Recombinant follicle-stimulating hormone β injection
Chinese Pinyin's ancestor, rough throwing speed, β injection.
standard
Primakon refill for injection:
Each refill contains follicle stimulating hormone (FSH) of 300 iu, 600 IU or 900 IU.
The concentration of follicle stimulating hormone β in injection is 833 IU/mL, which is equivalent to 83.3μg protein /mL (that is, the biological activity per mg protein is about 10000 IUFSH).
Prikang water injection:
50 international units /0.5 ml and 100 international units /0.5 ml.
Every 0.5ml injection contains 50 100 international unit (IU) of follicle stimulating hormone (FSH), which is equivalent to 5 10 microgram of protein per injection (the biological activity in vivo is equivalent to 10000 IU FSH/ mg protein).
parcel
Primakon refill for injection:
This product includes 1 Precon refills and 6 (300 IU and 600 IU refills) or 9 (900 IU refills) Precon pens. The refill adopts I-type colorless waterproof glass bottle, sealed with rubber stopper and aluminum cover (with rubber pad). The concentration of injection is 833 international units/ml.
Prikang water injection:
Polycom is packed in type I waterproof injection glass bottle and rubber stopper, and sealed with aluminum cover.
50 IU and 100 IU packages include 1 per box and 5 pieces per box.
store
Primakon refill for injection:
Store in the refrigerator (2℃-8℃) and cannot be frozen.
Put the refill in the outer box.
Prikang water injection:
Store in the dark at 2-8℃.
term of validity
Primakon refill for injection:
36 months.
Once the refill rubber plug is punctured by a needle, it must be used within 28 days.
Prikang water injection:
36 months.
executive standard
Primakon refill for injection:
Registration standard of imported drugs: JS200800 13.
Prikang water injection:
Registration standard of imported drugs: JS2008006 1
Registration authentication number
Primakon refill for injection:
The registration numbers of imported drugs are: S20 1 1000 110002, S20 1 10003.
Prikang water injection:
Registration number of imported drugs: 50 iu: S20 1 10060.
Registration number of imported drugs:100iu: s 20110061.
Production enterprise
Primakon refill for injection:
Manufacturer: Vettel Pharmaceutical Co., Ltd.; Company KG
Production addresses: Schutzenstrasse 87 and 99/ 10 1, D-882 12 Ravensburg, Germany.
Packaging Factory: Organon (Ireland) Co., Ltd.
Address of packaging factory: Word Company, Delai South Road, Dublin, Ireland.
Prikang water injection:
Enterprise name: N.V. Organon
Address: kloosterstraat 6,5349 aboss
composition
Primakon refill for injection:
The main component of this product and its chemical name are recombinant follicle stimulating hormone (FSH) (follicle stimulating hormone β). Auxiliary materials include sucrose, sodium citrate, L- methionine, polysorbate 20 and benzyl alcohol dissolved in water, and the pH value is adjusted with sodium hydroxide and/or hydrochloric acid.
Prikang water injection:
The main component of this product and its chemical name are recombinant follicle stimulating hormone (FSH) (follicle stimulating hormone β). Auxiliary materials include sucrose, sodium citrate, L- methionine and polysorbate 20, and the pH value is adjusted with sodium hydroxide and/or hydrochloric acid.
Colorless transparent liquid. Primakon refill for injection:
1, used for anovulatory patients (including polycystic ovary disease, namely PCOD) who have no response to clomiphene citrate treatment.
2. Used in assisted reproductive technology for superovulation, such as in vitro fertilization/embryo transfer (IVF/ET), gametophyte transfer in fallopian tube (GIFT) and intracytoplasmic sperm injection (ICSI), so as to obtain the development of multiple follicles.
Prikang water injection:
1, which is ineffective for anovulation (including polycystic ovary syndrome, PCOS) and clomiphene citrate.
2. Used in assisted reproductive technology for superovulation, such as in vitro fertilization-embryo transfer (IVF-ET), gamete intrafallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI), so as to obtain the development of multiple follicles. Primakon refill for injection:
This product should be used under the supervision of a doctor with experience in infertility treatment.
Stop ovulation
Continuous medication, the initial dose is 50 IU per day, at least 7 days. If the ovary is unresponsive, the dosage is gradually increased until follicular development and/or plasma estradiol level show an appropriate pharmacodynamic response. Generally, it is most appropriate to increase the estradiol level by 40- 100% every day. After that, maintain this dose until it reaches the pre-ovulation state. When ultrasonic examination shows that the diameter of the dominant follicle is at least 18 mm and/or the plasma estradiol level is 300-900 pg/ml (1000-3000 pmol/ml), it indicates that the pre-ovulation state has been reached. This state can generally be achieved after 7- 14 days of treatment. At this time, stop using this product and use human chorionic gonadotropin (hCG) to induce ovulation.
If too many follicles react or the concentration of estradiol rises too fast, that is, the concentration of estradiol increases exponentially every day for 2-3 consecutive days, the dosage needs to be reduced.
In view of the fact that the diameter of follicles exceeding 14 mm can lead to pregnancy, there is a risk of multiple pregnancies if there are multiple follicles exceeding 14 mm before ovulation. In this case, hCG should be stopped and contraceptive measures should be taken to prevent multiple pregnancies.
