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Meloxivet

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Summary for the public


What is Meloxivet?

Meloxivet is a white to yellowish opaque oral suspension which is to be given mixed with food. Meloxivet contains the active substance meloxicam and exists in 2 different strengths (0.5 and 1.5 mg/ml, respectively). Meloxivet is a ‘generic’: this means that Meloxivet is similar to a ‘reference veterinary medicine’ already authorised in the EU (Metacam 1.5 mg/ml oral suspension). Studies have been carried out to prove that Meloxivet is ‘bioequivalent’ to the reference veterinary medicine: this means that Meloxivet is equivalent to Metacam 1.5 mg/ml suspension in the way it is absorbed and used by the body.


What is Meloxivet used for?

Meloxivet is used in dogs to relieve inflammation and pain in musculo-skeletal disorders. It can be used for both acute disorders, such as those seen after an injury, and chronic (long term) disorders.

Meloxivet is given to the dog once a day, with food, at the dose of 0.2 mg/kg on the first day, then as 0.1 mg/kg afterwards. The amount of suspension to be used is measured using a special dosing syringe (provided in the package), and poured on the food.


How does Meloxivet work?

Meloxivet contains meloxicam, which belongs to a class of medicines called nonsteroidal antiinflammatory drugs (NSAIDs). Meloxicam acts by inhibition of prostaglandin synthesis. As the prostaglandins are substances that trigger inflammation, pain, exudation and fever, meloxicam reduces those responses.


How has the effectiveness of Meloxivet been studied?

A study looked at how Meloxivet was absorbed and its effects in the body, in comparison with Metacam 1.5 mg/ml oral suspension.


What are the side-effects of Meloxivet?

Occasional side effects of Meloxivet are those seen with NSAIDs, such as loss of appetite, vomiting, diarrhoea, blood appearing in the stools and apathy (lack of vitality).

These side effects occur usually within the first week of treatment and are generally transient (temporary). They disappear once treatment has stopped. In very rare cases, they may be serious or fatal.


What are the precautions for the person who gives the medicine or comes into contact with the animal?

People who are hypersensitive (allergic) to NSAIDs should avoid contact with Meloxivet.

If the product is swallowed by a person, the advice of a doctor should be sought immediately.


Why has Meloxivet been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) considered that, in accordance with European Union requirements, Meloxivet has been shown to be bioequivalent to Metacam 1.5 mg/ml oral suspension. Therefore the CVMP’s view was that, as for Metacam 1.5 mg/ml oral suspension, Meloxivet’s benefits are greater than its risks when treating inflammation or pain in muscles or joints in dogs and they recommended that Meloxivet should be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.


Other information about Meloxivet

The European Commission granted a marketing authorisation valid throughout the European Union, for Meloxivet to Janssen Pharmaceutica N.V. on 14 November 2007 Information on the prescription status of this product may be found on the label of the carton.

Authorisation details
Name: Meloxivet
EMEA Product number: EMEA/V/C/000124
Active substance: meloxicam
INN or common name: Meloxicam
Species: Dogs
ATCvet Code: QM01AC06
Generic: A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.
Marketing Authorisation Holder: Janssen Pharmaceutica N.V.
Revision: 2
Date of issue of Market Authorisation valid throughout the European Union: 14/11/2007
Contact address:
Janssen Pharmaceutica N.V.
Turnhoutseweg 30
B-2340 Beerse
Belgium



