Scalibor (65 cm)
Active substance
ATC code
Species
Dogs
Indications
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.
Dose to be administered and administration route
The 65cm long collar is to be used on large 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.
Adverse reactions
Dogs
|
Rare (1 to 10 animals / 10,000 animals treated): |
Localised skin reaction (pruritus/scratching, erythema/rash, hair loss)1Hypersensitivity reaction1 |
|
Very rare (<1 animal / 10,000 animals treated, including isolated reports): |
Behavioural disorder (lethargy, hyperactivity)2Digestive 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.
Dispensing
NFA-VPS - Non-Food Animal – Veterinarian, Pharmacist, SQP
TRUSTED SOURCE
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Scalibor Protectorband 1.0 g medicated collar for large dogs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One white collar of 65 cm length (25 g) contains:
Active substance:
|
Deltamethrin Excipients: |
1.0 g |
|
Titanium dioxide (E171) |
0.375 g |
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Medicated collar.
White collar of smooth consistency with a plastic buckle at one extremity.
4. CLINICAL PARTICULARS
4.1 Target species
Dogs
4.2 Indications for use, specifying the target species
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.
4.3 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.
4.4 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.
4.5 Special precautions for use
Special precautions for use in animals
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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wash hands with soap and cold water after fitting the collar.
People with known hypersensitivity to triphenyl phosphate should avoid contact with the veterinary medicinal product and the treated animal. Seek medical advice in case of hypersensitivity reactions.
This veterinary medicinal product contains deltamethrin which may cause transient tingling, itchiness, and blotchy redness on exposed skin.
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.
Special precautions for the protection of the environment:
While occasional contact with water does not reduce the effectiveness of the collar, it should always be removed before swimming and bathing the dog to avoid adverse effects on aquatic organisms. Dogs must be prevented from swimming in water for the first five days of wearing the collar.
4.6 Adverse reactions (frequency and seriousness)
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] |
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.
4.7 Use during pregnancy, lactation or lay
Pregnancy:
Can be used during pregnancy.
Lactation:
Can be used during lactation.
4.8 Interaction with other medicinal products and other forms of interaction
Do not use with other ectoparasiticides containing organophosphates.
4.9 Amount(s) to be administered and administration route
The 65 cm long collar is to be used on large 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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
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.
4.11 Withdrawal period(s)
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: ectoparasiticides, insecticides and repellents, pyrethrins and pyrethroids
ATC Vet Code: QP53AC11.
5.1 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.
5.2 Pharmacokinetic particulars
Deltamethrin 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.
5.3 Environmental properties
Deltamethrin is harmful to fish and other aquatic organisms.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Titanium dioxide (E171)
Organo Ca-Zn soap blend
Epoxidized soya bean Oil
Diisooctyl Adipate
Triphenyl Phosphate
Polyvinyl Chloride
6.2 Major 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
Store below 25 °C.
Keep the foil sachet in the outer carton.
6.5 Nature and composition of immediate packaging
One collar is packed into a sachet made of paper-aluminium-polyethylene or paperaluminium-polyester-polyethylene and secured in the outer carton.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Medicines should not be disposed of via wastewater.
Do not contaminate ponds, waterways or ditches with the product or packaging as this may be dangerous for fish and other aquatic organisms.
Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required.
7. MARKETING AUTHORISATION HOLDER
MSD Animal Health UK Limited
Walton Manor, Walton
Milton Keynes
Buckinghamshire
MK7 7AJ
8. MARKETING AUTHORISATION NUMBER
Vm 01708/5079
9. DATE OF FIRST AUTHORISATION
21 March 2002
10. DATE OF REVISION OF THE TEXT
July 2023
11. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS
Veterinary medicinal product not subject to prescription.
Approved: 21 July 2023
[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.
