Program Tablets 409.8 mg

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Lufenuron

Available from:

Elanco Europe Ltd

ATC code:

QP53BC01

INN (International Name):

Lufenuron

Pharmaceutical form:

Tablet

Prescription type:

AVM-GSL - Authorised Veterinary Medicine – General Sales List

Therapeutic group:

Dogs

Therapeutic area:

Insect Growth Regulator

Authorization status:

Expired

Authorization date:

1993-07-08

Summary of Product characteristics

Revised: October 2020
AN. 00949/2020
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Program Tablets 409.8mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
mg/tablet
Lufenuron
409.8000
Excipients
Ferric Oxide Brown (E172)
0.0448
Titanium dioxide (E171)
6.6911
For a full list of excipients see section 6.1
3.
PHARMACEUTICAL FORM
Tablet.
White, round biconvex tablets
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE
For the prevention and lasting control of flea infestation in dogs.
Effective against the
dominant flea species _Ctenocephalides felis _and_ C. canis_.
4.3
CONTRA-INDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
I)
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Use only in weaned puppies.
If signs of flea infestation or disease persist or appear, consult
your veterinary
surgeon.
II)
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
MEDICINAL PRODUCT TO ANIMALS
Wash hands after use.
Revised: October 2020
AN. 00949/2020
Page 2 of 4
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
On very rare occasions, nervous signs, itching, vomiting or diarrhoea
have been
reported in dogs following treatment with Program Tablets.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
Can be used during pregnancy and lactation.
4.8
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
4.9
AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
The minimum recommended dose rate is 10mg/ai/kg/month.
Recommended monthly dose:
Dog weight – 21 kg to 40 kg = 1 tablet
Dog weight – 41 kg to 80 kg = 2 tablets
In order to avoid under-dosing in growing puppies, they should be
weighed each
month prior to dosing.
To be fully effective the tablets MUST be administered together with
food, e.g. added
to a portion of the daily food, hidden in pieces of meat, etc. or
administered by mouth
after feeding. After administration, the dog should be watched for
several minutes to
ensure th