Inflacam

meloxicam

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This is a summary of the European public assessment report (EPAR). 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 summary cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).

What is Inflacam?

Inflacam is a medicine that contains the active substance meloxicam. It is available as oral suspensions (1.5 mg/ml, 15 mg/ml), chewable tablets (1 mg, 2.5 mg) and solutions for injection (5 mg/ml, 20 mg/ml).

Inflacam is a ‘generic’, which means that Inflacam is similar to a ‘reference veterinary medicine’ already authorised in the European Union (Metacam).

What is Inflacam used for?

Inflacam 1.5-mg/ml oral suspension is used in dogs to relieve inflammation and pain. It can be used for chronic (long-term) musculoskeletal disorders and for acute (sudden and short-lived) disorders for instance due to injury.

Inflacam 15-mg/ml oral suspension is used in horses to relieve inflammation and pain in both acute and chronic musculoskeletal disorders.

Inflacam chewable tablets are used in dogs to relieve inflammation and pain in chronic musculoskeletal disorders as well as in acute disorders.

Inflacam solution for injection (5 mg/ml) can be used to relieve inflammation and pain in dogs following surgery involving the bones or soft tissue (tissue just below the skin), and in cats following ovariohysterectomy (spaying) and minor soft-tissue surgery.

Inflacam solution for injection (5 mg/ml) is used in cattle, together with appropriate antibiotic therapy, to reduce signs of disease in acute respiratory infection (infections of the lungs and airways). It can be used for diarrhoea in combination with oral rehydration therapy to reduce signs of the disease in calves of over one week of age and young, non-lactating cattle.

Inflacam solution for injection (5 mg/ml) is used in pigs to reduce the symptoms of lameness (inability to walk normally) and inflammation in noninfectious locomotor disorders (diseases that affect the ability to move) and for the relief of postoperative pain associated with minor soft-tissue such as castration (surgical removal of the testicles).

Inflacam solution for injection (20 mg/ml) is used in cattle, together with appropriate antibiotic therapy, to reduce clinical signs in acute respiratory infection (infections of the lungs and airways) and to treat acute mastitis (inflammation of the udder). It can be used for diarrhoea in combination with oral rehydration therapy to reduce signs of the disease in calves of over one week of age and young, non-lactating cattle.

Inflacam solution for injection (20 mg/ml) is used in pigs to reduce the symptoms of lameness and inflammation in noninfectious locomotor disorders (diseases that affect the ability to move) and for the treatment of diseases after farrowing (giving birth) such as puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome), together with appropriate antibiotic therapy.

Inflacam solution for injection (20 mg/ml) is used in horses to relieve colic (abdominal pain) and the inflammation and pain in musculoskeletal disorders.

How does Inflacam work?

Inflacam contains meloxicam, which belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Meloxicam acts by blocking an enzyme called cyclo-oxygenase which is involved in the production of prostaglandins. As prostaglandins are substances that trigger inflammation, pain, exudation and fever, meloxicam reduces these signs of disease.

How has Inflacam been studied?

Since Inflacam is a generic medicine, studies have been conducted to determine that it is bioequivalent to the reference medicine, Metacam. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What benefit has Inflacam shown during the studies?

Based on the findings of the studies, Inflacam was considered to be bioequivalent to the reference medicine. Consequently, Inflacam’s benefit is taken as being the same as that of the reference medicine.

What is the risk associated with Inflacam?

Side effects sometimes seen with other NSAIDs, such as loss of appetite, vomiting, diarrhoea, blood appearing in the stools, renal (kidney) failure and apathy (lack of vitality) are occasionally seen with Inflacam in dogs and cats. In dogs, these generally occur within the first week of treatment and usually disappear once treatment has stopped. In very rare cases, they may be serious or fatal.

In horses given the oral suspension, slight urticaria (itchy rash) and diarrhoea were observed in clinical trials.

A slight temporary swelling at the injection site following injection under the skin was observed in cattle and pigs. In horses, a temporary swelling at the injection site can occur but resolves without intervention.

In very rare cases, potentially serious or fatal anaphylactoid reactions (similar to severe allergic reactions) may occur following administration of the solution for injection and should be treated symptomatically.

Inflacam must not be used in animals with liver, heart or kidney problems, bleeding disorders, or suffering from irritation or ulcers of the digestive tract. It must not be used in animals which are hypersensitive (allergic) to the active substance or to any of the other ingredients.

Inflacam should not be used in pregnant or lactating horses and dogs, but it can be used during pregnancy and lactation for cattle and pigs.

Inflacam must not be used in dogs or horses less than six weeks of age or in cattle less than one week of age when used in the treatment of diarrhoea. It must not be used in cats weighing less than 2 kg.

What is the withdrawal period?

The withdrawal period is the time allowed after administration of the medicine before the animal can be slaughtered and the meat used for human consumption. It is also the time allowed after administration of the medicine before the milk can be used for human consumption. 

