Product Details - IVOTAN®

FOR ANIMAL USE ONLY

1*

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

STORAGE
Store below 30 °C, away from sunlight.

CAUTION

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.
  • Dispose of empty containers according to local waste disposal regulations and do not reuse for any other purpose.
  • 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 re-use 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.

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 have 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 ivermectin/kg of body mass. Each mℓ contains 10 mg of ivermectin sufficient to treat 50 kg of body mass.
Pigs: The approved dose level is 1 mℓ/33 kg (303 µg/kg) subcutaneously.
Sheep: Inject Ivotan® subcutaneously at the recommended dosage level of 200 µg ivermectin per kilogram of body mass (1 mℓ/50 kg body mass).

Example:

Body mass (kg)Dose volume (mℓ)
CATTLEPIGS
Up to 5011,5
51 - 10023,0
101 - 15034,5
151 - 20046,0
201 - 25057,5
251 - 30069,0
301 - 350710,5
351 - 400812,0
401 - 450913,5

 

Body mass (kg)Dose volume (mℓ)
SHEEP
Up to 250,5
26 - 501,0
51 - 751,5
76 - 1002,0

 

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 16 gauge 2,0 cm 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. Other administration sites are the skin under the foreleg (axilla) and 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

1.   Internal Parasites
For the treatment of gastrointestinal roundworms in cattle and sheep, and Parafilaria bovicola (false bruising) and eye-worm (Thelazia) in cattle. For the treatment of roundworms (Ascaris suum and Strongyloides ransomi) in pigs.
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 mass, and of pigs when given subcutaneously into the neck region at a dose rate of 303 µg/kg (1 mℓ/33 kg) body mass.

2.   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 screw-worms present at time of injection. Protects against screw-worm 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 one week after treatment. Sows should be treated at least one week before farrowing to minimise transfer of mites to newborn baby pigs.

3.   Nasal worm (Oestrus ovis)
Sheep: Controls (*) all stages (first, second and third instar larvae).

EFFICACY

Cattle Roundworm SpeciesImmatureAdultControls* against re-infestation 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 to 89 % effective)
‡ An interval of 70 days must elapse after treatment, to allow lesions to heal.

Sheep Roundworm SpeciesImmatureAdultControls* 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 to 89 % effective)

Pig Roundworm SpeciesImmatureAdult
Large roundworm
(Ascaris suum)
**
White bankrupt worm
(Strongyloides ransomi)
**

* Controls (≥ 90 % effective)

PRESENTATION
50 mℓ and 500 mℓ amber bottle with a rubber stopper and aluminium seal.

REGISTRATION HOLDER
Intervet South Africa (Pty) Ltd.
20 Spartan Road, Spartan
1619, RSA
Tel: +27 (0) 11 923 9300
Fax: +27 (0) 11 392 3158
www.msd-animal-health.co.za

MANUFACTURER
Burchem Research (Pty) Ltd.
54 Elektron Avenue
Isando

DATE OF PUBLICATION OF THIS PACKAGE INSERT
14 March 2005