Loxicom - patient leaflet, side effects, dosage

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

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT

Marketing authorisation holder: 
Norbrook Laboratories (Ireland) Limited 
Rossmore Industrial Estate 
Monaghan 
Ireland

Manufacturer responsible for batch release: 
Norbrook Manufacturing Limited 
Rossmore Industrial Estate 
Monaghan Town 
Co. Monaghan 
H18 W620 
Ireland 

Norbrook Laboratories Limited 
105 Armagh Road 
Newry 
Co. Down, BT35 6PU 
United Kingdom 

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

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

3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS

One ml contains: 
Meloxicam 20 mg 
Ethanol 150mg 
A yellow solution. 

4. INDICATIONS

Cattle: 
For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle. 
For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle. 
For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy. 
For the relief of post-operative pain following dehorning in calves. 

Pigs: 
For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation. 
For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy. 

Horses: 
For use in the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders. 
For the relief of pain associated with equine colic. 

5. CONTRAINDICATIONS

Do not use in horses less than 6 weeks of age. 
Do not use in pregnant or lactating mares. 
Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic di­sorders, or where there is evidence of ulcerogenic gastrointestinal lesions. 
Do not use in case of hypersensitivity to the active substance or to any of the excipients. 
For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.

6. ADVERSE REACTIONS

Administration of the product by the subcutaneous route in cattle and the intramuscular route in pigs is well tolerated; only a slight transient swelling at the injection site following subcutaneous 
administration was observed in cattle treated in clinical studies. 

In horses, transient swellings at the injection site can occur but resolves without intervention. 
In very rare cases (less than 1 animal in 10,000 animals treated, including isolated reports), anap­hylactoid reactions which may be serious (including fatal), may occur and should be treated 
symptomatically. 

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon

7. TARGET SPECIES

Cattle, pigs and horses.

8. DOSAGE FOR EACH SPECIES, METHOD AND ROUTE(S) OF ADMINISTRATION 

Cattle: 
Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e., 2.5 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, 
as appropriate. The recommended maximum volume to be administered at a single injection site is 10 ml. 

Pigs: 
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e., 2.0 ml/100 kg body weight) in combination with antibiotic therapy, as appropriate. If required, a second 
administration of meloxicam can be given after 24 hours. The recommended maximum volume to be administered at a single injection site is 2 ml.

Horses: 
Single intravenous injection as a dosage of 0.6 mg meloxicam/kg body weight (i.e., 3.0 ml/100 kg body weight). 

For use in the alleviation of inflammation and the relief of pain in both acute and chronic muscu­loskeletal disorders, a suitable oral therapy containing meloxicam, administered in accordance 
with label recommendations, may be used for continuation of treatment. 

Do not exceed 50 broachings per vial. If more than 50 broachings are required, the use of a draw-off needle is recommended

9. ADVICE ON CORRECT ADMINISTRATION

Avoid introduction of contamination during use.

10. WITHDRAWAL PERIOD(S)

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.

11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children. 
This veterinary medicinal product does not require any special storage conditions. 
Shelf life after first broaching the glass vial: 28 days. 
Do not use after the expiry date (EXP) stated on the carton and vial after EXP.

12. SPECIAL WARNINGS

Treatment of calves with Loxicom 20 minutes before dehorning reduces post-operative pain. Loxicom alone will not provide adequate pain relief during the dehorning procedure. To obtain adequate pain relief during surgery co-medication with an appropriate analgesic is needed. 

Special precautions for use in animals:
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought. 
Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral rehydration, as there may be a potential risk of renal toxicity. 
In case of inadequate relief of pain when used in the treatment of equine colic, careful re-evaluation of the diagnosis should be made as this could indicate the need for surgical intervention. 

Special precautions to be taken by the person administering the veterinary medicinal product to animals: 
Accidental self-injection may give rise to pain. People with known hypersensitivity to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product. 
In case of accidental self-injection, seek medical advice immediately and show this package leaflet or the label to the physician. 

Use during pregnancy and lactation: 
Cattle and pigs: Can be used during pregnancy and lactation. 
Horses: See section „Contraindica­tions“. 

Interaction with other medicinal products and other forms of interaction:
Do not administer concurrently with glucocorticos­teroids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents. 

Overdose (symptoms, emergency procedures, antidotes): 
In the case of overdose, symptomatic treatment should be initiated. 

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Any unused medicines or waste materials should not be disposed of via wastewater or household waste but in accordance with local requirements. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.

15. OTHER INFORMATION

Cardboard box with either 1 or 12 colourless glass injection vial(s) each containing 30, 50 or 100 ml. 
Cardboard box with 1, 6 or 12 colourless glass injection vial(s) each containing 250 ml. 
Not all pack sizes may be marketed

Each vial is closed with a bromobutyl bung and sealed with an aluminium cap. 

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation hol­der

Loxicom 1 mg chewable tablets for dogs Loxicom 2.5 mg chewable 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: 
Norbrook Laboratories (Ireland) Limited 
Rossmore Industrial Estate 
Monaghan 
Ireland 

Manufacturer responsible for batch release: 
Norbrook Manufacturing Limited 
Rossmore Industrial Estate 
Monaghan Town 
Co. Monaghan 
H18 W620 
Ireland 

Norbrook Laboratories Limited 
105 Armagh Road, 
Newry, 
Co. Down, 
BT35 6PU 
United Kingdom

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Loxicom 1 mg chewable tablets for dogs. 
Loxicom 2.5 mg chewable tablets for dogs. 
meloxicam 

3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS

One chewable tablet contains: 
Meloxicam 1 mg 
Meloxicam 2.5 mg 

Light brown oval biconvex tablet with a score line on one face and plain on the other. The tablet can be divided into equal halves. 

4. INDICATION(S)

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

5. CONTRAINDICATIONS

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 in dogs less than 6 weeks of age or less than 4 kg body weight. 
Do not use in case of hypersensitivity to the active substance or to any of the excipients.