Protect Flea and Worm Treatment Tablets for Small Dogs

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: VMD (Veterinary Medicines Directorate)

सक्रिय संघटक:

Lufenuron, Milbemycin Oxime (A3 and A4)

थमां उपलब्ध:

Elanco Europe Ltd

ए.टी.सी कोड:

QP54AB51

INN (इंटरनेशनल नाम):

Lufenuron, Milbemycin Oxime (A3 and A4)

फार्मास्यूटिकल फॉर्म:

Film-coated tablet

प्रिस्क्रिप्शन प्रकार:

POM-V - Prescription Only Medicine – Veterinarian

चिकित्सीय समूह:

Dogs

चिकित्सीय क्षेत्र:

Insect Growth Regulator

प्राधिकरण का दर्जा:

Expired

प्राधिकरण की तारीख:

2014-06-23

उत्पाद विशेषताएं

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 SMALL DOGS
5.75 mg/ 115 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCES
Milbemycin oxime
5.75 mg
Lufenuron
115.00 mg
Excipient:
Titanium dioxide (E171)
1.9 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
“GNG” 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
Pr