Universal reference book for medicines
Product name: Puregon В® (PUREGON)

Active substance: follitropin beta

Type: Recombinant human follicle-stimulating hormone

Manufacturer: NV ORGANON (The Netherlands)
Composition, form of production and packaging
Solution for the / m and s / to the introduction is
transparent, colorless.

1 f.

foliotropin beta (recombinant) * 100 IU (10 Ојg)

Excipients: sucrose - 25 mg, sodium citrate dihydrate - 7.35 mg, methionine - 0.25 mg, polysorbate 20 - 0.1 mg, hydrochloric acid 0.1 n or sodium hydroxide 0.1 n - up to pH 7, water d / u - up to 0.5 ml.

0.5 ml - bottles of colorless glass in volume 3 ml (1) - packs cardboard.

0.5 ml - bottles of colorless glass in volume 3 ml (5) - packs cardboard.

0.5 ml - bottles of colorless glass in volume of 3 ml (10) - packs cardboard.

Solution for the / m and s / to the introduction is transparent, colorless.

1 f.

foliotropin beta (recombinant) * 150 IU (15 Ојg)

Excipients: sucrose - 25 mg, sodium citrate dihydrate - 7.35 mg, methionine - 0.25 mg, polysorbate 20 - 0.1 mg, hydrochloric acid 0.1 n or sodium hydroxide 0.1 n - up to pH 7, water d / u - up to 0.5 ml.

0.5 ml - bottles of colorless glass in volume 3 ml (1) - packs cardboard.

0.5 ml - bottles of colorless glass in volume 3 ml (5) - packs cardboard.

0.5 ml - bottles of colorless glass in volume of 3 ml (10) - packs cardboard.

Solution for the / m and s / to the introduction is transparent, colorless.

1 f.

foliotropin beta (recombinant) * 200 IU (20 Ојg)

Excipients: sucrose - 25 mg, sodium citrate dihydrate - 7.35 mg, methionine - 0.25 mg, polysorbate 20 - 0.1 mg, hydrochloric acid 0.1 n or sodium hydroxide 0.1 n - up to pH 7, water d / u - up to 0.5 ml.

0.5 ml - bottles of colorless glass in volume 3 ml (1) - packs cardboard.

0.5 ml - bottles of colorless glass in volume 3 ml (5) - packs cardboard.

0.5 ml - bottles of colorless glass in volume of 3 ml (10) - packs cardboard.

The solution for the sc administration is clear, colorless.

1 cartridge

foliotropin beta (recombinant) * 300 IU

Auxiliary substances: sucrose - 21 mg, sodium citrate dihydrate 6.17 mg, polysorbate 20-0.105 mg, benzyl alcohol 4.2 mg, methionine 0.21 mg, hydrochloric acid 0.1 n or sodium hydroxide 0.1 n up to pH 7, water d / and - 0.42 ml.

0.36 ml - 1.5 ml colorless glass cartridges (1) complete with needles (6 pcs.) - plastic packaging (1) - cardboard packs.

The solution for the sc administration is clear, colorless.

1 cartridge

foliotropin beta (recombinant) * 600 IU

Excipients: sucrose 39 mg, sodium citrate dihydrate 11.5 mg, polysorbate 20 0.177 mg, benzyl alcohol 7.8 mg, methionine 0.39 mg, hydrochloric acid 0.1 n or sodium hydroxide 0.1 N up to pH 7, water d / and - up to 0.78 ml.

0.72 ml - colorless glass cartridges of 1.5 ml volume (1) complete with needles (6 pcs.) - plastic packaging (1) - cardboard packs.

The solution for the sc administration is clear, colorless.

1 cartridge

follitropin beta (recombinant) * 900 IU

Excipients: sucrose - 58.5 mg, sodium citrate dihydrate 17.2 mg, polysorbate 20 0.234 mg, benzyl alcohol 11.7 mg, L-methionine 0.59 mg, hydrochloric acid 0.1 n or sodium hydroxide 0.1 n up to pH 7, water q / and - up to 1.17 ml.

1.08 ml - cartridges (1) complete with needles (9 pcs.) - packs of cardboard.