Product Characteristics

ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS


1.
NAME OF VETERINARY THE MEDICINAL PRODUCT
Meloxivet 0.5 mg/ml oral suspension for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition for 1 ml:
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.
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
If side effects occur, treatment should be discontinued and the advice of the veterinarian should be
sought. Avoid use in any dehydrated, hypovolaemic or hypotensive dog, as there is a potential risk
of increased renal toxicity.
2/29
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 and apathy have occasionally been reported.
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.
4.7 Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and lactation
(see section 4.3).
4.8 Interaction with other medicinal products and other forms of interaction
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Meloxivet must not be administered in
conjunction with other NSAIDs or glucocorticosteroids.
Pre- treatment with anti-inflammatory substances may result in additional or increased adverse
reactions and accordingly a treatment-free period with such should be observed for at least 24 hours
before commencement of treatment. The treatment-free period, however, should take into account the
pharmacokinetic properties of veterinary products used previously.
4.9 Amounts to be administered and administration route
Oral use.
Shake well before use.
To be administered with food.
Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is to
be continued once daily by oral administration (24 hour intervals) at a maintenance dose of 0.1 mg
meloxicam/kg body weight.
Particular care should be taken with regard to the accuracy of dosing.
The suspension has to be given with the measuring syringe provided in the package. The syringe fits
onto the bottle and has a kg-body weight scale which corresponds to the maintenance dose (ie. 0.1 mg
meloxicam/kg body weight). Thus for the first day, twice the maintenance volume will be required.
A clinical response is normally seen within 3 - 4 days. Treatment should be discontinued after 10 days
at the latest if no clinical improvement is apparent.
Avoid introduction of contamination during use.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
In case of overdose symptomatic treatment should be initiated.
4.11 Withdrawalperiod(s)
Not applicable.
3/29
5.
PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Anti-inflammatory and Antirheumatic products, Non-steroids,ATCvet
code: QM01AC06
5.1 Pharmacodynamic properties
Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative
and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it
also inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that
meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).
5.2 Pharmacokinetic particulars
Absorption
Meloxicam is completely absorbed following oral administration and maximal plasma concentrations
are obtained after approximately 6.1 hours. When the product is used according to the recommended
dosage regime, steady state concentrations of meloxicam in plasma are reached on the second day of
treatment.
Distribution
There is a linear relationship between the dose of meloxicam administered and plasma concentration
observed in the therapeutic dose range. Approximately 97 % of meloxicam is bound to plasma
proteins. The volume of distribution is 0.3 1/kg.
Metabolism
Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas
urine contains only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid
derivative and to several polar metabolites. All major metabolites have been shown to be
pharmacologically inactive.
Elimination
Meloxicam is eliminated with a half-life of 24 hours. Approximately 75 % of the administered dose of
meloxicam is eliminated via faeces and the remainder via urine.
6.
PHARMACEUTICAL PARTICULARS
6.1 List of excipients
microcrystalline cellulose
xanthan gum
carboxymethylcellulose
sodium benzoate
sodium saccharinate
glycerol
sorbitol
citric acid monohydrate
sodium hydroxide
purified water
6.2 Incompatibilities
None known.
4/29
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 6 months.
6.4. Specialprecautionsforstorage
This veterinary medicinal product does not require any special storage conditions .
6.5 Nature and composition of immediate packaging
10 ml: amber glass bottle (type III) with polyethylene child resistant closure, polyethylene insert and
amber polypropylene dosing syringe.
30 ml: amber glass bottle (type III) with polypropylene child resistant closure, polyethylene insert and
amber polypropylene dosing syringe.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
7.
MARKETING AUTHORISATION HOLDER
Janssen Pharmaceutica N.V.
Turnhoutseweg 30
B-2340 Beerse, Belgium
Tel: +32(0)14.60.21.11
Fax: +32(0)14.60.21.00
8.
MARKETING AUTHORISATION NUMBER(S)
EU/2/07/077/001
EU/2/07/077/002
9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
14/11/2007
10. DATE OF REVISION OF THE TEXT
12/11/2009
Detailed information on this product is available on the website of the European Medicines Agency
(EMEA) http://www.emea.europa.eu/.
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
5/29
1.
NAME OF VETERINARY THE MEDICINAL PRODUCT
Meloxivet 1.5 mg/ml oral suspension for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition for 1 ml:
Active substance:
Meloxicam
1.5 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.
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
If side effects occur, treatment should be discontinued and the advice of the veterinarian should be
sought. Avoid use in any dehydrated, hypovolaemic or hypotensive dog, as there is a potential risk
of increased renal toxicity.
6/29
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 and apathy have occasionally been reported.
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.
4.7 Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and
lactation (see section 4.3).
4.8 Interaction with other medicinal products and other forms of interaction
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Meloxivet must not be administered in
