Information för alternativet: Bimectin Vet. 10 Mg/Ml Injektionsvätska, Lösning, visa andra alternativ

Välj alternativ:

1. Bimectin Vet. 18,7 Mg/G Oral Pasta
2. Bimectin Vet. 10 Mg/Ml Injektionsvätska, Lösning

Document: Bimectin vet. solution for injection ENG SmPC change

• Bimectin vet. solution for incjection SmPC
• Bimectin vet. solution for injection ENG SmPC

---

Summary of the Product Characteristics

Bimectin vet. 10 mg/ml, solution for injection

Active substance(s)

1 ml contains:

Ivermectin 10 mg

For a full list of excipients, see section 6.1

Solution for injection.

Clear colourless to slightly yellow coloured solution.

4. Clinical Particulars

4.1 Target species

Cattle, reindeer and pigs.

4.2 Indications for use, specifying the target species

Bimectin vet. Injection is indicated for treatment of the following parasites of cattle, reindeer and pigs.

Cattle:

Gastro-intestinal roundworms(adult and fourth stage larvae, L₄)

Ostertagia ostertagi.(including inhibited L₄)

Ostertagia lyrata

Haemonochus placei

Trichostrongylus axei

Trichostrongylus colubriformis (L₄)

Cooperia spp.

Oesophagostomum radiatum

Nematodirus spathiger(adult)

Lungworms (adult and fourth stage larvae, L₄)

Dictyocaulus viviparus.

Warbles (larval stages)

Hypoderma bovis

Hypoderma lineatum.

Mange mites

Sarcoptes scabiei var. bovis

Psoroptes bovis

Lice

Linognathus vituli

Haematopinus eurysternus

Reindeer

Larval stages of Hypoderma tarandi.

Pigs:

Gastro-intestinal roundworms(adult and fourth stage larvae, L₄)

Ascaris suum

Hyostrongylus rubidus

Oesophagostomum spp.

Strongyloides ransomi (adult)

Lungworms

Metastrongylus spp. (adult)

Mange mites

Sarcoptes scabiei var. suis

Lice

Haematopinus suis

4.3 Contraindications

Should not be given to animals with known hypersensitivity to ivermectin.

Special precautions for use in animals

Avermectins/Melbecycins may not be well tolerated in all non-target species (cases of intolerance with fatal outcome are reported in dogs especially Collies, Old English Sheepdogs and related breeds or crosses, and also in turtles/tortoises).

Special precautions to be taken by the person administering the veterinary medicinal product to animals

None specific.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Severe overdose (4-30 mg/kg) can lead to lethargy, ataxia and tremor.

4.11 Withdrawal Periods

Slaughter: Cattle 49 days, reindeer and pigs 28 days.

Lactating cows producing milk for human consumption should not be treated. Dry cows and heifers should not be treated within 60 days prior to calving.

5. Pharmacological Properties

Pharmacotherapeutic group: Endectocides

ATC vet code: QP54AA01

5.1 Pharmacodynamic properties

Ivermectin is a member of the macrocyclic lactone class of endectocides, which can bind selectively to glutamate-gated chloride ion channels that occur in several 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 and 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 acid (GABA).

The margin of safety for compounds of this class is attributable to the fact that mammals do not have glutamate-gated chloride channels. In addition, the macrocyclic lactones have a low affinity for other mammalian ligand-gated chloride channels and they do not readily cross the blood-brain barrier in normal conditions.

5.2 Pharmacokinetic particulars

Maximum plasma concentration in cattle is reached on average in 5,5 days and in pigs in 3,5 days after administration. The mean elimination half-life is 6 days in cattle and 5,5 days in pigs. Ivermectin is distributed to tissues in the following order: liver > fat > kidney > muscle in cattle and fat > liver > kidney > muscle in pigs. The substance is only partially metabolised. Unmetabolised ivermectin and degradation products are excreted to about 98 % in faeces and 2 % in urine.

Due to lack of incompatibility studies, this veterinary medicinal drug should not be mixed with other veterinary medicinal drugs.

2 years.

After first opening, the product should be used within 28 days.

Keep the container in the outer carton, in order to protect from light.

Vials of polyethylene sealed with bromobutyl stoppers and aluminium overseals in cartons.

Packaging sizes:

1 x 50 ml 1 x 250 ml 1 x 6 x 250 ml 1 x 500 ml

Free ivermectin is very toxic to fish and other water-borne organisms. Residual drug must be handed in to the pharamacy for destruction.

Bimeda (Cross vetpharm Group Ltd.)

Broomhill Road

Tallaght

Dublin 24

Irland

2001-03-09/2006-03-09

2009-10-01