Oramec

Oramec drench is an ivermectin based wormer for sheep. Oramec is used for the treatment and control of gastro-intestinal worms, lungworms and nasal bots.

Active Ingredient:Ivermectin

Target Species: Sheep

Treats and Controls: Gastro-intestinal worms, lungworms, nasal bots

Administration Method: Oral drench

Withdrawal Time: 6 days for sheep intended for meat and offal. Not permitted for use on sheep producing milk for human consumption

Dosage for sheep: 2.5 ml per 10 kg of bodyweight.

Always read the label and all enclosed information for Oramec Oral Suspension before administering to animals!

Commonly asked questions about Oramec Drench

Q. Will Oramec  kill worms that are resistant to control by white drenches?

A.Yes. Oramec is routinely used in wormer rotation programmes. Also, it is often used to treat sheep that are brought in from market and neighbouring farms where the worming history is either not known or may be in doubt. It makes sense to treat all sheep with Oramec and keep them isolated, preferably on hard standing, for 48 hours before mixing them with the main flock.

Q. Will Oramec control inhibited time-bomb worms and help prevent the spring rise?

A. Yes. Treat the ewes just before you house the sheep or just prior to lambing. This will kill the dormant worms in the sheep that would emerge in the spring and contaminate pasture at the time when lambs are beginning to graze.

How sheep contract worms:

Features of Oramec

• An ivermectin based wormer for sheep. 
• Used for the treatment and control of gastro-intestinal worms, lungworms and nasal bots.
• Withdrawel period of 6 days for sheep intended for meat and offal. 
• Not permitted for use on sheep producing milk for human consumption

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT
ORAMEC Drench for Sheep 0.8 mg/ml

2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance
Ivermectin 0.8 mg/ml
Excipients
Benzyl Alcohol 31.0 mg/ml
For a full list of excipients, see section 6.1

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

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.

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 gammaaminobutyric
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.

6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Propylene Glycol
Polysorbate 80
Benzyl Alcohol
Disodium Phosphate Dodecahydrate
Sodium Dihydrogen Phosphate Dihydrate
PurifiedWater

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

9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
30th September 2009

10 DATE OF REVISION OF THE TEXT
31st March 2011

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