Potencil 10 % premix for medicated feed for pigs

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
Phenoxymethylpenicillin
Available from:
Elanco Europe Ltd
ATC code:
QJ01CE02
INN (International Name):
Phenoxymethylpenicillin
Dosage:
10 percent weight/weight
Pharmaceutical form:
Premix for medicated feeding stuff
Prescription type:
POM: Prescription Only Medicine as defined in relevant national legislation
Therapeutic area:
phenoxymethylpenicillin
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization number:
VPA10397/023/001
Authorization date:
2016-06-17

Read the complete document

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT

Potencil 10% premix for medicated feed for pigs

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Phenoxymethylpenicillin potassium (penicillin V) 10.0% w/w in an inert carrier.

For a full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Premix for medicated feed

4 CLINICAL PARTICULARS

4.1 Target Species

Pigs.

4.2 Indications for use, specifying the target species

For the treatment and control of Streptococcal meningitis and septicaemia caused by Streptococcus suis II.

Also for the treatment and control of porcine pleuropneumonia caused by Actinobacillus (Haemophilus)

pleuropneumoniae, and treatment and control of secondary bacterial pneumonia caused by Pasteurella multocida

4.3 Contraindications

Do not use in liquid feed.

Do not use for direct feeding to animals.

Do not use in animals known to be hypersensitive to penicillins.

4.4 Special warnings for each target species

None.

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4.5 Special precautions for use

Special precautions for use in animals

Care must be taken to ensure accurate mixing.

Avoid the introduction of contamination during use.

Special precautions for the person administering the veterinary medicinal product to animals

Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin

contact.

Hypersensitivity to penicillins may lead to cross-reactions to cephalosporins and vice versa.

Allergic reactions

to these substances may occasionally be serious.

Do not handle this product if you know you are sensitised, or if you have been advised not to work with such

preparations.

Handle this product with great care to avoid exposure taking all recommended precautions.

Wear protective clothing, gloves and a dust mask, either a disposable half-mask respirator conforming to European

Standard EN 149 or a non-disposable respirator to European Standard EN 140 with a filter EN143 when preparing

medicated feed.

If you develop symptoms following exposure such as skin rash, you should seek medical advice and show the doctor

this warning.

Swelling of the face, lips or eyes or difficulty in breathing are more serious symptoms and require urgent

medical attention.

Wash hands after use.

4.6 Adverse reactions (frequency and seriousness)

None known.

4.7 Use during pregnancy, lactation or lay

Studies to determine the safety of this product for use during pregnancy have not been conducted in pigs.

Use in

pregnant pigs should be in accordance with a benefit/risk assessment by the responsible veterinarian.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amounts to be administered and administration route

For oral administration after incorporation in pelleted feed or meal.

The recommended dosage for pigs is 10 mg

potassium penicillin per kg bodyweight daily for up to 6 consecutive weeks for meningitis and septicaemia, and for up

to 2 weeks for pleuropneumonia and pneumonic pasteurellosis.

This is achieved by an inclusion level of 2 kg

Potencil/tonne of feed.

When incorporated into pellets, the mix can be pre-conditioned with steam for up to 5 minutes and pelleted at

temperatures within the feed of 70ºC.

To allow thorough dispersion of the product, Potencil should be mixed with a small quantity of feed prior to mixing

into the bulk of the feed.

After inclusion of Potencil, feed must be used within 14 days from manufacture, due to the known instability of

Potencil.

This product should be incorporated by a licensed feed manufacturer only.

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

None known.

4.11 Withdrawal Period(s)

Pigs must not be slaughtered for human consumption during treatment or for 24 hours (1 day) thereafter.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

ATC Vet Code: QJ01CE02

5.1 Pharmacodynamic properties

Beta-lactam antibiotics, such as the penicillins, prevent the bacterial cell wall from forming by interfering with the final

stage of peptidoglycan synthesis.

They inhibit the activity of transpeptidase enzymes which catalyze cross-linkage of

the glycopeptide polymer units that form the cell wall.

The final step in the action of these substances probably

involves inactivation of an inhibitor of autolytic enzymes in the cell wall.

They exert a bactericidal action, but cause

lysis only of growing cells.

5.2 Pharmacokinetic properties

The penicillins are organic acids that are generally available as the sodium or potassium salt of the free acid.

Acid

hydrolysis limits the systemic availability of most penicillins from oral preparations, but not penicillin V.

Penicillins

(pK 2.7) are predominantly ionized in plasma, have relatively small apparent volumes of distribution (0.2 -0.3 L/kg)

and have short half lives (0.5 -1.2 hours) in domestic animals.

After absorption, they are widely distributed in the

extracellular fluids of the body, but they cross biological membranes poorly as they are ionized and are poorly soluble

in lipids.

Entry across biological membranes or through the blood-brain or blood-cerebrospinal fluid barrier is

enhanced by inflammation, so that inhibitory drug concentrations may be attained at these sites that are normally

inaccessible to penicillin.

Penicillins are eliminated almost entirely by the kidneys which results in very high levels in the urine.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Liquid Paraffin

Limestone

6.2 Incompatibilities

None known.

6.3 Shelf-life

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

Shelf-life when incorporated into feed: 14 days.

6.4 Special precautions for storage

Do not store above 25

Store in a dry place.

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6.5 Nature and composition of immediate packaging

Pack size:

2 kg, 3 kg and 6 kg

Container:

2 ply low density polyethylene lined multi-walled paper bag

Closure:

Heat seal

Pack size:

25 kg

Container:

3 ply low density polyethylene lined multi-walled paper sack

Closure:

LDPE liner closed with plastic coated metal closure.

Paper sack is stitched.

Not all pack sizes may be marketed.

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

Any unused product or waste material should be disposed of in accordance with national requirements.

7 MARKETING AUTHORISATION HOLDER

Elanco Europe Ltd

Lilly House

Priestley Road

Basingstoke

Hampshire

RG24 9NL

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

VPA 10397/023/001

9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 1

May 2001

Renewal of the last authorisation: 1

May 2006

10 DATE OF REVISION OF THE TEXT

June 2016

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