Olab Sultrim 21% premix for medicated feed

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
Trimethoprim; Sulfadiazine
Available from:
Old Castle Laboratories Ltd
ATC code:
QJ01EW10
INN (International Name):
Trimethoprim; Sulfadiazine
Dosage:
21 percent
Pharmaceutical form:
Premix for medicated feeding stuff
Prescription type:
POM: Prescription Only Medicine as defined in relevant national legislation
Therapeutic group:
Pigs
Therapeutic area:
sulfadiazine and trimethoprim
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization number:
VPA10892/001/001
Authorization date:
1995-04-24

Read the complete document

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT

Olab Sultrim 21% premix for medicated feed

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

3 PHARMACEUTICAL FORM

Premix for medicated feed

A pale brown, uniform, meal-like mix

4 CLINICAL PARTICULARS

4.1 Target Species

Pigs

4.2 Indications for use, specifying the target species

For the use in the treatment of diseases caused by bacteria sensitive to potentiated sulphonamide preparations.

4.3 Contraindications

Do not use in animals with known hypersensitivity to the active substances.

4.4 Special warnings for each target species

None

Each kg contains:

Active Substances

Sulphadiazine

178.40 mg

Trimethoprim

35.60 g

Excipient

For a full list of excipients, see section 6.1

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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 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.

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

A dust mask complying with BS2091 or BS6016 must be worn when mixing the product into the feed.

Wear impervious gloves when handling this product.

Wash all exposed skin after use of this product.

4.6 Adverse reactions (frequency and seriousness)

None.

4.7 Use during pregnancy, lactation or lay

This product is safe for use in pregnant sows.

4.8 Interaction with other medicinal products and other forms of interaction

This product is not recommended for use with any other premix or oral medication.

4.9 Amounts to be administered and administration route

For oral administration after incorporation into complete feed.

Pigs:

The recommended therapeutic dose is 30 mg of combined actives per kg bodyweight

daily.

To achieve this dose,

product

should be mixed into feed at

the following inclusion rates to provide approximately 25 mg.kg

bodyweight

Sulphadiazine and 5 mg.kg

bodyweight Trimethoprim.

Treatment should be continued for a period of five days.

To ensure thorough dispersion of the product it should be first mixed with 20 kg of feed ingredients before incorporation

into a suitable final feed.

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

None known

Age of Pig

(Weeks-kg)

Average Feed

Intake - kg

Inclusion

feed/day

8 weeks (20 kg bodyweight)

1 kg

2.8 kg per tonne

12 weeks (30 kg bodyweight)

1.5 kg

2.8 kg per tonne

14 weeks (45 kg bodyweight)

2.0 kg

2.8 kg per tonne

16 weeks (60 kg bodyweight)

2.5 kg

2.8 kg per tonne

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4.11 Withdrawal Period(s)

Pigs must not be slaughtered for human consumption during treatment.

Pigs may be slaughtered for human consumption only after 10 days after the last treatment.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antibacterials for systemic use, combinations of sulphonamides and trimethoprim

ATCvet Code: QJ01EW10

5.1 Pharmacodynamic properties

Sulphadiazine:

This sulphonamide is one of the more active members of the group and has been used with trimethoprim at the same ratio

in a number of products.

Trimethoprim:

Trimethoprim is widely used in human and veterinary medicine to potentiate sulphonamides of which a number may be

used.

The usual ratio of the combination for therapy is 1:5, trimethoprim:sulphonamide for most products.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Medium chain triglyceride

Soya meal

6.2 Incompatibilities

None known

6.3 Shelf-life

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years

Shelf-life after incorporation into feed:

4 weeks

6.4 Special precautions for storage

Do not store above 25°C.

Protect from light.

6.5 Nature and composition of immediate packaging

A pale brown meal mix in LDPE lined 20 kg triple-layered paper bags.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be

disposed of in accordance with local requirements.

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7 MARKETING AUTHORISATION HOLDER

Oldcastle Laboratories

Cogan Street

Oldcastle

County Meath

8 MARKETING AUTHORISATION NUMBER(S)

VPA 10892/001/001

9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 24

April 1995

Date of last renewal: 23

April 2010

10 DATE OF REVISION OF THE TEXT

August 2015

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