SUMMARY OF PRODUCT CHARACTERISTICS

1. Name of the veterinary medicinal product

Norodine 80 Tablets

2. Qualitative and quantitative composition

Active Substance:

Each tablet contains:

Trimethoprim 80 mg

Sulfadiazine 400 mg.

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 Norodine 80 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

Norodine 80 Tablets are not suitable for use in cats.

4.4 Special Warnings for each target species

No special warnings.

4.5 Special precautions for use

Special precautions for use in animals

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.

Not recommended in dogs with known hypersensitivity, or hepatic dysfunction.

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.

2. If you develop symptoms following exposure such as a 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 sulphonamides. If either of these conditions occur, it is recommended that medication is stopped and that future treatment is avoided. 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

Norodine 80 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

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

No treatment specified.

Not applicable.

5. pharmacological properties

Pharmacotherapeutic group: Antibacterials for systemic use.

ATC Vet Code: QJ01EW10

5.1 Pharmacodynamic properties

Sulphadiazine (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 and bactericidal action against many Gram-positive and Gram-negative aerobic bacteria and a large proportion of anaerobic bacteria.

5.2 Pharmacokinetic properties

Bioavailibility of SDZ after oral administration is good, with a plasma half-life of about 4 hours. TMP is well absorbed after oral administration, with a shorter half-life. Antibacterial synergism occurs over a wide range of dose combinations. Both substances are metabolised in the liver and excreted largely in the urine.

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

6.1 List of excipients

Cellulose microcrystalline

Povidone (K30)

Lactose Monohydrate

Sodium Starch Glycollate

Magnesium Stearate

6.2 Incompatibilities

None known.

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

Do not store above 25ºC. Store in a dry place.

Protect from light.

White polypropylene securitubs sealed with a white polyethylene push-fit, tamper evident cap. The tablets are packaged in quantities of 100 and 500 tablets.

Not all pack sizes may be marketed.

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

Newry

Co. Down, BT35 6JP

Northern Ireland

8. MARKETING AUTHORISATION NUMBER(S)

Vm 02000/4085

9. DATE OF FIRST AUTHORISATION

28^thAugust 1987

10. DATE OF REVISION OF THE TEXT

November 2008.