Pentomycin Suspension for Injection

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
Benzylpenicillin procaine ; Dihydrostreptomycin (as the sulfate)
Available from:
Univet Limited
ATC code:
QJ01CE09
INN (International Name):
Benzylpenicillin procaine ; Dihydrostreptomycin (as the sulfate)
Dosage:
200, 200 milligram(s)/millilitre
Pharmaceutical form:
Suspension for injection
Prescription type:
POM: Prescription Only Medicine as defined in relevant national legislation
Therapeutic group:
Cattle, Pigs, Sheep
Therapeutic area:
procaine benzylpenicillin
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization number:
VPA10990/005/001
Authorization date:
1987-10-01

Read the complete document

Health Products Regulatory Authority

08 May 2018

CRN000XVX

Page 1 of 6

1 NAME OF THE VETERINARY MEDICINAL PRODUCT

Pentomycin Suspension for Injection

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

Active substance

Procaine benzylpenicillin

200 mg

Dihydrostreptomycin

200 mg

(as dihydrostreptomycin sulphate)

Excipients

Methyl parahydroxybenzoate

1.0 mg

Sodium formaldehyde sulfoxylate

0.432 mg

For a full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Suspension for injection.

A white to off-white aqueous suspension.

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 bacteria sensitive to penicillin and

dihydrostreptomycin in cattle, sheep and pigs.

4.3 Contraindications

Do not administer to animals known to be sensitive to penicillin.

Do not use when it is known that penicillinase-producing staphylococcus organisms

are present.

Health Products Regulatory Authority

08 May 2018

CRN000XVX

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4.4 Special warnings for each target species

Occasionally in sucking and fattening pigs administration of products containing

procaine penicillin may cause a transient pyrexia, vomiting, shivering, listlessness and

incoordination.

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

abortion has been reported.

The maximum dose volume recommended at any one site for Cattle is 20 ml.

4.5 Special precautions for use

Special precautions for use in animals:

Use of this 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.

Whenever possible the product should only be used on the basis on susceptibility

testing.

Special precautions to be taken by the person administering the veterinary

medicinal product to animals:

Penicillin and cephalosporins may cause hypersensitivity (allergy) following injection,

inhalation, ingestion or skin contact. Hypersensitivity to penicillin may lead to cross

sensitivity to cephalosporins and vice versa. Allergic reaction to these substances can

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 and eyes

or difficulty with breathing are more serious symptoms and require urgent medical

attention.

Health Products Regulatory Authority

08 May 2018

CRN000XVX

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4.6 Adverse reactions (frequency and seriousness)

Occasional allergies to penicillins have been observed but these are very rare.

Hypersensitivity (allergic) reactions to penicillins can vary from localised swelling to

anaphylaxis and death.

Occasionally in sucking and fattening pigs administration of products containing

procaine penicillin may cause a transient pyrexia, vomiting, shivering, listlessness and

incoordination.

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

abortion has been reported.

Procaine penicillin G can, under certain circumstances, be toxic and even lethal to

pigs and this is thought to be due to a sudden release of toxic amounts of free

procaine. The symptoms include shivering, lassitude, inappetence, vomiting, cyanosis

of the extremities and pronounced pyrexia (40

C and over). A vulval discharge may

appear and some animals may abort. Alarming side-effects are most likely to occur

when pigs with erysipelas are injected with an older and/or, heat-affected procaine

penicillin formulation. Treatment with 5 mg dexamethasone will result in rapid

recovery.

4.7 Use during pregnancy, lactation or lay

Procaine penicillin and dihydrostreptomycin are safe for use in pregnant animals.

Not for use in lactating ewes producing milk for human consumption.

4.8 Interaction with other medicinal products and other forms of interaction

Tetracyclines are bacteriostatic antibiotics that may interfere with a bactericidal agent

such as penicillin. Since penicillin acts by inhibiting cell wall synthesis, agents such as

tetracyclines, which inhibit protein synthesis, could mask the bactericidal effect of

penicillin.

If penicillin is used with a tetracycline, it would be prudent to observe the following

points when possible:

1. Be sure that adequate amounts of each agent are given; antagonism is most likely

to occur when barely sufficient amounts of each agent are given.

2. Begin administration of the penicillin at least a few hours before the administration

of tetracycline.

Health Products Regulatory Authority

08 May 2018

CRN000XVX

Page 4 of 6

4.9 Amounts to be administered and administration route

The recommended dose is 4 ml per 100 kg bodyweight i.e. 8 mg procaine penicillin

and 10 mg dihydrostreptomycin sulphate per kg. The dose should be given once

daily for up to 3 consecutive days.

To ensure a correct dosage bodyweight should be determined as accurately as

possible to avoid under-dosing.

For intramuscular administration only.

Species

Dose (ml)

kg Bodyweight

Cattle

Calf

Sheep

Lamb

Piglet

Clean the area of injection and swab with spirit.

The maximum dose volume recommended at any one site for Cattle is 20 ml.

Administer alternately on the left side and the right side.

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

Do not exceed the stated dose.

4.11 Withdrawal period(s)

Cattle:

Meat and offal: 21 days.

Milk: 72 hours.

Sheep:

Meat and offal: 21 days.

Milk: Not to be used in lactating ewes producing milk for human consumption.

Pigs:

Meat and offal: 21 days.

Health Products Regulatory Authority

08 May 2018

CRN000XVX

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5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

ATC Vet Code: QJ01RA01

Pharmacotherapeutic Group: Penicillins, combinations with other antibacterials

5.1 Pharmacodynamic properties

Penicillins are rapidly absorbed when injected in an aqueous suspension by the

intramuscular route. However, absorption of Penicillin G from a procaine penicillin

preparation is prolonged, with peak blood levels being attained at approximately 2-4

hours and declining below therapeutic levels at 24 hours in pigs and 48 hours in

cattle and sheep.

Dihydrostreptomycin is also absorbed rapidly. Peak plasma concentration occurs

within 1 hour. The blood levels will decline a lot faster (below therapeutic levels at 12

hours) than the penicillin G due to a slower absorption of the penicillin from the

procaine preparation.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Methyl parahydroxybenzoate

Sodium formaldehyde sulfoxylate

Simethicone emulsion

Sodium citrate

Potassium dihydrogen phosphate

Disodium edetate

Povidone K12

Water for injections

6.2 Major 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: 4 weeks.

Health Products Regulatory Authority

08 May 2018

CRN000XVX

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6.4 Special precautions for storage

Store in a refrigerator (2

C to 8

Do not freeze.

6.5 Nature and composition of immediate packaging

Type II, siliconised clear glass, 50 ml and 100 ml vials containing an aqueous, sterile

suspension, closed with nitryl rubber stoppers and sealed with aluminium seals.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal

products or waste materials derived from the use of such products

Unused product or waste material should be disposed of in accordance with current

practice for pharmaceutical waste under national waste disposal regulations.

7 MARKETING AUTHORISATION HOLDER

Univet Limited

Tullyvin

Cootehill

Co. Cavan.

Ireland

8 MARKETING AUTHORISATION NUMBER(S)

VPA10990/005/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

September 2007

10 DATE OF REVISION OF THE TEXT

May 2018

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