Co Trimazine

Main information

  • Trade name:
  • Co Trimazine Tablets 120 mg
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Co Trimazine Tablets 120 mg
    United Kingdom
  • Language:
  • English

Other information

Status

  • Source:
  • VMD - Veterinary Medicines Directorate
  • Authorization status:
  • Expired
  • Authorization number:
  • 41687/4001
  • Last update:
  • 21-12-2016

Summary of Product characteristics

Revised: October 2012

AN: 00752/2012

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Co Trimazine Tablets 120 mg

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

Active Substance(s): mg

Trimethoprim  20.00

Sulfadiazine          100.00

Excipients:

Titanium dioxide (E171)                             0.27

For a full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Coated tablet.

An off white, sugar coated, unscored, circular tablet.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs

Adult Cats

4.2 Indications for use, specifying the target species

The tablets are effective in treating alimentary tract infections, 

respiratory and urogenital infections, skin and wound infections, and 

eye and ear infections where susceptible organisms are present.

4.3 Contraindications

For use in adult cats only.

4.4 Special Warnings for each target species

A low incidence of polyarthropathy and Keratoconjunctivitis Sicca (Dry

Eye)   has   been   reported   in   dogs   following   oral   administration   of

potentiated sulphonamides. If either of these conditions occurs, it is

Page 1 of 5

Revised: October 2012

AN: 00752/2012

recommended that medication is stopped and that future treatment with

similar products is avoided.

4.5.1 Special precautions for use

Special precautions for use in animals

Use of the product should be based on susceptability testing of

bacteria isolated from the animal. If this is not possible, therapy

should   be   based   on   local   (regional,   farm   level)   epidemiological

information about susceptability of the target bacteria.

The tablets should not be divided.

When   given   to   cats   the   tablets   should   not   be   crushed   before

administration.

Maintain adequate fluid intake during treatment.

ii. Special precautions to be taken by the person administering the

veterinary medicinal product to animals

Take care to avoid skin contact. 

Wash hands after use.

Sulphonamides   may   cause   hypersensitivity   (allergy)   following

injection, inhalation, ingestion or skin contact. Hypersensitivity to

sulphonamides may lead to cross reaction with other antibiotics.

Allergic reactions to these substances may occasionally be serious.

1.   Do   not   handle   this   product   if   you   know   you   are   sensitive   to

sulphonamides.

2. If you develop symptoms following exposure such as skin rash,

you should seek medical advice and show the doctor this warning.

4.6 Adverse reactions (frequency and seriousness)

Sulphonamide sensitivity is rare in companion animals but should be

considered in cases of unexpected responses to treatment.

4.7 Use during pregnancy, lactation or lay

Co-trimazine   Tablets   120   mg   can   be   safely   administered   during

pregnancy and lactation.

4.8 Interaction   with   other   medicinal   products   and   other   forms   of

interaction

No known interactions.

Page 2 of 5

Revised: October 2012

AN: 00752/2012

4.9 Amounts to be administered and administration route

Administer orally by hand.  The daily dose is 30 mg of combined active

ingredient   per   kg   bodyweight.    This   is   achieved   using   the   following

doses:

Dogs and adult cats:  1 tablet per 4 kg bodyweight.

Treatment should be continued for up to 5 days or until 2 days after

symptoms have subsided. 

To   ensure   a   correct   dosage,   bodyweight   should   be   determined   as

accurately as possible to avoid underdosing.

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

necessary

No data available.

4.11 Withdrawal period

Not applicable

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic   group:    Combinations   of   Sulfonamides   &

Trimethoprim.

ATC Vet Code:  QJ01EW10

5.1 Pharmacodynamic properties

Sulfadiazine (SDZ) inhibits the incorporation of para-aminobenzoic acid

into folic acid and trimethoprim (TMP) inhibits the enzyme dihydrofolate

reductase (DHFR) which converts dihydrofolic acid into tetrahydrofolic

acid.     (TMP)   and   (SDZ)   act   together   synergistically   with   a   double-

blockade mode of action.   The combination is bactericidal     inhibiting

sequential steps in the synthesis of purines which are required for DNA

synthesis.   TMP-SDZ combinations have a broad bactericidal action

against many gram-positive and gram-negative aerobic bacteria and a

large proportion of anaerobic bacteria.

Page 3 of 5

Revised: October 2012

AN: 00752/2012

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Titanium Dioxide (E171).

Microcrystalline Cellulose,

Lactose Monohydrate,

Sodium Starch Glycollate,

Povidone K17,

Magnesium Stearate,

Sucrose,

Talc purified.

6.2 Incompatibilities

Not applicable

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2

years.

6.4 Special precautions for storage

Do not store above 25oC.

Store in a dry place.

Protect from light.

6.5 Nature and composition of immediate packaging

White opaque polypropylene tub with white opaque polyethylene cap

(push fit) (tamper evident) containing 100 tablets.

6.6 Special   precautions   for   the   disposal   of   unused   veterinary

medicinal product or waste materials derived from the use of such

products

Any   unused   product   or   waste   material   should   be   disposed   of   in

accordance with national requirements.

7. MARKETING AUTHORISATION HOLDER

Listow Limited

9 Belgrave Square

London

SW1X 8PH

Page 4 of 5

Revised: October 2012

AN: 00752/2012

8. MARKETING AUTHORISATION NUMBER(S)

Vm

 41687/4001

9. DATE OF FIRST AUTHORISATION

Date: 20 November 1997

10. DATE OF REVISION OF THE TEXT

Date: October 2012 

Page 5 of 5

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