Cattle

For meat, the withdrawal period is 15 days. For milk, it is five days.

Pigs

For meat, the withdrawal period is five days.

Horses

For meat, the withdrawal period is five days for the 20-mg/ml solution for injection and three days for the 15-mg/ml oral suspension. The product is not authorised to use in horses producing milk for human consumption.

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

People who are hypersensitive to NSAIDs should avoid contact with Inflacam. If someone swallows or accidentally injects themselves with the medicine, the advice of a doctor should be sought immediately.

Why has Inflacam been approved?

The CVMP considered that, in accordance with European Union requirements, Inflacam has been shown to be bioequivalent to Metacam. Therefore the CVMP’s view was that, as for Metacam, Inflacam’s benefits are greater than its risks when used for the approved indications and the Committee recommended that Inflacam be given a marketing authorisation. The benefit-risk balance may be found in the scientific discussion module of this EPAR.

Other information about Inflacam:

The European Commission granted a marketing authorisation valid throughout the European Union for Inflacam on 9 December 2011. Information on the prescription status of this product may be found on the label of the carton.

Name Language First published Last updated
Inflacam : EPAR - Summary for the public BG = bălgarski 16/12/2011 28/11/2012
Inflacam : EPAR - Summary for the public ES = español 16/12/2011 28/11/2012
Inflacam : EPAR - Summary for the public CS = čeština 16/12/2011 28/11/2012
Inflacam : EPAR - Summary for the public DA = dansk 16/12/2011 28/11/2012
Inflacam : EPAR - Summary for the public DE = Deutsch 16/12/2011 28/11/2012
Inflacam : EPAR - Summary for the public ET = eesti keel 16/12/2011 28/11/2012
Inflacam : EPAR - Summary for the public EL = elliniká 16/12/2011 28/11/2012
Inflacam : EPAR - Summary for the public EN = English 16/12/2011 28/11/2012
Inflacam : EPAR - Summary for the public FR = français 16/12/2011 28/11/2012
Inflacam : EPAR - Summary for the public IT = italiano 16/12/2011 28/11/2012
Inflacam : EPAR - Summary for the public LV = latviešu valoda 16/12/2011 28/11/2012
Inflacam : EPAR - Summary for the public LT = lietuvių kalba 16/12/2011 28/11/2012
Inflacam : EPAR - Summary for the public HU = magyar 16/12/2011 28/11/2012
Inflacam : EPAR - Summary for the public MT = Malti 16/12/2011 28/11/2012
Inflacam : EPAR - Summary for the public NL = Nederlands 16/12/2011 28/11/2012
Inflacam : EPAR - Summary for the public PL = polski 16/12/2011 28/11/2012
Inflacam : EPAR - Summary for the public PT = português 16/12/2011 28/11/2012
Inflacam : EPAR - Summary for the public RO = română 16/12/2011 28/11/2012
Inflacam : EPAR - Summary for the public SK = slovenčina 16/12/2011 28/11/2012
Inflacam : EPAR - Summary for the public SL = slovenščina 16/12/2011 28/11/2012
Inflacam : EPAR - Summary for the public FI = suomi 16/12/2011 28/11/2012
Inflacam : EPAR - Summary for the public SV = svenska 16/12/2011 28/11/2012

This EPAR was last updated on 15/10/2013 .

Authorisation details

Product details

Product details for Inflacam
NameInflacam
Agency product numberEMEA/V/C/002497
Active substance

meloxicam

International non-proprietary name (INN) or common name

meloxicam

Species HorsesDogsPigsCattleCats
Anatomical therapeutic chemical veterinary (ATCvet) codeQM01AC06
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.

Publication details

Publication details for Inflacam
Marketing-authorisation holder

Chanelle Pharmaceuticals Manufacturing Ltd

Revision4
Date of issue of marketing authorisation valid throughout the European Union09/12/2011

Contact address:

