Florfenidem Injectable 300 mg/ml

Injectable Solution

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FLORFENIDEM
300 mg/ml, solution for injection for swine, cattle and sheep

1. NAME AND ADRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER, IF DIFFERENT
Delos Impex ’96 S.R.L.
81, Horia, Closca si Crisan Street,
Otopeni, Ilfov District, Romania
Tel. +40-372 714 433 Fax: +40-0372 871 445

2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Florfenidem, 300 mg/ml, solution for injection for swine, cattle and sheep.

3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
Each ml of Florfenidem contains:
Florfenicol (active substance) ……………………………………… 300 mg

4. INDICATIONS

Swine: treatment of acute outbreaks of swine respiratory disease caused by strains of Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae and Pasteurella multocida susceptible to florfenicol.

Cattle:
For metaphylactic (where the presence of the disease in the herd has been established) and therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni. The presence of the disease in the herd should be established before preventive treatment.

Sheep:
Treatment of ovine respiratory tract infections due to Mannheimia haemolytica Pasteurella multocida and Histophilus somni susceptible to florfenicol.

5. CONTRAINDICATIONS
Do not administer to boars, adult bulls and rams intended for breeding purposes.
Do not use in the case of known hypersensitivity to the active substance or to any of the excipients.
Do not administer to piglets weighing less than 2 kg. Do not administer in lambs under 7 weeks of age.

6. ADVERSE REACTIONS
Swine
Commonly observed adverse effects are transient diarrhoea and/or peri-anal and rectal erythema/oedema which may affect 50% of the animals. These effects can be observed for one week.
Transient swelling lasting up to 5 days may be observed at the site of injection. Inflammatory lesions at the injection site may be seen up to 21 days.
Cattle:
A decrease in food consumption and transient softening of the faeces may occur during the treatment period. The treated animals recover quickly and completely upon termination of treatment.
Administration of the product by the intramuscular and subcutaneous routes may cause inflammatory lesions at injection site which persist for 14 days.
In very rare cases, anaphylactic shocks have been reported in bovines.
Sheep:
A decrease in food consumption may occur during the treatment period. The treated animals recover quickly and completely upon termination of treatment.
Administration of the product by the intramuscular route may cause inflammatory lesions at the injection site which may persist up to 28 days. Typically, these are mild and transient.

7. TARGET SPECIES
Swine, cattle and sheep.

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

Swine:
15 mg/kg bodyweight (1 mL per 20 kg) by intramuscular injection into the neck muscle twice at 48 hour intervals using a 16-gauge needle.
The volume administered per injection site should not exceed 10 mL.

Cattle – for treatment
IM route: 20 mg/kg bodyweight (1ml/15kg) to be administered twice 48 hours apart using a 16 gauge needle.
SC route: 40 mg/kg bodyweight (2ml/15kg) to be administered once only using a 16 gauge needle. The dose volume given at any one injection site should not exceed 10 ml.
The injection should only be given in the neck muscle.
Cattle – for prevention
SC route: 40 mg/kg bodyweight (2ml/15kg) to be administered once only using a 16 gauge needle. The dose volume given at any one injection site should not exceed 10 ml.
The injection should only be given in the neck.

Use a dry sterile needle and syringe. To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.

Sheep:
20 mg florfenicol/kg bodyweight (1 ml/15 kg bodyweight) by intramuscular injection daily for three consecutive days. The volume administered per injection site should not exceed 4 ml.
Pharmacokinetic studies showed that mean plasma concentrations remain above MIC90 (1 μg/ml) for up to 18 hours after administration of the product at the recommended treatment dose. The pre-clinical data provided support the recommended treatment interval (24 hours) for target pathogens with MIC up to 1 μg/ml.

9. ADVICE ON CORRECT ADMINISTRATION
As the vial should not be broached more than 20 times, the user should select the most appropriate vial size according to the target species to be treated. When treating groups of animals in one run, use a draw-of needle that has been placed in the vial stopper to avoid excess broaching of the stopper. The draw-of needle should be removed after treatment.
It is recommended to treat animals in the early stages of disease and to evaluate the response to treatment within 48 hours after the second injection. If clinical signs of respiratory disease persist 48 hours after the last injection, treatment should be changed using another formulation or another antibiotic and continued until clinical signs have resolved.

10. WITHDRAWAL PERIOD

Meat and offal:
Swine:
14 days

Cattle:by IM (at 20 mg/kg bodyweight, twice): 30 days
by SC (at 40 mg/kg bodyweight, once): 44 days
Sheep: 39 days

Milk: Not permitted for use in lactating animals producing milk for human consumption including pregnant animals intended to produce milk for human consumption.
The withdrawal period is calculated from the last administration of the drug. It should be noted that whatever the withdrawal period no food of animal origin can be given to humans during the period of treatment.

11. SPECIAL PRECAUTIONS FOR STORAGE
Keep away from reach and sight of children!
Store in original packaging, at temperature below 25oC.
Do not refrigerate.
Protect from frost.
Do not use after expiry date which is stated on the label.
Shelf life after first broaching the immediate packaging: 28 days

SPECIAL WARNINGS
Do not exceed the recommended treatment dose or the recommended duration of treatment.
Swab septum before removing each dose. Use a dry sterile needle and syringe.
To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.
The vial should not be broached more than 20 times.
The product should be used in conjunction with susceptibility testing and take into account official and local antimicrobial policies. Use of the product deviating from the instructions given by the SPC may increase the prevalence of bacteria resistant to the florfenicol and may decrease the effectiveness of treatment with other amphenicols due to the potential for cross resistance.
Do not use the product in known cases of sensitivity to active ingredient or excipients.
Care should be taken to avoid accidental self-injection. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. The direct contact with skin should be avoided due to hypersensitization and contact dermatitis. Personal protective equipment consisting of gloves should be worn when handling the veterinary medicinal product. Do not smoke, drink or eat during administration of the product.
Studies in laboratory animals have not revealed any evidence of embryo- or foeto-toxic potential for florfenicol. However, the safety of the product in sows during pregnancy and lactation has not been demonstrated. Do not use the product during pregnancy and lactation.
Interactions with other medicinal products and other forms of interaction are not known.
In swine after administration of 3 times the recommended dose or more a reduction in feeding, hydration and weight gain has been observed. After administration of 5 times the recommended dose or more, vomiting has also been noted.
In sheep after administration of 3 times the recommended dose or more a transient reduction in feed and water consumption has been observed. Additional secondary effects that were noted included an increased incidence of lethargy, emaciation and loose faeces.
Head tilt was seen after administration of 5 times the recommended dose and was considered most likely a result of irritation at the injection site.
No overdosage cases were reported in cattle.
Do not mix with other veterinary medicinal products.

12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS
For the environmental protection, medicines should not be disposed of via wastewater or household waste. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

13. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

14. OTHER INFORMATION
100 and 250 ml colorless polypropylene vials closed with bromobutyl rubber stoppers with aluminium seals.
Secondary package:
Carton box containing 1 vial.

Not all pack sizes may be marketed.
For any information regarding this veterinary medicinal product, please contact the local representative of the marketing authorization holder.
Delos Impex ’96 S.R.L.
81, Horia, Closca si Crisan Street,
Otopeni, Ilfov District, Romania
Tel. +40-372 714 433 Fax: +40-0372 871 445