Parofor 140 mg/ml solution for use in drinking water, milk or milk replacer for pre-ruminant cattle and pigs

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
Paromomycin
Available from:
Huvepharma NV
ATC code:
QA07AA06
INN (International Name):
Paromomycin
Dosage:
140 milligram(s)/millilitre
Pharmaceutical form:
Oral solution
Prescription type:
POM: Prescription Only Medicine as defined in relevant national legislation
Therapeutic group:
Cattle, Pigs
Therapeutic area:
paromomycin
Therapeutic indications:
Antibiotics
Authorization status:
Authorised
Authorization number:
VPA10782/026/001
Authorization date:
2017-08-04

Read the complete document

Health Products Regulatory Authority

04 August 2017

CRN000TRW

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1 NAME OF THE VETERINARY MEDICINAL PRODUCT

Parofor 140 mg/ml solution for use in drinking water, milk or milk replacer for

pre-ruminant cattle and pigs

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Per 1 ml:

Active substance:

Paromomycin sulfate 200 mg, equivalent to paromomycin base 140

mg or

140.000 IU of paromomycin activity

Excipients:

Methyl parahydroxybenzoate (E218) 1.0 mg

Propyl parahydroxybenzoate (E216) 0.1 mg

Sodium metabisulphite (E223) 4.0 mg

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Solution for use in drinking water, milk or milk replacer.

A clear yellow to amber solution.

4 CLINICAL PARTICULARS

4.1 Target Species

Cattle (pre-ruminant calves), pigs.

4.2 Indications for use, specifying the target species

Treatment of gastro-intestinal infections caused by Escherichia coli susceptible to

paromomycin.

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4.3 Contraindications

Do not use in animals with known hypersensitivity to paromomycin, other

aminoglycosides or any of the excipients.

Do not use in cases with impaired function of the kidneys or liver.

Do not use in ruminating animals.

Do not use in turkeys due to the risk of selection for antimicrobial resistance in

intestinal bacteria.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals

The uptake of medication by animals can be altered as a consequence of illness. In

case of insufficient uptake of water/milk animals should be treated parenterally using

a suitable injectable product following the advice of the veterinarian.

The use of the product should be combined with good management practices e.g.

good hygiene, proper ventilation, no overstocking.

Since the product is potentially ototoxic and nephrotoxic, it is recommended to

assess kidney function.

Special care should be taken when considering administration of the product to

newborn animals due to the known higher gastrointestinal absorption of

paromomycin in neonates. This higher absorption could lead to an increased risk of

oto- and nephrotoxicity. The use of the product in neonates should be based on a

benefit/risk assessment by the responsible veterinarian.

Prolonged or repeated use of the product should be avoided by improving

management practices and through cleansing and disinfection.

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.

Official, national and regional antimicrobial policies should be taken into account

when the product is used.

Use of the product deviating from the instructions given in the SPC may increase the

prevalence of bacteria resistant to paromomycin and may decrease the effectiveness

of treatment with aminoglycosides due to the potential for cross-resistance.

Aminoglycosides are considered as critical in human medicine. Consequently, they

should not be used as a first line treatment in veterinary medicine.

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Special precautions to be taken by the person administering the veterinary

medicinal product to animals

This product contains paromomycin, which can cause allergic reactions in some

people.

People with known hypersensitivity (allergy) to paromomycin or any other

aminoglycosides should avoid contact with the product.

Avoid contact with the skin and eyes.

Personal protective equipment consisting of protective clothing and impervious

gloves should be worn when handling the veterinary medicinal product.

In the event of accidental contact with the skin or eyes, rinse with plenty of water.

If you develop symptoms following exposure, such as skin rash, you should seek

medical advice and show the physician this warning. Swelling of the face, lips and

eyes or difficulty in breathing are more serious symptoms and require urgent medical

attention.

Do not eat, drink and smoke when handling the product.

Do not ingest. In case of accidental ingestion, seek medical advice immediately and

show the label to the physician.

Wash hands after use.

4.6 Adverse reactions (frequency and seriousness)

On rare occasions soft faeces have been observed.

Aminoglycoside antibiotics such as paromomycin can cause oto- and

nephrotoxicity.

4.7 Use during pregnancy, lactation or lay

Laboratory studies in the rat and rabbit have not produced any evidence of

teratogenic, foetotoxic or maternotoxic effects. The use is not recommended during

pregnancy.

