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Date: Sunday, May 22, 2022 1:32

Description: 2015-Elanco-logo
Telephone: 01256 353131 (24 hr response) Veterinary Technical Services
Release 2.68
Rycoben SC 2.50 % w/v Oral Suspension for sheep
 
Species: Sheep
Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for sheep, Flukicides, Combination fluke/wormers, Tapeworm products
Active ingredient: Cobalt Sulphate, Ricobendazole, Sodium Selenate
Product:Rycoben SC 2.50 % w/v Oral Suspension for sheep
Product index: Rycoben SC 2.50 % w/v Oral Suspension for sheep
Sheep - meat: 3 days
Withdrawal notes: Not for use in sheep producing milk for human consumption.
Qualitative and quantitative composition
% w/v
Active ingredients
Albendazole oxide (ricobendazole)
2.50
Other Ingredients:
Cobalt sulphate (heptahydrate)
1.80 [equivalent to 0.377% w/v elemental cobalt]
Sodium selenate (anhydrous)
0.097 [equivalent to 0.041% w/v elemental selenium]
Antimicrobial preservatives:
Methyl parahydroxybenzoate
0.15
Propyl parahydroxybenzoate
0.015
Sodium Metabisulphate
0.1
For a full list of excipients, see section Pharmaceutical Particulars
Pharmaceutical form
Oral suspension.
A pink coloured aqueous oral suspension
Clinical particulars
Target species
Sheep
Indications for use, specifying the target species
Broad spectrum worm and fluke drench;
For the control of adult and larval stages of benzimidazole-sensitive gastro-intestinal roundworms (Bunostomum, Chabertia, Cooperia, Haemonchus, Nematodirus, Oesophagostomum, Teledorsagia, Strongyloides and Trichostrongylus), tapeworms (Moniezia) and lungworms (Dictyocaulus filaria), and for the control of adult liver fluke (Fasciola hepatica) and the treatment of chronic, but not acute, fascioliasis in sheep.
Ovicidal to round worm eggs.
Also aids in the prevention of cobalt and selenium deficiency.
Contraindications
Ewes should not be treated at the fluke and worm dose during tupping and until one month after the tups are removed.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Not recommended for use in cattle.
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 body weight, misadministration of the product, or lack of calibration of the dosing device (if any).
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 test(s) strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used.
Resistance to benzimidazoles has been reported in Teladorsagia, Haemonchus, Cooperia, and Trichostrongylus species in small ruminants. Therefore the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of nematodes and recommendations on how to limit further selection for resistance to anthelmintics.
Special precautions for use
i. Special precautions for use in animals
Shake container well before use.
For oral administration only.
The product should only be used in areas known to be deficient in cobalt and selenium. Do not administer other cobalt and selenium supplements concurrently unless specifically advised by your vet. If in doubt, consult a veterinary surgeon.
Not to be diluted.
ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wash hands after use.
Avoid direct contact with the product.
In the case of accidental eye exposure, flush copiously with water for at least 15 minutes, holding the eye open, and seek medical attention.
In the event of accidental skin exposure, wash the affected area with soap and water. If irritation persists, seek medical attention.
Adverse reactions (frequency and seriousness)
If you notice any side effects, or you think that the medicine has not worked, please inform your veterinary surgeon.
Use during pregnancy, lactation or lay
At the worm dose, Rycoben SC for Sheep is suitable for the treatment of sheep of all ages; however, care should be taken not to exceed the recommended dose, especially during the first month of pregnancy.
Ewes should not be treated at the fluke and worm dose during tupping and until one month after the tups are removed.
Ensure careful handling of ewes if used near lambing time.
Interaction with other medicinal products and other forms of interaction
None known
Amounts to be administered and administration route
Do not mix with other products.
Administer orally using standard drenching equipment.
To ensure administration of a correct dose, body weight should be determined as accurately as possible; accuracy of the dosing device should be checked.
Use the dose volume appropriate to the heaviest animals when treating on a group basis.
Worm Dose:
Dosage: 5mg albendazole oxide* per kg bodyweight (1ml per 5kg bodyweight). The dosage rates of trace elements are 0.75mg cobalt per kg and 0.08mg selenium per kg bodyweight.
