Scalibor Protectorband 0.76 g Medicated Collar for Small and Medium Sized Dogs

Composition

One white collar of 48 cm length (19 g) contains:

Active substance:

Deltamethrin 0.76 g

Excipients:

Titanium dioxide (E171) 0.285g

For the full list of excipients, see section 6.1.

6.1 List of excipients

Titanium Dioxide (E171)

Organo Ca-Zn Soap Blend

Epoxidized Soya Bean Oil

Diisooctyl Adipate

Triphenyl Phosphate

Polyvinyl Chloride

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Pharmaceutical form

Medicated collar.

White collar of smooth consistency with a plastic buckle at one extremity.

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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.

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Target species

Dogs

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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.

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Dosage

The 48 cm long collar is to be used on small and medium 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.

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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.

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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.

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Warnings

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.

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Use during pregnancy, lactation or lay

Pregnancy:

Can be used during pregnancy.

Lactation:

Can be used during lactation.

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Interactions

Do not use with other ectoparasiticides containing organophosphates.

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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.

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Special warnings

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.

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Withdrawal period

Not applicable.

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Incompatibilities

None known.

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Immediate packaging

One collar is packed into a sachet made of paper-aluminium-polyethylene or paper-aluminium-polyester-polyethylene and secured in the outer carton.

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Storage

Store below 25°C.

Keep the foil sachet in the outer carton.

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Shelf life

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

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Disposal of unused product

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.

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Additional information

8 MARKETING AUTHORISATION NUMBER

Vm 06376/5000

9 DATE OF FIRST AUTHORISATION

21 March 2002

10 DATE OF REVISION OF THE TEXT

December 2024

11 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS

Veterinary medicinal product not subject to prescription.

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Registration holder

Intervet International B.V.

Wim de Körverstraat 35

5831 AN

Boxmeer

Netherlands

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