FOSTIMON Powder and solvent for solution for injection (2017)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
1. Name of the medicinal product
FOSTIMON 75 IU, powder and solvent for solution for injection.
2. Qualitative and quantitative composition
One vial contains 75 IU of urofollitropin (follicle-stimulating hormone FSH): 1 ml of reconstituted solution contains either 75 IU, 150 IU, 225 IU, 300 IU, 375 IU or 450 IU of urofollitropin when respectively ...
3. Pharmaceutical form
Powder and solvent for solution for injection. The powder is white to off-white and the solvent is clear and colourless.
4.1. Therapeutic indications
Sterility in women: Anovulation (including polycystic ovarian syndrome, PCOS) in women who have been unresponsive to treatment with clomifene citrate. Controlled ovarian hyperstimulation to induce the ...
4.2. Posology and method of administration
Posology Treatment with Fostimon should be initiated under the supervision of a physician experienced in the treatment of infertility problems. There are great inter- and intra-individual variations in ...
4.3. Contraindications
Hypersensitivity to FSH or to any of the excipients. Ovarian enlargement or cysts not related to polycystic ovarian syndrome. Gynaecological bleeding of unknown cause. Ovarian, uterine or breast carcinoma. ...
4.4. Special warnings and precautions for use
Self-injections of Fostimon should be performed only by motivated, trained and well informed patients. Prior to self-injections, the patient must be shown how to perform a subcutaneous injection, showing ...
4.5. Interaction with other medicinal products and other forms of interaction
No drug/drug interaction studies have been conducted for Fostimon in humans. Although there is no clinical experience, it is expected that the concomitant use of Fostimon and clomifene citrate may enhance ...
4.6. Pregnancy and lactation
Pregnancy Fostimon is not indicated during pregnancy and lactation. No teratogenic risk has been reported following controlled ovarian stimulation, in clinical use with urinary gonadotropins. To date no ...
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. However, FOSTIMON is unlikely to have influence on the patients performance to drive and use machines.
4.8. Undesirable effects
Adverse reactions (ADRs) reported in clinical trials with FOSTIMON are listed in the table below by body system and frequency. Most events were of mild to moderate severity. Within each system organ class, ...
4.9. Overdose
No data on acute toxicity of FSH in humans is available, but the acute toxicity of urinary gonadotropin preparations in animal studies has been shown to be very low. Too high a dosage of FSH may lead to ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Gonadotropins <b>ATC CODE:</b> G03GA04 The active substance in Fostimon is highly purified Follicle Stimulating Hormone (FSH), obtained from human Menopausal Gonadotropin ...
5.2. Pharmacokinetic properties
After subcutaneous injection of 300 IU of Fostimon, C<sub>max</sub> is 5.74 ± 0.95 IU/l, and T<sub>max</sub> is 21.33 ± 9.18 hours. AUC<sub>0-∞</sub> is 541.22 ± 113.83 IU/l×hour, which is approximately ...
5.3. Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity, with recombinant FSH. The Ames test did not show any mutagenic activity of FSH. No carcinogenicity ...
6.1. List of excipients
<u>Powder:</u> lactose monohydrate <u>Solvent:</u> sodium chloride and water for injections
6.2. Incompatibilities
In the absence of compatibility studies, this product must not be mixed with other medicinal products.
6.3. Shelf life
2 years. After reconstitution, immediate use is recommended.
6.4. Special precautions for storage
Do not store above 25°C. Keep the vial and the ampoule in the outer carton, in order to protect from light.
6.5. Nature and contents of container
Powder in a vial (type I glass), with a stopper (bromobutylrubber), with a seal (aluminium) and a flip-off cap (plastic) + 1 ml of solvent in an ampoule (type I glass); pack size of 1, 5 and 10 sets. ...
6.6. Special precautions for disposal and other handling
The solution must be prepared just before injection. One vial is for single use only. The medicinal product must be reconstituted under aseptic conditions. Fostimon must only be reconstituted with the ...
7. Marketing authorization holder
IBSA Farmaceutici Italia S.r.l, Via Martiri di Cefalonia 2, 26900 Lodi Italy
8. Marketing authorization number(s)
PL 21039/0005
9. Date of first authorization / renewal of the authorization
30/03/2006
10. Date of revision of the text
22/12/2017
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