Bodyweight
Dosage
Doses per litre
Up to 10kg
2 ml
500
11-20kg
4 ml
250
21-30kg
6 ml
166
31-40kg
8 ml
125
41-50kg
10 ml
100
51-60kg
12 ml
83
61-70kg
14 ml
71
Over 70kg
16 ml
62
Fluke and Worm Dose:
Dosage: 7.5mg albendazole oxide* per kg bodyweight (1.5ml per 5kg bodyweight). The dosage rates of trace elements are 1.125mg cobalt per kg and 0.12mg selenium per kg bodyweight.
Bodyweight
Dosage
Doses per litre
Up to 7kg
2 ml
500
8-13kg
4 ml
250
14-20kg
6 ml
166
21-26kg
8 ml
125
27-33kg
10 ml
100
34-40kg
12 ml
83
41-46kg
14 ml
71
47-53kg
16 ml
62
54-59kg
18 ml
55
60-66kg
20 ml
50
67-73kg
22 ml
45
Over 73kg
24 ml
41
Overdose (symptoms, emergency procedures, antidotes), if necessary
The therapeutic margin for this product is high and problems due to overdosage are therefore unlikely.
Withdrawal period(s)
Meat: Animals must not be slaughtered for human consumption during treatment. Sheep may be slaughtered for human consumption only after 3 days from the last treatment.
Milk: Not for use in sheep producing milk for human consumption.
Pharmacological particulars
Pharmacotherapeutic group: Anthelmintic
ATC vet code: QP52AC11
Pharmacodynamic properties
Albendazole oxide (ricobendazole) is an anthelmintic belonging to the benzimidazole group. Its mode of action, in common with other benzimidazoles is the disruption of microtubule formation by extensive binding to nematode tubulin. It is active against larval and adult stages, and is ovicidal.
Pharmacokinetic particulars
Albendazole oxide is slowly metabolised to a range of metabolites by hydroxylation, oxidation to sulphones, deacetylation to form amines and reduction to negligible amounts of albendazole. The most important metabolites are the sulphone and the 2-amino sulphone, neither of which is anthelmintically active.
Pharmaceutical particulars
List of excipients
Methyl Parahydroxybenzoate
Propyl Parahydroxybenzoate
Sodium Metabisulphate
Cobalt Sulphate Heptahydrate
Sodium Selenate (anhydrous)
Propylene Glycol
Xanthan Gum
Aluminium Magnesium Silicate
Sorbitan Monolaurate
Polysorbate 80
Simeticone
Di-Sodium Phosphate Dihydrate
Citric Acid Monohydrate
Purified Water
Incompatibilities
None known
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years
Special precautions for storage
Store in tightly closed original container in a safe place.
Do not store above 25°C. Do not freeze.
Store away from food, drink and animal feedingstuffs.
Nature and composition of immediate packaging
A pink coloured aqueous suspension contained within a natural (translucent), low density polyethylene flexi-pack of 1, 2.5 or 5 litre capacity, closed with a white, polypropylene, screw cap and surlyn coated foil induction seal.
OR
White high density polyethylene backpacks containing 0.8, 2.2 or 5 litre closed with a screw fit blue polypropylene cap.
A separate dosing gun is available for the 1, 2.5 and 5 litre flexi pack presentations.
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
HARMFUL to fish and aquatic life. Do not contaminate ponds, waterways or ditches with the product or used container.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
N/A
Marketing Authorisation Number
Vm 00879/4010
Significant changes
Date of the first authorisation or date of renewal
26 July 2000
Date of revision of the text
October 2020
Any other information
Legal category
Legal category: POM-VPS
GTIN
GTIN description:Rycoben SC 2.50 % w/v Oral Suspension for sheep 0.8L
GTIN:05037694011994
GTIN description:Rycoben SC 2.50 % w/v Oral Suspension for sheep 2.2L
GTIN:05037694012007
GTIN description:Rycoben SC 2.50 % w/v Oral Suspension for sheep 5L
GTIN:05037694012014