Program Plus Film-coated Tablets 23 mg/460 mg

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: VMD (Veterinary Medicines Directorate)

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
09-01-2023

Viambatanisho vya kazi:

Lufenuron, Milbemycin Oxime (a3 And A4)

Inapatikana kutoka:

Elanco Europe Ltd

ATC kanuni:

QP54AB51

INN (Jina la Kimataifa):

Lufenuron, Milbemycin Oxime (a3 And A4)

Dawa fomu:

Film-coated tablet

Dawa ya aina:

POM-V - Prescription Only Medicine – Veterinarian

Kundi la matibabu:

Dogs

Eneo la matibabu:

Anthelmintic; Insect Growth Regulator

Idhini hali ya:

Expired

Idhini ya tarehe:

2000-10-19

Tabia za bidhaa

                                Revised: September 2021
AN: 00886/2021 & 00889/2021
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
PROGRAM Plus film-coated tablets 23mg/460 mg
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
PROGRAM Plus 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: September 2021
AN: 00886/2021 & 00889/2021
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
PROGRAM Plus 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
PROGRAM Plus.
ii.
Special precautions to be taken by the
                                
                                Soma hati kamili