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 (m)1 treats (± head)
< 1001 mℓ/10 kg100 or more
101 to 1501566
151 to 2002050
201 to 2502540
251 to 3003033
301 to 3503528
351 to 4004025
401 to 4504522
451 to 5005020
501 to 5505518
551 to 6006016
601 to 6506515
Animals weighing more than 650 kg should receive an additional 5 mℓ/50 kg.
 
Body weight (kg)Dose (m)2 treats (± head)
< 1001 mℓ/10 kg200 or more
101 to 15015133
151 to 20020100
201 to 2502580
251 to 3003066
301 to 3503557
351 to 4004050
401 to 4504544
451 to 5005040
501 to 5505536
551 to 6006032
601 to 6506530
Animals weighing more than 650 kg should receive an additional 5 mℓ/50 kg.
Body weight (kg)Dose (m)5 treats (± head)
< 1001 mℓ/10 kg500 or more
101 to 15015333
151 to 20020250
201 to 25025200
251 to 30030166
301 to 35035142
351 to 40040125
401 to 45045111
451 to 50050100
501 to 5505590
551 to 6006083
601 to 6506576
Animals weighing more than 650 kg should receive an additional 5 mℓ/50 kg.
Body weight (kg)Dose (m)10 treats (± head)
< 1001 mℓ/10 kg1 000 or more
101 to 15015666
151 to 20020500
201 to 25025400
251 to 30030333
301 to 35035284
351 to 40040150
401 to 45045222
451 to 50050200
501 to 55055180
551 to 60060166
601 to 65065154
Animals weighing more than 650 kg should receive an additional 5 mℓ/50 kg.
Body weight (kg)Dose (m)15 treats (± head)
< 1001 mℓ/10 kg1 500 or more
101 to 150151 000
151 to 20020750
201 to 25025600
251 to 30030500
301 to 35035428
351 to 40040375
401 to 45045333
451 to 50050300
501 to 55055273
551 to 60060250
601 to 65065231
Animals weighing more than 650 kg should receive an additional 5 mℓ/50 kg.
Body weight (kg)Dose (m)20 treats (± head)
< 1001 mℓ/10 kg2 000 or more
101 to 150151 333
151 to 200201000
201 to 25025800
251 to 30030666
301 to 35035571
351 to 40040500
401 to 45045444
451 to 50050400
501 to 55055363
551 to 60060333
601 to 65065307
Animals weighing more than 650 kg should receive an additional 5 mℓ/50 kg.

EFFICACY

ParasiteImmatureAdultControls 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 age2 weeks4 weeks6 weeksAdult
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