* - the specific biological activity in vivo is approximately 10 000 IU FSH / ml protein.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

Recombinant follicle-stimulating hormone (FSH), which is obtained by recombinant DNA technology, using the culture of Chinese hamster ovary cells, into which the genes of human FSH subunits are introduced.
The primary amino acid sequence of recombinant DNA is identical to that of natural human FSH. There are small differences in the structure of the hydrocarbon chain.
FSH provides normal growth and maturation of follicles and the synthesis of sex steroid hormones.
The level of FSH in women is a factor determining the onset and duration of follicular development, as well as the time of their maturation. Thus, Puregon В® can be used to stimulate the development of follicles and the synthesis of estrogens in certain disorders of the ovaries. In addition, Puregon В® is used to induce multiple development of follicles during artificial insemination (for example, in in vitro fertilization / embryo transplantation (IVF / PE), intrauterine insemination (ICU) and intracytoplasmic sperm injection (ICSI).) After treatment with PuregonВ® chorionic gonadotropin (CG) is usually administered to induce the final stage of follicular maturation, the resumption of meiosis and ovulation.
PHARMACOKINETICS

After IM or p / c injection of PuregonВ® Cmax FSH in the blood plasma is achieved within 12 hours. Due to the gradual release of the drug from the injection site and long T 1/2 (12 to 70 hours, an average of 40 hours) FSH remains elevated for 24-48 hours, and therefore repeated administration of the same dose of FSH leads to a further increase in the concentration of FSH 1.5-2 times compared with a single administration.
This allows to achieve a therapeutic concentration of FSH in the blood.
Pharmacokinetic parameters after IM and / or injection of Puregon В® are not significantly different.
In both ways, the bioavailability of the drug is about 77%.Recombinant FSH is biochemically similar to FSH isolated from human urine and similarly distributed, metabolized and excreted from the body.
INDICATIONS

Treatment of female infertility in the following cases:

- Anovulation (including polycystic ovary syndrome / PCOS) in women who are insensitive to clomiphene treatment;

- Induction of superovulation, for the induction of multiple development of follicles during artificial insemination (for example, in IVF / PE, VMI and ICSI techniques).

DOSING MODE

Begin treatment with Puregon В® followed by a doctor who has experience in the treatment of infertility.

The dose should be selected individually depending on the response of the ovaries, under the supervision of ultrasound and the concentration of estradiol.

Puregon В® is effective at a lower total dose and shorter treatment time than necessary for maturation, compared to FSH obtained from urine, which minimizes the risk of ovarian hyperstimulation.

The total experience in the treatment of infertility by in vitro fertilization indicates that success is most likely during the first 4 courses of therapy and subsequently gradually decreases.

With anovulation , a consistent treatment regimen is recommended, starting with the daily administration of 50 IU of PuregonВ® for at least 7 days.
In the absence of ovarian response, the daily dose is gradually increased until follicle growth and / or an increase in the plasma estradiol concentration, indicating an optimal pharmacodynamic response. The optimal daily concentration of estradiol in plasma is 40-100%.
The daily dose thus obtained is then maintained until the preovulation condition is reached.
The state of preovulation is determined by the presence of a dominant follicle with a diameter of at least 18 mm (according to ultrasound) and / or extrapyantrum concentrations in the blood plasma of 300-900 picograms / ml (1000-3000 pmol / L).
Typically, to achieve this condition requires 7-14 days of treatment.

After this, the administration of the drug is stopped and ovulation is induced by the administration of HC.
If the number of follicles is too high or the concentration of estradiol increases too quickly, i.e. more than 2 times a day for 2-3 consecutive days, then the daily dose should be reduced. Since each follicle with a diameter of more than 14 mm is preovulatory, the presence of several follicles with a diameter of more than 14 mm carries the risk of multiple pregnancies. In this case, HCG is not administered and measures are taken to protect against possible pregnancy to prevent multiple pregnancies.
For the induction of superovulation in the conduct of artificial insemination, various stimulation schemes are used.
For at least 4 days, 150-225 IU of the drug is recommended. After that, the dose can be selected individually, based on the response of the ovaries. In clinical studies, it has been shown that it is usually sufficient to use a maintenance dose of 75-375 IU for 6-12 days, but in some cases longer treatment may be required.
Puregon В® can be used either alone or in combination with a GnRH agonist or antagonist to prevent premature ovulation peak.
If GnRH analogs are used, higher total doses of Puregon В® may be required.
The ovarian reaction is monitored by ultrasound and the determination of the concentration of estradiol in plasma.
In the presence of at least 3 follicles with a diameter of 16-20 mm (according to US) and the presence of a good ovarian response (estradiol concentration in blood plasma of 300-400 picograms / ml (1000-1300 pmol / l) per follicle with a diameter of more than 18 mm), induce the final phase of follicular maturation by the administration of CG. After 34-35 hours, aspirate the eggs.
Application rules

