Loxicom (meloxicam) – Labelling - QM01AC06

Updated on site: 21-Sep-2017

Medication name: Loxicom
ATC: QM01AC06
Substance: meloxicam
Manufacturer: Norbrook Laboratories Limited

Article Contents

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Carton box 15 and 30 ml bottle

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Loxicom 0.5 mg/ml oral suspension for dogs

2.STATEMENT OF THE ACTIVE AND OTHER SUBSTANCES

Each ml contains:

Meloxicam 0.5 mg

Sodium benzoate 1.5 mg

3.PHARMACEUTICAL FORM

Oral suspension.

4.PACKAGE SIZE

15 ml

30 ml

5.TARGET SPECIES

Dogs.

6.INDICATION(S)

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.

7.METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use.

Shake well before use.

To be administered with food or directly into the mouth.

Avoid introduction of contamination during use.

Read the package leaflet before use.

8.WITHDRAWAL PERIOD

Not applicable.

9.SPECIAL WARNING(S), IF NECESSARY

Do not use in pregnant or lactating animals.

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 OUR OF THE SIGHT AND REACH OF CHILDREN”

Keep out of the sight and reach of children.

15.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Norbrook Laboratories Limited

Station Works

Newry

Co. Down, BT35 6JP

United Kingdom

16.MARKETING AUTHORISATION NUMBER(S)

EU/2/08/090/001 [15 ml]

EU/2/08/090/002 [30 ml]

17.MANUFACTURERS BATCH NUMBER

BN:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

15 and 30 ml bottle

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Loxicom 0.5 mg/ml oral suspension for dogs

2.QUANTITY OF THE ACTIVE SUBSTANCE(S)

Meloxicam 0.5 mg/ml

3.CONTENT BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES

15 ml

30 ml

4.ROUTE OF ADMINISTRATION

Oral use.

Shake well before use.

5.WITHDRAWAL PERIOD

Not applicable.

6.BATCH NUMBER

BN:

7.EXPIRY DATE

EXP:

Once opened, use within 6 months

8.THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Carton box 10, 32, 100, 2 x 100 ml and 200 ml bottle

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Loxicom 1.5 mg/ml oral suspension for dogs.

2.STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S)

Each ml contains:

Meloxicam 1.5 mg

Sodium benzoate 1.5 mg

3. PHARMACEUTICAL FORM

Oral Suspension.

4. PACKAGE SIZES

10 ml

32 ml

100 ml

200 ml

2 x 100 ml

5. TARGET SPECIES

Dogs.

6.INDICATIONS

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.

7. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use.

Shake well before use.

To be administered with food or directly into the mouth.

Avoid introduction of contamination during use.

Read the package leaflet before use.

8. WITHDRAWAL PERIOD

Not applicable.

9. SPECIAL WARNING(S), IF NECESSARY

Do not use in pregnant or lactating animals.

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.

12SPECIAL 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 SIGHT AND REACH OF CHILDREN”

Keep out of the sight and reach of children.

15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Norbrook Laboratories Limited

Station Works

Newry

Co. Down, BT35 6JP

United Kingdom

16. MARKETING AUTHORISATION NUMBER(S)

EU/2/08/090/003 [10 ml]

EU/2/08/090/004 [32 ml]

EU/2/08/090/005 [100 ml]

EU/2/08/090/032 [200 ml]

EU/2/08/090/033 [2 x 100 ml]

17.MANUFACTURER’S BATCH NUMBER

BN:

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE

100 ml, 2 x 100 ml and 200 ml bottle

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Loxicom 1.5 mg/ml oral suspension for dogs.

2. STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S)

Each ml contains:

 

Meloxicam

1.5 mg

Sodium benzoate

1.5 mg

3. PHARMACEUTICAL FORM

Oral Suspension.

4. PACKAGE SIZES

100 ml.

200 ml

5. TARGET SPECIES

Dogs.

6. INDICATIONS

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.

7. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use.

Shake well before use.

To be administered with food or directly into the mouth.

Avoid introduction of contamination during use.

Read the package leaflet before use.

8. WITHDRAWAL PERIOD

Not applicable.

9. SPECIAL WARNING(S), IF NECESSARY

Do not use in pregnant or lactating animals.

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.

12SPECIAL 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 SIGHT AND REACH OF CHILDREN”

Keep out of the sight and reach of children.