conjunction with other NSAIDs or glucocorticosteroids.
Pre- treatment with anti-inflammatory substances may result in additional or increased adverse
reactions and accordingly a treatment-free period with such should be observed for at least 24 hours
before commencement of treatment. The treatment-free period, however, should take into account the
pharmacokinetic properties of veterinary products used previously.
4.9 Amounts to be administered and administration route
Oral use.
Shake well before use.
To be administered with food.
Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is to
be continued once daily by oral administration (24 hour intervals) at a maintenance dose of 0.1 mg
meloxicam/kg body weight.
Particular care should be taken with regard to the accuracy of dosing.
The suspension has to be given with the measuring syringes provided in the package of the 30 ml and
150 ml pack size or with one of the two measuring syringes provided in the package of the 10 ml pack
size. The syringe fits onto the bottle and has a kg-body weight scale which corresponds to the
maintenance dose (ie. 0.1 mg meloxicam/kg body weight). Thus for the first day, twice the
maintenance volume will be required.
The suspension of the 10 ml pack size could be administered using the smallest syringe for dogs less
than 8 kg body weight (one graduation corresponding to 0.5 kg of body weight) or the largest syringe
for dogs over than 8 kg body weight (one graduation corresponding to 2.0 kg of body weight).
A clinical response is normally seen within 3 - 4 days. Treatment should be discontinued after 10 days
at the latest if no clinical improvement is apparent.
Avoid introduction of contamination during use.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
In case of overdose symptomatic treatment should be initiated.
7/29
4.11 Withdrawalperiod(s)
Not applicable.
5.
PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Anti-inflammatory and Antirheumatic products, Non-steroids,ATCvet
code: QM01AC06
5.1 Pharmacodynamic properties
Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative
and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it
also inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that
meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).
5.2 Pharmacokinetic particulars
Absorption
Meloxicam is completely absorbed following oral administration and maximal plasma concentrations
are obtained after approximately 6.1 hours. When the product is used according to the recommended
dosage regime, steady state concentrations of meloxicam in plasma are reached on the second day of
treatment.
Distribution
There is a linear relationship between the dose of meloxicam administered and plasma concentration
observed in the therapeutic dose range. Approximately 97 % of meloxicam is bound to plasma
proteins. The volume of distribution is 0.3 1/kg.
Metabolism
Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas
urine contains only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid
derivative and to several polar metabolites. All major metabolites have been shown to be
pharmacologically inactive.
Elimination
Meloxicam is eliminated with a half-life of 24 hours. Approximately 75 % of the administered dose of
meloxicam is eliminated via faeces and the remainder via urine.
6.
PHARMACEUTICAL PARTICULARS
6.1 List of excipients
microcrystalline cellulose
xanthan gum
carboxymethylcellulose
sodium benzoate
sodium saccharinate
glycerol
sorbitol
citric acid monohydrate
sodium hydroxide
purified water
8/29
6.2 Incompatibilities
None known.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 6 months.
6.4. Special precautions for storage
This veterinary medicinal product does not require any special storage conditions .
6.5 Nature and composition of immediate packaging
10 ml presentation: amber glass bottle (type III) with polyethylene child resistant closure, polyethylene
insert and clear polypropylene dosing syringe. Two measuring syringes are provided.
30 ml and 150 ml presentation: amber glass bottle (type III) with polypropylene child resistant closure,
polyethylene insert and clear polypropylene dosing syringe.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
7.
MARKETING AUTHORISATION HOLDER
Janssen Pharmaceutica N.V.
Turnhoutseweg 30
B-2340 Beerse, Belgium
Tel: +32(0)14.60.21.11
Fax: +32(0)14.60.21.00
8.
MARKETING AUTHORISATION NUMBER(S)
EU/2/07/077/003
EU/2/07/077/004
EU/2/07/077/005
9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
14/11/2007
10. DATE OF REVISION OF THE TEXT
12/11/2009
Detailed information on this product is available on the website of the European Medicines Agency
(EMEA) http://www.emea.europa.eu/.
9/29
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable
10/29
ANNEX II
A.
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR
BATCH RELEASE
B.
CONDITIONS OR RESTRICTIONS OF THE MARKETING
AUTHORISATION REGARDING SUPPLY OR USE
C.
CONDITIONS OR RESTRICTIONS OF THE MARKETING
AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
D.
STATEMENT OF THE MRLs
11/29
A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer(s) responsible for batch release
Lusomedicamenta S.A.
Estrada Consiglieri Pedroso, 69 B Queluz de Baixo
2730-055 Barcarena
Portugal
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
To be supplied only on veterinary prescription.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
Not applicable.
D. STATEMENT OF THE MRLs
Not applicable.
12/29
ANNEX III
LABELLING AND PACKAGE LEAFLET
13/29
A. LABELLING
14/29
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Carton box for bottle 10 and 30 ml
1.
NAME OF VETERINARY THE MEDICINAL PRODUCT
Meloxivet 0.5 mg/ml oral suspension for dogs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each ml contains:
Meloxicam
0.5 mg
3.
PHARMACEUTICAL FORM
Oral suspension
4.
PACKAGE SIZE
10 ml
30 ml
5.
TARGET SPECIES
Dogs
6.
INDICATION(S)
Acute and chronic musculo-skeletal disorders.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Read the package leaflet before use.
Shake well before use.
To be administered with food.
Avoid introduction of contamination during use.
8.
WITHDRAWAL PERIOD
Not applicable.
15/29
Sodium benzoate
1 mg
 