To prevent pain when injected and to minimize the leakage of the drug from the injection site, the solution should be slowly injected into the / m and s / c.
It is necessary to alternate the sites of the SC administration to avoid the development of fatty atrophy. Unused solution should be disposed of.
The injection of Puregon В® can be performed by a woman or her partner who received detailed instructions from a doctor.
Self-administration of the drug is permissible only for patients who have good skills and a constant opportunity to consult a specialist.
The drug, produced in cartridges , is designed to be injected with a pen-injector "Puregon Peng".
In this case, the drug is administered sc.
When using the pen-injector "Puregon Peng" it is necessary to take into account that the handle is an exact device releasing the dose established on it.
It is shown that when using a pen-injector, 18% more FSH is injected than with a syringe. This can be significant, in particular, when changing the injector handle to an ordinary syringe, and vice versa, in one cycle of treatment. Some dose adjustment is especially needed when switching from a syringe to a pen to avoid an unacceptable increase in the dose administered.
The drug, produced in vials , is intended for administration with a syringe .

Stage 1 - Preparation of the syringe

To administer the drug should be used disposable sterile syringes and needles.
The syringe volume should be small enough to introduce the prescribed dose accurately.If the solution is opaque or contains mechanical inclusions, it can not be used. The contents of the bottle should be used immediately after puncturing the rubber plug.The solution remaining after a single application is discarded. First, remove the bottle cap valve. Put the needle on the syringe and pierce the rubber stopper of the bottle with a needle. Collect the solution in a syringe and replace the needle with a needle for injection. Holding the syringe with the needle up, gently tap it on the side to expel the air bubbles in the top of the syringe, then press the piston until the air is completely removed until only the PuregonВ® solution remains in the syringe. If necessary, additional pressure is applied to the piston to establish the volume of the solution to be injected.
Step 2 - Place of introduction

The most suitable place for the n / v introduction - the abdomen around the navel with moving skin and a layer of fat.
With each injection, you need to slightly change the injection site. You can inject the drug into other parts of the body.
Stage 3 - Preparation of the site of administration

To reduce the discomfort with the introduction of the needle, you can make a few claps at the site of the proposed injection.
Hands should be washed and the site of injection is wiped with a disinfectant solution (eg 0.5% chlorhexidine) to remove surface bacteria. Treat approximately 6 cm around the point where the needle enters, and wait for about a minute to allow the disinfectant solution to dry.
Step 4 - Inserting the needle

Slightly pull the skin.
With the other hand, insert the needle at an angle of 90 В° under the surface of the skin.
Step 5 - Checking the correct position of the needle

With the correct position of the needle, the piston is quite difficult to return.

Penetrating into the syringe blood indicates that the needle pierced a vein or artery.
In this case, take out the syringe, cover the injection site with a tampon with a disinfectant and apply pressure, and the bleeding will stop in 1-2 minutes. Do not use the solution and remove it from the syringe. Start again from the 1st stage, using a new needle and syringe, and a new vial of the drug.
Step 6 - Administration of the solution

Lower the piston slowly and gradually to correctly enter the solution and not damage the skin tissue.

Step 7 - Remove the syringe

Quickly remove the syringe, cover the injection site with a tampon with a disinfectant and apply pressure.
Careful massage of this place (with constant pressure) promotes the distribution of the solution of Puregon В® and helps to avoid unpleasant sensations.
SIDE EFFECT

Local reactions: hematoma, pain, hyperemia, edema, pruritus (observed in 3 of 100 patients treated with Puregon В® ).
Most of these reactions are mild and quick-passing.
Systemic allergic reactions: erythema, urticaria, rash and itching (observed in 1 of 1000 patients treated with Puregon В® ).

Also may be noted:

- Ovarian hyperstimulation syndrome (about 4 out of 100 women receiving treatment with the drug).

Clinical symptoms of mild hyperstimulation of the ovaries are nausea, diarrhea, bloating and abdominal pain due to impaired venous circulation and irritation of the peritoneum, as well as an increase in the ovaries due to cysts.
In rare cases, there was a pronounced ovarian hyperstimulation syndrome that threatened the patient's life and was characterized by the presence of large, inclined ovarian cysts, ascites, hydrothorax and weight gain due to fluid retention in the body. In rare cases, ovarian hyperstimulation syndrome may be accompanied by the development of venous or arterial thromboembolism.
- soreness, pain and / or engorgement of the mammary glands;

- spontaneous abortion;

- increased probability of multiple pregnancy;

- Increased likelihood of ectopic pregnancy.

When treated with Puregon В® in combination with CG, as well as with other gonadotropic hormones, thromboembolism is rarely possible.

