Ivotan®
Antiparasitic remedy for cattle, sheep and pigs.
FOR ANIMAL USE ONLY
IVOTAN® Reg. No. G2858 (Act 36/1947)
Namibia Reg. No. V01/18.1.2/731 [NS0]
INDICATIONS
Antiparasitic remedy for cattle, sheep and pigs.
COMPOSITION
Contains: Ivermectin 1 % m/v
*macrocyclic lactones
CAUTION
STORAGE INSTRUCTIONS
- Store below 30 °C, away from sunlight.
WARNINGS
- Withdrawal period: Cattle and sheep must not be slaughtered for human consumption within 21 days of last treatment. Pigs must not be slaughtered for human consumption within 28 days of last treatment.
- Do not use in lactating cattle or sheep where milk or milk products are intended for human consumption.
- Do not use in dairy cattle within 28 days before calving, where milk or milk products are intended for human consumption.
- Do not administer intravenously or intramuscularly.
- KEEP OUT OF REACH OF CHILDREN, UNINFORMED PERSONS AND ANIMALS.
- Although this remedy has been extensively tested under a large variety of conditions, failure thereof may ensue as a result of a wide range of reasons. If this is suspected, seek veterinary advice and notify the registration holder.
PRECAUTIONS
- Do not reuse empty bottles.
- Refrain from smoking and eating while handling the product.
- Wash hands after use.
- Vaccination of cattle against clostridial infections (e.g. black quarter) is strongly recommended.
- Sheep should have been vaccinated against pulpy kidney (enterotoxaemia) before treatment.
- Dispose of any containers, disposable equipment and any other waste after use, in accordance with National Environmental Management: Waste Act, 2008 (Act No. 59 of 2008).
N.B. Transitory discomfort has been observed in some cattle following subcutaneous administration. A low incidence of soft tissue swelling at the injection site has been observed. These reactions disappeared without treatment.
DIRECTIONS FOR USE – USE ONLY AS DIRECTED
Shake well before use.
DOSAGE
Cattle: Inject Ivotan® subcutaneously at the approved dosage level of 200 µg/kg of body weight. Each 1 mℓ contains 10 mg of ivermectin, sufficient to treat 50 kg of body weight.
Pigs: The approved dose level is 1 mℓ/33 kg (300 µg/kg) subcutaneously.
Sheep: Inject Ivotan® subcutaneously at the recommended dosage level of 1 mℓ/50 kg (200 µg/kg)
Example:
| Body weight (kg) | Dose volume (mℓ) | |
| Cattle | Pigs | |
| Up to 50 | 1 | 1,5 |
| 51 – 100 | 2 | 3,0 |
| 101 – 150 | 3 | 4,5 |
| 151 – 200 | 4 | 6,0 |
| 201 – 250 | 5 | 7,5 |
| 251 – 300 | 6 | 9,0 |
| 301 – 350 | 7 | 10,5 |
| 351 – 400 | 8 | 12,0 |
| 401 – 450 | 9 | 13,5 |
| Body weight (kg) | Dose volume (mℓ) |
| Sheep | |
| Up to 25 | 0,5 |
| 26 – 50 | 1,0 |
| 51 – 75 | 1,5 |
| 76 – 100 | 2,0 |
ADMINISTRATION
- Ivotan® is to be given subcutaneously only.
- Do not administer intramuscularly or intravenously.
- The solution may be administered with any standard automatic or single-dose equipment.
- Use aseptic technique.
- In cattle, inject under the loose skin in front of or behind the shoulder.
- Use of a 2,0 cm 16-gauge needle is suggested.
- Appropriate vaccination precautions should be taken, in areas where the risk of clostridial infections of cattle such as black quarter and malignant oedema are present.
- In sheep, the loose skin behind the shoulder is an acceptable site or the skin under the foreleg (axilla) or the inside of the thigh.
- Ensure that the needle is carefully inserted, and that the solution does not leak from the injection site.
- In wool sheep, be certain that the needle has penetrated the wool and skin before delivering the dose.
- Administer to pigs subcutaneously in the neck.
Ivotan® has demonstrated an adequate safety margin at the recommended dose level and may be used in breeding animals.
ENVIRONMENTAL SAFETY
Studies indicate that when Ivotan® comes into contact with the soil, it readily and tightly binds to the soil and becomes inactive over time. Drug containers and any residual contents should be disposed of safely as per local waste disposal regulations, as free Ivotan® may adversely affect fish and certain waterborne organisms.
INSTRUCTIONS FOR USE WITH AUTOMATIC DOSING EQUIPMENT
- Sterilise all equipment before using, by boiling in clean water for 15 to 20 minutes.
