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Cimalgex

Main information

  • Trade name:
  • Cimalgex 80 mg chewable tablets for dogs
  • Available from:
  • Vetoquinol SA
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug
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Documents

Localization

  • Available in:
  • Cimalgex 80 mg chewable tablets for dogs
    European Union
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Musculo-skeletal system
  • Therapeutic area:
  • Dogs

Other information

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Status

  • Source:
  • EMA - European Medicines Agency
  • Authorization date:
  • 18-02-2011
  • EMEA code:
  • EMEA/V/C/000162
  • Last update:
  • 09-08-2016

Patient Information leaflet

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PACKAGE LEAFLET

Cimalgex 8 mg chewable tablets for dogs

Cimalgex 30 mg chewable tablets for dogs

Cimalgex 80 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

Vétoquinol SA

Magny Vernois

F-70200 Lure

France

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Cimalgex 8 mg chewable tablets for dogs

Cimalgex 30 mg chewable tablets for dogs

Cimalgex 80 mg chewable tablets for dogs

Cimicoxib

3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS

Each tablet contains:

Cimicoxib 8 mg

Cimicoxib 30 mg

Cimicoxib 80 mg

Tablets are oblong, white to pale brown, with a break-line on both sides and can be divided into equal

halves.

4. INDICATIONS

For the treatment of pain and inflammation associated with osteoarthritis, and the management of peri-

operative pain due to orthopaedic or soft tissue surgery, in dogs.

5. CONTRAINDICATIONS

Do not use in dogs less than 10 weeks of age.

Do not use in dogs suffering from stomach or digestive system disorders or in dogs with bleeding

problems.

Do not use at the same time as corticosteroids or other non-steroidal anti-inflammatory drugs

(NSAIDs).

Do not use if the dog is hypersensitive to cimicoxib or any of the other ingredients in the product.

Do not use in breeding, pregnant or lactating animals. See Section 12 below (“Special precautions for

dogs”).

17

6. ADVERSE REACTIONS

Mild gastro-intestinal disorders (vomiting and/or diarrhoea) were very commonly reported but these

only lasted for a short time.

On rare occasions, serious gastrointestinal problems such as bleeding and ulcer formation have

occurred. Other adverse reactions including loss of appetite or lethargy may also be observed on rare

occasions.

In very rare cases, increases in kidney function results (renal biochemistry parameters) were noted. As

for any long term NSAID treatment, kidney function should be monitored.

If any observed adverse effect persists after stopping treatment, the advice of your veterinary surgeon

should be sought.

If adverse reactions such as persistent vomiting, repeated diarrhoea, blood in the stools, sudden weight

loss, loss of appetite, lethargy or worsening of liver or kidney function results occur, use of the product

should be discontinued and the advice of your veterinary surgeon should be sought immediately.

If you notice any serious effects or other effects not mentioned in this leaflet, please inform your

veterinary surgeon.

7. TARGET SPECIES

Dogs.

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

Oral use.

Cimalgex tablets can be given to dogs with or without food. The tablets are flavoured and studies (in

healthy Beagle dogs) show they are likely to be taken voluntarily by most dogs.

The recommended dose of cimicoxib is 2 mg per kg bodyweight, once daily, according to the dosage

table below:

Number of Tablets and Tablet Strength

(mg cimicoxib)

Bodyweight of

dog (kg)

Cimalgex 8 mg

Cimalgex 30 mg Cimalgex 80 mg

3.0 - 4.0 1

4.1 - 7.5 ½

7.6 - 15.0 1

15.1 - 20.0 ½

20.1 - 40.0 1

40.1 - 60.0 1+½

>60.1 2

18

Treatment duration:

Management of peri-operative pain due to orthopaedic or soft tissue surgeries: one dose 2 hours

prior to surgery, followed by 3 to 7 days of treatment, based on the judgment of your veterinary

surgeon.