Superovulation induction in assisted reproductive technology
Different stimulation schemes can be used. It is suggested that the initial dose should be at least 100-225 IU in the first 4 days, and then the dose should be adjusted individually according to the ovarian response. Foreign clinical studies show that this product can be used continuously for 6- 12 days at a maintenance dose of 75-375 IU, or it may take a long treatment time.
Prekang can be used alone or in combination with GnRH agonists or antagonists to prevent premature luteinization. When GnRH agonists are used, a large dose of Prekang is needed to obtain a suitable ovarian response.
Ovarian reaction can be monitored by ultrasound combined with plasma estradiol concentration measurement. When the ultrasound examination shows that at least three follicles with a diameter of 16-20 mm appear, and the estradiol response is good [each follicle with a diameter greater than 18 mm, the corresponding plasma estradiol concentration is 300-400pg/ml (1000-1300pmol/ml).
dosage
The refill for injection is a precise device that can accurately and quantitatively administer drugs. The dosage of FSH of refilling agent for injection is 65438 08% higher than that of ordinary syringe. In the same treatment cycle, when replacing the refill for injection with a conventional syringe, especially when replacing the refill for injection from a conventional syringe, it may be necessary to adjust the dose appropriately to prevent the dose from being too large.
The response of ovary to exogenous gonadotropin varies from person to person, so it is impossible to make a unified dosage table. Its dosage must be adjusted individually according to ovarian response, which requires ultrasonic monitoring and detection of estradiol concentration.
In the clinical comparative study of prematurity and urinary FSH at home and abroad, prematurity is better than urinary FSH, and it can be achieved with lower total dose and shorter course of treatment. Therefore, we can consider using a lower dose of this product, which is not only beneficial to the development of follicles, but also can reduce the risk of ovarian overstimulation.
The clinical experience of using Prekang is based on more than three cycles of treatment for the above two indications. The experience of in vitro fertilization shows that the success rate of the first four treatments remains stable, and then gradually decreases.
use
Do not use the injection if it is opaque or has particles.
Prekang injection with refill is administered by subcutaneous injection and should be used in conjunction with Prekang pen. You should follow the instructions of the Pricon pen. The air bubbles in the refill should be removed before injection (see the description of the pen). Used refills cannot be refilled. Do not mix other drugs in the refill. Dispose of the needle immediately after injection. Unused drugs or wastes should be disposed of according to local requirements.
The administration site should be changed to avoid fat atrophy.
Under the correct guidance of the doctor, the patient can inject himself with the refill for injection.
Prikang water injection:
This product should be carried out under the guidance of an experienced doctor.
The response of ovary to exogenous gonadotropin varies greatly among individuals, so it is impossible to formulate a unified dosage table. The dosage must be adjusted individually according to the response of ovary, which requires ultrasonic monitoring and detection of estradiol concentration.
Clinical studies at home and abroad show that in the process of promoting follicular development, compared with urinary FSH, this product requires lower total dose and shorter medication time. Therefore, we can consider using a lower dose of this product to reduce the risk of ovarian hyperstimulation.
This product can be used alone to promote ovulation, and can also be used with GnRH analogues to prevent early LH peak. For the latter, especially when GnRH agonist is used, it is necessary to use a higher dose of this product to obtain a suitable follicular response.
1, which is ineffective for anovulation (including polycystic ovary syndrome, PCOS) and clomiphene citrate.
Intramuscular injection or subcutaneous injection. Every day 1 time.
Continuous medication. The initial dose is usually 50IU per day for at least 7 days. If the ovary is unresponsive, the daily dose can be gradually increased according to follicular development and/or plasma estradiol concentration, suggesting an appropriate pharmacodynamic response. Generally, the daily increase of estradiol level is 40- 100%. After that, maintain the dose until it reaches the pre-ovulation state. When ultrasonic examination shows that the diameter of at least one dominant follicle reaches 18mm and/or the plasma estradiol concentration reaches 300-900 pg/ml (1000-3000 pmol/L), it indicates that the pre-ovulation state has been reached. This state can generally be achieved after 7- 14 days of treatment. At this time, we can stop using this product and use human chorionic gonadotropin (hCG) to induce ovulation.
If the number of follicles that react is too large or the concentration of estradiol increases too fast, that is, estradiol increases exponentially every day for 2-3 consecutive days, it needs to be reduced. In view of the fact that the follicle diameter exceeding 14mm may lead to pregnancy, multiple follicles exceeding 14mm before ovulation are at risk of multiple pregnancies. In this case, hCG should be stopped to avoid pregnancy and prevent multiple pregnancies.
2. Used in assisted reproductive technology for superovulation.
Intramuscular injection or subcutaneous injection. Every day 1 time.
Different stimulation schemes can be used. It is suggested that the initial dose should be at least 150-225 IU in the first four days, and then the dose should be adjusted individually according to the ovarian response. The ovarian response can be monitored by ultrasound combined with the determination of plasma estradiol concentration, and the recommended dose adjustment range is generally 50- 100 IU. Foreign clinical studies show that it is enough to use this product for 6- 12 days and maintain the maintenance dose of 75-375 IU per day, or it may take a long treatment time. When ultrasound shows that at least three follicles with a diameter of 16-20mm are proved to have a good estradiol response (the plasma estradiol concentration of each follicle with a diameter greater than 18mm is about 300-400 pg/ml (1000-1300 pmol/L)), the concentration of estradiol in the plasma will increase.
Foreign experience shows that the success rate of obtaining suitable follicles by using this product is relatively stable in the first four cycles of treatment, and then gradually decreases.