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Date: Thursday, February 13, 2025 13:16

Release 2.207
Folltropin 700 IU Powder and Solvent for solution for injection
 
Species: Cattle
Therapeutic indication: Pharmaceuticals: Hormones and therapeutically related products: Others
Active ingredient: Follicle Stimulating Hormone (FSH)
Product:Folltropin 700 IU Powder and Solvent for solution for injection
Product index: Folltropin 700
Cattle - milk: Zero hours
Cattle - meat: Zero days
Incorporating:
Presentation
Powder and solvent for solution for injection. Powder: Freeze dried off-white powder. Solvent: Clear, colourless solution. Reconstituted solution: Clear, slightly pink solution.
Uses
To induce superovulation in reproductively mature heifers or cows.
Dosage and administration
For intramuscular administration only.
Dissolve the product only with the solvent provided. Use strict aseptic technique when preparing and withdrawing the product.
Regimen:
Start injections on day 8 to 10 following observed or induced oestrus. Administer 2.5 ml (87.5 I.U.) of Folltropin intramuscularly, twice daily, for 4 days. In conjunction with the 6th dose of Folltropin, administer prostaglandin F2α or a prostaglandin F2α analogue, at their manufacturer's recommended dose, to cause luteolysis.
Breed animals at 12 and 24 hours after the onset of oestrus or 60 and 72 hours after prostaglandin treatment. Additional inseminations may be conducted at 12 hour intervals if indicated.
Contra-indications, warnings, etc
Do not use in males, in reproductively immature or pregnant cattle or in cases of hypersensitivity to the active substance.
Special precautions for use in animals:
The product should only be used in clinically healthy cows and mature heifers, which are cycling normally. There is a wide range in response to superovulation between animals. There may be a small proportion of non-responders in any group treated.
Collection of embryo is normally started on day 7 following observed oestrus or first breeding. Prior to breeding and the collection of fertilized embryo from these animals, oestrus will have to be induced with prostaglandin F2α or a prostaglandin F2α analogue.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Care should be taken when handling the product to avoid self-injection. Accidental self-injection of FSH may cause biological effects in women and to the unborn child. In case of accidental self- injection in women who are pregnant, or whose pregnancy status is unknown, seek medical advice immediately and show the package leaflet or the label to the physician.
Use during pregnancy
Laboratory studies with FSH in rats and rabbits have shown evidence of embryotoxicity/foetotoxicity. The safety of the product has not been assessed in pregnant cattle. Do not use in pregnant cattle.
Interaction with other medicinal products and other forms of interaction:
None known.
Overdose (symptoms, emergency procedures, antidotes), if necessary:
Cows were able to respond to the product consistently throughout a series of 3 treatments. No adverse reactions were detected in treated cows after the injection of 400 mg Folltropin as a single dose.
Withdrawal period(s):
Meat and offal: Zero days
Milk: Zero hours
Major incompatibilities:
Do not mix with any other veterinary medicinal product except the solvent supplied for use with the veterinary medicinal product.
Adverse events
Very rare
(<1 animal / 10,000 animals treated, including isolated reports):
Ovarian cyst*, lack of heat**
* Following administration for three superovulation cycles, but did not prevent pregnancy
** Following superovulation a delayed return to heat is possible
Reporting adverse events is important. It allows continuous safety monitoring of a product. If you notice any side effects, even those not already listed in this package leaflet, or you think that the medicine has not worked, please contact, in the first instance, your veterinarian. You can also report any adverse events to the marketing authorisation holder or the local representative of the marketing authorisation holder using the contact details at the end of this leaflet, or via your national reporting system: https://www.gov.uk/report-veterinary-medicine-problem
Pharmaceutical precautions
Keep out of the sight and reach of children.
Freeze-dried powder and solvent vials: Do not store above 25 °C.
Reconstituted solution: store in a refrigerator (2 - 8°C)
Keep the vials in the outer carton in order to protect from light.
Shelf life following reconstitution according to directions: 4 days.
Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
When the product is reconstituted, using the in-use shelf-life which is specified on this package leaflet, the date on which any product remaining in the container should be discarded should be worked out. This discard date should be written in the space provided on the label.
Do not freeze after mixing. Discard any unused portion of the reconstituted solution.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Legal category
Legal category: POM-V
Packaging quantities
Pack Sizes: Cardboard box containing one vial of powder and one vial of 20 ml of solvent
Not all pack sizes may be marketed.
Further information
Follicle Stimulating Hormone from an extract of porcine pituitary glands for use in cattle.
Pharmacotherapeutic group: Sex hormones and modulators of the genital system, gonadotrophins.
ATCvet code: QG03GA90
Pharmacodynamic properties: FSH is the initiator of ovarian activity since it directly promotes growth of ovarian follicles. The administration of exogenous FSH to mammals at the time of follicular wave emergence stimulates growth of all follicles over 1.7 mm diameter which would normally be lost to atresia during each oestrus cycle. Multiple growing follicles require FSH stimulation until they are mature enough to respond to LH for the final stages of maturation and ovulation. This usually takes a period of approximately 4 days. In cattle, fertilised ova produced by superovulation with FSH, PMSG and other pharmacological agents containing high concentrations of LH have shown reduced fertilisation. Folltropin contains porcine pituitary extract with FSH activity and low LH activity.
Pharmacokinetic particulars: When administered by intramuscular injection, FSH of porcine origin is rapidly absorbed from the site of injection. It has a half-life of 5 hours and FSH cannot be detected in the blood stream 12 hours after injection. FSH is inactivated by the liver and then excreted by the kidneys.
 
Marketing Authorisation Number
Folltropin GB: Vm 08007/5005
Folltropin NI: Vm 08007/3004
Significant changes
GTIN
GTIN description:Folltropin 700 IU Powder and Solvent for solution for injection
GTIN:03605874392960