Relief of pain and inflammation associated with osteoarthritis: 6 months. For longer-term

treatment, regular monitoring should be undertaken by your veterinary surgeon.

9. ADVICE ON CORRECT ADMINISTRATION

None.

10. WITHDRAWAL PERIOD

Not applicable.

11. SPECIAL STORAGE PRECAUTIONS

Keep out of the reach and sight of children.

This veterinary medicinal product does not require any special storage conditions.

Blister packs - Any remaining half tablets should be stored in the blisters but discarded if not used

within 2 days.

Bottles - Any remaining half tablets should be stored in the bottle but discarded if not used within 90

days.

Do not use after the expiry date stated on the label.

12. SPECIAL WARNINGS

Special precautions for dogs

The safety of this veterinary medicinal product has not been established in young dogs, so careful

monitoring by your veterinary surgeon is recommended if the dog is less than 6 months of age.

Use in animals suffering from impaired cardiac or hepatic function, may involve additional risk. If

such use cannot be avoided, these animals require careful veterinary monitoring. Avoid using this

product in any animals which are dehydrated, hypovolaemic or hypotensive, as it may increase the risk

of renal toxicity.

Use this veterinary medicinal product under strict veterinary monitoring in dogs with a risk of stomach

ulcers or if the animal previously displayed intolerance to other NSAIDs.

Do not use in breeding, pregnant or lactating bitches. Although no data are available in dogs, studies

with laboratory animals have shown effects on their fertility and foetal development.

Cimalgex should not be administered in conjunction with corticosteroids or other NSAIDs. Pre-

treatment with other anti-inflammatory substances may result in additional or increased adverse effects

and accordingly a treatment-free period with such drugs should be observed before starting treatment

with Cimalgex. The treatment-free period should take into account the pharmacokinetic properties of

the veterinary medicinal products used previously.

19

Special precautions for people

Cimicoxib may cause skin sensitisation. Wash hands after use of the veterinary medicinal product.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the

label to the physician.

People with a known hypersensitivity to cimicoxib should avoid contact with the veterinary medicinal

product.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE

MATERIALS, IF ANY

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

18/02/2011

Detailed information on this product is available on the website of the European Medicines Agency

http://www.ema.europa.eu/

15. OTHER INFORMATION

Cimicoxib is a non-narcotic, non-steroidal anti-inflammatory drug (NSAID) drug. It selectively

inhibits the cyclooxygenase 2 enzyme (COX-2), which is responsible for pain, inflammation or fever.

The cyclooxygenase 1 enzyme (COX-1) which has protective functions, for example, in the digestive

tract and kidneys, is not inhibited by cimicoxib.

After oral administration in dogs at the recommended doses, cimicoxib is rapidly absorbed.

Metabolism of cimicoxib is extensive. The major metabolite, demethylated cimicoxib is mainly

eliminated in faeces by the biliary route and, to a lesser extent, in urine. The other metabolite,

glucuronide conjugate of the demethylated cimicoxib, is eliminated in urine.

In an artificially induced pain model in dogs it was shown that the pain and inflammation reducing

effects of cimicoxib lasted for approximately 10-14 hours.

All strengths of Cimalgex tablets are available in the following pack sizes and types:

Aluminium blisters (each strip containing 8 tablets) packaged into an outer cardboard box. Pack

sizes of 8, 32 or 144 tablets.

Plastic (HDPE) bottle (containing 45 tablets) with child resistant plastic (PP) closure packaged into

an outer cardboard box.

Not all pack sizes may be marketed.

Summary of Product characteristics

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1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Cimalgex 8 mg chewable tablets for dogs

Cimalgex 30 mg chewable tablets for dogs

Cimalgex 80 mg chewable tablets for dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

Active substance:

Cimalgex 8 mg cimicoxib 8 mg

Cimalgex 30 mg cimicoxib 30 mg

Cimalgex 80 mg cimicoxib 80 mg

For a full list of excipients see section 6.1.

3. PHARMACEUTICAL FORM

Chewable tablets.