9.
SPECIAL WARNING(S), IF NECESSARY
Do not use in pregnant or lactating dogs
10. EXPIRY DATE
EXP
Once opened, use within 6 months.
11. SPECIAL STORAGE CONDITIONS
This veterinary medicinal product does not require any special storage conditions .
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Dispose of waste material in accordance with local requirements.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only - to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Janssen Pharmaceutica N.V.
Turnhoutseweg 30
B-2340 Beerse, Belgium
16. MARKETING AUTHORISATION NUMBER(S)
EU/2/07/077/001
10 ml
17. MANUFACTURER’S BATCH NUMBER
Lot
16/29
EU/2/07/077/002
30 ml
 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Label bottle 10 and 30 ml
1.
NAME OF VETERINARY THE MEDICINAL PRODUCT
Meloxivet 0.5 mg/ml oral suspension for dogs
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
Meloxicam 0.5 mg/ml
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
10 ml
30 ml
4.
ROUTE(S) OF ADMINISTRATION
Oral use.
To be administered with food.
5.
WITHDRAWAL PERIOD
Not applicable.
6.
BATCH NUMBER
Lot
7.
EXPIRY DATE
EXP
Once opened, use within 6 months.
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
17/29
 
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Carton box for bottle 10, 30 and 150 ml
1.
NAME OF VETERINARY THE MEDICINAL PRODUCT
Meloxivet 1.5 mg/ml oral suspension for dogs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each ml contains:
Meloxicam
1.5 mg
3.
PHARMACEUTICAL FORM
Oral suspension
4.
PACKAGE SIZE
10 ml
30 ml
150 ml
5.
TARGET SPECIES
Dogs
6.
INDICATION(S)
Acute and chronic musculo-skeletal disorders.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Read the package leaflet before use.
Shake well before use.
To be administered with food.
Avoid introduction of contamination during use.
8.
WITHDRAWAL PERIOD
Not applicable.
18/29
Sodium benzoate
1 mg
 
9.
SPECIAL WARNING(S), IF NECESSARY
Do not use in pregnant or lactating dogs
10. EXPIRY DATE
EXP
Once opened, use within 6 months.
11. SPECIAL STORAGE CONDITIONS
This veterinary medicinal product does not require any special storage conditions .
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Dispose of waste material in accordance with local requirements.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only - to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Janssen Pharmaceutica N.V.
Turnhoutseweg 30
B-2340 Beerse, Belgium
16. MARKETING AUTHORISATION NUMBER(S)
EU/2/07/077/003
10 ml
EU/2/07/077/004
30 ml
EU/2/07/077/005
150 ml
17. MANUFACTURER’S BATCH NUMBER
Lot
19/29
 
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
Label bottle 150 ml
1.
NAME OF VETERINARY THE MEDICINAL PRODUCT
Meloxivet 1.5 mg/ml oral suspension for dogs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each ml contains:
Meloxicam
1.5 mg
3.
PHARMACEUTICAL FORM
Oral suspension
4.
PACKAGE SIZE
150 ml
5.
TARGET SPECIES
Dogs
6.
INDICATION(S)
Acute and chronic musculo-skeletal disorders.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Read the package leaflet before use.
Shake well before use.
To be administered with food.
Avoid introduction of contamination during use.
8.
WITHDRAWAL PERIOD
Not applicable.
20/29
Sodium benzoate
1 mg
 
