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Date: Monday, June 24, 2024 10:58

Description: 2015-Elanco-logo
Telephone: 01256 353131 (24 hr response) Veterinary Technical Services
Release 11.14
Program 80 mg Suspension for Injection Cats
 
Species: Cats
Active ingredient: Lufenuron
Product:Program® 80 mg Suspension for Injection Cats
Product index: Program 80 mg Suspension for Injection Cats
Incorporating:
Qualitative and quantitative composition
Active ingredient: Lufenuron 80 mg per syringe (0.8ml of a 10% suspension)
For a full list of excipients see pharmaceutical particulars.
Pharmaceutical form
Suspension for injection. White, aqueous suspension.
Clinical particulars
Target species: Cats greater than or equal to 4 kg bodyweight.
Indications for use, specifying the target species
The product is intended for the 6-month long-term prevention and control of flea infestations and the treatment of FAD (flea allergic dermatitis) in cats. The product is effective against the pre-audit stages of the dominant flea species, Ctenocephalides felis and C. canis. It can be administered to all cats, including weaned kittens as well as pregnant and lactating queens.
Contra-indications
None known.
Special warnings for each target species
Not to be used in dogs.
In the cat, to achieve a six month flea control, a small subcutaneous depot is required. Injection site reaction may occur in some cats, in particular a small painless swelling at the injection site which disappears, in general, after a few weeks
Special precautions for use
i.Special precautions for use in animals
For subcutaneous administration only.
The injection should be carried out under aseptic conditions.
ii.Special precautions to be taken by the person administering the medicinal product to the animals
Care should be taken to avoid accidental self injection. In the case of accidental self injection seek medical advice.
Avoid contact with skin and eyes. In the event of accidental eye or skin contact, wash/irrigate the area with clean running water.
Seek medical attention if irritation persists.
Wash hands after use.
Adverse reactions (frequency and seriousness)
The product is well tolerated by all cats but may cause a transient mild and painless reaction at the injection site. In rare cases, lethargy may occur for a few hours after injection, however, it quickly disappears
Use during pregnancy, lactation or lay
No harmful effects are to be expected when this product is given during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction
No evidence of interactions with other medicaments has been observed
Amounts to be administered and administration route
The minimum recommended dose is 10 mg Lufenuron per kg bodyweight when administered parenterally.
Weight of cats
Less than 4 kg
Equal to or greater than 4 kg
Dose
1 PROGRAM 40mg Suspension for Injection Syringe
80 mg Suspension for Injection Syringe
For the product to be fully effective, the whole content of the syringe must be injected subcutaneously, e.g. dorsally anterior to the shoulder blades. It is recommended that cats be re-treated at 6-month intervals to ensure continuous effective control of flea development.
The syringe must be shaken vigorously to reconstitute the suspension and then injected immediately.
If cats have a high level of flea infestation at the start of treatment, it may be necessary to apply a flea adulticide during the first one or two months. In cases of severe hypersensitivity further use of an adulticide may be needed. It is essential that all cats (except for unweaned kittens) living in a household are treated to stop flea infestation. Dogs in the same household should be treated as recommended by the prescribing veterinary surgeon.

Overdose (symptoms, emergency procedures, antidotes) if necessary
No significant untoward effects due to overdosing have been observed in the target animal safety studies.
Withdrawal Period
Not applicable
Pharmacological particulars
ATC vet code: QP53BX01
Pharmacotherapeutic group: Ectoparaciticides, insecticides and repellents, Ectoparasiticides for systemic use, Other ectoparasiticides for systemic use
The active ingredient, Lufenuron, is an insect development inhibitor (IDI) belonging to the chemical class of benzoylureas.
Pharmacodynamic Properties
Lufenuron (INN) is an inhibitor of chitin synthesis and deposition. When administered systemically to the animal, fleas infesting the cat ingest the active ingredient with their bloodmeal and transfer it to their eggs. As a consequence, the formation of larval chitin structures, a process essential to insects, and the development of viable offspring are blocked.
Pharmacokinetic Properties
After subcutaneous administration of the product, the active ingredient is absorbed from the injection site and preferentially sequestered in the adipose tissues, from where it is continuously released metabolically unchanged into the bloodstream. Effective blood levels of Lufenuron are attained within 21 days after the initial injection, and the low elimination rate assures an effective concentration of the active ingredient in the bloodstream (above 50-100 ppd) for at least 6 months.
Pharmaceutical particulars
List of excipients
Polysorbate 21
Povidone 12
Sodium Chloride
Water for injection
Incompatibilities
None known.
Shelf Life
Shelf life of the veterinary medicinal product as packaged for sale: 4 years.
Special Precautions for Storage
Protect from freezing.
The syringe must only be used once.
Nature and Contents of Container
The product is available as prefilled sterile, disposable 1 ml Dupharject Type I glass syringes, containing a withdrawable volume of 0.8 ml. The syringes are ready to use and fitted with a stainless steel needle (gauge 25; 0.5 x 16 mm).
Pack Size
10 individually blistered syringes are packed in a cardboard box.
Special Precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products, if appropriate.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
NA
Marketing Authorisation Number
Vm 00879/4038
Significant changes
Date of the first authorisation or date of renewal
24 December 1997
Date of revision of the text
March 2016
Any other information
Legal category
Legal category: POM-V
GTIN
GTIN description:PROGRAM INJECTION (CAT) 10 x 0.8
GTIN:05037694001582