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CHLOROMED
This product is not recommended for concurrent administration with any other oral medication.
Do not add the product to feed overloaded with polyvalent cations such as Ca
and Fe
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 product should not be used in case of known resistance to other tetracyclines.
For oral administration.

The recommended therapeutic dose is 20 mg chlortetracycline hydrochloride per kg bodyweight (equivalent to 20 grams of Chloromed 150 mg/g Oral Powder per 150 kg bodyweight) per day administered for seven days. This should be given in a divided daily dose i.e. 10 g morning and 10 g evening. As a guide to dosing pigs of different weight, see table.

The product should be administered to small quantities of feed for immediate consumption by individual animals. Larger groups should be treated with medicated feeding stuff.

The product should be mixed thoroughly into a part of the daily feed ration and should be administered prior to the feeding. It should be ensured that the calculated dose is completely taken up by the animal.

If animals don’t recover within 3 days after oral medication, diagnosis should be reconsidered and treatment should be changed, if necessary.

To ensure the correct dosage and to avoid possible under-dosing, the bodyweight and the amount of product administered should be determined as accurately as possible. To determine the correct amount of product, a calibrated weighing scale should be used.

Dosing Table
Do not exceed the stated dose.
Chlortetracycline toxicity is low. If digestive disturbances do occur, treatment should be discontinued.
Pigs:
Meat and offal: 6 days.
Pharmacotherapeutic group: Tetracycline for systemic use.
ATCvet code: QJ01AA03
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.
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
6.1 List of excipients
Medium Chain Triglycerides.
Soya Bean Meal.
Colloidal Anhydrous Silica.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Shelf life of the veterinary medicinal product as packaged for sale: 2 years
Shelf-life after first opening the immediate packaging: 28 days
Store in a dry place.
Store in the original container.
Protect from light.
1 kg, clear low density polyethylene bag laminated with metallised polyester
Any unused product or waste materials should be disposed of in accordance with national requirements.
Pigs:
The product is indicated in the treatment of respiratory disease in pigs caused by micro-organisms sensitive to chlortetracycline.
Do not use in animals with known hypersensitivity to tetracycline.
Do not use in animals with severe liver and renal disorders.
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.
The product is efficient only against bacterial strains most sensitive to chlortetracycline. 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.

Inappropriate use of the 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 product is not recommended as it may lead to the development of bacterial resistance.
Handle this 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 product to feed.

Those handling the 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.

Direct contact of the product with the skin, eyes and mucous membranes should be avoided.

Wear protective gloves, overalls and approved safety glasses.

In case of accidental exposure, wash area immediately with water.

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

Hands and exposed skin should be washed thoroughly after use.
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Chloromed 150 mg/g Oral Powder for Pigs.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: Each g contains 150 mg chlortetracycline hydrochloride.

Excipient(s): For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral Powder.
A coarse, yellow powder.
4. CLINICAL PARTICULARS
4.1 Target species
4.2 Indications for use, specifying the target species
4.3 Contraindications
4.4 Special warnings for each target species
4.5 Special precautions for use
Special precautions for use in animals
Special precautions to be taken by the person administering the veterinary medicinal product to animals
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 product should be used only in pregnant sows according to the benefit/risk assessment of the responsible veterinarian.
Chlortetracycline toxicity is low. If digestive disturbances do occur, treatment should be discontinued.
On rare occasions the following adverse reactions may occur: allergic reactions and photosensitivity; gastrointestinal disorders; disorders of the liver and the kidneys. If suspected adverse reactions occur, treatment should be discontinued.
See Section 4.7
10 DATE OF REVISION OF THE TEXT
9. DATE OF FIRST AUTHORISATION
8. MARKETING AUTHORISATION NUMBER
7. MARKETING AUTHORISATION HOLDER
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
January 2011
14 January 2011
Vm 05150/4002
Univet Ltd.
Tullyvin
Cootehill
Co. Cavan
Ireland
Other precautions
4.6 Adverse reactions (frequency and seriousness)
4.7 Use during pregnancy, lactation or lay
4.8 Interaction with other medicinal products and other forms of interaction
4.9 Amounts to be administered and administration route
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4.11 Withdrawal periods
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic particulars
6. PHARMACEUTICAL PARTICULARS
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and composition of immediate packaging
Pigs

SUMMARY OF PRODUCT CHARACTERISTICS

None.
Pig Bodyweight (kg)Daily amount (g) of Chloromed 150Dose (g) – to be given TWICE daily
15 kg 2g1g
30 kg 4g2g
60 kg8g 4g
75 kg10g 5g
150 kg20g 10g
3+
2+
Description
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