15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Norbrook Laboratories Limited

Station Works

Newry

Co. Down, BT35 6JP

United Kingdom

16. MARKETING AUTHORISATION NUMBER(S)

EU/2/08/090/005 [100 ml]

EU/2/08/090/032 [200 ml]

EU/2/08/090/033 [2 x 100 ml]

17. MANUFACTURER’S BATCH NUMBER

BN:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

10 and 32 ml bottle

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Loxicom 1.5 mg/ml oral suspension for dogs.

2. QUANTITY OF THE ACTIVE SUBSTANCE(S)

Meloxicam 1.5 mg/ml

3. CONTENT BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES

10 ml

32 ml

4.ROUTE(S) OF ADMINISTRATION

Oral use.

Shake well before use.

Avoid introduction of contamination during use.

5. WITHDRAWAL PERIOD

Not applicable.

6. BATCH NUMBER

BN:

7. EXPIRY DATE

EXP:

Once opened, use within 6 months.

8. THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Carton box 10 ml, 20 ml and 100 ml bottle

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Loxicom 5 mg/ml solution for injection for dogs and cats

2. STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S)

Each ml contains:

 

Meloxicam

5 mg

Ethanol, anhydrous

150 mg

3. PHARMACEUTICAL FORM

Solution for injection.

4. PACKAGE SIZES

10 ml

20 ml.

100 ml

5. TARGET SPECIES

Dogs and cats.

6. INDICATIONS

Dogs:

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders. Reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery.

Cats:

Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.

7. METHOD AND ROUTE(S) OF ADMINISTRATION

Dogs:

Musculo-skeletal disorders: single subcutaneous injection.

Post-operative pain: single intravenous or subcutaneous injection.

Cats:

Post-operative pain: single subcutaneous injection.

Avoid introduction of contamination during use.

Read the package leaflet before use.

8. WITHDRAWAL PERIOD

Not applicable.

9. SPECIAL WARNING(S), IF NECESSARY

Do not use in pregnant or lactating animals.

10. EXPIRY DATE

EXP:

Shelf-life of broached vial: 28 days.

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 SIGHT AND REACH OF CHILDREN”

Keep out of the sight and reach of children.

15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Norbrook Laboratories Limited

Station Works

Newry

Co. Down, BT35 6JP

United Kingdom

16. MARKETING AUTHORISATION NUMBER(S)

EU/2/08/090/006 [10 ml]

EU/2/08/090/007 [20 ml]

EU/2/08/090/008 [100 ml]

17. MANUFACTURER’S BATCH NUMBER

BN:

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE

100 ml bottle

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Loxicom 5 mg/ml solution for injection for dogs and cats

2. STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S)

Each ml contains:

 

Meloxicam 5 mg

 

Ethanol, anhydrous

150 mg

3. PHARMACEUTICAL FORM

Solution for injection.

4. PACKAGE SIZES

100 ml

5. TARGET SPECIES

Dogs and cats.

6. INDICATIONS

Dogs:

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders. Reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery.

Cats:

Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.

7. METHOD AND ROUTE(S) OF ADMINISTRATION

Dogs:

Musculo-skeletal disorders: single subcutaneous injection.

Post-operative pain: single intravenous or subcutaneous injection.

Cats:

Post-operative pain: single subcutaneous injection.

Avoid introduction of contamination during use.

Read the package leaflet before use.

8. WITHDRAWAL PERIOD

Not applicable.

9. SPECIAL WARNING(S), IF NECESSARY

Do not use in pregnant or lactating animals.

10. EXPIRY DATE

EXP:

Shelf-life of broached vial: 28 days.

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 SIGHT AND REACH OF CHILDREN”

Keep out of the sight and reach of children.

15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Norbrook Laboratories Limited

Station Works

Newry

Co. Down, BT35 6JP

United Kingdom

16. MARKETING AUTHORISATION NUMBER(S)

EU/2/08/090/008 [100 ml]

17. MANUFACTURER’S BATCH NUMBER

BN:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

10 and 20 ml bottle

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Loxicom 5 mg/ml solution for injection for dogs and cats

2. QUANTITY OF THE ACTIVE SUBSTANCE(S)

Meloxicam 5 mg/ml

3. CONTENT BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES

10 ml

20 ml

4. ROUTE(S) OF ADMINISTRATION

Dogs: intravenous or subcutaneous use.

