STIMUFOL

ANNEX I

 

SUMMARY OF PRODUCT CHARACTERISTICS

 

1. Name of the Veterinary Medicinal Product STIMUFOL®

 

2. Qualitative and Quantitative Composition

Active substances:

• Porcine follitropin (pFSH): 500 µg

• Porcine lutropin (pLH): 100 µg

Excipients:

• For the list of excipients, see section 6.1.

 

3. Pharmaceutical Form

Lyophilisate for injection with solvent.

 

4. Clinical Information

 

4.1 Target species

Cattle.

 

4.2 Indications for use, specifying the target species

pFSH combined with pLH induces superovulation or polyovulation in bovine females when administered at a specific stage of the oestrous cycle. Before treatment, normal ovarian function must be confirmed.

 

4.3 Contraindications

Do not use in animals with ovarian dysfunction, or in animals whose sexual cycle has not reached or has exceeded the recommended period for initiating treatment.

 

4.4 Special warnings for each target species

None.

 

4.5 Special precautions for use

 

I) In animals:

• Observe standard aseptic conditions.

• After reconstitution, the product may be stored in the vial for up to 4 days between +2 °C and +8 °C, protected from light.

 

II) By the person administering the veterinary medicinal product:

• Individuals with known hypersensitivity to follitropin or lutropin should avoid contact.

• Pregnant women should handle the product with caution.

 

4.6 Adverse reactions (frequency and severity)

• Administration to lactating cows may reduce milk production.

• In rare cases, anaphylactic reactions may occur.

 

4.7 Use during pregnancy, lactation or lay

Not applicable.

 

4.8 Interactions with other medicinal products and other forms of interaction

None known.

 

4.9 Posology and method of administration

Reconstitute the lyophilisate in 10 ml solvent. Administer intramuscularly in 8 injections, twice daily at 12-hour intervals over 4 days. Treatment should begin between day 9 and day 13 of the oestrous cycle. Injections should be given at different sites. A luteolytic treatment must be administered concomitantly.

Cows:

• Recommended dose: 450–500 µg pFSH over 4 days.

• Fractionation:

  • Equal parts: 1.1–1.25 ml per injection.

  • Decreasing volumes, e.g.:

    • Day 1: 1.7–1.9 ml twice daily

    • Day 2: 1.4–1.6 ml twice daily

    • Day 3: 0.8–0.9 ml twice daily

    • Day 4: 0.6 ml twice daily

Alternative scheme:

• Day 1: 1.4–1.6 ml twice daily

• Day 2: 1.2–1.4 ml twice daily

• Day 3: 1.0 ml twice daily

• Day 4: 1.0 ml twice daily

Heifers:

• Recommended dose: 320–360 µg pFSH over 4 days.

• Fractionation:

  • Equal parts: 0.8–0.9 ml per injection.

  • Decreasing volumes, e.g.:

    • Day 1: 1.1–1.2 ml twice daily

    • Day 2: 0.9–1.0 ml twice daily

    • Day 3: 0.6–0.7 ml twice daily

    • Day 4: 0.6–0.7 ml twice daily

 

4.10 Overdose (symptoms, emergency procedures, antidotes)

Not applicable.

 

4.11 Withdrawal period(s)

• Meat and offal: zero days

• Milk: zero days

 

5. Pharmacological Properties

Pharmacotherapeutic group: Gonadotropins, combinations.
ATCvet code: QG03GA99

 

5.1 Pharmacodynamic properties

pFSH combined with pLH induces superovulation or polyovulation in cattle when administered at a specific stage of the oestrous cycle. Normal ovarian function must be confirmed before treatment.

 

5.2 Pharmacokinetic properties

• Short half-life natural molecules: approximately 5 hours for pFSH and <1 hour for pLH.

• Maximum plasma concentration of pFSH reached about 3 hours post-injection, followed by a gradual decline.

• Consequently, twice-daily injections for 4 days are required.

 

6. Pharmaceutical Particulars

 

6.1 List of excipients

• Sodium chloride: 90 mg

• Methyl parahydroxybenzoate: 10 mg

• Propyl parahydroxybenzoate: 2.5 mg

• Water for injections q.s. to 10 ml

 

6.2 Incompatibilities

None known.

 

6.3 Shelf life

• As packaged for sale: 2 years

• After reconstitution: up to 4 days at +2 °C to +8 °C, protected from light

 

6.4 Special precautions for storage

Store refrigerated (+2 °C to +8 °C). Protect from light.

 

6.5 Nature and composition of immediate packaging

• Lyophilisate: Type I glass vial with rubber stopper and aluminium cap

• Solvent: Type I glass vial

• Carton contains: 1 vial of lyophilisate and 1 vial of 10 ml solvent

 

6.6 Special precautions for disposal of unused medicinal product or waste materials

Dispose of in accordance with local requirements. Keep out of reach and sight of children.

 

7. Marketing Authorisation Holder

Reprobiol SRL
Rue du Pelé-Bois 20
B-4590 Ouffet, Belgium
Tel: +32 (0)86 477 333
Fax: +32 (0)86 477 333
E-mail: info@reprobiol.be

 

8. Marketing Authorisation Number(s)

BE-V157997

 

9. Date of First Authorisation / Renewal of the Authorisation

• First authorisation: 03/06/1992

• Renewal: 14/05/2012

 

10. Date of Revision of the Text

12/07/2022

Dispensing category: Veterinary prescription only.

Source: Version 8.2, 12/07/2022, RCP AFMPS

Source : https://app.fagg-afmps.be/pharma-status/api/files/62bc7ea51e5c015ab3082084