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CHLOROMED
Univet Ltd.
Tullyvin
Cootehill
Co. Cavan
Ireland
VM 05150/40003
14 January 2011
January 2011
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION
10. DATE OF REVISION OF THE TEXT
Active substance: Each g contains 150 mg chlortetracycline hydrochloride.
Excipient(s): For a full list of excipients, see section 6.1.
Premix for medicated feeding stuff.
A coarse, yellow powder.
Pigs
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.
4.4 Special warnings for each target species
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.
Special precautions for use in animals

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.

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

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.

Other precautions
None.
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
This product is not recommended for concurrent administration with any other oral medication.
Do not incorporate the product in 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 after incorporation in a feeding stuff by a facility licensed to medicate feed.

Administration
The recommended therapeutic dose is 20 mg per kg bodyweight daily i.e. 20 grams of Chloromed 150 mg/g Premix 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 the correct dosage and to avoid under-dosing, the 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 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:
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.
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.
Medium Chain Triglycerides.
Soyal 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 of the immediate packaging: 1 month.
Shelf life after incorporation into meal or pelleted feed: 4 weeks (if stored below 25°C)
Store in a dry place.
Store in the original container.
Protect from light.
25 kg, white low density polyethylene bag in a triple layered paper bag.
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.
4.5 Special precautions for use
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
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and composition of immediate packaging
Any unused product or waste materials should be disposed of in accordance with national requirements.
4.3 Contraindications
4.2 Indications for use, specifying the target species
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Target species
Chloromed 150 mg/g Premix for medicated feeding stuff for pigs

SUMMARY OF PRODUCT CHARACTERISTICS

... mgChloromed/kg bw/day x Average bw (kg) of animals to be treated
Average daily feed intake (kg/animal)
... mg Chloromed/kg of feed
=
3+
2+
Description
Description
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