Cats: subcutaneous use.

5. WITHDRAWAL PERIOD

Not applicable.

6. BATCH NUMBER

BN:

7. EXPIRY DATE

EXP:

Shelf-life of opened bottle: 28 days

Once broached, use by……………………….

8. THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Carton box 5 ml, 15 ml and 30 ml bottle

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Loxicom 0.5 mg/ml Oral Suspension for Cats.

Meloxicam

2.STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Meloxicam: 0.5 mg/ml

Sodium Benzoate: 1.5 mg/ml

3. PHARMACEUTICAL FORM

Oral suspension.

4. PACKAGE SIZE

5 ml, 15 ml and 30 ml

5. TARGET SPECIES

Cats.

6. INDICATION(S)

Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in cats, e.g. orthopaedic and soft tissue surgery.

Alleviation of inflammation and pain in acute and chronic musculo-skeletal disorders.

7. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use.

Shake well before use.

To be administered orally either mixed with food or directly into the mouth using the Loxicom measuring syringe provided.

Avoid introduction of contamination during use. Read the package leaflet before use.

8. WITHDRAWAL PERIOD

Not applicable.

9. SPECIAL WARNING(S), IF NECESSARY

Do not use in pregnant or lactating animals.

Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.

Do not use incase of hypersensitivity to the active substance or to any of the excipients. Do not use in cats less than 6 weeks old.

10. EXPIRY DATE

EXP:

Shelf-life of opened bottle: 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 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 SIGHT AND REACH OF CHILDREN”

Keep out of the sight and reach of children.

15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Norbrook Laboratories Limited

Newry

Co. Down

United Kingdom

Telephone number: 02830260200

Fax number: 02830260201

16. MARKETING AUTHORISATION NUMBER(S)

EU/2/08/090/009

EU/2/08/090/027

EU/2/08/090/028

17. MANUFACTURER’S BATCH NUMBER

BN:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMEMEDIATE PACKAGING UNITS 5 ml, 15 ml and 30 ml bottle label

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Loxicom 0.5 mg/ml Oral Suspension for Cats.

2. QUANTITY OF THE ACTIVE SUBSTANCE(S)

Meloxicam 0.5 mg/ml

3. CONTENT BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES

5 ml, 15 ml and 30 ml

4. ROUTE(S) OF ADMINISTRATION

Oral use.

Shake well before use.

To be administered with food or directly into the mouth using the Loxicom measuring syringe provided.

Avoid introduction of contamination during use. Read the package leaflet before use.

5. WITHDRAWAL PERIOD

Not applicable.

6. BATCH NUMBER

BN:

7. EXPIRY DATE

EXP:

Shelf-life of opened bottle: 6 months.

Once broached, use by……..

8. THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

To be supplied only on veterinary prescription.

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Carton box 30 ml, 50 ml , 100 ml and 250 ml bottle

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Loxicom 20 mg/ml solution for injection for cattle, pigs and horses Meloxicam

2. STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S)

Meloxicam

20 mg/ml

Ethanol

150 mg/ml

3. PHARMACEUTICAL FORM

Solution for injection.

4. PACKAGE SIZES

1 x 30 ml

1 x 50 ml

1 x 100 ml

1 x 250 ml

6 x 250 ml

12 x 30 ml

12 x 50 ml

12 x 100 ml

12 x 250 ml

5. TARGET SPECIES

Cattle, pigs and horses

6. INDICATIONS

Cattle:

Acute respiratory infection.

Diarrhoea in calves of over one week of age and young, non-lactating cattle. Acute mastitis.

Relief of post-operative pain following dehorning in calves.

Pigs:

Non-infectious locomotor disorders.

Puerperal septicaemia and toxaemia (MMA syndrome) with antibiotic therapy.

Horses:

Acute and chronic musculo-skeletal disorders.

Pain associated with equine colic.

7.METHOD AND ROUTES OF ADMINISTRATION

Cattle: Single subcutaneous or intravenous injection.

Pigs: Single intramuscular injection. If required, a second administration can be given after 24 hours. Horses: Single intravenous injection.

Read the package leaflet before use.

8. WITHDRAWAL PERIOD

Cattle:

Meat and offal:

15 days

Milk: 5 days

Pigs: Meat and offal:

5 days

 

 

Horses:

Meat and offal:

5 days.

