Protect Flea and Worm Treatment Tablets for Large Dogs

Land: Storbritannia

Språk: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

Aktiv ingrediens:

Lufenuron, Milbemycin Oxime (A3 and A4)

Tilgjengelig fra:

Elanco Europe Ltd

ATC-kode:

QP54AB51

INN (International Name):

Lufenuron, Milbemycin Oxime (A3 and A4)

Legemiddelform:

Film-coated tablet

Resept typen:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutisk gruppe:

Dogs

Terapeutisk område:

Insect Growth Regulator

Autorisasjon status:

Expired

Autorisasjon dato:

2014-06-23

Preparatomtale

Revised: November 2016
AN: 01048/2016
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
PROTECT FLEA AND WORM TREATMENT TABLETS FOR LARGE DOGS
23 mg/ 460 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCES
Milbemycin oxime
23.0 mg
Lufenuron
460.0 mg
Excipient:
Titanium dioxide (E171)
7.5 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets
White, pentagonal, biconvex, bevel-edged, coated tablets with
“GKG” on one
side and “CGV” on the reverse.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Protect Flea and Worm Treatment is used for the prevention of fleas
(_Ct. felis, _
_Ct. canis_, preadult stages), and for the concurrent prevention of
heartworm
(elimination of L3/L4 larval stages of _Dirofilaria immitis) _and/or
treatment of
adult stages of gastrointestinal nematodes such as hookworms
(_Ancylostoma _
_caninum)_, roundworms (_Toxocara canis) _and whipworms (_Trichuris
vulpis_).
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance, to the
adjuvants
or to any of the excipients.
Revised: November 2016
AN: 01048/2016
Page 2 of 6
4.4
SPECIAL WARNINGS
Ideally, tablets are administered on the same day each month. If an
interval is
greater than 6 weeks, treatment should be resumed immediately and be
continued at monthly intervals and, in case of heartworm prevention, a
veterinarian should be consulted.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
In heartworm risk regions_, _or in case it is known that a dog has
been
travelling to and from heartworm risk regions, before commencing
Protect Flea and Worm Treatment, as with any other heartworm
preventive, a veterinary consultation is advised to exclude the
presence
of any concurrent infestation of _Dirofilaria immitis_. In the case of
a
positive diagnosis, adulticidal therapy is indicated before
administering
Prote