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Seven

Main information

  • Trade name:
  • Seven Seas Vetzyme 15% w/w Flea Rid Reflective Flea Collar for Dogs
  • Available from:
  • Virbac S.A.
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug
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Documents

Localization

  • Available in:
  • Seven Seas Vetzyme 15% w/w Flea Rid Reflective Flea Collar for Dogs
    United Kingdom
  • Language:
  • English

Other information

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Status

  • Source:
  • VMD - Veterinary Medicines Directorate
  • Authorization status:
  • Expired
  • Authorization number:
  • 05653/4090
  • Last update:
  • 21-12-2016

Summary of Product characteristics

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Revised: August 2010

AN: 02271/2008

SUMMARY OF THE PRODUCT CHARACTERISTICS

1 NAME OF THE VETERINARY MEDICINAL PRODUCT

Seven Seas Vetzyme 15% w/w Flea Rid Reflective Flea Collar for Dogs

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient

Dimpylate..............................................................................15 % w/w

Each 24g collar contains 3.6 g of dimpylate

Each 41g collar contains 6.15 g of dimpylate

Excipients

Flash Black 19976..................................................................0.0087% w/w for brown collar

Flash Black 19976..................................................................0.026% w/w for black collar

Red Ferric Oxide (E172) .......................................................0.035% w/w for brown collar

Ariabel Scarlet .......................................................................0.5% w/w for red collar

Lithol Rubine K4566 ..............................................................0.001% w/w for pink collar

Lithol Rubine K4566...............................................................0.1% w/w for red collar

Flash Beige 40232.................................................................0.3% w/w for beige collar

Flash Blue 47949.................................................................... 0.16% w/w for blue collar

Titanium dioxide (E171) ........................................................0.45% w/w for pink collar

Titanium dioxide (E171).........................................................0.15% w/w for white collar

Titanium dioxide (E171).........................................................0.1% w/w for green collar

Titanium dioxide (E171) ........................................................0.12% w/w for yellow collar

Quinoline Yellow Aluminium Lake (E104) ..............................0.48% w/w for yellow collar

Flash Yellow 47948.................................................................0.3% w/w for yellow collar

Tartrazine lake (E102)............................................................0.28% w/w for green collar

Blue alphazurine.....................................................................0.12% w/w for green collar

For a full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Collar.

Black or brown or beige or red or blue or green or yellow or pink or white supple

plastic trip provided with a buckle and with a characteristic odour.

4 CLINICAL PARTICULARS

4.1 Target Species

Dogs

4.2 Indications for use

For the control of fleas and ticks on dogs for up to 5 months

Revised: August 2010

AN: 02271/2008

4.3 Contra-indications

Do not use on puppies under 12 weeks of age.

4.4 Special warnings for each target species

Do not use if your dog is sick or recovering from an illness.

Do not allow animals to chew the collar

Fleas from pets often infest the animal’s basket, bedding and regular resting areas

such as carpets and soft furnishings which should be treated with a suitable

insecticide and vacuumed regularly.

4.5 Special precautions for use

i. Special precautions for use in animals

For external use only

ii. User warnings

Do not allow children to play with the collar.

Do not allow children to suck or chew the collar.

Do not smoke, eat or drink while handling collar.

DO NOT SLEEP WITH PETS WEARING COLLARS.

Dimpylate is an organophosphorus compound: DO NOT handle if under medical

advice not to work with ANTICHOLINESTERASES.

IF YOU FEEL UNWELL AFTER HANDLING THE COLLAR, SEEK MEDICAL

ADVICE.

Wash hands thoroughly after handling collar.

4.6 Adverse reactions (frequency and seriousness)

Remove the collar immediately should any signs of skin irritation or adverse reaction

occur.

REMOVE THE COLLAR FROM DOG IMMEDIATELY SHOULD ANY SIGNS OF

DROWSINESS, LISTLESSNESS OR RESPIRATORY DIFFICULTIES DEVELOP

SOON AFTER FIXING OF COLLAR.

4.7 Use during pregnancy, lactation or lay

Not for use on nursing or lactating bitches.