 

Not authorised for use in horses producing milk for human consumption.

9. SPECIAL WARNING(S), IF NECESSARY

Read the package leaflet before use.

10. EXPIRY DATE

EXP {month/year}

Shelf life of broached vial: 28 days.

Once broached, use by …

11.SPECIAL STORAGE PRECAUTIONS

Read the package leaflet before use.

12.SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS WASTE

MATERIALS, IF ANY

Dispose of 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 on veterinary prescription.

14. THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”

Keep out of the sight and reach of children.

15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Norbrook Laboratories Limited

Station Works

Newry

Co. Down, BT35 6JP

United Kingdom

16.MARKETING AUTHORISATION NUMBERS

EU/2/08/090/010 30 ml

EU/2/08/090/011 50 ml

EU/2/08/090/012 100 ml

EU/2/08/090/013 250 ml

EU/2/08/090/014 6 x 250 ml

EU/2/08/090/015 12 x 30 ml

EU/2/08/090/016 12 x 50 ml

EU/2/08/090/017 12 x 100 ml

EU/2/08/090/018 12 x 250 ml

17. MANUFACTURER’S BATCH NUMBER

BN:

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE

100 ml and 250 ml bottle

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Loxicom 20 mg/ml solution for Injection for Cattle, Pigs and Horses

Meloxicam

2. STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S)

Meloxicam

20 mg/ml

Ethanol

150 mg/ml

3. PHARMACEUTICAL FORM

Solution for injection.

4. PACKAGE SIZES

100 ml

250 ml

5. TARGET SPECIES

Cattle, pigs and horses

6. INDICATION(S)

Cattle:

Acute respiratory infection.

Diarrhoea in calves of over one week of age and young, non-lactating cattle.

Acute mastitis.

Relief of post-operative pain following dehorning in calves.

Pigs:

Non-infectious locomotor disorders.

Puerperal septicaemia and toxaemia (MMA syndrome) with antibiotic therapy.

Horses:

Acute and chronic musculo-skeletal disorders.

Pain associated with equine colic.

7. METHOD AND ROUTE(S) OF ADMINISTRATION

Cattle: Single subcutaneous or intravenous injection.

Pigs: Single intramuscular injection. If required, a second administration can be given after 24 hours. Horses: Single intravenous injection.

Read the package leaflet before use.

8. WITHDRAWAL PERIOD

Cattle:

Meat and offal:

15 days

Milk: 5 days

Pigs:

Meat and offal:

5 days

 

Horses:

Meat and offal:

5 days.

 

Not authorised for use in horses producing milk for human consumption.

9. SPECIAL WARNING(S), IF NECESSARY

Read the package leaflet before use.

10. EXPIRY DATE

EXP {month/year}

Shelf life of broached vial: 28 days.

Once broached, use by …

11. SPECIAL STORAGE PRECAUTIONS

Read the package leaflet before use.

12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR

WASTE MATERIALS, IF ANY

Dispose of 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 SIGHT AND REACH OF CHILDREN”

Keep out of the sight and reach of children.

15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Norbrook Laboratories Limited

Station Works

Newry

Co. Down, BT35 6JP

United Kingdom

16. MARKETING AUTHORISATION NUMBERS

EU/2/08/090/012 100 ml

EU/2/08/090/013 250 ml

EU/2/08/090/014 6 x 250 ml

EU/2/08/090/017 12 x 100 ml

EU/2/08/090/018 12 x 250 ml

17. MANUFACTURER’S BATCH NUMBER

BN:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

30 ml and 50 ml bottle

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Loxicom 20 mg/ml solution for injection for cattle, pigs and horses

Meloxicam

2. QUANTITY OF THE ACTIVE SUBSTANCE

Meloxicam 20 mg/ml

3.CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER

30 ml

50 ml

4.ROUTES OF ADMINISTRATION

Cattle: SC or IV

Pigs: IM

Horses: IV

5. WITHDRAWAL PERIOD

Cattle:

Meat and offal:

15 days

Milk: 5 days

Pigs: Meat and offal:

5 days

 

 

Horses:

Meat and offal:

5 days.

 

Not authorised for use in horses producing milk for human consumption.

