ORAMEC Drench for Sheep 0.8 mg/ml

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
Ivermectin
Available from:
Merial Animal Health Limited
ATC code:
QP54AA01
INN (International Name):
Ivermectin
Dosage:
0.8 milligram(s)/millilitre
Pharmaceutical form:
Oral solution
Prescription type:
LM: Licensed Merchant as defined in relevant national legislation
Therapeutic group:
Sheep
Therapeutic area:
ivermectin
Therapeutic indications:
Endectoparasiticides
Authorization status:
Authorised
Authorization number:
VPA10857/018/001
Authorization date:
1994-10-01

Read the complete document

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT

ORAMEC Drench for Sheep 0.8 mg/ml

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

3 PHARMACEUTICAL FORM

Oral solution.

4 CLINICAL PARTICULARS

4.1 Target Species

Sheep.

4.2 Indications for use, specifying the target species

ORAMEC Drench for Sheep is highly effective for the treatment

and control

of mixed infections with the following

gastrointestinal roundworms (including benzimidazole-resistant strains of Haemonchus contortus, Ostertagia circumcincta

and levamisole-resistant strains of H. contortus, O. circumcincta and T. colubriformis):

Gastrointestinal roundworms (adult and fourth larval stage)

Haemonchus contortus*

Ostertagia circumcincta*

Trichostrongylus spp.

Cooperia spp.

Nematodirus spp.

Including N. battus

Strongyloides papillosus

Oesophagostomum spp.

Chabertia ovina

Lungworms (adult and fourth larval stage)

Dictyocaulus filaria

Nasal bot (all larval stages)

Oestrus ovis

* including benzimidazole resistant strains.

Active substance

Ivermectin

0.8 mg/ml

Excipients

Benzyl Alcohol

31.0 mg/ml

For a full list of excipients, see section 6.1

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4.3 Contraindications

Do not use in animals with known hypersensitivity to the active ingredient.

4.4 Special warnings for each target species

Care should be taken to avoid the following practices because they increase the risk of development of resistance and could

ultimately result in ineffective therapy:

Too frequent and repeated use of anthelmintics from the same class, over an extended period of time.

Underdosing which may be due to underestimation of bodyweight, misadministration of the product, or lack of

calibration of the dosing device.

Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal

Egg Count Reduction Test).

Where the results of the tests strongly suggest resistance to a particular anthelmintic, an

anthelmintic belonging to another pharmacological class and having a different mode of action should be used.

4.5 Special precautions for use

Special precautions for use in animals:

No special precautions are required.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

Wash hands after use.

Do not smoke or eat while handling the product.

Avoid contact with skin and eyes. If this occurs, rinse affected area immediately with water.

4.6 Adverse reactions (frequency and seriousness)

ORAMEC Drench for Sheep is readily accepted by the animal.

Some sheep may cough immediately after treatment.

This passing response is of no consequence.

4.7 Use during pregnancy, lactation or lay

ORAMEC Drench for Sheep can be administered to ewes at any stage of pregnancy or lactation provided that the milk

is not used for human consumption.

ORAMEC Drench for Sheep will not affect the fertility of breeding ewes and rams

and can be given to all ages of animals including young lambs.

4.8 Interaction with other medicinal products and other forms of interaction

ORAMEC Drench for Sheep may be used concurrently with clostridial vaccine without any adverse effects.

Adequate

vaccination of sheep against clostridial infections is strongly recommended.

4.9 Amounts to be administered and administration route

Oral administration with a dosing gun of 2.5 ml per 10 kg bodyweight (corresponding to the recommended dose rate of

0.2 mg ivermectin per kg bodyweight).

To ensure administration of a correct dose, bodyweight should be determined as accurately as possible.

If animals are to be treated collectively rather than individually, they should be grouped according to their bodyweight

and dosed accordingly, in order to avoid under- or overdosing.

Use properly calibrated dosing equipment.

ORAMEC Drench for Sheep has demonstrated a wide safety margin at the recommended dose level.

ORAMEC Drench

for Sheep may be used in sheep of all ages.

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

At doses up to 4 mg ivermectin per kg administered by stomach tube (20x the recommended dose level) undesirable

toxic reactions occurred.

Acute symptoms (ataxia, staggering gait, incoordination, depression) were observed at the

dose rate of 8 mg/kg (40x the recommended dose level) during a study carried out on 4 animals.

Twenty-four hours

later, the animals showed only mild incoordination and depression.

Three days post dose all the animals were nearly normal.

It is possible that the signs of toxaemia were due to the

propylene glycol.

No antidote has been identified; however, symptomatic treatment may be beneficial.

4.11 Withdrawal Period(s)

Animals intended for human consumption must not be slaughtered during treatment.

Animals intended for human consumption may only be slaughtered from 6 days after the last treatment.

Do not use in lactating sheep producing milk for human consumption.

Sheep must not be treated within 60 days prior to the commencement of lactation, if milk is to be used for human

consumption.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Phamacotherapeutic group: Anthelmintics, ivermectin.

ATCvet code: QP54AA01

5.1 Pharmacodynamic properties

Ivermectin is a member of the macrocyclic lactone class of endectocides which have a unique mode of action.

Compounds of the class bind 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 parasite.

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 properties

Maximum plasma concentration:

The maximum plasma concentration is reached in 6 hours after oral administration and ranges from 12 to 34 ng/ml at

the dose rate of 0.3 mg ivermectin per kg bodyweight.

This concentration gradually decreases to range from 2 to 7

ng/ml 2 days post dose.

Excretion:

length of time and route:

A liquid chromatographic method with fluorescence detection indicates that after oral administration of 0.3 mg

ivermectin per kg bodyweight, the liver (target tissue) has average residues ranging from 72 ppb at 1 day post dose to 8

ppb at 7 days post dose.

At early time periods fat had higher residues than liver.

By 5 days post dose the liver and fat

residues were equivalent.

Fat averaged 145 ppb at 1 day, declining to 9 ppb at 7 days.

Muscle and kidney had lower

residues at all withdrawal time periods studied.

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6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Propylene Glycol

Polysorbate 80

Benzyl Alcohol

Disodium Phosphate Dodecahydrate

Sodium Dihydrogen Phosphate Dihydrate

Purified Water

6.2 Incompatibilities

None known

6.3 Shelf-life

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years

6.4 Special precautions for storage

Do not store above 25°C. Protect from direct sunlight.

6.5 Nature and composition of immediate packaging

The product is packaged in polyethylene backpacks containing 1 litre, 2.5 litres and 5 litres, and in polyethylene

jerrycans containing 1 litre.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials

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

under national waste disposal regulations.

Studies indicate that when ivermectin comes in contact with the soil, it readily

and tightly binds to the soil and becomes inactive over time.

Do not contaminate lakes and streams with unused product or

waste material as free ivermectin may adversely affect fish and certain water borne organisms.

7 MARKETING AUTHORISATION HOLDER

Merial Animal Health Ltd,

PO Box 327,

Sandringham House,

Harlow Business Park,

Harlow,

Essex CM19 5TG,

England.

8 MARKETING AUTHORISATION NUMBER(S)

VPA 10857/018/001

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9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

September 2009

10 DATE OF REVISION OF THE TEXT

March 2011

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