PACKAGE LEAFLET

LIDOPRIM S, Injectable solution

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing Authorisation  holder

PRODIVET Pharmaceuticals sa, Hagbenden 39C, B -4731 EYNATTEN

Manufacturer for the batch release

AniMedica West Herstellungs GmbH, Im Südfeld 9, D-48308 SENDEN-BÖSENSELL

NAME OF THE VETERINARY MEDICINAL PRODUCT

LIDOPRIM S, injectable solution

STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Per ml
Active substances: Trimethoprim 40 mg – Sulfamethoxazole 200 mg
Excipients: Benzyl Alcohol - Sodium Hydroxide - Glycerin Formal - N,N-Dimethylacetamide - Propylene Glycol - Water for injection up to 1 ml.

INDICATION(S)

Treatment of infections caused by germs sensitive to the combination Trimethoprim – Sulfamethoxazole subject to obtaining effective concentrations in the infectious site in calves and piglets. It is recommended to carry out suitable tests of sensitivity before starting the treatment. The treatment will be undertaken only if the sensitivity to the combination is established.

CONTRAINDICATIONS

Do not use in case of:

• Severe renal failure.
• Alteration of the haematopoietic function.

Do not use in case of hypersensitivity to the active substances or to any of the excipients.

ADVERSE REACTIONS

• Vomiting.
• Hypersensitivity reactions to Sulphonamides.
• Cristalluria.
• Aplasic anaemia.
• Thrombocytopenia.

If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

TARGET SPECIES

Calves and piglets..

DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

LIDOPRIM S^® is administered through intramuscular injection for 3 to 5 days.

• Calves: 30 mg (5 mg Trimethoprim + 25 mg Sulfamethoxazole) /kg that is to say 1 ml / 8 kg BW single in day
• Piglets: 30 mg (5 mg Trimethoprim + 25 mg Sulfamethoxazole) /kg that is to say 1 ml / 8 kg BW single in day

To ensure correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing.
The treatment must not exceed 5 days.

ADVICE ON CORRECT ADMINISTRATION

 

WITHDRAWAL PERIOD

Cattle: meat and offals: 24 days after the last injection.
Piglets: meat and offals: 4 days after the last injection.

SPECIAL STORAGE PRECAUTIONS

Keep out of reach and sight of children.
Store below 25° C, in the original package.
Shelf life after opening: 28 days, in the closed vial, below 25°C and protected from light.

SPECIAL WARNING(S)

Special precautions of use in the animal

• Taking into account the high degree of resistance reported, the use of the product will be done according to the result of the tests of sensitivity
• It is advised to know and supervise the renal function
• Interactions can happen by a simultaneous use of drugs which can influence the hepatic metabolism and the haematopoietic function
• Water must be available permanently during the treatment.

Special precautions to be taken by the person who administers the veterinary medicinal product to the animals

For the user:
This drug contains Trimethoprim and Sulfamethoxazole. People who are hypersensitive to  Trimethoprim or/and Sulfamethoxazole should avoid every contact with LIDOPRIM S. In case of accidental self-injection seek immediately medical advice and show the package leaflet to the physician.
For the doctor:
This drug contains Trimethoprim and Sulfamethoxazole. In case of strong dosis injection, start a forced diuresis, control the blood picture and ensure a suitable blood monitoring, including electrolytes.

Use during pregnancy, lactation or lay

LIDOPRIM S is for young animals.

Interaction with other medicinal products and other forms of interaction

Don’t inject in combination with other solutions in particular with local anesthetics based on esters of para-aminobenzoic acid.

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

When administered in normal doses, this association doesn’t produce any toxic clinical effects, except for possible hypersensitivity reactions which can usually be treated symptomatically with antihistamines or corticosteroids.

Incompatibilities

In the absence of compatibility studies, LIDOPRIM S must not be mixed with other veterinary medicinal products.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIAL, IF ANY

LIDOPRIM S should not be disposed of via wastewater or household waste
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

December 2013

OTHER INFORMATION

BE-V140621

Available on prescription only

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder:
PRODIVET Pharmaceuticals S.A./N.V.
Hagbenden 39c
B - 4731 EYNATTEN
Phone : 00 32 (0)87 85 20 25
e-mail : info@prodivet.com

LIDOPRIM S_NOT_GB_ V4_20131223