6. BATCH NUMBER

BN {number}

7. EXPIRY DATE

EXP {month/year}

Shelf life of broached vial: 28 Days

Once broached, use by …

8. THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

To be supplied only on veterinary prescription.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Carton

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Loxicom 1 mg chewable tablets for dogs

Loxicom 2.5 mg chewable tablets for dogs

Meloxicam

2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Meloxicam 1 mg / chewable tablet

Meloxicam 2.5 mg / chewable tablet

3. PHARMACEUTICAL FORM

Chewable tablet

4. PACKAGE SIZE

10 tablets

20 tablets

100 tablets

500 tablets

5. TARGET SPECIES

Dogs

6. INDICATION(S)

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.

7.METHOD AND ROUTE OF ADMINISTRATION

To ensure correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing or overdosing.

Read the package leaflet before use.

8. WITHDRAWAL PERIOD

Not applicable.

9. SPECIAL WARNING(S), IF NECESSARY

Read the package leaflet before use.

10. EXPIRY DATE

EXP {month/year}

Shelf-life of the halved tablet: 24-hours

11. SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Store in the original package in order to protect from light.

12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR

WASTE MATERIALS, IF ANY

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of 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 SIGHT AND REACH OF CHILDREN”

Keep out of sight and reach of children.

15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Norbrook Laboratories Limited

Station Works

Newry

Co. Down, BT35 6JP

United Kingdom

16. MARKETING AUTHORISATION NUMBER(S)

Loxicom 1 mg chewable tablets for dogs:

EU/2/08/090/019 – 1 x 10 tablets

EU/2/08/090/020 – 2 x 10 tablets

EU/2/08/090/021 – 10 x 10 tablets

EU/2/08/090/022 – 50 x 10 tablets

Loxicom 2.5 mg chewable tablets for dogs:

EU/2/08/090/023 – 1 x 10 tablets

EU/2/08/090/024 – 2 x 10 tablets

EU/2/08/090/025 – 10 x 10 tablets

EU/2/08/090/026 – 50 x 10 tablets

17. MANUFACTURER’S BATCH NUMBER

BN

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Blisters

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Loxicom 1 mg chewable tablets for dogs

Loxicom 2.5 mg chewable tablets for dogs

Meloxicam

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Norbrook Laboratories Limited

3.EXPIRY DATE

EXP

4.BATCH NUMBER

BN

5.THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Carton Box labelling

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Loxicom 50 mg/g oral paste for horses

Meloxicam

2. STATEMENT OF THE ACTIVE AND OTHER SUBSTANCES

Meloxicam

50 mg/g

Benzyl alcohol

10 mg/g

3. PHARMACEUTICAL FORM

Oral Paste

4. PACKAGE SIZES

1 x 8.4 g syringe

7 x 8.4 g syringes

14 x 8.4 g syringes

5. TARGET SPECIES

Horses

6. INDICATION(S)

Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in horses.

7. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

8. WITHDRAWAL PERIOD

Horses: Meat and offal: 3 days.

Not authorised for use in animals producing milk for human consumption.

9. SPECIAL WARNING(S), IF NECESSARY

Read the package leaflet before use

10. EXPIRY DATE

EXP {month/year}

Shelf life after first opening the immediate packaging: 28 days

11. SPECIAL STORAGE CONDITIONS

Store below 30 ºC.

12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS 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 SIGHT AND REACH OF CHILDREN”

Keep out of the sight and reach of children.

15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Norbrook Laboratories Limited

Station Works

Newry

Co. Down, BT35 6JP

United Kingdom

16.MANUFACTURER’S AUTHORISATION NUMBER(S)

EU/2/08/090/029 (1 syringe)

EU/2/08/090/030 (1 x 7 syringes)

EU/2/08/090/031 (1 x 14 syringes)

17. MANUFACTURER’S BATCH NUMBER

BN:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Syringe labelling

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Loxicom 50 mg/g oral paste for horses

Meloxicam

2. QUANTITY OF THE ACTIVE SUBSTANCE(S)

Meloxicam

50 mg/g

Benzyl alcohol

10 mg/g

3. CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER

8.4 g

4.METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

5. WITHDRAWAL PERIOD

Meat and offal: 3 days.

Not authorised for use in animals producing milk for human consumption.

6. BATCH NUMBER

BN {number}

7. EXPIRY DATE

EXP {month/year}

Shelf life after first opening the immediate packaging: 28 days

8. THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

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