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Co Trimazine

Main information

  • Trade name:
  • Co Trimazine Tablets 120 mg
  • Available from:
  • Listow Limited
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug
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Documents

Localization

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

Other information

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Status

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

Summary of Product characteristics

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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

i. 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

There are no safety alerts related to this product.

20-12-2016

UNIPRIM (Trimethoprim And Sulfadiazine) Powder [Neogen Corporation]

UNIPRIM (Trimethoprim And Sulfadiazine) Powder [Neogen Corporation]

Updated Date: Dec 20, 2016 EST

US - DailyMed

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