Ecomectin 10 mg/ml Injection 500ml (Ivermectin)

Health Products Regulatory Authority Click here to download Data Sheet Summary of Product Characteristics 1. Name of the Veterinary Medicinal Product Ecomectin 10 mg/ml Solution for Injection 2. Qualitative and Quantitative Composition Each 1 ml contains: Active substance: Ivermectin – 10 mg Excipient(s): Benzyl alcohol – 10 mg For a full list of excipients, see section 6.1. 3. Pharmaceutical Form Solution for injection A clear, colourless solution. 4. Clinical Particulars 4.1 Target Species Cattle, sheep, and pigs. 4.2 Indications for Use Cattle For the treatment of gastrointestinal nematodes, lungworms, eyeworms, warble flies, mites, and lice in beef and non-lactating dairy cattle. Effective against: Gastrointestinal worms (adults and 4th stage larvae): Ostertagia ostertagi, Ostertagia lyrata, Haemonchus placei, Trichostrongylus colubriformis, Cooperia spp., Bunostomum phlebotomum, Oesophagostomum radiatum Lungworms: Dictyocaulus viviparus Eyeworms: Thelazia spp. Warble flies: Hypoderma bovis, H. lineatum Mites: Psoroptes ovis, Sarcoptes scabiei var. bovis Lice: Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus Prevents reinfection for: 7 days: Haemonchus placei, Cooperia spp., Trichostrongylus axei 14 days: Ostertagia ostertagi, Oesophagostomum radiatum 21 days: Dictyocaulus viviparus Sheep For treatment of psoroptic mange (sheep scab), gastrointestinal nematodes, lungworms, and nasal bots. Effective against: Gastrointestinal worms: Ostertagia circumcincta, Haemonchus contortus, Trichostrongylus spp., Cooperia curticei, Nematodirus filicollis Lungworms: Dictyocaulus filaria Mange mites: Psoroptes ovis Nasal bot: Oestrus ovis Pigs For treatment of gastrointestinal nematodes, lungworms, lice, and mange mites. Effective against: Gastrointestinal worms: Ascaris suum, Hyostrongylus rubidus, Oesophagostomum spp., Strongyloides ransomi Lungworms: Metastrongylus spp. Lice: Haematopinus suis Mange mites: Sarcoptes scabiei var. suis 4.3 Contraindications Do not use in lactating dairy cows or sheep producing milk for human consumption. Do not use in dairy animals within 60 days of calving/lambing. Do not use in cases of known hypersensitivity to ivermectin. Do not administer intravenously or intramuscularly. 4.4 Special Warnings for Each Target Species Avoid frequent or repeated use from the same class of anthelmintics. Underdosing increases resistance risk—ensure accurate weight estimation and device calibration. One injection is not sufficient for sheep scab—use two doses. Resistance to ivermectin has been reported; local resistance patterns should guide use. 4.5 Special Precautions for Use In Animals: Fatal intolerance in non-target species like Collies and tortoises has been reported. Do not combine with lungworm vaccination within 28 days. In cattle, treat after warble fly season to avoid adverse effects from larval death in sensitive areas. By Users: Avoid eating, drinking, or smoking when handling. Wash hands after use. Avoid self-injection—can cause irritation. 4.6 Adverse Reactions Temporary discomfort post-injection (e.g. jumping or rolling in cattle). Local swelling may occur but resolves within 1–4 weeks. 4.7 Use During Pregnancy or Lactation Safe during pregnancy in cows, ewes, and sows. Do not use in lactating animals producing milk for human consumption. Does not affect male fertility. 4.8 Interactions Do not use with lungworm vaccinations within 28 days before or after administration. 4.9 Amounts to be Administered and Administration Route Subcutaneous injection only. Use aseptic technique. Cattle: 1 ml per 50 kg bodyweight (200 mcg/kg ivermectin) Inject in front of or behind shoulder with 17G x ½" needle Sheep: 0.5 ml per 25 kg bodyweight Use 2 injections (7 days apart) for sheep scab Lambs <20 kg: 0.1 ml per 5 kg Pigs: 1.5 ml per 50 kg bodyweight (300 mcg/kg ivermectin) Piglets <16 kg: 0.1 ml per 3 kg Use appropriate syringes for small doses. Use draw-off needles for 200 ml and 500 ml bottles. 4.10 Overdose Symptoms: ataxia, depression No antidote - treat symptomatically Safe up to 3x the recommended dose in trials 4.11 Withdrawal Periods Cattle: Meat & offal – 49 days. Milk – Do not use. Sheep: Meat & offal – 42 days. Milk – Do not use. Pigs: Meat & offal – 28 days. 5. Pharmacological Properties Ivermectin is a member of the macrocyclic lactone group (avermectins), with endectocidal activity against a wide range of internal and external parasites.