SUMMARY OF PRODUCT CHARACTERISTICS

1. Name of the veterinary medicinal product

Norodine 20 Coated Tablets

2. Qualitative and quantitative composition

Active Substance:

Each tablet contains:

Trimethoprim 20mg

Sulfadiazine 100 mg.

Excipients:

Titanium dioxide (E171) 0.27mg.

For a full list of excipients, see section 6.1

Coated tablet.

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

4. Clinical Particulars

Dogs

Adult Cats

Alimentary tract infections, respiratory and urogenital infections, skin and wound infections, and eye and ear infections where susceptible organisms are present

4.3 Contraindications

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 recommended that medication is stopped and that future treatment with similar products is avoided.

None

Special precautions for use in animals

The tablets should not be divided.

When given to cats the tablets should not be crushed before administration.

Maintain adequate fluid intake during treatment.

Not to be used in cases of hepatic renal impairment or blood dyscrasia

Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local epidemiological information.

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 reactions 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 a skin rash, you should seek medical advice and show the doctor this warning.

Sulphonamide sensitivity is rare in companion animals but should be considered in cases of unexpected responses to treatment.

Norodine 20 Tablets can be safely administered during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

No known interactions.

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 the correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing.

No data available

Not applicable

5. pharmacological properties

Pharmacotherapeutic group: Sulphonamides

ATC Vet Code: QJ01EW10

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.

Sulphonamides are absorbed rapidly after oral administration and diffuse rapidly into tissues. Elimination is mainly by metabolism in the liver and excretion in the urine. Trimethoprim also diffuses well into body tissues and though eliminated quicker, the combination remains active for sufficient time to achieve effective antimicrobial activity.

6. Pharmaceutical particulars

Titanium Dioxide (E171)

Cellulose Microcrystalline

Lactose Monohydrate

Sodium starch Glycollate

Povidone (K17)

Magnesium Stearate

Sucrose

Talc Purified

None known.

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

Do not store above 25ºC.

Protect from light.

Store in a dry place.

White polypropylene securitubs sealed with a white, low density, push fit, tamper evident polyethylene cap containing 100 tablets.

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

Norbrook Laboratories Limited

Station Works,

Camlough Road

NEWRY

Co. Down, BT35 6JP

Northern Ireland

8. MARKETING AUTHORISATION NUMBER(S)

Vm 02000/4096

9. DATE OF FIRST AUTHORISATION

20^th November 1987

10. DATE OF REVISION OF THE TEXT

November 2008