Parofor 70000 IU/g powder 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:
70000 international unit(s)/gram
Pharmaceutical form:
Powder for use in drinking water
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:
VPA10782/014/001
Authorization date:
2014-09-12

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Health Products Regulatory Authority

06 September 2019

CRN008V67

Page 1 of 5

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT

Parofor 70000 IU/g powder for use in drinking water, milk or milk replacer for pre-ruminant cattle and pigs

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Per 1 gram:

Active substance:

70,000 IU of paromomycin activity (as paromomycin sulfate)

Excipients:

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Powder for use in drinking water, milk or milk replacer

A white to almost white powder.

4 CLINICAL PARTICULARS

4.1 Target Species

Cattle (pre-ruminant calves), pig.

4.2 Indications for use, specifying the target species

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

4.3 Contraindications

Do not use in cases of 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 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.

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06 September 2019

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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 crossresistance.

Aminoglycosides are considered as critical in human medicine. Consequently, they should not be used as a first line treatment

in veterinary medicine.

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. Anyone with known hypersensitivity

(allergy) to aminoglycosides should avoid contact with the veterinary medicinal product. 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.

Personal protective equipment consisting of protective clothing and impervious gloves should be worn when handling the

veterinary medicinal product.

Do not eat, drink and smoke when handling the product. Wash hands after use. In case of accidental ingestion, seek medical

advice immediately and show the package leaflet or label to the physician.

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.

Use in a well-ventilated area. Avoid inhaling the powder while preparing the medicated water or milk replacer. Avoid contact

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

attention if irritation persists.

4.6 Adverse reactions (frequency and seriousness)

Aminoglycoside antibiotics such as paromomycin can cause oto- and nephrotoxicity.

On rare occasions soft faeces has been observed.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

Laboratory studies in rat and rabbit have not produced any evidence of teratogenic, foetoxic or maternotoxic effects. The use is

not recommended during the pregnancy.

4.8 Interaction with other medicinal products and other forms of interactions

General anaesthetics and muscle relaxants increase the neuro-blocking effect of aminoglycosides, which can lead to acute

paralysis and apnoea.

Do not use concurrently with loop 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: 17500 – 35000 IU per kg BW/day (equivalent to 2.5-5 g of product/10 kg BW/day)

Pigs: 17500 – 28000 IU per kg BW/day (equivalent to 2.5-4 g of product/10 kg BW/day)

Health Products Regulatory Authority

06 September 2019

CRN008V67

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For the administration through the 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:

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. Any remaining quantities of

medicated fluids should be removed after 6 hours (in milk/milk replacer) or 24 hours (in water).

To assure administration of the exact daily amount of product suitably calibrated weighing equipment should be used.

For the administration of the product commercially available dosing pumps can be used. The solubility of the product has been

tested at the maximum concentration of 95 g/L.

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

Meat and offal: 3 days

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: intestinal antiinfectives; 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-dependant manner. Five mechanisms of resistance have been identified: changes of the

ribosome due to mutations, reduction of permeability of bacterial cell wall or active efflux, inactivation of aminoglycosides by

enzymes and enzymatic substitution of the molecular target. The first three resistance mechanisms arise from mutations of

certain genes on chromosomes. The fourth and fifth resistance mechanisms only occur following intake of a transposon or

plasmid coding for resistance. Paromomycin selects for resistance and cross-resistances at high frequency against a variety of

other aminoglycosides among intestinal bacteria.

5.2 Pharmacokinetic particulars

Following oral administration of paromomycin, hardly any absorption takes place and the molecule is eliminated unchanged

via the faeces.

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CRN008V67

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5.3 Environmental properties

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

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Silica, colloidal anhydrous

Glucose monohydrate

6.2 Major 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: 6 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

Store below 25°C.

Keep the sachet tightly closed.

6.5 Nature and composition of immediate packaging

Block-bottom polyethylene/aluminium/polyethylene terephthalate sachet of 1000g - 500g – 250g

Sachet of polyethylene foil/aluminium/polypropylene foil of 25 g, placed into a cardboard box, 40 sachets per box.

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

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be

disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

8 MARKETING AUTHORISATION NUMBER(S)

VPA10782/014/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 12

September 2014

Date of latest renewal: 19

July 2019

Health Products Regulatory Authority

06 September 2019

CRN008V67

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10 DATE OF REVISION OF THE TEXT

September 2019

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