Oblong, white to pale brown, chewable tablets with a break-line on both sides.

The tablets can be divided into equal halves.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

For the treatment of pain and inflammation associated with osteoarthritis, and the management of peri-

operative pain due to orthopaedic or soft tissue surgery, in dogs.

4.3 Contraindications

Do no use in dogs less than 10 weeks of age.

Do not use in dogs suffering from gastrointestinal disorders or haemorrhagic disorders.

Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs

(NSAIDs).

Do not use in case of hypersensitivity to cimicoxib or to any of the excipients.

Do not use in breeding, pregnant and lactating animals.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals

Since the safety of the medicinal product has not been adequately demonstrated in young animals,

careful monitoring is advised during the treatment of young dogs aged less than 6 months.

2

Use in animals suffering from impaired cardiac or hepatic function, may involve additional risk. If

such use cannot be avoided, these animals require careful veterinary monitoring.

Avoid using this product in any animals which are dehydrated, hypovolaemic or hypotensive, as it

may increase the risk of renal toxicity.

Use this veterinary medicinal product under strict veterinary monitoring where there is a risk of

gastrointestinal ulceration, or if the animal previously displayed intolerance to NSAIDs.

Special precautions to be taken by the person administering the veterinary medicinal product to

animals

Cimicoxib may cause skin sensitisation. Wash hands after use.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the

label to the physician.

People with a known hypersensitivity to cimicoxib should avoid contact with the veterinary medicinal

product.

4.6 Adverse reactions (frequency and seriousness)

Mild and transient gastro-intestinal disorders (vomiting and/or diarrhoea) were very commonly

reported.

On rare occasions, serious gastrointestinal disorders such as haemorrhage and ulcer formation have

been noted. Other adverse reactions including anorexia or lethargy may also be observed on rare

occasions.

In very rare cases, increases in renal biochemistry parameters were noted. As for any long term

NSAID treatment, renal function should be monitored.

If any observed adverse effect persists after stopping treatment, the advice of a veterinarian should be

sought.

If adverse reactions such as persistent vomiting, repeated diarrhoea, faecal occult blood, sudden

weight loss, anorexia, lethargy or worsening of renal or hepatic biochemistry parameters occur, use of

the product should be discontinued and appropriate monitoring and/or treatment should be put in place.

4.7 Use during pregnancy, lactation or lay

Do not use in breeding, pregnant or lactating bitches. Although no data are available in dogs, studies

with laboratory animals have shown effects on their fertility and foetal development.

4.8 Interaction with other medicinal products and other forms of interaction

Cimalgex should not be administered in conjunction with corticosteroids or other NSAIDs. Pre-

treatment with other anti-inflammatory substances may result in additional or increased adverse effects

and accordingly a treatment-free period with such drugs should be observed before the

commencement of treatment with Cimalgex. The treatment-free period should take into account the

pharmacokinetic properties of the veterinary medicinal product used previously.

4.9 Amounts to be administered and administration route

Oral use.

Cimalgex tablets can be administered with or without food. The tablets are flavoured and studies (in

healthy Beagle dogs) show they are likely to be taken voluntarily by most dogs.

3

The recommended dose of cimicoxib is 2 mg per kg bodyweight, once daily, according to the dosage

table below:

Number of Tablets and Tablet Strength

(mg cimicoxib)

Bodyweight of

dog (kg)

Cimalgex 8 mg

Cimalgex 30 mg

Cimalgex 80 mg

3.0 - 4.0 1

4.1 - 7.5 ½

7.6 - 15.0 1

15.1 - 20.0 ½

20.1 - 40.0 1

40.1 - 60.0 1+½

>60.1 2

Treatment duration:

Management of peri-operative pain due to orthopaedic or soft tissue surgeries: one dose 2 hours

prior to surgery, followed by 3 to 7 days of treatment, based on the judgment of the attending

veterinarian.

