Product Details - IVOTAN®

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

 

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 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.

 

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 (300 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)

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 mass (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 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.

 

  1. Nasal worm (Oestrus ovis)

Sheep: Controls (*) all stages (first, second and third instar larvae).

 

EFFICACY

Cattle Roundworm Species

Immature

 

Adults

 

Controls* 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 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 to 89 % effective)

 

Pig Roundworm Species

Immature

Adult

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 Electron Avenue

Isando

 

DATE OF PUBLICATION OF THIS PACKAGE INSERT

14 March 2005