9.
SPECIAL WARNING(S), IF NECESSARY
Do not use in pregnant or lactating dogs
10. EXPIRY DATE
EXP
Once opened, use within 6 months.
11. SPECIAL STORAGE CONDITIONS
This veterinary medicinal product does not require any special storage conditions .
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Dispose of waste material in accordance with local requirements.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only - to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Janssen Pharmaceutica N.V.
Turnhoutseweg 30
B-2340 Beerse, Belgium
16. MARKETING AUTHORISATION NUMBER(S)
EU/2/07/077/005
17. MANUFACTURER’S BATCH NUMBER
Lot
21/29
 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Label bottle 10 and 30 ml
1.
NAME OF VETERINARY THE MEDICINAL PRODUCT
Meloxivet 1.5 mg/ml oral suspension for dogs
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
Meloxicam 1.5 mg/ml
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
10 ml
30 ml
4.
ROUTE(S) OF ADMINISTRATION
Oral use.
5.
WITHDRAWAL PERIOD
Not applicable.
6.
BATCH NUMBER
Lot
7.
EXPIRY DATE
EXP
Once opened, use within 6 months.
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
22/29
 
B. PACKAGE LEAFLET
23/29
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:
Janssen Pharmaceutica N.V.
Turnhoutseweg 30
B-2340 Beerse, Belgium
Manufacturer for the batch release :
Lusomedicamenta S.A.
Estrada Consiglieri Pedroso, 69 B Queluz de Baixo
2730-055 Barcarena
Portugal
2.
NAME OF VETERINARY THE MEDICINAL PRODUCT
Meloxivet 0.5 mg/ml oral suspension for dogs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each 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.
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 and apathy have occasionally been reported. 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.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
24/29
7.
TARGET SPECIES
Dogs.
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Oral use. To be administered with food .
The suspension has to be given with the measuring syringe provided in the package. The syringe fits
onto the bottle and has a kg-body weight scale which corresponds to the maintenance dose (ie. 0.1 mg
meloxicam/kg body weight). Thus for the first day, twice the maintenance volume will be required.
Dosage
Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is to
be continued once daily by oral administration (24 hour intervals) at a maintenance dose of 0.1 mg
meloxicam/kg body weight.
Route and method of administration
Shake bottle well.
Push down and
unscrew bottle top.
Attach the dosing
syringe to the bottle
by gently pushing the
end onto the top the
bottle
Turn the bottle
syringe upside down.
Pull the plunger out
until the black on the
plunger corresponds
to your dog’s
bodyweight in
kilograms.
Turn the bottle right
way up and with a
twisting movement
separate the dosing
syringe from the
bottle.
By pushing the
plunger in empty the
contents of the syringe
onto the food.
A clinical response is normally seen within 3 - 4 days. Treatment should be discontinued after 10 days
at the latest if no clinical improvement is apparent.
Avoid introduction of contamination during use.
9.
ADVICE ON CORRECT ADMINISTRATION
Particular care should be taken with regard to the accuracy of dosing. Please carefully follow the
instructions of the veterinarian.
10. WITHDRAWAL PERIOD
Not applicable.
25/29
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
This veterinary medicinal product does not require any special storage conditions.
After each dose, the tip of the syringe should be wiped and the bottle cap screwed back on tightly. The
syringe should be stored in the carton box in between uses.
Do not use after the expiry date stated on the label and carton after EXP.
Shelf life after first opening the container: 6 months.
12. SPECIAL WARNING(S)
If side effects occur, treatment should be discontinued and the advice of a veterinarian should be
sought. Avoid use in any dehydrated, hypovolaemic or hypotensive dog, as there is a potential risk of
increased renal toxicity.
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Meloxivet must not be administered in
conjunction with other NSAIDs or glucocorticosteroids.
Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects
and accordingly a treatment-free period with such drugs should be observed for at least 24 hours
before commencement of treatment. The treatment-free period, however, should take into account the
pharmacokinetic properties of the products used previously.
In the case of overdose symptomatic treatment should be initiated.
People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal
product.
In case of accidental ingestion, seek medical advice immediately and show this package leaflet or the
label to the physician.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
12/11/2009
Detailed information on this product is available on the website of the European Medicines Agency
(EMEA) http://www.emea.europa.eu/.
15. OTHER INFORMATION
10 ml presentation: amber glass bottle (type III) with polyethylene child resistant closure, polyethylene
