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Microsoft word - promectine data sheet.doc

PROMECTINE
Technical Data Sheet


PROMECTINE
Ivermectin (INN) 1%

Injectable solution
Subcutaneous route
For veterinary use
Composition:
Ivermectin, 10 mg; Excipient q.s. 1 ml.
Properties:
Ivermectin is an internal antiparasitic agent of avermectin group, it has a broad
spectrum of activity, and it is obtained from the fermentation of Streptomyces
avermitilis
.
Ivermectin is an endectocide of the macrocyclic lactone class. Compounds of this class
bind selectively and with great affinity to the chloride ion channels regulated by the
glutamate which are in the nerves and in the muscular cells of invertebrates. This leads
to an increase in the permeability of the cell membrane to the chloride ions giving a
hyperpolarisation of the nervous and muscular cell. This gives as a result the paralysis
and death of the parasite. Compounds belonging to this class may also interact with
other chloride channels regulators, such as the ones regulated by the gamma-
aminobutiric acid (GABA) neurotransmitter.
The safety margin for this class of compounds is due to the fact that mammals do not
have chloride channels regulated by glutamate. Macrocyclic lactones have a low
affinity for other chloride channels regulators in mammals and do not readily cross the
blood-brain barrier.
Indications and species of destination:
-Cattle:
Promectine is indicated for the effective treatment of gastrointestinal and pulmonar
nematodosis, grubs, sucking lice, hammocks and mites of psoroptic and sarcoptic
mange. It is also helpful in the control of chewing lice, mites of chorioptic mange and
bovine tropical ticks.
-Gastrointestinal roundworms: Ostertagia ostertagi (adults and inhibited forms).
-Lungworms: Dictyocaulus viviparus (adults).
-Other nematodosis: Thelazia spp. (adults), Parafilaria bovicola (adults).
-
Grubs (the three parasitic stages): Dermatobia hominis, Hypoderma spp.
-
Sucking lice: Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus.
Manges and other mite infestations caused by:
-Mites: Psoroptes ovis (sin. P. communis var. bovis), Sarcoptes scabiei var. bovis.
-Hammocks: Ornithodoros savignyi
Promectine injection helps in the control of:
-Chewing lice: Damalinia bovis
-Bovine tropical ticks: Boophilus microplus, B. decoloratus
- Mites of chorioptic mange: Chorioptes bovis.

PROMECTINE
Technical Data Sheet


The clinical problems to be treated will be caused by parasitic forms sensitive to
ivermectin.

Dosage:
Administer by subcutaneous route the recommended dose of 0.2 mg of ivermectin per
kg of body weight (equivalent to 1 ml/50 kg b.w.) in a single dose. Equivalent to:
100 2 150 3 200 4 250 5 300 6 350 7 400 8 450 9 500 10 550 11 600 12 Inject under the loose skin in front or behind the shoulder. It is recommended to use a needle of calibre 16 and 15 to 20 mm length. Use sterile equipment. In order to guarantee the correct dose it may be exactly determined the weight of the animal. Special precautions for use:
It is not for intravenous or intramuscular use.
Use sterile equipment of injection and sanitize the injection site by applying a suitable
disinfectant to reduce risk of clostridial infection of the injection site. In case of infection
the animals should be treated with appropriate antibiotics. It is recommended that the
animals to be treated should be previously vaccinated against these infections.
Contact should be avoided between treated and non-treated infected herds and
between non-infected herds until at least 7 days after last treatment.
The product is effective in all stages of cattle grubs. However, for most effective results,
cattle should be treated as soon as possible after the end of the heel fly season.
Destruction of Hypoderma larvae (cattle grubs) at the period when these grubs are in
vital areas may cause undesirable host-parasite reactions. Killing Hypoderma lineatum
when it is in the tissue surrounding the esophagus may cause salivation and bloat;
killing Hypoderma bovis when it is in the vertebral canal may cause staggering or
paralysis. Cattle should be treated either before or after these stages of grub
development.
Cattle treated with the product after the end of the heel fly season may be retreated
again during the winter for internal parasites, mange mites or sucking lice without
danger of grub-related reactions.
The frequent and repeated use of ivermectin may develop resistance.
PROMECTINE
Technical Data Sheet


Special safety precautions to be taken by the person that administers the
product:
Do not smoke or drink while the product is handled. Wash hands after using.
Keep out of reach of children.
In case of accidental auto-injection adress to a medical center showing the label, box
or leaflet of the product.
If losses of the product are produced, direct contact with eyes, mucous, wounds or
inflammed skin should be avoided. It is recommended to wash the area with plenty of
water.

Contraindications:
Not described.

Special warnings

Avermectins are not well tolerated for some animal species for which these drugs are
not authorized (severe cases of intolerance have been seen with the result of death in
dogs, specially collies, shepherd English dogs, other similar breeds and their crosses,
as well as in turtles).
Do not administer in lactating females producing milk for human consumption or in the 2
months prior to parturition.

Side effects:
In some bovine animals, after subcutaneous administration of the product, some
inflammatory reactions have been seen in the injection site. These site reactions
disappear without treatment.

Interactions:
Not described.

Use during gestation and lactating periods:
At the recommended use level, no
adverse effects on fertility or pregnancy have been seen in the recommended animals.
Overdose:
Ataxia and depression was produced when a single dose of 4.0 mg of ivermectin per kg
was administered by subcutaneous route in bovines.
A symptomatic treatment should be followed in case of overdose problems.
Withdrawal time:
Meat: 49 days.
Milk: Do not administer in lactating females producing milk for human consumption. Do
not administer in pregnant females producing milk for human consumption during two
months prior to parturition.
Storage conditions:
Keep at a temperature below 25ºC, in a dry place and protected from light.
Presentations:
Vials of 100 ml and 250 ml .
Keep all medicines out of reach of children
Veterinary prescription only

PROMECTINE
Technical Data Sheet


Invesa
Industrial Veterinaria, S.A.
Esmeralda 19
E-08950 Esplugues de Llobregat
Barcelona, Spain
www.invesagroup.com

Source: http://www.bytrade.org/products/ANIMAL%20HEALTH/Promectine-%20Label.pdf

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