Chloromed 150 mg/g Premix for Medicated Feeding Stuff for Pigs

Composition

Active substance:

Each g contains:

Chlortetracycline hydrochloride 150 mg

Excipients:

A coarse, yellow powder.

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Pharmacological properties

4.1 ATCvet code: QJ01AA03

4.2 Pharmacodynamics

Chlortetracycline hydrochloride is a predominantly bacteriostatic antibiotic, interfering with bacterial protein synthesis of the rapidly growing and reproducing bacterial cell. Chlortetracycline has a broad spectrum of activity, including Gram-positive aerobes, Gram-negative anaerobes and Mycoplasmas. Resistance is known to occur in respiratory pathogens of pigs and cross-resistance occurs between chlortetracycline and other tetracyclines.

The Clinical and Laboratories Standards Institute (CLSI) breakpoints established for tetracyclines are as follows:

Organisms other than streptococci: S: ≤ 4μg/ml, I: 8 μg/ml; R: ≥ 16 μg/ml.

4.3 Pharmacokinetics

Following oral administration, maximum blood levels are achieved within approximately 2- 8 hours. Steady state plasma concentrations of chlortetracycline are maintained throughout the twice daily seven day treatment period.

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Target species

Pigs.

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Indications

The veterinary medicinal product is indicated in the treatment of respiratory disease in pigs caused by micro- organisms sensitive to chlortetracycline.

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Dosage

Administration:

Oral use

The recommended therapeutic dose is 20 mg per kg bodyweight daily i.e. 20 grams per 150 kg bodyweight.

For the preparation of the medicated feed the body weight of the animals to be treated and their actual intake of feed should be taken into account. To ensure a correct dosage body weight should be determined as accurately as possible.

The required dose should be measured by suitably calibrated weighing equipment. During the treatment period, only feed medicated with the veterinary medicinal product should be supplied. To provide the required amount of active substance per kg medicated feed the premix has to be incorporated into the feed according to the following formula:

(… mg veterinary medicinal product/kg bw/day x Average bw (kg) of animals to be treated) / (Average daily feed intake (kg/animal)) = ⋯ mg veterinary medicinal product / kg of feed

Treatment should be continued for a period of seven days. If animals don’t recover within 3 days after oral medication, diagnosis should be reconsidered and treatment should be changed, if necessary.

The uptake of medicated feed depends on the clinical condition of the animals. In order to achieve the correct dosage the chlortetracycline hydrochloride inclusion rate in feed should be adjusted for feed intake.

Pelleting should not be conducted at temperatures in excess of 70°C.

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Contraindications

Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Do not use in animals with severe liver and renal disorders.

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Adverse reactions

1. If digestive disturbances occur, treatment should be discontinued.

If suspected adverse reactions occur, treatment should be discontinued.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the immediate packaging for respective contact details.

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Warnings

Special precautions for safe use in the target species:

The veterinary medicinal product is efficient only against bacterial strains most sensitive to chlortetracycline. Use of the veterinary medicinal 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

Inappropriate use of the veterinary medicinal product may increase the prevalence of bacteria resistant to chlortetracycline and may decrease the effectiveness of treatment with related substances, due to the potential for cross-resistance.

Long term use of this veterinary medicinal product is not recommended as it may lead to the development of bacterial resistance.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

Handle this veterinary medicinal product with care to avoid exposure when adding to feed and administering medicated feed to the animals. Take adequate measures to avoid dust formation when adding the veterinary medicinal product to feed.

Those handling the veterinary medicinal product should do so in a mechanically ventilated area.

Wear either a disposable half-mask respirator conforming to European Standard EN149 or a non-disposable respirator to European Standard EN 140 with a filter to EN 143.

Personal protective equipment consisting of gloves, overalls and approved safety glasses should be worn when handling the veterinary medicinal product.

Direct contact of the veterinary medicinal product with the skin, eyes and mucous membranes should be avoided. In case of accidental exposure, wash area immediately with water.

Do not smoke, eat or drink when handling the veterinary medicinal product.

Hands and exposed skin should be washed thoroughly after use.

Special precautions for the protection of the environment:

Not applicable.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

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Use during pregnancy, lactation or lay

Pregnancy and Lactation:

The use is not recommended during pregnancy or lactation. The treatment of pregnant animals with chlortetracycline may result in adverse effects on skeletal and tooth development in the foetus. Therefore, the veterinary medicinal product should be used only in pregnant sows according to the benefit/risk assessment of the responsible veterinarian.

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Interactions

This veterinary medicinal product is not recommended for concurrent administration with any other oral medication.

Do not incorporate the veterinary medicinal product in feed overloaded with polyvalent cations such as Ca2+ and Fe3+ because the formation of chlortetracycline complexes with these cations is possible.

Do not administer together with antacids, kaolin and iron preparations and in conjunction with bactericidal antibiotics like beta-lactams.

The veterinary medicinal product should not be used in cases of known resistance to other tetracyclines.

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Overdose

Do not exceed the stated dose.

Chlortetracycline toxicity is low. If digestive disturbances do occur, treatment should be discontinued.

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Special warnings

The uptake of oral medication by animals can be altered as a consequence of illness. In case of insufficient uptake of feed, animals should be treated parenterally.

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Withdrawal period

Meat and offal: 6 days.

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Incompatibilities

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

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Immediate packaging

25 kg, white low density polyethylene bag in a triple layered paper bag.

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Storage

Store in the original container.

Protect from light.

Store in a dry place.

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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.

Shelf life after incorporation into meal or pelleted feed: 28 days. (if stored below 25˚C).

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Disposal of unused product

Medicines should not be disposed of via wastewater or household waste.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

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Additional information

Vm 05150/4003

8 DATE OF FIRST AUTHORISATION

14 January 2011

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

May 2026

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Approved: 10 June 2026

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Registration holder

Univet Limited

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