- Boiled needles should be stored in an antiseptic solution before use and changed frequently when injecting animals.
- Remove the draw-off assembly from the sterile pack. Handle carefully to avoid contamination.
- Connect plastic tube firmly to dosing syringe.
- Disinfect rubber stopper with methylated spirits or other suitable chemical disinfectant. Hold bottle upright and fully insert draw-off needle into the center of the rubber stopper. Secure firmly with cap.
- Hang bottle comfortably in inverted position from neck, shoulder or belt. Use bracket with necktie provided.
- Gently prime injector. Equipment is now ready for use.
- After use, remove draw-off assembly from pack and flush out entire apparatus with water before storing.
- If the connecting tube is reused, it should be boiled for 15 to 20 minutes before use, along with the injecting syringe and needles.
INDICATIONS
- Internal Parasites
For the treatment of gastrointestinal roundworms in cattle and sheep, and Parafilaria bovicola (false bruising) and eye-worm (Thelazia) in cattle.
Efficacy: Ivotan® is effective against the above-mentioned internal parasites of cattle and sheep when given subcutaneously at the recommended dose rate of 200 µg/kg (1 mℓ/50 kg) body weight.
- External Parasites
Cattle: Kills sucking lice, biting lice and mange mites. Controls sand tampan infesting cattle for up to 3 days after treatment. Kills cattle screwworm present at time of injection. Protects against screwworm strikes for 2 weeks after administration.
Controls blue ticks (Rhipicephalus boophilus)spp. on cattle. For control of blue ticks, treatment must be repeated every 21 days.
Sheep: Kills sheep scab mites (Psoroptes communis ovis). Two treatments, 7 days apart, might be necessary to kill sheep scab mites. Controls itch mites (Psorergates ovis).
Pigs: Kills mange mites (Sarcoptes scabiei var. suis).
Note: Ivotan® has a persistent ivermectin level sufficient to control mite infestations throughout the duration of the life cycle. However, since the effect is not immediate, care must be taken to prevent re-infestation from exposure to untreated animals or contaminated facilities. Generally, pigs should not be moved to clean quarters or exposed to uninfested pigs for approximately 1 week after treatment. Sows should be treated at least 1 week before farrowing, to minimise transfer of mites to newborn baby pigs.
- Nasal worm (Oestrus ovis)
Sheep: Controls (•) all stages (1st, 2nd and 3rd instar larvae).
EFFICACY
| Cattle Roundworm Species | Immature | Adult | Controls(•) against reinfestation for |
| Wireworm (Haemonchus placei) | • | • | 14 days |
| Brown stomach worm (Ostertagia ostertagi) | • | • | 21 days |
| Cattle bankrupt worm (Cooperia spp.) | • | • | 14 days |
| Hookworm (Bunostomum phlebotomum) | • | • | |
| Nodular worm (Oesophagostomum radiatum) | • | • | 21 days |
| Lungworm (Dictyocaulus viviparus) | • | • | 21 days |
| Eye-worm (Thelazia rhodesii) | • | ||
| False bruising (Parafilaria bovicola) | ••‡ |
• Controls (≥ 90 % effective)
•• Aids in control (60 – 89 % effective)
‡ An interval of 70 days must elapse after treatment, to allow lesions to heal.
| Sheep Roundworm Species | Immature | Adult | Controls• against reinfestation for |
| Wireworm (Haemonchus contortus) | • | • | 7 days |
| Brown stomach worm (Teladorsagia circumcinta) | • | • | |
| Bankrupt worm (Trichostrongylus colubriformis) | • | • | |
| Long-necked bankrupt worm (Nematodirus spathiger) | •• | ||
| Hookworm (Gaigeria pachyscelis) | • | • | |
| Nodular worm (Oesophagostomum columbianum) | • | • | |
| Large-mouthed bowel worm (Chabertia ovina) | • | • | |
| Lungworm (Dictyocaulus filaria) | • | • |
• Controls (≥ 90 % effective)
•• Aids in control (60 – 89 % effective)
PRESENTATION
50 mℓ and 500 mℓ amber bottle with a rubber stopper and aluminium seal.
Not all pack sizes may necessarily be marketed.
REGISTRATION HOLDER
Intervet South Africa (Pty) Ltd.
20 Spartan Road, Spartan
1619, RSA
Tel: +27 (0) 11 923 9300
E-mail: msdahza@msd.com
www.msd-animal-health.co.za
DATE OF PUBLICATION OF THIS PACKAGE INSERT
14 March 2005