Paramectin 0.5 % Pour-On Solution for Cattle

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
Ivermectin
Available from:
Norbrook Laboratories Limited
ATC code:
QP54AA01
INN (International Name):
Ivermectin
Dosage:
0.5 percent weight/volume
Pharmaceutical form:
Pour-on solution
Prescription type:
LM: Licensed Merchant as defined in relevant national legislation
Therapeutic group:
Cattle
Therapeutic area:
ivermectin
Therapeutic indications:
Endectoparasiticides
Authorization status:
Authorised
Authorization number:
VPA10999/095/001
Authorization date:
2001-06-29

Read the complete document

Health Products Regulatory Authority

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Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT

Paramectin 0.5 % Pour-On Solution for Cattle

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Substance

Ivermectin 0.5 % w/v

For a full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Pour-on Solution.

4 CLINICAL PARTICULARS

4.1 Target Species

Cattle (beef and non-lactating cattle).

4.2 Indications for use, specifying the target species

The product is indicated for the treatment and control of the following harmful

species of gastrointestinal roundworms, lungworms, eyeworms, warbles, mites and

lice.

Gastrointestinal roundworms (adults and fourth stage larvae):

Ostertagia ostertagi (including inhibited O ostertagi), Haemonchus placei,

Trichostrongylus axei, Trichostrongylus colubriformis, Cooperia spp,

Oesophagostomum radiatum, Strongyloides papillosus (adult), Trichuris spp (adult).

Occasionally variable activity may be observed against H. placei (L4), Cooperia spp, T.

axei and T. colubriformis.

Lungworms (adult and fourth stage larvae)

Dictyocaulus viviparus

Eyeworms (adult)

Thelazia rhodesii

Warbles (parasitic stages)

Hypoderma bovis, Hypoderma lineatum

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Sucking Lice

Linognathus vituli, Haematopinus eurysternus,

Biting Lice

Damalinia (Bovicola) bovis

Mange mites

Chorioptes bovis, Sarcoptes scabiei var bovis

4.3 Contraindications

Do not use in dairy cows, during lactation or the dry period, and in beef cows during

the lactation period when milk is intended for human consumption. Do not use in

pregnant heifers within 60 days prior to calving.

4.4 Special warnings for each target species

Assess bodyweight as accurately as possible before calculating the dosage.

4.5 Special precautions for use

Special precautions for use in animals

To avoid secondary reactions due to death of Hypoderma larvae in the oesophagus

or in the spine it is recommended to administer the product at the end of the period

of warble fly activity and before the larvae reach their resting sites. Consult your

veterinarian on the correct timing of treatment.

Do not treat cattle when their hair or hide is wet. Do not treat cattle if rain is

expected, as rain within 2 hours of treatment may reduce efficacy. Do not apply to

areas of skin which have mange scabs or other lesions or to areas contaminated with

mud or manure.

The product has been formulated for topical application specifically for cattle. It

should not be administered to other species as severe adverse reactions may occur.

Cases of intolerance with fatal outcome are reported in dogs, especially Collies, old

English Sheepdogs and related breeds or crosses, and also in turtles/tortoises.

Frequent and repeated use may lead to the development of resistance. It is

important that the correct dose is given in order to minimise the risk of resistance. To

avoid under dosing animals should be grouped according to their body weight and

dosed according to the heaviest animal in the group.

Special precautions to be taken by the person administering the veterinary

medicinal product to animals

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Highly flammable - keep away from heat, sparks, open flame or other sources of

ignition.

The product may be irritating to human skin and eyes and the user should be careful

not to apply it to himself or other persons. Operators should wear rubber gloves and

boots with a waterproof coat when applying the product. Protective clothing should

be washed after use. If accidental skin contact occurs, wash the affected area

immediately with soap and water. If accidental eye exposure occurs, flush the eyes

immediately with water and get medical attention.

Do not smoke or eat while handling the product. Wash hands after use. Use only in

well ventilated areas or outdoors.

4.6 Adverse reactions (frequency and seriousness)

None.