Remove fleas from young puppies and nursing bitches by careful use of a flea

comb.

4.8 Interaction with other medicinal products and other forms of interaction

Do not use any other insecticides while the collar is being worn or within 7 days of

removal.

Revised: August 2010

AN: 02271/2008

4.9 Amounts to be administrated and administration route

Insecticidal collar for dogs weighing 24 g and 60 cm in length.

Insecticidal collar for large dogs weighing 41 g and 65 cm in length.

Remove the collar from sachet and fasten around the dog’s neck. When fitted to the

growing dog, ensure the collar is loosened as the animal grows. In the fully-grown

dog, a correct fitting will allow two fingers to be inserted between the collar and the

neck. Any excess length of collar extending beyond the buckle should be cut and

disposed of with the domestic refuse.

The collar does not need to be removed when the animal is being bathed as the

insecticidal activity remains unaffected by water. Leave in place until the collar

effective life is exhausted.

Replace after 4 months if re-infestation with ticks or fleas is a risk.

4.10 Overdose (symptoms, emergency procedures, antidotes) if necessary

Dimpylate is an organophosphorus insecticide and atropine is antidotal.

Remove the collar immediately if any signs of skin irritation or adverse reactions

occur. Signs of overdosage include drowsiness, listlessness or respiratory

difficulties.

4.11 Withdrawal period

Not applicable

5 PHARMACOLOGICAL PROPERTIES

ATC VetCode: QP53AF03

Seven Seas Vetzyme 15% w/w Flea Rid Reflective Flea Collar for Dogs contains

dimpylate insecticide.

5.1 Pharmacodynamic properties

Dimpylate, an organophosphorus parasiticide, is active against common fleas

(Ctenocephalides) and ticks (Rhipicephalus or Dermacentor) of dogs. It acts mainly

by inhibiting insect enzymes such as cholinesterases. This is achieved when

dimpylate competes with acetylcholine, responsible for nerve impulses, by binding

to the esterase site of the cholinesterase molecules.

Acetylcholine, degraded at a lower pace, accumulates and induces disorders.

Because the metabolism of dimpylate in insects is very slow, irreversible poisoning

is achieved.

In mammals, cholinesterase activity similarly decreases. However, this is only

transitory since enzyme synthesis is resumed and dimpylate is degraded within a

very-short period of time.

Dimpylate being slowly released from the collar matrix, the product remains active

for up to 5 months.

Revised: August 2010

AN: 02271/2008

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Flash Black 19976

Red Ferric Oxide (E172)

Ariabel Scarlet

Lithol Rubine K4566

Flash Beige 40232

Tartrazine Lake (E102)

Blue Alphazurine Lake

Titanium Dioxide (E171)

Flash Blue 47949

Quinoline Yellow Certolake (E104)

Flash Yellow 47948

Dibutyl Phthalate

Calcium Sterate

Polyvinyl Chloride

Epoxidised Soyabean Oil

6.2 Incompatibilities

None Known

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years

6.4 Special precautions for storage

Do not remove the collar from the pack until ready-to-use.

Do not store above 25°C.

Protect from direct sunlight.

6.5 Nature and composition of immediate packaging

Blister pack of one collar: pocket and lid in acrylonitrile/methyl acrylate/butadiene

co-polymer on backing card.

Sachet: paper/polyethylene/aluminium foil/polyethylene laminate.

Box containing one or two sachets of one collar (24g or 41g)

Not all pack sizes may be marketed

6.6 Special precautions for the disposal of unused veterinary medicinal product

or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such

veterinary medicinal products should be disposed of in accordance with local

requirements.

EXTREMELY DANGEROUS to fish and aquatic life. Do not contaminate ponds,

waterways or ditches with the product or empty container.

Revised: August 2010

AN: 02271/2008

7 MARKETING AUTHORISATION HOLDER

Virbac

1ère avenue - 2065 m - L.I.D

06516 Carros Cedex

France

8 MARKETING AUTHORISATION NUMBER

Vm

05653/4090

9 DATE OF FIRST AUTHORISATION

23/01/2000

10 DATE OF REVISION OF THE TEXT

August 2010

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