DE-VERMIN
1. Name DE-VERMIN
2. Qualitative and quantitative composition
Active Substances:
Ivermectin 0.2% F
Other Relevant Substances:
This product does not contain any antimicrobial preservative.
3. Pharmaceutical form
Solution for injection.
4. Pharmacological properties
Mechanism of action
Ivermectin is a member of the macrocyclic lactone class
of endectocides which have a unique mode of action.
Compounds of the class bind selectively and with high
affinity to glutamate-gated chloride ion channels which
occur in invertebrate nerve and muscle cells. This leads
to an increase in the permeability of the cell membrane
to chloride ions with hyperpolarization of the nerve
or muscle cell, resulting in paralysis and death of
the parasite. Compounds of this class may also interact
with other ligand-gated chloride channels, such as those
gated by the neurotransmitter gamma-aminobutyric (GABA).
The margin of safety for compounds of this class is
attributable to the fact that mammals do not have glutamate-gates
chloride channels, the macrocyclic lactones have a low
affinity for other mammalian ligand-gated chloride channels
and they do not readily cross the blood-brain barrier.
Pharmacokinetics
Maximum plasma concentration
Cattle
At a dose level of 0.2mg ivermectin per kg a maximum
plasma concentration of 35-50ng/ml is reached in ＼ 2
days and the half-life in plasma is of 2.8 days.
It is also established that ivermectin is carried mainly
in the plasma (80%). This distribution between plasma
and blood cells remains relatively constant.
Pig
During trials carried out at a dose level of 0.3mg ivermectin
per kg bodyweight, peak plasma concentrations were reached
in 3 (＼0.5) days and the drug persisted in plasma for
up to 28 days.
Excretion: length of time and route
Cattle
Only about 1-2% is excreted in the urine the remainder
is excreted in the faeces, approximately 60% of which
is excreted as unaltered drug. The remainder is excreted
as metabolites or degradation products.
Pigs
Biliary excretion is also the major route of ivermectin
excretion in pigs.
5. Clinical particulars
5.0 Target species
Cattle and Pigs.
5.1 Indications for use
DE-VERMIN Injection is indicated for the effective treatment
and control of the following harmful parasites of cattle
and pigs:
Cattle:
Gastro-intestinal roundworms (adult and fourth stage
larvae)
Ostertagia spp. (including inhibited O.ostertagi)
Haemonchus placei
Trichostrongylus axei
Trichostrongylus colubriformis
Cooperia spp.
Oesophagostamum radiatum
Nematodirus helvetianus (adult)
N. spathiger (adult)
Lungworms (adult and fourth stage larvae):
Dictyocaulus viviparus.
Warbles
Hypoderma bovis
H. lineatum.
Mange mites
Psoroptes bovis
Sarcoptes scabiei var. bovis.
Sucking lice
Linognathus vituli
Haematopinus eurysternus.
Pigs:
Gastrointestinal roundworms: (adult and fourth stage
larvae):
Ascaris suum
Hyostrongylus rubidus
Oesophagostomum spp.
Strongylides ransomi (adult and somatic larval stage)
Lungworms
Metastrongylus spp. (adult)
Lice:
Haematopinus suis
Mange mites
Sarcoptes scabiei var. suis
The use of the product in cattle should take into account
geographical differences in the occurrence patterns
of parasites.
5.2 Contra indications
Do not administer by the intravenous or intramuscular
route.
Do not use in animals with known hypersensitivity to
the active ingredient.
DE-VERMIN has been formulated specifically for use in
cattle and pigs only. Dogs and cats may be adversely
affected by the concentrations of active substance in
this product if they are allowed to ingest spilled product
of have access to used containers.
5.3 Undesirable effects
Cattle
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.
Pigs
Mild and transient pain reactions may be seen in some
pigs following subcutaneous injection.
All these reactions disappeared without treatment.
5.4 Special precautions for use
Administer the product only subcutaneously because intramuscular
administration causes persistent drug residues at the
site of injection.
