NOAH Compendium

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Date: Tuesday, April 16, 2024 15:28

Release 2.37
Oramec Drench
 
Species: Sheep
Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for sheep
Active ingredient: Ivermectin
Product:Oramec Drench
Product index: Oramec Drench
Sheep - meat: 6 days
Withdrawal notes: If milk is to be used for human consumption animals should not be treated within 60 days prior to the commencement of lactation
Incorporating:
Qualitative and quantitative composition
Each ml contains:
Active ingredient: Ivermectin 0.8mg
Excipients: Preservative: Benzyl Alcohol 31 mg
For the full list of excipients, see below.
Pharmaceutical form
Oral solution. Clean, clear, slightly yellow liquid.
Clinical particulars
Target species
Sheep.
Indications for use
The product is indicated for the treatment and control of gastrointestinal nematodes, lungworms and nasal bots of sheep. The product at the recommended dose rate of 200 mcg ivermectin per kg bodyweight provides effective control against the following parasites of sheep:
Gastro-intestinal roundworms (adult and immature): Haemonchus contortus, Teladorsagia circumcincta, Trichostrongylus spp., Cooperia spp., Nematodirus spp. including N. battus, Strongyloides papillosus, Oesophagostomum spp. and adult Chabertia ovina.
Inhibited larval stages and benzimidazole-resistant strains of H. contortus and T. circumcincta are also controlled.
Lungworms (adult and immature): Dictyocaulus filaria.
Nasal bot (all larval stages): Oestrus ovis.
Contra-indications
The product has been formulated specifically for use in sheep. Do not use in other species, as severe adverse reactions, including fatalities in dogs, may occur.
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 body weight, misadministration of the product, or lack of calibration of the dosing device (if any).
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 test(s) strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used. Resistance to macrocyclic lactones (which includes ivermectin) has been reported in Teladorsagia spp. in sheep within the EU. Therefore, the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of nematodes and recommendations on how to limit further selection for resistance to anthelmintics.
Special precautions for use in animals
No special precautions are required.
Special precautions to be taken by the person administering the product to animals
Do not smoke, eat or drink while handling the product. Wash hands after use. Avoid contact with skin and eyes. Wear impervious gloves when handling or administering the product. As absorption through the skin can occur, in case of accidental spillage onto the skin or eyes, wash the affected area with clean running water immediately. Seek medical attention of irritation persists.
Adverse reactions
Some sheep may cough immediately after treatment. This passing response is of no consequence.
Use during pregnancy, lactation or lay
Ewes may be treated at any stage of pregnancy.
Interactions
No interactions have been observed.
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). The dosing gun should be calibrated sufficiently accurately to ensure precise dosing of young sheep.
To ensure administration of a correct dose, bodyweight should be determined as accurately as possible; accuracy of the dosing device should be checked. Do not mix with other products.
Overdose
The product has demonstrated a wide safety margin at the recommended dose level. The product may be used in sheep of all ages.
During a study to assess toxicological effects only mild incoordination and depression were observed at 20 x the recommended dose level (4 mg ivermectin per kg bodyweight, administered by stomach tube). At 40 x the recommended dose level (8 mg ivermectin per kg bodyweight, also administered by stomach tube) acute symptoms (ataxia, staggering gait, incoordination and depression) were observed. Within 24 hours nearly all animals appeared normal and within 3 days all animals appeared clinically normal.
No antidote has been identified, however, symptomatic treatment may be beneficial.
Withdrawal periods
Meat and offal: 6 days.
Do not use in lactating animals producing milk for human consumption.
If milk is to be used for human consumption animals should not be treated within 60 days prior to the commencement of lactation.
Pharmaceutical particulars
Excipient
Benzyl alcohol
Incompatibilities
None known.
Shelf life
Shelf life of the product as packaged for sale: 2 years.
Special precautions for storage
Do not store above 25 °C. Protect from direct sunlight.
Immediate packaging
1, 2.5 and 5 litre containers. Not all pack sizes may be marketed.
Disposal
EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE. Do not contaminate surface waters or ditches with the product or used container. Any unused product or waste materials derived from such products should be disposed of in accordance with local requirements.
Marketing Authorisation Number
Vm 08327/4191
Significant changes
Legal category
Legal category: POM-VPS
GTIN
GTIN description:Oramec Drench 1 litre
GTIN:3661103015260
GTIN description:Oramec Drench 2.5 litre
GTIN:3661103015277
GTIN description:Oramec Drench 5 litre
GTIN:3661103015284