Supaverm Oral Suspension

Supaverm Oral Drench is a highly effective orally administered treatment against immature and mature fluke, roundworms, lungworm, tapeworm (head and segments) and larval stages nasal bot fly in sheep and lambs. Supaverm 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, mebendazole

Target Species: Sheep

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

Administration Method: Oral Drench

Withdrawal Time: 65 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 Supaverm before administering to animals!

• Sheep should be treated in early spring to make sure all adult fluke are eliminated and that the egg shedding is reduced. This should be done before the population of snails increases. Treatment should be repeated 10 to 12 weeks later.
• The infective challenge of fluke begins to gain momentum in July and reaches it's peak in the autumn.
• Treatment should take place every 6 - 12 weeks depending on the challenge from mid summer until the end of the year when the challenge from metacercarial should have reduced.
• It is important to make sure that fluke does not make it onto your farm through new livestock that is introduced to your farm. New livestock must be quarantined and treated with a suitable flukicide.
• Wet areas should not be used for grazing at times of high risk from fluke.
• If your livestock persists to show signs of fluke infection after treatment you should seek professional help.

Rotate and protect:

Since there is a limited amount of products available for the treatment of fluke and there is an ever growing resistance to triclabendazole (the active ingredient used in other popular flukicides), it is important to protect ALL flukicide products. It is a necessity that all sheep farmers establish a competent control of fluke for the future.

Triclabendazole resistance is a reality and a strategic rotation program with Flukiver and/or Sperverm can reduce the danger of fluke developing a resistance on your farm.

"A Different Class Of Flukicide"

1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Supaverm Oral Suspension.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active Substances:
Closantel (as Closantel Sodium Dihydrate) 50 mg
Mebendazole 75 mg
For a full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM
Oral 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 liver fluke, gastro-intestinal nematodes, lungworms, cestodes and larval stages of some
arthropods.
Trematodes:
Liver flukes:
Fasciola hepatica (adults + 5-8 week immatures)
Fasciola gigantica (adults + 8 week immatures)
Nematodes:
Roundworms:
Haemonchus contortus (adults, immatures, inhibited stages and BZ-resistant strains)
Bunostomum spp. (adult)
Chabertia ovina (adults + immatures)
Gaigeria pachyscelis (adults + immatures)
Oesophagostomum spp. (adults)
Capillaria spp. (adults)
Cooperia spp. (adults)
Nematodirus spp. (adults + immatures)
Ostertagia circumcinta (adults + immatures)
Trichostrongylus axei (adults)
Trichostrongylus colubriformis (adults + immatures)
Trichostrongylus vitrinus (adults)
Trichuris ovis (adults)
Strongyloides papillosus (adults + immature)
Lungworms:
Dictyocaulus filaria (adults + immatures)
Cestodes:
Avitellina spp.
Moniezia spp.
Arthropods:
Oestrus ovis (nasal bot) 1st, 2nd and 3rd instar.
Ticks (Ixodes ricinus) feeding on sheep at the time of treatment are likely to produce fewer viable eggs.

4.3 Contraindications
Do not administer to animals with known hypersensitivity to the active ingredients.

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:
Supaverm is to be administered carefully with a drenching gun. Care must be taken to avoid causing injury to the
mouth or pharynx during dosing.
Do not exceed the stated dose.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Wash splashes from eyes and skin immediately.
Take off immediately any contaminated clothing.
Wash hands and exposed skin before meals and after work.

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

4.7 Use during pregnancy, lactation or lay
Supaverm 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.
Bodyweight of animals should be assessed accurately.
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.
Do not exceed the stated dose of Supaverm.
Shake well before use. Invert at least 10 times before use.
The recommended dose is 10 mg/kg BW closantel + 15 mg/kg BW mebendazole. This corresponds to 1 ml per 5 kg
BW.
Supaverm is to be administered by means of a drenching gun.
All sheep on infested pasture should be dosed at regular intervals during the fluke season. The interval between dosing
will depend on the level of pasture contamination; in severe fluke seasons, dosing every 6-8 weeks may be necessary.
Supaverm is active against worm eggs and prevents pasture contamination with fluke eggs for approximately 13
weeks. Treatment intervals of 10-12 weeks throughout the fluke season are recommended.
Because of its long half-life, closantel will protect for several weeks against reinfections with the following species in
sheep:
Residual activity Dose (mg/kg) Protection Period
Haemonchus contortus 10 7 weeks
Oesophagostomum columbianum 10 2 weeks
Gaigeria pachyscelis 10 8 weeks
Oestrus ovis 10 8 weeks
The veterinary surgeon should give advice regarding appropriate dosing programmes and stock management to achieve
adequate parasite control for both fluke- and roundworm infestations.

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

4.11 Withdrawal Period(s)
Meat and offal: 65 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, combinations of benzimidazoles and related substances.
ATCvet Code: QP52AC30

5.1 Pharmacodynamic properties
Supaverm is a combination of the salicylanilide closantel and the benzimidazole mebendazole. Closantel is highly
effective against liver flukes, haematophagous nematodes and larval stages of some arthropods. Mebendazole is highly
active against gastro-intestinal nematodes, lungworms and cestodes.
Mode of action:
Closantel is an uncoupler of the mitochondrial oxidative phosphorylation resulting in inhibition of the ATP-synthesis.
This induces a dramatic change in the energy metabolism which finally leads to the death of the parasite.
Mebendazole has a selective anthelmintic action through a specific interaction with the microtubular system of the
absorptive cells, leading to an irreversible lytic destruction and death of the worm.
5.2 Pharmacokinetic properties
Closantel is rapidly absorbed into the systemic circulation after oral administration and peak plasma levels are attained
at 24-48 hours after dosing. In plasma, closantel is bound for more than 99% to albumin. As a result, tissue
distribution is very limited. On average, tissue levels are 15 times lower than plasma levels.
The elimination half-life from plasma and tissues is 2 to 3 weeks. Metabolism is absent and the main excretion route is
the bile. The urinary excretion is negligible.
Mebendazole is poorly soluble in aqueous systems, which results in a low dissolution rate and a low absorption. This
is reflected by the high faecal excretion of unchanged parent drug. The very small fraction absorbed is almost
completely metabolised by first pass metabolism in the liver, which consists of carbamate hydrolysis and ketone
reduction. The degradation products are conjugated to glucuronides and excreted with the bile and urine. The urinary
excretion is relatively poor and consists almost exclusively of metabolites. The kinetics of the active ingredients are
not altered when used in combination.

6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Propylene Glycol
Microcrystalline cellulose and carmellose sodium
Hypromellose
Sodium Laurilsulfate
Simethicone emulsion 30%
Purified Water
Citric Acid 0.5% solution (for pH adjustment)
Sodium Hydroxide 1N solution (for pH adjustment)

6.2 Incompatibilities
None known.

6.3 Shelf-life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years

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

6.5 Nature and composition of immediate packaging
Container: Polyethylene bottles of 1, 2.5, 5, 10 and 20 litres containing a white suspension.
Closure: Ureum screw cap with HDPE insert.
Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials
Do not contaminate ponds, waterways or ditches with product or used containers.
Dispose of used containers safely.
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
United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)
VPA 10047/042/001

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

10 DATE OF REVISION OF THE TEXT
April 2013

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Agridirect
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