CONTRAINDICATIONS

- tumors of the ovaries, breast, uterus, pituitary and hypothalamus;

- vaginal and uterine bleeding of unknown etiology;

- primary failure of the ovaries;

ovarian cysts or ovarian enlargement not associated with PCOS;

- violation of the anatomy of the genital organs, incompatible with pregnancy;

- myoma of the uterus, incompatible with pregnancy;

- decompensated diseases of the endocrine system (eg, thyroid, adrenal or pituitary diseases);

- pronounced impairment of liver and kidney function;

- Pregnancy;

- lactation period;

- hypersensitivity to any of the components of the drug.

PREGNANCY AND LACTATION

The use of Puregon В® during pregnancy and during breast-feeding is contraindicated.
Due to the fact that the clinical data on the use of the drug in pregnancy is not enough, then in the case of unintentional intake during pregnancy, the teratogenic effect of recombinant FSH can not be ruled out.
APPLICATION FOR FUNCTIONS OF THE LIVER

Contraindication: severe renal dysfunction.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Contraindication: marked violation of liver function.

SPECIAL INSTRUCTIONS

Before the start of treatment, the presence of endocrine diseases (for example, thyroid, adrenal or pituitary diseases) should be excluded.

Induction of ovulation with gonadotropic drugs increases the risk of developing multiple pregnancies.
Corresponding dose adjustment of FSH prevents the development of multiple follicles. With multiple pregnancies, there is a higher risk of complications during pregnancy and perinatal period. Before starting treatment, patients should be warned about the possibility of developing a multiple pregnancy.
The first administration of Puregon В® should be performed under the direct supervision of a physician.

In women who undergo artificial insemination (especially IVF), there are often abnormalities of the fallopian tubes, which increases the risk of developing an ectopic pregnancy.
Therefore, it is important to obtain an early ultrasound confirmation of the intrauterine fetal positioning.
In women who undergo artificial insemination, the risk of early termination of pregnancy is higher than with natural conception.

The frequency of congenital malformations with the use of assisted reproductive technologies (ART) can be slightly higher than with natural fertilization.
Perhaps this is due to the characteristics of the parents (for example, their age or characteristics of the sperm), as well as the higher frequency of multiple pregnancy with ART.There are no indications that an increase in the risk of congenital malformation is associated with the use of gonadotropins.
Before the start of treatment and regularly during the treatment should be carried out ultrasound to monitor the development of follicles and determine the concentration of estradiol in the plasma.
In addition to the development of too many follicles, the concentration of estradiol in plasma can grow very rapidly (ie, more than 2 times a day for 2-3 consecutive days), reaching extremely high values. The diagnosis of ovarian hyperstimulation can be confirmed by ultrasound. Transient deviation of the results of liver function tests may indicate hepatic dysfunction, which may be accompanied by morphologic changes on liver biopsy, as has been reported in association with ovarian hyperstimulation syndrome.
Women of the recognized risk groups against thrombosis, for example, relevant personal or family history, severe obesity (BMI> 30 kg / m 2) Or undiagnosed thrombophilia, may be at increased risk of venous or arterial thromboembolic events during treatment with gonadotropins, even without concomitant ovarian hyperstimulation syndrome. In the treatment of women is necessary to compare the likelihood of successful induction of ovulation and the potential risk of complications. Note, however, that pregnancy itself is accompanied by an increased risk of thrombosis.
Puregon В® may contain traces of streptomycin and / or neomycin. These antibiotics may cause hypersensitivity reactions.
Impact on the ability to drive vehicles and manage mechanisms

Not detected.

OVERDOSE

Information on acute overdose of the drug Puregon В® absent. The use of FSH in high doses may lead to the development of ovarian hyperstimulation syndrome, symptoms of which are described above.
Treatment: at occurrence of undesirable symptoms hyperstimulation (not associated with induction of superovulation during in vitro fertilization) administering the drug Puregon В® should be discontinued. In this case, care should be taken to the prevention of the development of the pregnancy and to give up the introduction of HGH, which could aggravate the adverse effects. Treatment should be aimed at addressing the symptoms of ovarian hyperstimulation syndrome.
DRUG INTERACTION

Simultaneous use of the drug Puregon В® and clomiphene may enhance ovarian response.
After the pituitary desensitization using GnRH agonists to achieve sufficient ovarian response may require a higher dose formulation Puregon В® .
Pharmaceutically compatible with other drugs.
TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B. The drug should be protected from light, reach of children at a temperature of from 2 В° to 8 В° C;
Do not freeze. Shelf life - 3 years.
After insertion of the needle into the cartridge, the solution can be stored for 28 days maximum.
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