4.8 Interaction with other medicinal products and other forms of interaction

General anaesthetics and muscle relaxing products increase the neuro-blocking

effect of aminoglycosides. This may cause paralysis and apnoea.

Do not use concurrently with strong diuretics and potentially oto- or nephrotoxic

substances.

4.9 Amounts to be administered and administration route

Oral use.

Pre-ruminant cattle: administration in milk/milk replacer.

Pigs: administration in drinking water.

Duration of treatment: 3-5 days.

Pre-ruminant cattle: 25-50 mg paromomycin sulfate per kg BW/day (equivalent to

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04 August 2017

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0.125 – 0.25 ml of product/kg BW/day).

Pigs: 25-40 mg paromomycin sulfate per kg BW/day (equivalent to 0.125 – 0.2 ml of

product/kg BW/day).

To ensure accurate measurement of the required volume of product, suitably

calibrated measuring equipment should be used.

For administration via drinking water, milk or milk replacer, the exact daily amount

of product should be calculated, based on the recommended dose, and the number

and weight of the animals to be treated, according to the following formula:

ml product / kg body

weight / day

Mean body weight

(kg) of animals to be

treated

= .... ml product per liter

drinking water /milk/milk

replacer

Mean daily water/milk/milk replacer consumption

(litre) per animal

To ensure a correct dosage body weight should be determined as accurately as

possible.

The uptake of medicated water/milk /milk replacer depends on several factors

including clinical conditions of the animals and the local conditions such as ambient

temperature and humidity. In order to obtain the correct dosage, drinking

water/milk/milk replacer uptake has to be monitored and the concentration of

paromomycin has to be adjusted accordingly.

Medicated drinking water/milk/milk replacer and any stock solutions should be

freshly prepared by carefully mixing the product in the requisite quantity of fresh

potable water /milk/milk replacer every 6 hours (in milk/milk replacer) or every 24

hours (in water).

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

Paromomycin when administered orally is hardly absorbed systemically. Harmful

effects due to accidental overdosing are highly unlikely.

4.11 Withdrawal period(s)

Pre-ruminant cattle

Meat and offal: 20 days

Pigs Meat and offal: 3 days

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5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: intestinal anti-infective; antibiotics.

ATC vet code: QA07AA06.

5.1 Pharmacodynamic properties

Paromomycin belongs to the group of aminoglycoside antibiotics. Paromomycin

changes the reading of messenger-RNA, which disrupts protein synthesis. The

bactericidal activity of paromomycin is mainly attributed to its irreversible binding to

ribosomes. Paromomycin has broad spectrum activity against numerous

Gram-positive and Gram-negative bacteria, including E. coli.

Paromomycin acts in a concentration-dependent manner. Four mechanisms of

resistance have been identified: changes of the ribosome, reduction of permeability,

inactivation by enzymes and substitution of the molecular target. The first three

resistance mechanisms arise from mutations of certain genes on chromosomes or

plasmids. The fourth resistance mechanism only occurs following intake of a

transposon or plasmid coding for resistance. Paromomycin selects for resistance and

cross-resistance to other aminoglycosides at a high frequency in intestinal bacteria.

5.2 Pharmacokinetic properties

Following oral administration of paromomycin, hardly any absorption takes place

and the molecule is eliminated unchanged via the faeces.

5.3 Enviormental properties

The active ingredient paromomycin sulfate is very persistent in the environment.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate (E216)

Sodium metabisulfite (E223)

Purified water

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6.2 Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be

mixed with other veterinary medicinal products.

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: 3 months.

Shelf life after reconstitution in drinking water: 24 hours

Shelf life after reconstitution in milk/milk replacer: 6 hours

6.4 Special precautions for storage

Product as packed for sale: do not store above 25°C.

After first opening: do not store above 25°C.

After reconstitution: there are no special restrictions on storage conditions.

6.5 Nature and composition of immediate packaging

White high density polyethylene bottle with tamper-evident screw polypropylene

closure of 125 ml, 250 ml, 500 ml and 1 L.

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, where appropriate

Any unused veterinary medicinal product or waste materials derived from such

veterinary medicinal products should be disposed of in accordance with local

requirements.

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7 MARKETING AUTHORISATION HOLDER

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

8 MARKETING AUTHORISATION NUMBER(S)

VPA 10782/026/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 4

August 2017

10 DATE OF REVISION OF THE TEXT

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