Meloxivet

מדינה: האיחוד האירופי

שפה: אנגלית

מקור: EMA (European Medicines Agency)

מרכיב פעיל:

meloxicam

זמין מ:

Eli Lilly and Company Limited 

קוד ATC:

QM01AC06

INN (שם בינלאומי):

meloxicam

קבוצה תרפויטית:

Dogs

איזור תרפויטי:

Musculo-skeletal system

סממני תרפויטית:

Alleviation of inflammation and pain in both acute and chronic musculoskeletal disorders.

leaflet_short:

Revision: 5

מצב אישור:

Withdrawn

תאריך אישור:

2007-11-14

עלון מידע

Medicinal product no longer authorised
24
B. PACKAGE LEAFLET
Medicinal product no longer authorised
25
PACKAGE LEAFLET FOR:
MELOXIVET 0.5 MG/ML ORAL SUSPENSION 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:
Eli Lilly and Company Limited
Elanco Animal Health
Lilly House, Priestley Road
Basingstoke
Hampshire RG24 9NL
United Kingdom
Manufacturer for the batch release
:
Lusomedicamenta S.A.
Estrada Consiglieri Pedroso, 69 B Queluz de Baixo
2730-055 Barcarena
Portugal
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Meloxivet 0.5 mg/ml oral suspension for dogs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
One ml contains:
Meloxicam
0.5 mg
Sodium benzoate
1 mg
4.
INDICATION(S)
Alleviation of inflammation and pain in both acute and chronic
musculo-skeletal disorders in dogs.
5.
CONTRAINDICATIONS
Do not administer Meloxivet:
- if your dog is pregnant or during lactation
-
if your dog is suffering from gastrointestinal disorders such as
irritation and haemorrhage, impaired
hepatic, cardiac or renal function and haemorrhagic disorders
-
if your dog is hypersensitive (allergic) to the active substance or to
any of the other ingredients.
-
if your dogs is less than 6 weeks of age
6.
ADVERSE REACTIONS
Typical adverse reactions of non-steroidal anti-inflammatory drugs
(NSAIDs) such as loss of appetite,
vomiting, diarrhoea, faecal occult blood, lethargy and renal failure
have occasionally been reported.
Medicinal product no longer authorised
26
These side effects occur generally within the first treatment week and
are in most cases transient and
disappear following termination of the treatment but in very rare
cases may be serious or fatal.
In very rare cases haemorrhagic diarrhoea, haematemisis,
gastrointestinal ulceration and elevated liver
enzymes have been reported.
If you notice any serious effects or other effects not mentioned in
this leaflet, please inform your
veteri

מאפייני מוצר

Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Meloxivet 0.5 mg/ml oral suspension for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains
ACTIVE SUBSTANCE:
Meloxicam
0.5 mg
EXCIPIENT:
Sodium benzoate
1 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension. White to yellowish opaque suspension.
_ _
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Alleviation of inflammation and pain in both acute and chronic
musculo-skeletal disorders in dogs.
4.3
CONTRAINDICATIONS
Do not use in pregnant or lactating dogs.
Do not use in dogs suffering from gastrointestinal disorders such as
irritation and haemorrhage,
impaired hepatic, cardiac or renal function and haemorrhagic
disorders.
Do not use in case of hypersensitivity to the active substance or to
any of the excipients.
Do not use in dogs less than 6 weeks of age.
4.4
SPECIAL WARNINGS
None.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Avoid use in any dehydrated, hypovolaemic or hypotensive dog, as there
is a potential risk of renal
toxicity.
Medicinal product no longer authorised
3
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO
ANIMALS
People with known hypersensitivity to Non-Steroidal Anti-Inflammatory
Drugs (NSAIDs) should
avoid contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and
show the package leaflet or the
label to the physician.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Typical adverse reactions of NSAIDs such as loss of appetite,
vomiting, diarrhoea, faecal occult blood,
lethargy and renal failure have occasionally been reported. In very
rare cases haemorrhagic diarrhoea,
haematemisis, gastrointestinal ulceration and elevated liver enzymes
have been reported.
These side effects occur generally