4.7 Use during pregnancy, lactation or lay

The product can be administered to beef cows at any stage of pregnancy or lactation

provided that the milk is not intended for human consumption.

Do not use in dairy cows, during lactation or the dry period, and in beef cows during

the lactation period, when milk is intended for human consumption. Do not use in

pregnant heifers within 60 days prior to calving.

4.8 Interaction with other medicinal products and other forms of interactions

None known.

4.9 Amounts to be administered and administration route

Ivermectin should be administered topically at 500 microgram per kg bodyweight (1

ml per 10 kg bodyweight).

The formulation should be applied along the midline of the back in a narrow strip

between the withers and the tailhead.

It is recommended that calves which are set-stocked in their first season of grazing

should be treated 3, 8 and 13 weeks after turn-out, for optimal benefit from the

persistent effect of ivermectin. This can protect the animals from parasitic

gastro-enteritis and lungworm disease throughout the grazing season, provided they

are set-stocked. All calves should be included in the program, and no untreated

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cattle should be added to the pasture. Treated animals should be monitored

according to good husbandry practices always.

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

In case of overdose a symptomatic treatment should be given. The symptoms of

overdose can be trembling, convulsions and coma.

4.11 Withdrawal period(s)

Edible tissues: 28 days.

Milk: Do not use in dairy cows, during lactation or the dry period, and in beef cows

during the lactation period, when milk is intended for human consumption.

Do not use in pregnant heifers within 60 days prior to calving.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Endectocide

ATC vet code: QP54AA01

5.1 Pharmacodynamic properties

Ivermectin in a 22,23-dihydro derivative of an avermectin (which is a fermentation

product produced by Streptomyces avermitilis) and consists of 2 homologues: B1a

and B1b. It is a parasiticide with nematocidal, insecticidal and acaricidal activity

documented in a wide range of domesticated animals.

Ivermectin is a macrocyclic lactone derivative and acts by inhibiting nerve impulses. It

binds selectively and with high affinity to glutamate-gated chloride ion channels

which occur in invertebrate nerve and muscle cells. This leads to an increase in the

permeability of the cell membrane to chloride ions with hyperpolarization of the

nerve or muscle cell, resulting in paralysis and death of the relevant parasites.

Compounds of this class may also interact with other ligand-gated chloride channels,

such as those gated by the neurotransmitter gamma-aminobutyric acid (GABA). The

margin of safety for compounds of this class is attributable to the fact that mammals

do not have glutamate-gated chloride channels. The macrocyclic lactones have a low

affinity for other mammalian ligand-gated chloride channels and they do not readily

cross the blood-brain barrier.

5.2 Pharmacokinetic particulars

After administration of the product, the ivermectin is absorbed through the skin into

the circulation of the treated animal. The maximum concentration in plasma occurs

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around 97 hours after application. Peak concentrations of about 11.3 ng/ml are

obtained.

Elimination is in the faeces (via biliary excretion).

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Crodamol CAP

Triethanolamine

Patent Blue V Dye

Isopropyl alcohol

6.2 Major incompatibilities

None known.

6.3 Shelf-life

Shelf-life: 2 years

Shelf-life after first opening of the container: 12 months

6.4 Special precautions for storage

Store below 30°C.

6.5 Nature and composition of immediate packaging

The product will be supplied in 250 ml and 1.0L single-neck, twin-neck and

squeeze-measure high density polyethylene dispensers and 2.5L and 5 L low density

polyethylene backpacks.

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

Ivermectin is extremely dangerous to fish and aquatic life. Do not contaminate

surface water or ditches with the product or used containers. Any unused product or

waste material should be disposed of safely in accordance with national requirements.

7 MARKETING AUTHORISATION HOLDER

Norbrook Laboratories Limited

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Station Works

Camlough Road

Newry

Co. Down

BT35 6JP

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

VPA10999/095/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 29 June 2001

Date of last renewal: 03 September 2006

10 DATE OF REVISION OF THE TEXT

December 2018

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