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Date: Friday, April 26, 2024 17:33

Release 2.87
Scalibor® Protectorband 0.76 g medicated collar for small and medium dogs and
Scalibor® Protectorband 1.0 g medicated collar for large dogs
 
Species: Dogs
Therapeutic indication: Pharmaceuticals: Ectoparasiticides: For dogs
Active ingredient: Deltamethrin
Product:Scalibor® Protectorband 0.76 g medicated collar for small and medium dogs and
Scalibor® Protectorband 1.0 g medicated collar for large dogs
Product index: Scalibor® Protectorband 0.76 g and 1.0 g
Incorporating:
Qualitative and quantitative composition
One white collar of 48 cm length (19 g) contains:
Active substance:
Deltamethrin 0.76 g;
Excipient: Titanium dioxide (E171) 0.285 g.
One white collar of 65 cm length (25 g) contains:
Active substance:
Deltamethrin 1.0 g;
Excipient: Titanium dioxide (E171) 0.375 g.
For the full list of excipients, see section "Pharmaceutical Particulars".
Pharmaceutical form
Medicated collar.
White collar of smooth consistency with a plastic buckle at one extremity.
Clinical particulars
Target species
Dogs
Indications for use
Control of infestations with ticks (Ixodes ricinus; Rhipicephalus sanguineus) for 5 to 6 months.
Control of blood sucking by phlebotomine sandflies (Phlebotomus perniciosus) for a period of 5 to 6 months.
Anti-feeding effect on adult mosquitoes of the species Culex pipiens pipiens for 6 months.
Contraindications
Do not use in puppies less than 7 weeks of age.
Do not use on dogs with skin lesions.
Do not use in animals known to be hypersensitive to pyrethroids.
Do not use on cats.
Special warnings for each target species
As the collar exerts its full effect after one week, the collar should be preferably applied 1 week before animals are likely to become exposed to infestation. In rare cases attachment of ticks can occur while wearing the collar. Under unfavourable conditions the transmission of infectious diseases through ticks or sandflies can therefore not be ruled out entirely.
Special precautions for use
In case of skin lesions remove the collar until symptoms have resolved.
The influence of shampooing on the duration of efficacy has not been investigated.
Operator warnings
Wash hands with soap and cold water after fitting the collar.
People with known hypersensitivity to the ingredients of the collar should avoid contact with the veterinary medicinal product and the treated animal. This veterinary medicinal product contains deltamethrin which may cause transient tingling, itchiness, and blotchy redness on exposed skin. Seek medical advice in case of hypersensitivity reactions.
Avoid letting children, in particular those under 2 years old, touch the collar, play with it or put it into their mouth.
Care should be taken not to allow young children to have prolonged intensive contact, e.g. sleeping with a pet wearing a collar.
Keep the sachet with the collar in the outer carton until use.
Other precautions
While occasional contact with water does not reduce the effectiveness of the collar, it should always be removed before swimming and bathing the dog because the active substance is harmful to fish and other aquatic organisms.
Dogs must be prevented from swimming in water for the first five days of wearing the collar.
Adverse reactions
Dogs
Rare
(1 to 10 animals / 10,000 animals treated):
Localised skin reaction (pruritus/scratching,erythema/rash, hair loss)1
Hypersensitivity reaction1
Very rare
(<1 animal / 10,000 animals treated, including isolated reports):
Behavioural disorder (lethargy, hyperactivity)2
Digestive tract disorders (vomiting, diarrhoea, hypersalivation)
Neurological disorders (ataxia, muscle tremor)3
1 involving the neck or the skin in general, which might indicate a local or general hypersensitivity reaction
2 often associated with skin irritation
3 subsides within 48 hours after removal of the collar
If any of these symptoms occur, the collar should be removed. Treatment should be symptomatic as no specific antidote is known.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See also section 16 of the package leaflet for respective contact details.
Use during pregnancy or lactation
Pregnancy: Can be used during pregnancy.
Lactation: Can be used during lactation.
Interactions
Do not use with other ectoparasiticides containing organophosphates.
Amounts to be administered and administration route
The 48 cm long collar is to be used on small and medium sized dogs.
The 65 cm long collar is to be used on large sized dogs.
For fastening around the neck. One collar per dog. For external use only. Remove the collar from the sealed protective sachet. Adjust the collar around the animal's neck without tightening it too tight. Two fingers side-by side should fit between the band and the dog's neck. Slide the end through the buckle and cut off any excess length extending beyond 5 cm.
Description: h-968
Overdose
In the unlikely event of the dog eating the collar the following symptoms may occur: Uncoordinated movements, tremor, drooling of saliva, vomiting, rigidity of the hindquarters. These symptoms usually subside within 48 hours. Diazepam can be used for symptomatic treatment if necessary.
Withdrawal period
Not applicable.
Pharmacological particulars
ATCvet code: QP53AC11.
Pharmacotherapeutic group
Ectoparasiticides, insecticides and repellents, pyrethrins and pyrethroids.
Pharmacodynamic properties
Insects and acarines are exposed to deltamethrin through contact. The mechanism of action is based on a sustained increase in the sodium permeability of the insect's nerve membranes. This results in hyperactivity followed by paralysis (shock effect), tremor and death of the parasite.
Pharmacokinetic properties
Deltramethrin is continuously released from the collar into the coat and the fatty film covering the skin. The active substance spreads from the site of direct contact over the entire skin surface through the lipids and in the hair. Deltamethrin is not absorbed systemically by the host.
Environmental properties
Deltamethrin is harmful to fish and other aquatic organisms.
Pharmaceutical particulars
Excipients
Titanium Dioxide (E171)
Organo Ca-Zn Soap Blend
Epoxidized Soya Bean Oil
Diisooctyl Adipate
Triphenyl Phosphate
Polyvinyl Chloride
Major incompatibilities
None known.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Special precautions for storage
The collar sealed inside the foil sachet should be stored in the outer carton. Store below 25 °C.
Immediate packaging
One collar is packed into a sachet made of paper-aluminium-polyethylene or paper-aluminium-polyster-polyethylene, and secured in the outer carton.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with national requirements.
Scalibor Protectorband should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Marketing Authorisation Number
UK(GB)
Vm 01708/5078 - Scalibor Protectorband 0.76 g medicated collar for small and medium dogs
Vm 01708/5079 - Scalibor Protectorband 1.0 g medicated collar for large dogs
Significant changes
Date of the first authorisation or date of renewal
21 March 2002
Date of revision of the text
July 2023.
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: NFA-VPS
GTIN
GTIN description:Scalibor 6 x 48cm:
GTIN:08713184062819
GTIN description:Scalibor 6 x 65cm:
GTIN:08713184031662