Product Details - PARAMAX 1 % INJECTABLE SOLUTION

Reg  No. G3083 Act 36/1947

Store below 30°C away from sunlight.

Composition:

Ivermectin 1% m/v

Indications:

Antiparasitic remedy for cattle and sheep, kills mange mites on pigs.

Warnings:

Do not slaughter cattle or sheep for human consumption within 21 days of last treatment, and pigs within 28 days of last treatment.

Do not use in dairy cattle within 28 days of calving.

Do not use in lactating cattle where milk or milk products are used for human consumption. 

Do not use intramuscularly or intravenously.

Keep out of reach of children, uninformed persons and animals.

Do not use in dairy cattle within 28 days of calving.

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 eat, drink or smoke while handling the product.

Store bottle in carton to protect from light.

Wash hands thoroughly after use.

Cattle should be vaccinated against Clostridial infections (e.g. Black quarter).

Sheep should be vaccinated against pulpy kidney (entero-toxaemia) before treatment.

Temporary discomfort has been observed in animals following subcutaneous injection. The pain reaction is sometimes intense, but usually transient.  A low incidence of soft tissue swelling at the injection site has been observed.  These reactions have disappeared without treatment. 

Efficacy for cattle:
Internal parasites of cattle: for the treatment of gastro-intestinal roundworms, Parafilaria bovicola (false bruising) and eye worm  (Thelazia).

PARAMAX 1% Injectable Solution is effective against the following internal parasites of cattle when given subcutaneously at the recommended dose of 200 µg/kg body mass.

* Control = ≥90% effective

** Aid in Control = 60 – 89% effective

The list contains the more important endoparasite species.  This anthelminitic may also be effective against other species.  For more information consult your veterinarian.

External parasites of cattle: 

Kills sucking and biting lice and mange mites. 

Controls sand tampans infesting cattle for up to 3 days after treatment. 

Kills cattle screw-worms present at time of injection.  Protects against screw-worms strikes for 2 weeks after administration. 

Controls blue ticks (Boophilus spp) on cattle.  For control of blue ticks, treatment must be repeated every 21 days.

Efficacy for sheep:
External parasites.

Kills sheep scab mites.

Controls Australian itch mites.

* Nasal worm all stages (1st, 2nd and 3rd instar larvae)

* (Control = ≥90% effective)

 * Control = ≥ 90% effective
** Aid in Control = 60 – 89% effective

The list contains the more important endoparasite species.  This anthelminitic may also be effective against other species.  For more information consult your veterinarian. 

Efficacy for pigs:
External parasites of pigs.

Kills mange mites (Sarcoptis scabiei  var suis).  (Recommended dose 300 µg/kg).

NOTE: PARAMAX 1 % Injectable Solution has a persistent drug 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 reinfestation 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.

Directions for use - Use only as directed:

Dosage:

CATTLE: PARAMAX 1% Injectable Solution for cattle should be given only by subcutaneous injection at the approved dosage level of 200 µg ivermectin per kilogram of body mass. Each mℓ contains 10 mg of ivermectin, sufficient to treat 50 kg of body mass.

Administration: PARAMAX 1% Injectable Solution is to be given by subcutaneous injection only.  Do not administer intramuscularly or intravenously. 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.  Use sterile equipment and follow aseptic procedures.
 
Appropriate vaccination precautions should be taken in areas where the risk of Clostridial infections of cattle such as black quarter (sponssiekte) and malignant oedema are present. 
 
Compatibility : PARAMAX 1% Injectable Solution may be used in cattle concurrently with clostridial vaccines, given at separate injection sites.
 
Dosage: SHEEP : PARAMAX 1% Injectable Solution should only be given at the following recommended dosage levels:

Administration: PARAMAX 1% Injectable Solution is to be given by subcutaneous injection only.  Do not administer intramuscularly or intravenously. The solution may be administered with any standard automatic or single-dose equipment.  Use aseptic technique.  The loose skin behind the shoulder, the skin under the foreleg (axilla) and the inside of the thigh are suitable sites for administration.  Ensure that the needle is carefully inserted and that the solution does not leak from the injection site.  In woolly sheep, ensure that the needle has penetrated the wool and skin before delivering the dose. 

For treatment of sheep scab outbreaks a single dose of 1 mℓ /50 kg (200 µg/kg) can be given. This should be done under Government supervision.

NOTE:  When treating an outbreak of sheep scab it is essential that:

All sheep on the farm must be accurately treated with the correct dose and marked after treatment.

All animals must be checked 7 - 10 days after treatment and any animals not marked must be treated.

Care must be taken that the full dose is administered to each sheep.

Under certain circumstances two treatments 7 days apart may be required to eliminate all scab mites.

An autumn treatment will kill third stages of nasal worm and a spring treatment will offset new infestations of this parasite.

A treatment in late autumn will remove residual summer roundworm burdens as well as first infestations of those roundworm species stimulated by cooler weather conditions.  The spring "off-shears" treatment will remove roundworm burdens which have built up during the winter and early spring infestations stimulated by the first rains.  This will contribute to reducing the contamination of "clean" summer grazing. 

Dosage: PIGS :  The approved dose level is 1,0 ml  per 33 kg (300 µg/kg) subcutaneously. Administer to pigs subcutaneously in the neck.

Instructions for use with automatic dosing equipment (200 mℓ and 500 mℓ packs):

Disinfect all needles and syringes 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 the plastic tube firmly to dosing syringe.  Use stepped adaptor provided if needed.

Remove cap from bottle and disinfect rubber stopper with methylated spirits or other suitable chemical disinfectant.  Hold bottle upright and fully insert draw-off needle into centre of rubber stopper.

Hang bottle comfortably in inverted position from neck, shoulder or belt.  Use attachment tapes 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 connecting tube is re-used, it should be boiled for 15 to 20 minutes before use along with the injecting syringe and needles.

Store partly used bottle in carton to protect from light.

Do not re-use empty bottles. 

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.

Drug containers and any residual contents should be disposed of safely (e.g. by burying or incinerating), as free ivermectin may adversely affect fish and certain water-borne organisms.

Presentation: 
10 x 20 mℓ, 50 mℓ, 200 mℓ and 500 mℓ

Registration holder:

Schering-Plough Animal Health
Co. Reg. No. 1934/005207/07  

† Macrocyclic lactone