Soluchlor 150 mg/g Oral Powder for Calves

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
Chlortetracycline hydrochloride
Available from:
Interchem Ireland Ltd
ATC code:
QJ01AA03
INN (International Name):
Chlortetracycline hydrochloride
Dosage:
150 milligram(s)/gram
Pharmaceutical form:
Oral powder
Prescription type:
POM: Prescription Only Medicine as defined in relevant national legislation
Therapeutic group:
Cattle
Therapeutic area:
chlortetracycline
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization number:
VPA10555/011/001
Authorization date:
2012-12-07

Read the complete document

Health Products Regulatory Authority

20 March 2018

CRN000VLN

Page 1 of 6

1 NAME OF THE VETERINARY MEDICINAL PRODUCT

Soluchlor 150 mg/g Oral Powder for Calves

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance:

Each g contains 150 mg chlortetracycline hydrochloride.

Excipient(s):

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Oral Powder.

Yellow uniform powder / a yellow powder.

4 CLINICAL PARTICULARS

4.1 Target Species

Calves (less than 6 months of age).

4.2 Indications for use, specifying the target species

Calves:

The product is indicated in the treatment of respiratory disease in calves caused by

Pasteurella spp., sensitive to chlortetracycline.

4.3 Contraindications

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.

Health Products Regulatory Authority

20 March 2018

CRN000VLN

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4.5 Special precautions for use

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.

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

Other precautions

None.

Health Products Regulatory Authority

20 March 2018

CRN000VLN

Page 3 of 6

4.6 Adverse reactions (frequency and seriousness)

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.

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.

4.7 Use during pregnancy, lactation or lay

Not applicable.

4.8 Interaction with other medicinal products and other forms of interaction

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

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 product should not be used in case of known resistance to other tetracyclines.

4.9 Amounts to be administered and administration route

For oral administration.

The recommended therapeutic dose is 20 mg chlortetracycline per kg bodyweight

(equivalent to 20 grams of the product 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.

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 animals.

Health Products Regulatory Authority

20 March 2018

CRN000VLN

Page 4 of 6

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

should be

determined as accurately as possible.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Do not exceed the stated dose.

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

be discontinued.

4.11 Withdrawal period(s)

Calves:

Meat and offal: 10 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.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Tetracycline for systemic use.

ATCvet code: QJ01AA03

5.1 Pharmacodynamic properties

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.

Health Products Regulatory Authority

20 March 2018

CRN000VLN

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5.2 Pharmacokinetic particulars

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.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Medium Chain Triglycerides.

Glucose Monohydrate.

Colloidal anhydrous silica.

6.2 Major incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be

mixed with other veterinary medicinal products.

6.3 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

6.4 Special precautions for storage

Store below 25°C.

Store in a dry place.

Store in the original container.

Protect from light.

6.5 Nature and composition of immediate packaging

1 kg, clear low density polyethylene bag laminated with metallised polyester.

6.6 Special precautions for the disposal of unused veterinary medicinal

products or waste materials derived from the use of such products

Any unused product or waste materials should be disposed of in accordance with

national requirements.

Health Products Regulatory Authority

20 March 2018

CRN000VLN

Page 6 of 6

7 MARKETING AUTHORISATION HOLDER

Interchem Ireland Ltd

29 Cookstown Industrial Estate,

Dublin 24

Ireland

8 MARKETING AUTHORISATION NUMBER(S)

VPA 10555/011/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 7

December 2012

Date of last renewal: 6

December 2017

10 DATE OF REVISION OF THE TEXT

March 2018

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