Chanelle Pharmaceuticals Manufacturing Ltd
Loughrea
Co. Galway
Ireland

Product information

Product information

27/09/2013  Inflacam -EMEA/V/C/002497 -IB/0005

Name Language First published Last updated
Inflacam : EPAR - Product Information SV = svenska 16/12/2011 15/10/2013
Inflacam : EPAR - Product Information SV = svenska 16/12/2011 15/10/2013
Inflacam : EPAR - Product Information SV = svenska 16/12/2011 15/10/2013
Inflacam : EPAR - Product Information SV = svenska 16/12/2011 15/10/2013
Inflacam : EPAR - Product Information SV = svenska 16/12/2011 15/10/2013
Inflacam : EPAR - Product Information SV = svenska 16/12/2011 15/10/2013
Inflacam : EPAR - Product Information SV = svenska 16/12/2011 15/10/2013
Inflacam : EPAR - Product Information SV = svenska 16/12/2011 15/10/2013
Inflacam : EPAR - Product Information SV = svenska 16/12/2011 15/10/2013
Inflacam : EPAR - Product Information SV = svenska 16/12/2011 15/10/2013
Inflacam : EPAR - Product Information SV = svenska 16/12/2011 15/10/2013
Inflacam : EPAR - Product Information SV = svenska 16/12/2011 15/10/2013
Inflacam : EPAR - Product Information SV = svenska 16/12/2011 15/10/2013
Inflacam : EPAR - Product Information SV = svenska 16/12/2011 15/10/2013
Inflacam : EPAR - Product Information SV = svenska 16/12/2011 15/10/2013
Inflacam : EPAR - Product Information SV = svenska 16/12/2011 15/10/2013
Inflacam : EPAR - Product Information SV = svenska 16/12/2011 15/10/2013
Inflacam : EPAR - Product Information SV = svenska 16/12/2011 15/10/2013
Inflacam : EPAR - Product Information SV = svenska 16/12/2011 15/10/2013
Inflacam : EPAR - Product Information SV = svenska 16/12/2011 15/10/2013
Inflacam : EPAR - Product Information SV = svenska 16/12/2011 15/10/2013
Inflacam : EPAR - Product Information SV = svenska 16/12/2011 15/10/2013
Inflacam : EPAR - Product Information SV = svenska 16/12/2011 15/10/2013
Inflacam : EPAR - Product Information SV = svenska 16/12/2011 15/10/2013

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Inflacam : EPAR - All Authorised presentations SV = svenska 16/12/2011 28/11/2012
Inflacam : EPAR - All Authorised presentations SV = svenska 16/12/2011 28/11/2012
Inflacam : EPAR - All Authorised presentations SV = svenska 16/12/2011 28/11/2012
Inflacam : EPAR - All Authorised presentations SV = svenska 16/12/2011 28/11/2012
Inflacam : EPAR - All Authorised presentations SV = svenska 16/12/2011 28/11/2012
Inflacam : EPAR - All Authorised presentations SV = svenska 16/12/2011 28/11/2012
Inflacam : EPAR - All Authorised presentations SV = svenska 16/12/2011 28/11/2012
Inflacam : EPAR - All Authorised presentations SV = svenska 16/12/2011 28/11/2012
Inflacam : EPAR - All Authorised presentations SV = svenska 16/12/2011 28/11/2012
Inflacam : EPAR - All Authorised presentations SV = svenska 16/12/2011 28/11/2012
Inflacam : EPAR - All Authorised presentations SV = svenska 16/12/2011 28/11/2012
Inflacam : EPAR - All Authorised presentations SV = svenska 16/12/2011 28/11/2012
Inflacam : EPAR - All Authorised presentations SV = svenska 16/12/2011 28/11/2012
Inflacam : EPAR - All Authorised presentations SV = svenska 16/12/2011 28/11/2012
Inflacam : EPAR - All Authorised presentations SV = svenska 16/12/2011 28/11/2012
Inflacam : EPAR - All Authorised presentations SV = svenska 16/12/2011 28/11/2012
Inflacam : EPAR - All Authorised presentations SV = svenska 16/12/2011 28/11/2012
Inflacam : EPAR - All Authorised presentations SV = svenska 16/12/2011 28/11/2012
Inflacam : EPAR - All Authorised presentations SV = svenska 16/12/2011 28/11/2012
Inflacam : EPAR - All Authorised presentations SV = svenska 16/12/2011 28/11/2012
Inflacam : EPAR - All Authorised presentations SV = svenska 16/12/2011 28/11/2012
Inflacam : EPAR - All Authorised presentations SV = svenska 16/12/2011 28/11/2012
Inflacam : EPAR - All Authorised presentations SV = svenska 16/12/2011 28/11/2012
Inflacam : EPAR - All Authorised presentations SV = svenska 16/12/2011 28/11/2012

Pharmacotherapeutic group

Anti-inflammatory and antirheumatic products, non-steroids

Therapeutic indication

Dogs

Alleviation of inflammation and pain in both acute and chronic musculoskeletal disorders.

To reduce postoperative pain and inflammation following orthopaedic and soft-tissue surgery.

Cats

To reduce postoperative pain after ovariohysterectomy and minor soft-tissue surgery.

Cattle

For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs.

For use in diarrhoea in combination with oral rehydration 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.

Pigs

For use in noninfectious 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.

For the relief of postoperative pain associated with minor soft-tissue such as castration.

Horses

For use in the alleviation of inflammation and relief of pain in both acute and chronic musculoskeletal disorders.

For the relief of pain associated with equine colic.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Inflacam : EPAR - Public assessment report SV = svenska 16/12/2011  
CVMP summary of positive opinion for Inflacam SV = svenska 14/10/2011  

Authorised

This medicine is approved for use in the European Union

More information on Inflacam