Co Trimazine

Main information

  • Trade name:
  • Co Trimazine Tablets 480 mg
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Co Trimazine Tablets 480 mg
    United Kingdom
  • Language:
  • English

Other information

Status

  • Source:
  • VMD - Veterinary Medicines Directorate
  • Authorization status:
  • Expired
  • Authorization number:
  • 41687/4004
  • 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 480 mg

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains

Active Substance(s): mg :

Trimethoprim   80 

Sulfadiazine  400 

Excipients:

For a full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Tablet.

A circular, uncoated, white tablet scored on one face.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

When susceptible organisms are present the Tablets may be effective in treating

the   following   conditions:   alimentary   tract   infections,   respiratory   and   urogenital

infections, skin and wound infections and eye and ear infections.

4.3 Contraindications

Co-trimazine Tablets 480 mg are not suitable for use in cats.

4.4 Special Warnings for each target species

No special warnings.

Page 1 of 4

Revised: October 2012

AN: 00752/2012

4.5 Special precautions for use

Special precautions for use in animals

Use of the product should be based on susceptibility testing of bacteria

isolated from the animal. If this is not possible, therapy should be based

on   local   (regional,   farm   level)   epidemiological   information   about

susceptibility of the target bacteria.

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)

A low incidence of polyarthropathy and Keratoconjunctivitis Sicca (Dry Eye) has

been reported in dogs following oral administration of potentiated sulfonamides.

If either of these conditions occur, it is recommended that medication is stopped

and that future treatment is avoided.

Sulfonamide 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

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 4

Revised: October 2012

AN: 00752/2012

4.9 Amounts to be administered and administration route

The daily dose is one tablet per 16 kg bodyweight administered orally, providing

30 mg of combined active ingredients per kg bodyweight. Treatment should be

continued for up to five 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 treatment specified.

4.11 Withdrawal period

Not applicable

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group:  Sulfonamides

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.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Microcrystalline Cellulose,

Povidone (K12),

Lactose monohydrate,

Sodium Starch Glycollate, Type A,

Magnesium stearate.

6.2 Incompatibilities

Not applicable

Page 3 of 4

Revised: October 2012

AN: 00752/2012

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 a  white opaque polyethylene cap (push fit)

(tamper evident) containing either 100 or 500 tablets.

Not all pack sizes may be marketed.

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

8. MARKETING AUTHORISATION NUMBER(S)

Vm  41687/4004

9. DATE OF FIRST AUTHORISATION

Date: 28 August 1997 

10. DATE OF REVISION OF THE TEXT

Date: October 2012

Page 4 of 4

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