Perlutex 5mg 20 tablets

Perlutex 5 mg tablets are suitable for dogs and cats. This remedy ensures the suppression of the mating season in dogs and cats. For a short-term suppression of the mating season in dogs 2 tablets per day should be given for 4 days, followed by 1 tablet daily for 12 days. The dose should be doubled for dogs weighing more than 15 kg. The treatment should only be started after a clear pro-oestrus bleeding. For long-term suppression of the mating season in cats 1 tablet per week should be given on a fixed day. The administration should begin during the anoestrus or dioestrus. Suppression occurs as long as the administration will be continued. The tablets should be administered orally.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

PERLUTEX 5 mg tablets for dogs and cats.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance
Per tablet:
Medroxyprogesterone acetate 5 mg

Excipients:
See section 6.1 for the full list of excipients.

3. PHARMACEUTICAL FORM

Tablet.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs, cats.

4.2 Indications for use, specifying the target species

Dogs:
Suppression of oestrus.

Cats:
Suppression of oestrus.

4.3 Contraindications

Do not use:

• In sexually immature animals.
• In pregnant animals (suspected or confirmed).
• In animals with vaginal discharge due to infections or symptoms of cystic endometrial hyperplasia.
• In animals with mammary tumours or diabetes mellitus.
• More than 3 days after the start of oestrus.
• In cats that are already in oestrus.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals
None.

Special precautions to be taken by the person administering the veterinary medicinal product
None.

4.6 Adverse reactions (frequency and seriousness)

• Temporary weight gain.
• Risk of developing mammary tumours, acromegaly (in dogs), cystic endometrial hyperplasia, or diabetes mellitus.

4.7 Use during pregnancy, lactation, or lay

Do not use during pregnancy or lactation.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amounts to be administered and administration route

Oral administration.

Short-term suppression of oestrus in dogs:
2 tablets per day for 4 days, followed by 1 tablet per day for 12 days.
The dose must be doubled for dogs weighing over 15 kg.
Treatment should only begin after clear confirmation of pro-oestrus bleeding.

Long-term suppression of oestrus in cats:
1 tablet per animal once per week on a fixed day of the week.
Administration must begin during the anoestrus or dioestrus phase; suppression will continue as long as administration is maintained.

4.10 Overdose (symptoms, emergency procedures, antidotes)

No adverse effects other than those mentioned in section 4.6 have been reported in cases of overdose.

4.11 Withdrawal periods

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Hormone
ATCvet code: QG03DA02

5.1 Pharmacodynamic properties

Medroxyprogesterone acetate is closely related to the natural corpus luteum hormone progesterone.
It is 20 to 30 times more potent than progesterone in suppressing ovulation in animals.
It works by inhibiting the secretion of the gonadotropic hormones FSH and LH via a feedback mechanism and by blocking receptors in target tissues.
It also stops or prevents the development of follicles and corpora lutea in the ovaries and exhibits anti-oestrogenic properties.

5.2 Pharmacokinetic properties

Medroxyprogesterone acetate is absorbed from the gastrointestinal tract after oral administration.
Peak plasma concentrations are reached after 1 hour in dogs and after 1-3 hours in cats.
Medroxyprogesterone acetate is metabolized in the liver.
No adverse effects on reproductive capacity have been observed after use of the product.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

• Gelatin
• Lactose
• Starch
• Magnesium stearate
• Talc

6.2 Major incompatibilities

Do not mix with other veterinary medicinal products, vaccines, or immunological agents.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

6.4 Special precautions for storage

Store below 25 °C.
Do not refrigerate or freeze.

6.5 Nature and composition of immediate packaging

20 tablets of 5 mg in PVC/Aluminium blister packs.
1 or 5 blister packs per box.
Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials

Unused veterinary medicinal products or waste materials should be disposed of in accordance with local regulations.