Acticam (meloxicam) - QM01AC06
Updated on site: 08-Feb-2018
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 Acticam?
Acticam contains meloxicam which belongs to a class of medicines having
Acticam is a ‘generic’: this means that Acticam 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 Acticam is ‘bioequivalent’ to the reference veterinary medicine: this means that Acticam is equivalent to Metacam 1.5 mg/ml suspension in the way it is absorbed and used by the body.
What is Acticam used for?
Dogs: Alleviation of inflammation and pain in both acute and chronic
Cats: Reduction of
© European Medicines Agency, 2012. Reproduction is authorised provided the source is acknowledged.
How does Acticam work?
Acticam contains meloxicam, which belongs to a class of medicines called
How has Acticam been studied?
Acticam has been investigated in comparison with Metacam which is already authorised in the EU. A study looked at how Acticam was absorbed and its effects in the body, in comparison with Metacam oral suspension 1.5mg/ml.
What benefit has Acticam shown during the studies?
Acticam is efficacious in alleviating the inflammation and pain in both acute and chronic musculo- skeletal disorders and reducing the post operative pain following orthopaedic and soft tissue surgery in dogs and in reducing the
What is the risk associated with Acticam?
Occasional side effects of Acticam 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 temporary. They disappear once treatment has stopped. In very rare cases, they may be serious or fatal.
Acticam should not be administered to pregnant or lactating animals as the safety of the product has not been established in these cases. Acticam should also not be used in animals suffering from gastrointestinal or hemorrhagic disorders and impaired renal or hepatic function, animals with known hypersensitivity to NSAIDs, and animals less than 6 weeks of age or in cats of less than 2 kg.
What are the precautions for the person who gives the medicine or comes into contact with the animal?
People with known hypersensitivity (allergic) to meloxicam should avoid contact with the product.
If the product is swallowed by a person, the advice of a doctor should be sought immediately.
In case of accidental
Why has Acticam been approved?
The Committee for Medicinal Products for Veterinary Use (CVMP) considered that, in accordance with European Union requirements, Acticam has been shown to be bioequivalent to Metacam
1.5 mg/ml oral suspension. The CVMP concluded that the benefits of Acticam exceed the risks for the alleviation of inflammation and pain in both acute and chronic
Other information about Acticam:
The European Commission granted a marketing authorisation valid throughout the European Union, for Acticam on 9 December 2008. Information on the prescription status of this product may be found on the label/outer package.
This summary was last updated in January 2012.