Sovereign®
Pour-on acaricide, flukicide and anthelmintic for cattle.
FOR EXTERNAL ANIMAL USE ONLY
SOVEREIGN®
Reg. No. G3831 (Act 36/1947)
Namibia Reg. No. V09/18.3.9/195 [NS0]
Pour-on for ticks, liver fluke and dewormer for cattle.
INDICATIONS
For the treatment and control of liver fluke (Fasciola hepatica), giant liver fluke (Fasciola gigantica), as well as ivermectin sensitive:
- Gastrointestinal roundworms:
- Brown stomach worm (Ostertagia ostertagi),
- Wireworm (Haemonchus placei),
- Cattle bankrupt worm (Cooperia spp.),
- Nodular worm (Oesophagostomum radiatum),
- Lungworm (Dictyocaulus viviparus),
- Eyeworm (Thelazia spp.),
- Ticks:
- Blue tick (Rhipicephalus spp.)
COMPOSITION
Contains: Ivermectin 15 g/ℓ
Triclabendazole 240 g/ℓ
Macrocyclic lactones
Benzimidazoles and probenzimidazoles
CAUTION
STORAGE INSTRUCTIONS
- Store below 30 °C.
- Protect from light.
- Close container when not in use.
PHARMACOLOGICAL ACTION FOR THE TREATMENT AND CONTROL OF BLUE TICKS
Please note that Sovereign® acts systemically after application along the top line of the animal. The active ingredient is absorbed through the skin and in order for it to control ticks, the ticks need to bite and take a blood meal from the animal treated with Sovereign®. For this reason, Sovereign® is designed to control blue tick numbers and not to prevent tick-borne diseases. When the tick population has been controlled through regular/strategic application of Sovereign®, the risk of tick-borne diseases may significantly decrease.
WARNINGS
- Withdrawal periods: Meat – Do not slaughter cattle for human consumption within 39 days of the last treatment.
Milk – Do not use in cattle producing milk for human consumption.
- Use only in well-ventilated areas or outdoors.
- DO NOT OVER- OR UNDERDOSE.
- The antiparasitic activity of ivermectin and triclabendazole may be impaired if Sovereign® is applied to areas of skin with mange scabs or lesions, or with dermatoses or adherent materials, e.g. caked mud or manure.
- Keep animals away from open flames during and immediately after application of Sovereign®.
- Avoid the use of electrical equipment e.g. livestock prodders on the animals during and immediately after application of Sovereign®.
- In the case of poisoning, seek medical advice immediately and show this package leaflet to the physician.
- 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
- Avoid contact with eyes. Should accidental contamination occur, hold eyes open and rinse with water for at least 15 minutes. Consult a physician.
- Do not eat, drink or smoke whilst handling the product.
- When handling Sovereign®, wear rubber gloves and wash them after each day’s use.
- The product should only be used with a Sovereign® applicator.
- 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) and do not reuse for any other purpose.
- Do not store unused containers for future use.
- Do not contaminate rivers, dams or any water sources with containers or waste.
DIRECTIONS FOR USE – USE ONLY AS DIRECTED
- Apply at 1 mℓ/10 kg body weight.
- Sovereign® is flammable. Please refer to Warnings.
- Apply the recommended amount of Sovereign® along the top line, on a concentrated area, along the rump-/lumbar area (middle of the back to the base of the tail).
- For long-haired animals (e.g., during winter months), it is recommended that Sovereign® is applied against the grain of the hair directly onto the skin.
- Sovereign® should be applied using a recommended applicator fitted with a fan-spray nozzle. Prior to and during use, check the accuracy of applicators.
- Dose the herd according to the heaviest animal by body weight in each group (cows, bulls, calves, heifers, etc.).
- Cattle should be weighed with either scales or with a weight band.
- To avoid overdosing where there is a large variation in size within the group, divide the dose into two or more lines based on body weight.
- It is not considered good management practice to treat animals if they are wet or if rain is imminent following treatment.
- To avoid operator contact with Sovereign® when concurrent treatments are carried out, Sovereign® should be applied last.
