CLORTETRADEM 10%

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PREMIX ANTIBIOTIC

Chlortetracycline HCl 100 mg/g.
Premix for medicated feed for pigs and chickens

Formula

Each gram of product contains:

Chlortetracycline HCl (active substance): 100 mg

In pigs for treatment of gastroenteritis, colibacillosis, salmonellosis, campylobacteriosis, listeriosis, swine erysipelas, bronchopneumonia, omphalophlebitis, mastitis, metritis, dermatitis caused by bacteria susceptible to chlortetracycline.

In chickens for treatment of mycoplasmosis, colibacillosis, pasteurellosis, salmonellosis, coryza, infectious sinusitis, staphylococci, hepatitis produced by Campylobacter spp., dermatitis caused by bacteria susceptible to chlortetracycline.

Administration

CLORTETRADEM 10% premix is administered in feed.

In chickens: 80-110 mg Chlortetradem 10% premix/kg body weight, for 3-5 consecutive days.

For chickens up to 14 days old: 1600 g of Chlortetradem 10% premix /1000 kg of feed, for 3-5 consecutive days.

For chickens over 14 days old: 1400 g of Chlortetradem 10% premix /1000 kg of feed, for 3-5 consecutive days.

In pigs: 88-110 mg Chlortetradem 10% premix/kg body weight, for 3-5 consecutive days.

In piglets up to 70 days old: 1600 g of Chlortetradem 10% premix/ 1000 kg of feed, for 3-5 consecutive days.

In youth and adults: administer 1400 g of Chlortetradem 10% premix / 1000 kg of feed, for 3-5 consecutive days.

In suckling piglets, the product will be administered one hour before or two hours after feeding with milk or milk substitutes.

The uptake of medicated feed is dependant on the clinical condition of animals. In order to obtain the correct dosage, the concentration in feed may have to be adjusted.

For any information regarding this veterinary medicinal product, please contact the local representative of the marketing authorization holder.

Contraindications

Do not administer to animals with known hypersensitivity to the active substance.

Do not administer to animals with renal failure.

Side effects

The toxicity of chlortetracycline is low, the administration of the product in the recommended doses does not cause adverse reactions.

In rare cases, allergic reactions and gastrointestinal, hepatic or renal disorders may occur, such as: anorexia, vomiting, diarrhea, abdominal colic, pancreatitis.

Teeth, the following can occur: dental pigmentation, tooth enamel hypoplasia in newborns and infants from sows treated with this product during pregnancy or after birth.

Special precautions for storage

Keep away from reach and sight of children.

Keep in original packaging, at temperature below 25^oC, protected from direct sunlight and moisture.

Shelf-life after first opening of primary package: 28 days.

Shelf life after incorporation into meal or pelleted feed: 7 days

Do not use after expiry date which is stated on the label.

Advice on correct administration

During treatment, the animals should eat only medicated feed. To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing. The product should be well mixed with the feed to be homogenous.

Withdrawal period

Meat and offal:

Pigs, chickens: 28 days.

Eggs: 7 days.

Special warnings

People with known hypersensitivity to any of the product ingredients should avoid contact with the veterinary medicinal product. To prevent any unpleasant effects, personal protective equipment consisting in rubber gloves, goggles and dust masks should be worn when administering the product. Wash hands and exposed skin after use.

In case of accidental ingestion or the occurrence of symptoms characterized by skin rash, seek medical advice. Serious symptoms such as face swelling, lips or eye lids, accompanied by breath difficulties, are life-threatening symptoms and need immediate medical attention.

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 (regional, farm level) epidemiological information about susceptibility of the target bacteria. National and regional antimicrobial policies should be taken into account when using the product.

Apart from the precipitation of some substances, due to the acidic pH, chlortetracycline degrades penicillin, erythromycin reducing their stability. Riboflavin degrades chlortetracycline even when present in low concentrations between 0.01% and 0.10%. Sodium bicarbonate administered orally together with chlortetracycline diminishes its effect by inhibiting dissolution in the stomach environment. Acting on the saprophytic intestinal flora, it decreases the synthesis of vitamin K and thus indirectly increases the action of anticoagulant substances. Corticosteroids associated with chlortetracycline increase the risk of candidiasis. The association with diuretic substances is not recommended: ethacrynic acid, furosemide (risk of increasing azotemia). Barbiturates decrease the activity of chlortetracycline (enzyme induction). Chlortetracycline precipitates in the presence of bivalent cations (Ca, Fe). The effect of chlortetracycline is reduced when it is associated with antacids, magnesium, aluminum, zinc, bismuth, milk, sodium carboxymethylcellulose, methylcellulose, sodium alginate, arabic gum, kaolin, bentonite.Tetracyclines should not be administered to animals that are anesthetized with alcohol because they potentiate the effect of alcohol.

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.