FLORCRID 30% inj

COMPOSITION

1 mL of product contains Florfenicol 300 mg.

TARGET SPECIES

Cattle, pigs

INDICATIONS

In the treatment of diseases caused by Florfenicol-susceptible germs.

Cattle - Preventive (in populations where diagnosis was confirmed) and curative treatment of respiratory infections produced by Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.

Pigs - Treatment of acute respiratory infections caused by Actinobacillus pleuropneumoniae și Pasteurella multocida.

CONTRAINDICATIONS

Do not administer to bulls and hogs used for breeding.

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

Do not use in piglets of less than 2 kg.

ADVERSE REACTIONS

Cattle - There may be a reduction in fodder consumption and soft stools during treatment.

When the treatment is discontinued, animals quickly and completely restore their appetite.

Intramuscular or subcutaneous administration may be accompanied by inflammatory lesions at the injection site that persist for 14 days.

In very rare situations, anaphylactic shock has been reported in cattle.

Usually the reactions are mild and transient.

Pigs - The most common side effects are transient diarrhoea, erythema, perianal and rectal oedema in 50% of the animals over a week.

At the injection site, swelling may occur for a period of 5 days.

Inflammatory lesions at the injection site can be observed for 28 days.

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

Cattle - Treatment: Intramuscular administration: 20 mg Florfenicol/kg body weight or 1 mL product/15 kg body weight, twice over a 48-hour interval.

Subcutaneous administration: 40 mg Florfenicol/kg body weight or 2 mL product/15 kg body weight, single administration.

Preventive: Subcutaneous administration: 40 mg Florfenicol/kg body weight or 2 mL product/15 kg body weight, single administration.

Pigs - Intramuscular administration: 15 mg Florfenicol/kg body weight or 1 mL product/20 kg body weight, twice over a 48-hour interval.

The weight of the animal will be assessed as accurately as possible to ensure a correct dose and avoid underdosing.

WARNINGS/ADVICE ON CORRECT ADMINISTRATION

For intramuscular administration, it is recommended to treat the animals in an early phase of the disease and to evaluate the response to treatment 48 hours after the second administration.

If clinical signs of respiratory disease persist 48 hours after the last injection, the treatment should be changed using another formula or another antibiotic and continued until the clinical signs disappear.

Wipe off the cap before taking each dose. Use sterile syringes and dry needles. 

Do not puncture the cover more than 25 times.

Injections should be performed in the neck with a no. 16 needle.

The volume of the dose administered in one place should not exceed 10 mL in cattle and 3 mL in pigs.

WITHDRAWAL PERIOD(S)

Cattle - Meat and offal: 30 days (intramuscular administration), 44 days (subcutaneous administration).

Pigs - meat and offal: 18 days.

Use in animals producing milk for human consumption is not authorised.

SHELF LIFE

Shelf life of the veterinary medicinal product as packaged for sale: 2 years. Shelf-life after first opening the immediate packaging: 28 days.

SPECIAL PRECAUTIONS FOR STORAGE

Do not store above 25°C. Do not refrigerate. Do not freeze.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

The use of the product should be based on antimicrobial susceptibility testing of bacteria isolated from animals.

If this is not possible, therapy should be based locally on epidemiological information on the target bacteria’s susceptibility.

Using the product in violation of the instructions provided in the SmPC may increase the prevalence of resistant bacteria and may decrease treatment effectiveness with other amphenicols due to their cross-resistance potential.

SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT:

Do not use this product in cases of known hypersensitivity to the active substances or to any of the excipients.

To avoid self-injection, the product should be handled with caution.

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

Direct skin contact should be avoided due to sensitisation, contact dermatitis or possible hypersensitisation reactions to amphenicols that may occur. 

Wearing protective gloves is recommended. Do not eat, drink or smoke during product administration.

USE DURING PREGNANCY AND LACTATION 

Studies in laboratory animals have revealed no embryotoxic or foetotoxic potential of florfenicol.

However, product safety in the target species has not been demonstrated regarding reproduction, gestation and lactation.

Use of the product during gestation and lactation is done after the risk-benefit balance has been assessed by the veterinarian.

OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES)

Cattle - There may be a reduction in fodder consumption and soft stools during treatment.

When the treatment is discontinued, animals quickly and completely restore their appetite.

Pigs - A decrease in weight gain, food and water consumption has been observed after a dose 3 times the recommended dose.

After a 5-fold higher dose than recommended, vomiting may occur.

INCOMPATIBILITIES

Do not mix with any other veterinary medicinal product.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY

Any unused veterinary medicinal product or waste materials derived from such products should be disposed of in accordance with local requirements.

Medicines should not be disposed of via waste water or household waste. Ask your vet for information on how to dispose of medicines no longer required.

These measures contribute to environmental protection.

PRESENTATION/PACKAGE 

100 mL, 250 mL and 500 mL polypropylene vials sealed with bromobutyl rubber stopper and aluminium cap.