Novem (meloxicam) - QM01AC06
Updated on site: 09-Feb-2018
|Manufacturer:||Boehringer Ingelheim Vetmedica GmbH|
- What is Novem and what is it used for?
- How is Novem used?
- How does Novem work?
- What benefits of Novem have been shown in studies?
- What are the risks associated with Novem?
- What are the precautions for the person who gives the medicine or comes into contact with the animal?
- What is the withdrawal period in food-producing animals?
- Why is Novem approved?
This document is a summary of the European Public Assessment Report. Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
This document cannot replace a
What is Novem and what is it used for?
Novem is an
In cattle, Novem is used to treat:
•acute respiratory infection (infection of the lungs and airways) together with antibiotics
•diarrhoea in calves of over one week of age and young,
•pain following dehorning in calves
•acute mastitis (inflammation of the udder) together with the main treatment with antibiotics.
In pigs, Novem is used to treat:
•lameness and inflammation in
•pain following minor soft tissue surgery such as castration
•infections that occur after farrowing (giving birth) such as puerperal septicaemia and toxaemia
How is Novem used?
Novem is available as a solution for injection and can only be obtained with a prescription. The dose to use depends on the animal and its bodyweight. Injections are given under the skin for cattle and into the muscles for pigs.
How does Novem work?
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Prescription drugs listed. Manufacturer: "Boehringer Ingelheim Vetmedica GmbH"
Novem contains meloxicam, which belongs to a class of medicines called
What benefits of Novem have been shown in studies?
Appropriate studies have been carried out in various target animals to show that Novem is effective and safe in its approved uses. The studies showed that the addition of Novem to antibiotic therapy significantly improved clinical parameters and reduced fever compared to antibiotics alone. Similarly, treatment combining rehydration solution and Novem was shown to be superior to rehydration solution alone.
What are the risks associated with Novem?
In cattle and pigs both subcutaneous and intramuscular administration are well tolerated; only a slight temporary swelling at the injection site following subcutaneous administration was observed in less than 10% of the cattle treated in clinical studies.
In very rare cases anaphylactoid (allergic) reactions which may be serious (including fatal) may occur and should be treated symptomatically.
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 Novem. If the product is accidentally
What is the withdrawal period in
The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat or milk used for human consumption.
The withdrawal period is 15 days for meat and five days for milk.
The withdrawal period for meat is five days.
Why is Novem approved?
The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Novem’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Other information about Novem:
The European Commission granted a marketing authorisation valid throughout the European Union, for Novem on 2 March 2004. The full EPAR for Novem can be found on the Agency’s website: ema.europa.eu/Find medicine/Veterinary Medicines/European public assessment reports. For more information about treatment with Novem, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
This summary was last updated in March 2017.