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
|Bodyweight in kg||Dose in ml||Doses per 1 ltr bottle||Doses per 2.5 ltr bottle||Doses per 5 ltr bottle|
Always read the label and all enclosed information for Flukiver before administering to animals!
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Summary of Characteristics
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Flukiver 5% w/v Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Closantel (as Clostanel sodium) 50 mg/ml
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
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.
Fasciola hepatica (average efficacy against 6 week immature stages is 86%)
Haemonchus contortus (including benzimidazole resistant strains)
Oestrus ovis (Sheep Nasal Bot Fly)
Ticks (lxodes ricinus) feeding on sheep at the time of treatment are likely to produce fewer viable eggs.
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
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.
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
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.
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,
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
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
Microcrystalline Cellulose and Carmellose sodium
Hypromellose 15 cps
Simethicone emulsion 30 %
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
8 MARKETING AUTHORISATION NUMBER(S)
9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
30th September 2009
10 DATE OF REVISION OF THE TEXT
Sheep Oral Drench
The drenching technique is a vital part of ensuring that the wormer does its job effectively.
Make sure the sheep are properly restrained and cannot leap around when they are being drenched so they swallow the whole amount.
Sheep can also suffer serious injury, or even death, if they are unrestrained and the gun penetrates the tissues at the back of the mouth.
Place a hand under the head and tilt slightly to the side.
Slot the nozzle in the gap between molar and incisor teeth and then over the back of the tongue.
If the wormer is just put into the mouth, it will bypass the rumen as it escapes down the oesophageal groove and will be less effective.
This is particularly important for white (BZ) drenches.
Dosing Weigh – do not guess Underestimating the weight of sheep is a common cause of underdosing. Select and weigh the biggest sheep in the group to determine the correct dose. If there is a wide range of weights, consider splitting the group, then weigh the heaviest in each section. Do not forget to check that the weigh crate is accurate before starting!
Calibrate and maintain the drench gun
Always check the gun is delivering the right amount before you drench. Remove the plunger from a 10 ml syringe, put a thumb over the end and squirt the dose into it, making sure there are no air bubbles left. Adjust the gun until the dose delivered is correct. Drenching guns should also be well maintained and replaced regularly. Clean with warm soapy water after use and check springs and tubes to make sure there are no kinks that will form air bubbles.
Research has shown that the efficacy of the white (BZ) and clear (AV) drenches can be improved by withholding food for 12–24 hours before treatment. It is not advised to deprive heavily pregnant ewes of food, so if you treat this class of stock with anthelmintics, you may wish to use yellow drenches (LV) because their efficacy is less dependent on rumen fill.
Wormers should be stored securely, away from direct sunlight at 4–25°C. Check the use-by date and, once open, use within the time shown on the packaging. Shake white (BZ) products well before use.
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