SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Apravet 100 g/kg premix for medicated feeding stuff for pigs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance:

Each kg contains:

Apramycin sulfate 100 g, equivalent to apramycin 100.000.000 IU

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Premix for medicated feeding stuff

Granular powder

4. CLINICAL PARTICULARS

4.1 Target species

Pigs

4.2 Indications for use, specifying the target species

Treatment of bacterial enteritis caused by micro-organisms susceptible to apramycin such as Escherichia coli.

4.3 Contraindications

Do not use in the cases of hypersensitivity to apramycin

Do not use in cats

4.4 Special warnings

The uptake of medication by animals can be altered as a consequence of illness. In case of insufficient uptake of feed animals should be treated parenterally.

The use of the product should be combined with good management practices e.g. good hygiene, proper ventilation, no overstocking.

4.5 Special precautions for use

Special precautions for use in animals

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

Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the apramycin and may decrease the effectiveness of treatment with aminoglycosides due to the potential for crossresistance

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

Wash hands carefully with soap and water after handling of the product.

When handling this product, inhalation of the dust must be avoided by wearing a disposable half-mask respirator conforming to European Standard EN 149 or a non-disposable respirator to European Standard EN 140 with a filter to EN 143.

Avoid contact with skin and eyes. Gloves should be worn whilst handling this product. If contact with skin or eyes occurs, wash area immediately with clean fresh water. If irritation persists seek medical attention.

4.6 Adverse reactions (frequency and seriousness)

None known

4.7 Use during pregnancy, lactation or lay

Laboratory studies have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.

The use is not recommended in pregnant or lactating sows.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amounts to be administered and administration route

The recommended dose is 4 to 8 mg of apramycin per kg of body weight,.

This medicated feed should be given as sole ratio during at least 21 days.

It is recommended to mix the required quantity of the product with a small amount of feed (20 – 50 kg) before mixing it in the total volume.

The consumption of the medicated feed may depend of the clinical condition of the animals. In order to guarantee a correct dosing, the concentration of the productin the feed should be adjusted accordingly.

To adjust dosing properly following calculation can be used:

… mg product/kg b.w./day x average b.w. of pigs (kg)= … kg of the product/tone of feed

average daily intake of feed (kg/animal)

Medicated feed may be pelleted using a pre-conditioning step for 5 minutes at a temperature not exceeding 85°C.

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

A single 100 fold overdosing in 5 pigs did not result in any mortality.

A 25 to 50 fold overdosing during 28 days, did not provoke any toxic effect.

4.11 Withdrawal period(s)

Meat and offal: 1 day

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: apramycin.

ATCvet code: QA07AA92

5.1 Pharmacodynamic properties

As an aminoglycoside antibiotic apramycin binds to the 30S ribosomal subunit and interferes with the protein synthesis. Through mechanisms not yet completely elucidated, it acts on the cell wall and is bactericidal. The overall spectrum includes many aerobic or facultative anaerobic Gram-negative bacteria, including Enterobacteriaceae. It has no activity against anaerobic bacteria or under anaerobic conditions.
Susceptibility of theE. colistrains from pigs to apramycin can vary geographically and over time.
The most important mechanism of resistance against apramycin is the production of modifying enzymes that are usually encoded by resistance genes derived from plasmids. Depending on their spectrum, these enzymes may cause cross-resistance between aminoglycosides. Resistance may also be caused by a change of the ribosomal attachment sites, or the conveying system allowing the penetration of the cell.

Until harmonised international interpretative criteria relevant for susceptibility testing are available for apramycin, nationally approved and validated methods should be followed.

5.2 Pharmacokinetic particulars

Apramycinis very poorly absorbed orally. Tissue distribution is limited but nevertheless the best of all aminoglycosides.

Apramycin is excreted in its active form via the kidney.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Starch, pregelatinised

Wheat meal

6.2 Incompatibilities

In absence of compatibility studies this veterinary medicinal product must not be mixed with other veterinary products.

6.3 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years

Shelf-life after first opening the immediate packaging: 6 months

Shelf life after incorporation into meal feed: 3 months

Shelf life after incorporation into pelleted feed: 1 month

6.4. Special precautions for storage

Veterinary medicinal product as packaged for sale:Do not store above 25C. Store in the original package. Protect from moisture.

Veterinary medicinal product after first opening of the immediate packaging: Do not store above 25°C.

Medicated feed (mashed and pelleted): Do not store above 25°C.

6.5 Nature and composition of immediate packaging

Polyethylene-lined multiple-layer paper bags of 1 kg, 5 kg and 20 kg.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

8. MARKETING AUTHORISATION NUMBER

Vm 30282/4019

9. DATE OF FIRST AUTHORISATION

14 August 2013

10. DATE OF REVISION OF THE TEXT

August 2013

PROHIBITION OF SALE, SUPPLY AND/OR USE

Consideration should be given to official guidance on the incorporation of medicated premixes in final feeds.

Approved: 14/08/2013