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Penacare

Main information

  • Trade name:
  • Penacare 300 mg/ml Suspension for Injection
  • Available from:
  • Listow Limited
  • Pharmaceutical form:
  • Suspension for injection
  • Prescription type:
  • POM-V - Prescription Only Medicine – Veterinarian
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug
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Documents

Localization

  • Available in:
  • Penacare 300 mg/ml Suspension for Injection
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Cattle, Pigs, Sheep
  • Therapeutic area:
  • Antimicrobial

Other information

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Status

  • Source:
  • VMD - Veterinary Medicines Directorate
  • Authorization status:
  • Authorized
  • Authorization number:
  • 41687/4015
  • Authorization date:
  • 01-06-1998
  • Last update:
  • 21-12-2016

Summary of Product characteristics

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Revised: May 2014

AN: 00116/2014

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Penacare 300 mg/ml Suspension for injection

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Substance:

Procaine Penicillin 300mg/ml (30% w/v)

Excipients:

Methyl parahydroxybenzoate 0.112%w/v (as preservative)

Ethyl parahydroxybenzoate 0.023%w/v (as preservative)

Propyl parahydroxybenzoate 0.016%w/v (as preservative)

For a full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Suspension for Injection

A white/off-white suspension for injection

4. CLINICAL PARTICULARS

4.1. Target species

Cattle

Sheep

Pigs

4.2. Indications for use, specifying the target species

For the treatment of infections caused by or associated with organisms

sensitive to penicillin.

In vitro tests have shown the following organisms to be sensitive: Actinomyces

pyogenes, Erysipelothrix rhusiopathiae, Listeria, Mannheimia haemolytica,

Pasteurella multocida, Staphylococcus spp (non-penicillinase producing) and

Streptococcus spp.

Indicated in the treatment of diseases caused by susceptible organisms

including:

erysipelas; navel/joint-ill; respiratory tract infections including pneumonia and

atrophic rhinitis; listeriosis; septicaemia; urogenital tract infections and the

control of secondary bacterial invaders in diseases of primary viral origin.

Revised: May 2014

AN: 00116/2014

4.3. Contra-indications

Do not inject intravenously or intrathecally.

Do not use in known cases of hypersensitivity to penicillin.

Not to be used in very small herbivores such as guinea pigs, gerbils and

hamsters.

4.4. Special Warnings for each target species

None.

4.5. Special precautions for use

i) Special precautions for use in animals

Care should be taken not to overdose.

Wherever possible, use of Penacare should be based on

susceptibility testing.

ii) Special precautions to be taken by the person administering the

veterinary medicinal product to animals

Care should be taken to avoid accidental self-injection.

Penicillins and cephalosporins may cause hypersensitivity (allergy)

following injection, inhalation, ingestion or skin contact.

Hypersensitivity to penicillin’s may lead to cross reactions to

cephalosporin’s and vice versa. Allergic reactions to these

substances may occasionally be serious.

1. Do not handle this product if you know you are sensitised, or if

you have been advised not to work with such preparations.

2. Handle this product with great care to avoid exposure, taking all

recommended precautions.

3. If you develop symptoms following exposure such as a skin

rash, you should seek medical advice and show the doctor this

warning. Swelling of the face, lips or eyes or difficulty with

breathing are more serious symptoms and require urgent

medical attention.

Wash hands after use.

4.6. Adverse reactions (frequency and seriousness)

Occasionally in sucking and fattening pigs, administration may cause a

transient pyrexia, vomiting, shivering, listlessness and inco-ordination.

Revised: May 2014

AN: 00116/2014

4.7. Use during pregnancy, lactation or lay

Can be safely administered to pregnant and lactating animals. However in

pregnant sows and gilts a vulval discharge which could be associated with

abortion has been reported.

4.8. Interaction with other medicinal products and other forms of interaction

It is recommended that other antibiotics should not be administered

concurrently.

4.9. Amounts to be administered and administration route

Shake the container before use.

Administer by deep intramuscular injection only.

The recommended dose rate is: 10 mg/kg bodyweight (1ml/30 kg) daily for 3 to

5 days.

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

Penicillins have a wide safety margin.

4.11. Withdrawal periods

Cattle: Meat – 7 Days

Milk – 84 Hours

Sheep: Meat: 7 Days

Milk: Not permitted for use in sheep producing milk for human

consumption.

Pigs: Meat – 7 days

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antibacterial

ATCVet Code: QJ01CE09

5.1. Pharmacodynamic properties

Antimicrobial activity is achieved by interference in the final stage of bacterial

cell wall synthesis by binding to the PBP's (penicillin binding proteins).

Revised: May 2014

AN: 00116/2014

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients

Methyl parahydroxybenzoate

Ethyl parahydroxybenzoate

Propyl parahydroxybenzoate

Povidone K12,

Potassium Dihydrogen Phosphate,

Sodium Citrate Dihydrate,

Polysorbate 80,

Simeticone,

Water for injections.

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 first opening the immediate packaging: 28 days.

6.4. Special precautions for storage

Do not store above 25 oC.

Protect from light.

Following withdrawal of the first dose, use the product within 28 days.

Discard unused suspension.

6.5. Nature and composition of immediate packaging

Sterile, white aqueous injection in clear Type II multidose glass vials of 50 ml

and 100 ml closed with bromobutyl bungs with aluminium overseals.

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 products should be disposed of in accordance with local

requirements.

7. MARKETING AUTHORISATION HOLDER

Listow Limited

9 Belgrave Square

London

SW1X 8PH

Revised: May 2014

AN: 00116/2014

8. MARKETING AUTHORISATION NUMBER

Vm:

41687/4015

9. DATE OF FIRST AUTHORISATION

Date: 1 June 1998

10. DATE OF REVISION OF THE TEXT

Date: May 2014

06 May 2014

There are no safety alerts related to this product.

There are no news related to this product.

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