Tulivin Logo
CHLOROMED
Univet Ltd.
Tullyvin
Cootehill
Co. Cavan
Ireland
VM 05150/4000
28 October 2009
March 2010
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.
Calves (less than 6 months of age).
Calves
The product is indicated in the treatment of respiratory disease in calves caused by
Pasteurella spp ., sensitive to chlortetracycline.
Do not use in calves over 6 months of age and dairy cows.
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.
i.     Special precautions for use in animals

Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies.

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.

ii.     Special precautions to be taken by the person administering the veterinary medicinal product to animals
Handle this product with care to avoid exposure when incorporating into feed and administering medicated feed to the animals.

Take adequate measures to avoid dust formation when incorporating the veterinary medicinal product into feed.

Persons 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.

Wear protective gloves, overalls and approved safety glasses.

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

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

iii.     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 photosensibility; gastrointestinal disorders; disorders of the liver and the kidneys. If suspected adverse reactions occur, treatment should be discontinued.
Due to the possible incorporation of chlortetracycline, treatment of pregnant and newborn animals can lead to dysfunctional development of the skeleton and teeth in foetal and growing animals.
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 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.
Calves
Meat and offal: 35 days.
Milk: The product is contraindicated for use in adult ruminants and dairy cows and should therefore not be used in animals producing milk for human consumption.
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 cattle 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 of the recommended dose, maximum blood levels of approximately 1 – 2 µg/ml are achieved within 2 – 8 hours and approximately 37% of the oral dose is systemically available. Steady state plasma concentrations of chlortetracycline are maintained throughout the twice-daily seven day treatment period. Chlortetracycline accumulates in the lung tissue resulting in higher concentrations at the site of activity. Chlortetracycline undergoes little metabolism and is excreted through both the urinary and bilary systems.
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 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.
Not applicable.
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 calves

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
=
Description
3+
2+
Description
$SIGNUP$
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