insert and an amber polypropylenedosing syringe.
30 ml presentation: amber glass bottle (type III) with polypropylene child resistant closure,
polyethylene insert and an amber polypropylene dosing syringe.
Not all pack sizes may be marketed.
26/29
PACKAGE LEAFLET FOR:
Meloxivet 1.5 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:
Janssen Pharmaceutica N.V.
Turnhoutseweg 30
B-2340 Beerse, Belgium
Manufacturer for the batch release :
Lusomedicamenta S.A.
Estrada Consiglieri Pedroso, 69 B Queluz de Baixo
2730-055 Barcarena
Portugal
2.
NAME OF VETERINARY THE MEDICINAL PRODUCT
Meloxivet 1.5 mg/ml oral suspension for dogs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each ml contains:
Meloxicam
1.5 mg
Sodium benzoate
1 mg
4.
INDICATION(S)
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.
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 and apathy have occasionally been reported. 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.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
27/29
7.
TARGET SPECIES
Dogs.
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Oral use. To be administered with food.
The suspension has to be given with the measuring syringe provided in the package of the 30 and 150
ml pack size or with one of the two measuring syringes provided in the package of the 10 ml pack
size. The syringe fits onto the bottle and has a kg-body weight scale which corresponds to the
maintenance dose (ie. 0.1 mg meloxicam/kg body weight). Thus for the first day, twice the
maintenance volume will be required.
Dosage
Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is to
be continued once daily by oral administration (24 hour intervals) at a maintenance dose of 0.1 mg
meloxicam/kg body weight.
Route and method of administration
Shake bottle well.
Push down and
unscrew bottle top.
Attach the dosing
syringe to the bottle
by gently pushing the
end onto the top the
bottle
Turn the bottle
syringe upside down.
Pull the plunger out
until the black on the
plunger corresponds
to your dog’s
bodyweight in
kilograms.
Turn the bottle right
way up and with a
twisting movement
separate the dosing
syringe from the
bottle.
By pushing the
plunger in empty the
contents of the syringe
onto the food.
A clinical response is normally seen within 3 - 4 days. Treatment should be discontinued after 10 days
at the latest if no clinical improvement is apparent.
Avoid introduction of contamination during use.
9.
ADVICE ON CORRECT ADMINISTRATION
Particular care should be taken with regard to the accuracy of dosing. Please carefully follow the
instructions of the veterinarian.
The suspension of the 10 ml pack size could be administered using the smallest syringe for dogs less
than 8 kg body weight (one graduation corresponding to 0.5 kg of body weight) or the largest syringe
for dogs over than 8 kg body weight (one graduation corresponding to 2.0 kg of body weight).
28/29
10.
WITHDRAWAL PERIOD
Not applicable.
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
This veterinary medicinal product does not require any special storage conditions.
After each dose, the tip of the syringe should be wiped and the bottle cap screwed back on tightly. The
syringe should be stored in the carton box in between uses.
Do not use after the expiry date stated on the label and carton after EXP.
Shelf life after first opening the container: 6 months.
12. SPECIAL WARNING(S)
If side effects occur, treatment should be discontinued and the advice of a veterinarian should be
sought. Avoid use in any dehydrated, hypovolaemic or hypotensive dog, as there is a potential risk
of increased renal toxicity.
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Meloxivet must not be administered in
conjunction with other NSAIDs or glucocorticosteroids.
Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects
and accordingly a treatment-free period with such drugs should be observed for at least 24 hours
before commencement of treatment. The treatment-free period, however, should take into account the
pharmacokinetic properties of the products used previously.
In the case of overdose symptomatic treatment should be initiated.
People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal
product.
In case of accidental ingestion, seek medical advice immediately and show this package leaflet or the
label to the physician.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
12/11/2009
Detailed information on this product is available on the website of the European Medicines Agency
(EMEA) http://www.emea.europa.eu/.
15. OTHER INFORMATION
10 ml presentation: amber glass bottle (type III) with polyethylene child resistant closure, polyethylene
insert and clear polypropylene dosing syringe. Two measuring syringes are provided.
30 ml and 150 ml presentation: amber glass bottle (type III) with polypropylene child resistant closure,
polyethylene insert and clear polypropylene dosing syringe.
Not all pack sizes may be marketed.
29/29


Source: European Medicines Agency



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