskeletal disorders.
5.
CONTRAINDICATIONS
Do not use if your dog
•
is pregnant or lactating or in bitches intended for breeding
•
has cardiac or hepatic disease
•
has had gastrointestinal ulceration or bleeding
•
is hypersensitive to the product
•
is dehydrated, hypovolaemic or hypotensive, as there is an increased
risk of renal toxicity.
Medicinal product no longer authorised
19
6.
ADVERSE REACTIONS
Vomiting or diarrhoea may occur due to treatment. Alopecia and
erythema may also occur
occasionally.
Typical undesirable side-effects associated with NSAIDs are vomiting,
soft faeces/diarrhoea, blood in
faeces, reduced appetite, lethargy and renal disorders. If there are
such undesirable effects, treatment
should be discontinued immediately. In rare cases, particularly in
older or in sensitive dogs, these
undesirable effects may be serious or fatal.
During clinical trial testing of the product, the incidence of
gastrointestinal reactions
(diarrhoea/vomiting) occurred in 1 out of 10 animals.
If you notice any other side effects, please inform your veterinary
surgeon.
7.
TARGET S
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Zubrin 50 mg oral lyophilisates for dogs
Zubrin 100 mg oral lyophilisates for dogs
Zubrin 200 mg oral lyophilisates for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
Tepoxalin
50 mg / oral lyophilisate
Tepoxalin
100 mg / oral lyophilisate
Tepoxalin
200 mg / oral lyophilisate
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral lyophilisates
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE
Reduction of inflammation and relief of pain caused by acute and
chronic musculoskeletal disorders.
4.3
CONTRAINDICATIONS
Do not use in pregnant or lactating dogs or in bitches intended for
breeding.
Use is contraindicated in animals suffering from cardiac or hepatic
disease, or where there is a history
of gastrointestinal ulceration, or bleeding, or where there is
hypersensitivity to the product.
Do not use in dehydrated, hypovolaemic or hypotensive dogs, as there
is an increased risk of renal
toxicity.
4.4
SPECIAL WARNINGS
Special care should be taken when treating dogs with marked renal
insufficiency.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Use in animals less than 6 months of age, with a weight below 5 kg, or
in aged animals, may involve
additional risk. If such use cannot be avoided, close veterinary
supervision to monitor for
gastrointestinal blood loss is necessary.
If side effects occur, treatment should be discontinued and the advice
of a veterinary surgeon should
be sought.
The recommended dose should not be exceeded.
Medicinal product no longer authorised
3
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
MEDICINAL PRODUCT TO ANIMALS
Tepoxalin is not water-soluble and becomes very sticky upon wetting.
If the oral lyophilisate
disintegrates prematurely, wash hands thoroughly.
In case of ingestion of a number of oral lyophilisates by a person,
the advice of a doctor should be
sought
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