Flukiver Oral Drench

Flukiver 5% Oral Drench is a highly effective orally administered treatment against immature and mature fluke, larval stages nasal bot fly in sheep. Flukiver 5% Oral Drench also fights against immature and adult stages of haemonchus contortus, including benzimidazole resistant strains. It has also been found at the time of treatment that ticks feeding on the sheep produce fewer viable eggs.

​Active Ingredient: Closantel

Target Species: Sheep

Treats and Controls: Liver fluke, larval stage nasal bots, haemonchus contortus

Administration Method: Oral Drench

Withdrawal Time: 42 days for animals intended for meat and offal, not permitted for use on animals producing milk for human consumption.

Dosage:1 ml per 5 kg of bodyweight

Always read the label and all enclosed information for Flukiver before administering to animals!

• Acute or untreated chronic infections which can lead to death
• Reduced lambing percentages and ewe fertility
• Reduced weight in new born lambs
• Infected lambs take longer to reach finish weight
• Reduced and lower quality wool yields
• Heightened susceptibility to clostridial infections

• Smaller fluke
• Production of eggs is drastically delayed
• The number of eggs laid is reduced
• The number of eggs hatching is reduced
• The re-contamination of pasture is reduced

1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Flukiver 5% w/v Oral Suspension

2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance
Closantel (as Clostanel sodium) 50 mg/ml
Excipients:
For a full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM
Oral suspension.
A white suspension

4 CLINICAL PARTICULARS
4.1 Target Species
Sheep and lambs.

4.2 Indications for use, specifying the target species
For the treatment and control of adult and immature liver fluke, haematophagous nematodes and larval stages of some
arthropods in sheep.
Liver fluke:
Fasciola hepatica (average efficacy against 6 week immature stages is 86%)
Fasciola gigantica
Haematophagous nematodes
Haemonchus contortus (including benzimidazole resistant strains)
Chabertia ovina
Gaigeria pachyscelis
Arthropods
Oestrus ovis (Sheep Nasal Bot Fly)
Ticks (lxodes ricinus) feeding on sheep at the time of treatment are likely to produce fewer viable eggs.

4.3 Contraindications
Do not use in animals with known hypersensitivity to the active ingredient.

4.4 Special warnings for each target species
Care should be taken to avoid the following practices because they increase the risk of development of resistance and could
ultimately result in ineffective therapy:
• Too frequent and repeated use of anthelmintics from the same class, over an extended period of time.
• Underdosing which may be due to underestimation of bodyweight, misadministration of the product, or lack of
calibration of the dosing device.
Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal Egg Count
Reduction Test). Where the results of the tests strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to
another pharmacological class and having a different mode of action should be used.

4.5 Special precautions for use
Special precautions for use in animals:
Do not overdose. Care should be taken when administering the product to avoid causing injury to the pharynx. Appropriate
drenching equipment to allow accurate dosing should be used.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Wash hands after administration.

4.6 Adverse reactions (frequency and seriousness)
At therapeutic doses Flukiver is not toxic and causes no side effects.

4.7 Use during pregnancy, lactation or lay
Flukiver can be used at any time during pregnancy and during the lactating period. See section 4.11.

4.8 Interaction with other medicinal products and other forms of interaction
None known.

4.9 Amounts to be administered and administration route
For oral administration.
If animals are to be treated collectively rather than individually, they should be grouped according to their bodyweight and dosed
accordingly, in order to avoid under- or overdosing.
Shake well before use.
1 ml of Flukiver per 5 kg bodyweight (i.e. 10 mg closantel per kg bodyweight).
Bodyweight of animals should be assessed accurately.
For example:
Bodyweight Dose
Up to 5 kg 1 ml
10 kg 2 ml
20 kg 4 ml
30 kg 6 ml
40 kg 8 ml
50 kg 10 ml
60 kg 12 ml
70 kg 14 ml
80 kg 16 ml
Fluke infestations
All sheep on infested pasture should be dosed at regular intervals during the fluke season (September - March).
Since closantel has been shown to delay egg laying for up to 13 weeks after artificial infection, treatment intervals of 10-12
weeks throughout the fluke season are recommended. In severe fluke seasons more frequent dosing may be necessary. The
treatment of ewes with a single dose of Flukiver in the spring will contribute to reducing pasture contamination during the
following summer and autumn.
Any sheep brought in from liver fluke infested areas should be dosed before they join the flock.
H. contortus
For the treatment and prevention of benzimidazole resistant and susceptible H. contortus, dose at lambing to help prevent
pasture contamination by infected ewes. Treat all animals at 6 weekly intervals during high risk periods in summer and
autumn.
The veterinary surgeon should give advice regarding appropriate dosing programmes and stock management to achieve adequate
parasite control.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Symptoms of acute overdosage include decreased vision or blindness, anorexia, inco-ordination and general weakness.

4.11 Withdrawal Period(s)
Meat: 42 days
Not authorised for use in ewes producing milk for human consumption including during the dry period. Do not use
within 1 year prior to the first lambing in ewes intended to produce milk for human consumption.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Anthelmintics, closantel.
ATCvet code: QP52AG09

5.1 Pharmacodynamic properties
Flukiver 5% oral suspension contains the salicylanilide closantel, a synthetic antiparasitic agent with high efficacy against
liver fluke and haematophagous nematodes in sheep and goats and against the larval stages of some arthropods in sheep.
Closantel uncouples the mitochondrial oxidative phosphorylation resulting in inhibition of ATP synthesis. This induces a
marked change in the energy metabolism of the parasite, which finally kills it.

5.2 Pharmacokinetic properties
Closantel is rapidly absorbed into the systemic circulation with peak plasma levels at 24-48 hours after dosing. The
bioavailability of an oral dose is 50% of a parenteral one. In plasma, closantel is bound to albumin for more than 99%. As
a result, tissue distribution is very limited. On average, tissue levels are 15 times lower than plasma levels. The
elimination half-life of closantel from plasma and tissues is approximately 2 to 4 weeks in sheep and about 8 days in goats.
Closantel is metabolised only to a slight extent and the main excretion route is the faeces via the bile. The urinary
excretion is negligible.

6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Propylene Glycol
Microcrystalline Cellulose and Carmellose sodium
Hypromellose 15 cps
Sodium Laurilsulfate
Simethicone emulsion 30 %
Purified water

6.2 Incompatibilities
None known

6.3 Shelf-life
Shelf-life of the veterinary medicinal product as packaged for sale: 4 years

6.4 Special precautions for storage
Do not store above 25oC.
Protect from light

6.5 Nature and composition of immediate packaging
The product is packed in white high density polyethylene flexipacks containing 1 litre, 2.5 litres and 5 litres of product.
Closures: Tamper evident high density polyethylene cap (screw-fit) with high density polyethylene screw fit nozzle cap.
Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials
Any unused product or waste material should be disposed of in accordance with national requirements.

7 MARKETING AUTHORISATION HOLDER
Eli Lilly & Company Limited
Elanco Animal Health
Lilly House
Priestly Road
Basingstoke
Hampshire
RG24 9NL

8 MARKETING AUTHORISATION NUMBER(S)
VPA 10047/037/001

9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
30th September 2009

10 DATE OF REVISION OF THE TEXT
February 2013

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Agridirect
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