Florfenicol 30% Oral Solution

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Common Name: Florfenicol 30% Oral Solution

Trade Name: Florphenicol 300

2.COMPOSITION

Each ml contains

Active Substance:

Florfenicol…………………………………………………300 mg

Excipients:

N,N-Dimethylacetamide………………………………..0.6ml

Propylene Glycol add to………………………………….1 ml

3.PHARMACEUTICAL FORM

Solution.

4.CLINICALPARTICULARS

4.1 Target animals

Cattle, Poultry.

4.2 Indications

Florphenicol 300 is indicated for preventive and therapeutic treatment of gastrointestinal and respiratory tract infections,caused by florfenicol sensitive micro-organisms such as Actinobacillus spp. Pasteurella spp. Salmonella spp.and Streptococcus spp. in swine and poultry.The presence of the

disease in the herd should be established before preventive treatment. Medication should be initiated

promptly when respiratory disease is diagnosed.

4.3 Dosage and administration

Cattle: 1ml for 8 – 10 L of water.

Poultry: 1ml for 4 – 6 L of water.

4.4 Contraindications

Not to be used in boars intended for breeding purposes, or in animals producing eggs or milk for human consumption.Do not administer in cases of previous hypersensitivity to florfenicol.

The use of floro-10 Oral during pregnancy and lactation is no recommended.

The product should not be used or stored in galvanized metal watering systems or containers.

4.5 Special warnings and special precautions for use

Special precautions for use in animals

The treated swine should be placed under special observation. On each of the five days of treatment, unmedicated drinking water should not be given until the full daily amount of medicated drinking water has been ingested by swine.If there are no signs of improvement after three days of treatment, the diagnosis should be reviewed and, if necessary, the treatment changed.In case of insufficient water intake, animals should be treated parenterally.

Special precautions for use in animals

Use of the product should be based on susceptibility testing of the bacteria isolated from the animal.

Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the florfenicol.

Official and local antimicrobial policies should be taken into account when the product is used.

Special precautions to be taken by the person administering the veterinary medicinal product to animals. This product may cause hypersensitivity (allergy).

People with known hypersensitivity to florfenicol, N,N-Dimethylacetamide or propylene glycol should avoid contact with the product.

Pregnant women and women of child-bearing age should avoid working with this product.

Contact of the product or the medicated drinking water with skin and eyes should be avoided.

Personal protective equipment consisting of protective gloves, coverall and safety glasses should be worn when handling and mixing the product.

Do not smoke, eat or drink when handling the product or mixing the medicated drinking water.

In case of accidental spillage into eyes, wash them immediately with water.

In case of contact with skin, wash the affected area immediately and remove any contaminated clothing.

If you develop symptoms following exposure such as skin rash, seek medical advice and take the package leaflet or the label with you.

Wash hands after use.

4.6 Side Effects

A decrease in food and water consumption and transient softening of the faeces or diarrhoea may occur during the treatment period.The treated animals recover quickly and completely upon termination of treatment.

In swine, commonly observed adverse effects are diarrhoea,peri-anal and rectal erythemal oedema and prolapse of the rectum. These effects are transient.

4.7 Use during pregnancy, lactation or lay

As no studies have been performed in swine during pregnancy and lactation, do not use the product in pregnant or lactating animals.

The product contains N,N-Dimethylacetamide, which is considered to be a reproductive toxicant.

4.8 Interaction with other medicinal products and other forms of interaction

No data available.

4.9 Overdose

In case of overdosing, a decrease in weight gain, water intake, peri-anal erythema and oedema and modification of some haematological and biochemical parameters indicative of dehydration may be observed

4.10 Withdrawal times

For meat:

Cattle: 21 days, Poultry:7 days.

Chicken: 5days.

5.1 Shelf life

Shelf-life of veterinary medicinal product as packaged for sale: 36months.

6.1 Special precautions for storage

Store below 30℃, and protect from light.

For veterinary use only.

Keep out of reach of children.