Relief of pain and inflammation associated with osteoarthritis: 6 months. For longer-term

treatment, regular monitoring should be undertaken by the veterinarian.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In an overdose study where 3 times (5.8 to 11.8 mg/kg body weight) and 5 times (9.7 to 19.5 mg/kg

body weight) the recommended dose was administered to dogs for a period of 6 months, a dose related

increase in gastrointestinal disturbances, which affected all dogs in the highest dose group, was noted.

Similar dose related changes to haematology and white blood cell counts, as well as renal integrity,

were also noted.

As with any NSAID, overdose may cause gastrointestinal, kidney, or liver toxicity in sensitive or

compromised dogs.

There is no specific antidote to this product. Symptomatic, supportive therapy is recommended

consisting of administration of gastrointestinal protective agents and infusion of isotonic saline.

4.11 Withdrawal period

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: non-steroidal anti-inflammatory drug, ATCvet code: QM01AH93

4

5.1 Pharmacodynamic properties

Cimicoxib is a non-steroidal anti-inflammatory drug belonging to the coxib group and acting by

selective inhibition of the enzyme cyclo-oxygenase 2. The cyclo-oxygenase enzyme (COX) is present

in two isoforms. COX-1 is usually a constitutive enzyme expressed in tissues, which synthesize

products responsible for normal physiologic functions (e.g. in the gastro-intestinal tract and kidneys).

COX-2 on the other hand, is mainly inducible and synthesized by macrophages and inflammatory cells

after stimulation by cytokines and other mediators of inflammation. COX-2 is involved in the

production of mediators, including PGE2, that induce pain, exudation, inflammation and fever.

In an in vivo inflammatory acute pain model, it was shown that the simulated effect of cimicoxib

lasted for approximately 10-14 hours.

5.2 Pharmacokinetic particulars

After oral administration in dogs at the recommended dose of 2 mg/kg without food, cimicoxib is

rapidly absorbed and the time to maximal concentration (T

max ) is 2.25 (± 1.24) hours. The peak

concentration (C

max ) is 0.3918 (± 0.09021) µg/ml, area under the curve (AUC) is 1.676 (± 0.4735)

µg.hr/ml, and oral bioavailability is 44.53 (± 10.26) percent.

The oral administration of cimicoxib with food did not significantly influence the bioavailability but

decreased significantly the observed T

max .

Metabolism of cimicoxib is extensive. The major metabolite, demethylated cimicoxib is mainly

eliminated in faeces by the biliary route and, to a lesser extent, in urine. The other metabolite,

glucuronide conjugate of the demethylated cimicoxib, is eliminated in urine. The elimination half-life

(t

1/2 ) is 1.38 (± 0.24) hours. The metabolising enzymes have not been fully investigated and slower

metabolism (up to four-fold increased exposure) has been noted in some individuals.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose monohydrate

Povidone K25

Crospovidone

Sodium laurylsulfate

Macrogol 400

Sodium stearyl fumarate

Pork liver powder

6.2 Incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years

Any remaining half tablets should be discarded after 2 days storage in the blisters.

Any remaining half tablets should be discarded after 90 days storage in the bottle.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

5

Any half tablets should be stored in the blister pack/bottle.

6.5 Nature and composition of immediate packaging

All strengths are available in the following pack sizes and types:

Aluminium blisters (each strip containing 8 tablets) packaged into an outer cardboard box. Pack

sizes of 8, 32 or 144 tablets.

Plastic (HDPE) bottle (containing 45 tablets) with child resistant plastic (PP) closure packaged into

an outer cardboard box.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste

materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal

products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Vétoquinol SA

Magny Vernois

F-70200 Lure

France

8. MARKETING AUTHORISATION NUMBER(S)

EU/2/10/119/001-012

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

18/02/2011

10. DATE OF REVISION OF THE TEXT

18/02/2011

Detailed information on this veterinary medicinal product is available on the website of the European

Medicines Agency: http://www.ema.europa.eu/

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

6

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