DOSAGE TABLE
| Body weight (kg) | Dose (mℓ) | 1 ℓ treats (± head) |
| < 100 | 1 mℓ/10 kg | 100 or more |
| 101 to 150 | 15 | 66 |
| 151 to 200 | 20 | 50 |
| 201 to 250 | 25 | 40 |
| 251 to 300 | 30 | 33 |
| 301 to 350 | 35 | 28 |
| 351 to 400 | 40 | 25 |
| 401 to 450 | 45 | 22 |
| 451 to 500 | 50 | 20 |
| 501 to 550 | 55 | 18 |
| 551 to 600 | 60 | 16 |
| 601 to 650 | 65 | 15 |
| Animals weighing more than 650 kg should receive an additional 5 mℓ/50 kg. | ||
| Body weight (kg) | Dose (mℓ) | 2 ℓ treats (± head) |
| < 100 | 1 mℓ/10 kg | 200 or more |
| 101 to 150 | 15 | 133 |
| 151 to 200 | 20 | 100 |
| 201 to 250 | 25 | 80 |
| 251 to 300 | 30 | 66 |
| 301 to 350 | 35 | 57 |
| 351 to 400 | 40 | 50 |
| 401 to 450 | 45 | 44 |
| 451 to 500 | 50 | 40 |
| 501 to 550 | 55 | 36 |
| 551 to 600 | 60 | 32 |
| 601 to 650 | 65 | 30 |
| Animals weighing more than 650 kg should receive an additional 5 mℓ/50 kg. | ||
| Body weight (kg) | Dose (mℓ) | 5 ℓ treats (± head) |
| < 100 | 1 mℓ/10 kg | 500 or more |
| 101 to 150 | 15 | 333 |
| 151 to 200 | 20 | 250 |
| 201 to 250 | 25 | 200 |
| 251 to 300 | 30 | 166 |
| 301 to 350 | 35 | 142 |
| 351 to 400 | 40 | 125 |
| 401 to 450 | 45 | 111 |
| 451 to 500 | 50 | 100 |
| 501 to 550 | 55 | 90 |
| 551 to 600 | 60 | 83 |
| 601 to 650 | 65 | 76 |
| Animals weighing more than 650 kg should receive an additional 5 mℓ/50 kg. | ||
| Body weight (kg) | Dose (mℓ) | 10 ℓ treats (± head) |
| < 100 | 1 mℓ/10 kg | 1 000 or more |
| 101 to 150 | 15 | 666 |
| 151 to 200 | 20 | 500 |
| 201 to 250 | 25 | 400 |
| 251 to 300 | 30 | 333 |
| 301 to 350 | 35 | 284 |
| 351 to 400 | 40 | 150 |
| 401 to 450 | 45 | 222 |
| 451 to 500 | 50 | 200 |
| 501 to 550 | 55 | 180 |
| 551 to 600 | 60 | 166 |
| 601 to 650 | 65 | 154 |
| Animals weighing more than 650 kg should receive an additional 5 mℓ/50 kg. | ||
| Body weight (kg) | Dose (mℓ) | 15 ℓ treats (± head) |
| < 100 | 1 mℓ/10 kg | 1 500 or more |
| 101 to 150 | 15 | 1 000 |
| 151 to 200 | 20 | 750 |
| 201 to 250 | 25 | 600 |
| 251 to 300 | 30 | 500 |
| 301 to 350 | 35 | 428 |
| 351 to 400 | 40 | 375 |
| 401 to 450 | 45 | 333 |
| 451 to 500 | 50 | 300 |
| 501 to 550 | 55 | 273 |
| 551 to 600 | 60 | 250 |
| 601 to 650 | 65 | 231 |
| Animals weighing more than 650 kg should receive an additional 5 mℓ/50 kg. | ||
| Body weight (kg) | Dose (mℓ) | 20 ℓ treats (± head) |
| < 100 | 1 mℓ/10 kg | 2 000 or more |
| 101 to 150 | 15 | 1 333 |
| 151 to 200 | 20 | 1000 |
| 201 to 250 | 25 | 800 |
| 251 to 300 | 30 | 666 |
| 301 to 350 | 35 | 571 |
| 351 to 400 | 40 | 500 |
| 401 to 450 | 45 | 444 |
| 451 to 500 | 50 | 400 |
| 501 to 550 | 55 | 363 |
| 551 to 600 | 60 | 333 |
| 601 to 650 | 65 | 307 |
| Animals weighing more than 650 kg should receive an additional 5 mℓ/50 kg. | ||
EFFICACY
| Parasite | Immature | Adult | Controls against reinfestation for (days) |
| Brown stomach worm (Ostertagia ostertagi) | • | • | 14 |
| Wireworm (Haemonchus placei) | • | • | 14 |
| Cattle bankrupt worm (Cooperia spp.) | • | • | 14 |
| Nodular worm (Oesophagostomum radiatium) | • | • | 21 |
| Lungworm (Dictyocaulus viviparus) | • | • | |
| Eyeworm (Thelazia spp.) | |||
| Fluke age | 2 weeks | 4 weeks | 6 weeks | Adult |
| Liver fluke (Fasciola hepatica) | • | • | • | • |
• Controls (≥ 90 % effective)
•• Aids in control (60 – 89 % effective)
The list contains the more important endoparasite species. This anthelmintic may also be effective against other species. For more information consult your veterinarian.
ENVIRONMENTAL SAFETY
Studies indicate that when ivermectin comes into contact with the soil, it readily and tightly binds to the soil and becomes inactive over time.
Containers and other residual contents should be disposed of safely, according to local waste disposal regulations and not reused for any other purpose, as free ivermectin may adversely affect fish and certain water-borne organisms.
IDENTIFICATION
Clear, blue, free flowing liquid with a slight characteristic odour.
PRESENTATION
1 ℓ, 2 ℓ or 5 ℓ high-density polyethylene (HDPE) backpacks OR
10 ℓ, 15 ℓ, 20 ℓ or 25 ℓ high-density polyethylene (HDPE) drums.
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 11 April 2011