ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
STIMUFOL
1. NAME OF THE VETERINARY MEDICINAL PRODUCT STIMUFOL®
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredients: Porcine Follitropin: 500 μg Porcine Lutropin: 100 μg Adjuvant (s): Water for Injection qsq 10 ml Excipient (s): For all excipients, see section 6.1.
3. PHARMACEUTICAL FORM Lyophilisate Injection + Solvent
4. CLINICAL INFORMATION
4.1 Target species Bovine animals
4.2 Indications for use specifying the target species Porcine follitropin (pFSH), associated with porcine lutropin (pLH), induces superovulation or polyovulation in the bovine female when administered at a given time in the sexual cycle. It is necessary to check, before any treatment, that the animal has a normal ovarian function.
4.3 Contraindications Do not use in animals with ovarian malfunction, animals whose sexual cycle has not yet reached or has already exceeded the recommended period for initiation of treatment.
4.4 Special warnings for each target species None
4.5 Special precautions for use Special precautions for use in animals i) Special precautions for use in animals Observe the usual aseptic conditions. After re-dissolution, the specialty held in its flask, between + 2 ° C and + 8 ° C and in the dark, can be kept for 4 days. (Ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals Persons with known hypersensitivity to follitropin and lutropin should avoid contact with the veterinary medicinal product. The product should be treated with caution by pregnant women.
4.6 Undesirable effects (frequency and severity) Administration of STIMUFOL on lactating cows may result in decreased lactation. In exceptional cases, anaphylactic reactions are observed.
4.7 Use when pregnant, lactating or laying Not applicable.
4.8 Drug interactions and others None known.
4.9 Dosage and route of administration Once a vial of lyophilisate has been put into solution in 10 ml of the solvent, the necessary amount should be injected intramuscularly in the form of 8 fractions. The injections are carried out at a rate of 2 per day at 12-hour intervals for 4 days. They start between the 9th and 13th days of the female bovine sex cycle. The fractionation of the dose used is carried out either in 8 equal parts or in 8 unequal parts for which the values decrease during the treatment. To this treatment is associated a complementary luteolytic treatment. Successive injections are performed at different points. Dosage: It is expressed as the total amount of pFSH injected into the bovine female. For the cow, the recommended dose is 450 to 500 μg of pFSH for the treatment of a duration of 4 days. – Split into 8 equal parts: 1.1 to 1.25 ml at each of the 8 injections. – Fractionation by injecting volumes decreasing, taking into account the dosage indicated above, according to the following examples: 1st example Day 1: 1.7 ml to 1.9 ml at each of the 2 injections. Day 2: 1.4 ml to 1.6 ml at each of the 2 injections. Day 3: 0.8 ml to 0.9 ml at each of the 2 injections. 4th day: 0.6 ml at each of the 2 injections. 2 nd example Day 1: 1.4 ml to 1.6 ml at each of the 2 injections. Day 2: 1.2 ml to 1.4 ml at each of the 2 injections. 3rd day: 1.0 ml with each of the 2 injections. 4th day: 1.0 ml to each of the 2 injections. For the heifer, the recommended dose is 320 to 360 μg of pFSH for a treatment lasting 4 days. – Fractionation into 8 equal parts: 3 RCP- version FR STIMUFOL 0.8 to 0.9 ml at each of the 8 injections. – Decreasing volume fraction to be injected, taking into account the dosage indicated above, according to the following example: 1st day: 1.1 ml to 1.2 ml at each of the 2 injections. Day 2: 0.9 ml to 1.0 ml at each of the 2 injections. Day 3: 0.6 ml to 0.7 ml at each of the 2 injections. 4 th day: 0.6 ml to 0.7 ml at each of the 2 injections.
4.10 Overdose (symptoms, emergency management, antidotes), if necessary Not applicable.
4.11 Waiting times Meat and offal: zero days. Milk: zero day
5. PHARMACOLOGICAL PROPERTIES
ATCvet code: QG03GA99 Pharmacotherapeutic group: combination of gonadotropins.
5.1 Pharmacodynamic properties Porcine follitropin (pFSH), associated with porcine lutropin (pLH), induces superovulation or polyovulation in the bovine female when administered at a given time in the sexual cycle. It is necessary to check, before any treatment, that the animal has a good ovarian functioning.
5.2 Pharmacokinetic characteristics> pFSH and pLH are very short half-life natural molecules (about 5 hours for pFSH and less than one hour for pLH). Maximum plasma levels of pFSH are reached about 3 hours after injection. Then there is a gradual decrease of these. Therefore, it is essential, for a treatment, to carry out 2 injections per day for 4 days.
6. PHARMACEUTICAL INFORMATION
6.1 List of excipients Sodium chloride: 90 mg Methyl parahydroxybenzoate: 10 mg Propyl parahydroxybenzoate: 2.5 mg Water for injections qsq 10 ml
6.2 Incompatibilities None known.
6.3 Shelf life Shelf life of the veterinary medicinal product as packaged for sale: 2 years Shelf life after dilution or reconstitution in accordance with instructions: After re-dissolving, the specialty held in its vial under the conditions described in point 6.4. Can be stored for 4 days. 4 RCP- version FR STIMUFOL
6.4 Special precautions for storage Store in a refrigerator (between + 2 ° C and + 8 ° C) in order to protect from light.
6.5 Nature and composition of primary packaging • Lyophilisate: type 1 glass with rubber stopper and aluminum cap. • Solvent: Type 1 glass A cardboard box contains 1 bottle of injectable lyophilisate of porcine follitropin and porcine lutropin and a 10 ml bottle of solvent.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials resulting from the use of these medicinal products Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. Keep out of reach and sight of children.
7. MARKETING AUTHORIZATION HOLDER
Reprobiol SPRL
Street of Pelé-Bois, 20
B-4590 Ouffet
such. : (32) (0) 86 477 333
Fax: (32) (0) 86 477 333
E-mail: info@reprobiol.be
8. MARKETING AUTHORIZATION NUMBER (S)
BE-V157997
9. DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: 03/06/1992
Date of renewal of the authorization: 14/05/2012
10.
DATE OF REVISION OF THE TEXT 12/07/2022
PROHIBITION OF SALE, SUPPLY AND / OR USE
On veterinary prescription.
Origin of the text
http://www.ircp.anmv.anses.fr/rcp.aspx?NomMedicament=STIMUFOL