Program Plus Film-coated Tablets 5.75 mg/115 mg

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: VMD (Veterinary Medicines Directorate)

Aktiivinen ainesosa:

Lufenuron, Milbemycin Oxime (a3 And A4)

Saatavilla:

Elanco Europe Ltd

ATC-koodi:

QP54AB51

INN (Kansainvälinen yleisnimi):

Lufenuron, Milbemycin Oxime (a3 And A4)

Lääkemuoto:

Film-coated tablet

Prescription tyyppi:

POM-V - Prescription Only Medicine – Veterinarian

Terapeuttinen ryhmä:

Dogs

Terapeuttinen alue:

Anthelmintic; Insect Growth Regulator

Valtuutuksen tilan:

Expired

Valtuutus päivämäärä:

2000-10-19

Valmisteyhteenveto

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 5.75mg/115 mg
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
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