5.5 Use during pregnancy and lactation
DE-VERMIN Injection for cattle and pigs can be administered
to beef cows at any stage of pregnancy or lactation
provided that the milk is not intended for human consumption.
It can be used in breeding sows and boars and will not
affect fertility. DE-VERMIN Injection for cattle and
pigs can be given to all ages of animals including young
calves and piglets.
Please refer to point 5.10.
5.6 Interaction with other medicaments
DE-VERMIN Injection can be used concurrently without
adverse effects with foot and mouth disease vaccine
or clostridial vaccine, given at separate injection
sites.
5.7 Posology and method of administration
Each ml contains 10mg of ivermectin sufficient to treat
50 kg of bodyweight of cattle, and 33 kg of bodyweight
of pigs. Replace with a fresh sterile needle after every
10 to 12 animals. Massage the injection site after administration
of the product. Injection of wet or dirty animals is
not recommended.
Cattle:
DE-VERMIN Injection should be given only by subcutaneous
injection at the recommended dosage level of 200 mcg
invermectin per kg bodyweight under the loose skin in
front of, or behind, the shoulder in cattle. This is
equivalent to 1ml per 50 kg bodyweight. The volume administered
per injection site should not exceed 10 ml.
Pigs:
In pigs, the recommended dosage level is 300 mcg ivermectin
per kg bodyweight. This is equivalent to 1ml per 33
kg bodyweight. The recommended route of administration
is by subcutaneous injection into the neck.
Young Pigs:
In young pigs, especially those below 16 kg for which
less that 0.5 ml DE-VERMIN Injection is indicated, dosing
accurately is important. The use of a syringe that can
accurately deliver as little as 0.1 ml is recommended.
5.8 Overdose
There is no specific antidote.
Cattle
Single doses of 4.0mg ivermectin per kg (20 x the use
level) given subcutaneously resulted in ataxia and depression.
Pigs
A dose of 30mg ivermectin per kg (100 x the recommended
dose of 0.3mg per kg) injected subcutaneously to pigs
caused lethargy, ataxia, bilateral mydriasis, intermittent
tremors, laboured breathing and lateral recumbency.
5.9 Special warnings for each target species
Details provided above apply. See also points 5.2, 5.3
and 5.5.
5.10 Withdrawal periods
Cattle: Must not be treated within 42 days of slaughter
for human consumption. Do not use in cattle producing
milk for human consumption or in dairy cows within 60
days prior to calving.
Pigs: Must not be treated within 28 days of slaughter
for human consumption.
5.11 Special precautions to be taken by the person administering
the product to animals
Take care to avoid self administration: the product
may cause local irritation and/or pain at the site of
injection.
Do not smoke or eat while handling the product.
Wash hands after use.
6. Pharmaceutical particulars
6.1 Incompatibilities
In the absence of incompatibility studies this veterinary
medicinal product must not be mixed with other veterinary
medicinal products.
6.2 Shelf-life
24 months.
Following withdrawal of the first dose use the product
within 28 days.
6.3 Special precautions for storage
None.
6.4 Nature and contents of container
Multidose polyethylene bottles of 50ml, 250ml and 500ml
sealed with bromobutyl seals and aluminium overseals.
6.5 Name or style and permanent address or registred
place of business of the marketing authorisation holder
Chanelle Animal Health Ltd.,
7 Rodney Street,
Liverpool,
L19 HZ,
United Kingdom.
6.6 Special precautions for the disposal of unused product
or waste material if any
Any unused veterinary medicinal product or waste material
derived from the product should be disposed of in accordance
with local requirements. The product should not enter
water courses as this may be dangerous to fish and other
aquatic organisms.
7.0 Additional informations
Marketing Authorisation Number VPA 10879/12/1
Date of Approval of SPC 14thApril, 2000
This SPC has been generated by the on the 29/08/2005
at 10:56:14
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