Release form and packaging Puregon
The drug is available in the form of a solution that is administered intramuscularly or subcutaneously. Considering that the drug is administered according to the prescribed scheme, for convenience it is manufactured in cartridges that fit into special pens (Puregon Pen), which allows you to make injections yourself without much difficulty. Thanks to this form of release, a woman can administer it herself.
Cartridges come in several options: 0.36 ml, 0.72 and 1.08 ml and come with a set of needles. To reduce pain during an injection, as well as to use up the solution during manipulation, today they use syringes that come with small needles or a special Puregon pen. This is a special device that allows you to avoid leakage of the drug during manipulation by medical workers or self-use, because if the drug is not in full, accordingly, the dose that is required to stimulate ovulation will not be completely administered.
Puregon 600me 0.72ml 1 pc. injection solution cartridge
pharmachologic effect
Replenishes FSH deficiency. Regulates the normal growth and maturation of follicles, the synthesis of sex steroid hormones.
Composition and release form Puregon 600me 0.72 ml 1 pc. injection solution cartridge
The solution for intramuscular and subcutaneous administration is transparent, colorless. — 1 fl.:
- Active ingredients: follitropin 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/i - up to 0.78 ml.
* - specific biological activity in vivo is approximately 10,000 IU FSH/ml protein.
0.72 ml - 1.5 ml colorless glass cartridges (1) complete with needles (6 pcs.) - plastic packaging (1) - cardboard packs.
Directions for use and doses
IM, s/c (slow). Anovulation - start with daily administration of 50-75 IU for 7 days, in the absence of ovarian response, the dose is gradually increased (optimally daily increase in plasma estradiol concentration by 40-100%); when the dominant follicle reaches a diameter of 18 mm or an estradiol level of 300-900 pg/ml, Puregon is canceled and human chorionic gonadotropin is administered. Induction of ovarian superovulation during in vitro fertilization in the first 4 days - 100-200 IU, then the dose is selected individually based on the reaction of the ovaries; usually 75-375 IU per day for 1-2 weeks is sufficient; in the presence of 3 follicles with a diameter of 16-20 mm and a plasma estradiol concentration of 300-400 pg/ml/follicle, the final phase of follicle maturation is stimulated with human chorionic gonadotropin; after 34-35 hours, oocytes are aspirated.
Indications for use Puregon 600me 0.72 ml 1 pc. injection solution cartridge
Female infertility due to anovulation (including polycystic ovary syndrome, refractory to clomiphene citrate); conducting assisted reproduction programs, incl. in vitro fertilization (to induce superovulation).
Contraindications
Hypersensitivity, tumors of the ovaries, breast, uterus, pituitary gland or hypothalamus, primary ovarian insufficiency, ovarian cysts or ovarian enlargement not associated with polycystic ovary syndrome, abnormal genital anatomy or uterine fibroids incompatible with pregnancy.
Application Puregon 600me 0.72 ml 1 pc. solution for injection cartridge during pregnancy and breastfeeding
Contraindicated during pregnancy. Lactating women should stop breastfeeding.
special instructions
It is recommended to constantly change the injection site. If symptoms of ovarian hyperstimulation appear (excluding preparation for in vitro fertilization), therapy should be discontinued. Before starting treatment, it is necessary to exclude diseases of the thyroid gland, adrenal glands and pituitary gland.
Side effects Puregon 600me 0.72 ml 1 pc. injection solution cartridge
Ovarian hyperstimulation (abdominal pain, nausea, diarrhea, enlargement of the ovaries and their cysts, rarely - rupture of ovarian cysts, ascites, hydrothorax, weight gain); at the injection site - swelling, pain, redness, itching. After ovulation induction, the risk of developing multiple pregnancies increases, and with in vitro fertilization, an ectopic pregnancy.
How to correctly set the dosage in pens?
Let's talk in more detail about pen syringes: how to use them correctly and how to correctly set the dose of the injected drug. This issue is very important, because incorrect administration of the drug dose can lead to a number of complications, including ovulation hyperstimulation syndrome, which is difficult to treat.
Before you start administering Puregon using a pen syringe, you should prepare a cartridge, pen, sterile disposable needle, alcohol for processing and cotton wool. The optimal place to store open cartridges is the refrigerator, from which you should remove the drug the day before. It can be stored in a room in a dark place for 90 days. A cartridge containing 300 IU of the drug will have a silver cap, a gold cap will contain 600 IU of the drug, and a cartridge with a blue cap will have 900 IU. Only the attending physician selects the dosage of the drug to stimulate ovulation. Before injection, wash your hands with soap twice, prepare the pen and remove the protective cap from it. Carefully remove the body from the pen, open the cartridge, treat it with a disinfectant and place it in a metal holder, then tighten it so that the yellow arrow on the body coincides with the black line on the base of the pen. This will indicate that the cartridge is inserted correctly. After making sure that the cartridge is filled correctly, put a sterile disposable needle on it, from which the protective film is removed and the needle is fixed by screwing it onto the base of the cartridge. After this, remove the cap from the needle and treat the skin. It is better to inject puregon subcutaneously into the abdomen in the fold under the navel or thigh, changing the location each time. After treating the injection site with a disinfectant, you need to let it dry and proceed with the injection itself. First of all, remove the cap from the needle, tap the cartridge to remove air bubbles, turn the handle until it clicks and press the button to inject and administer the drug, as a result of which a drop of liquid should appear.
After the syringe is filled, you need to select the dose of the drug. We will tell you how to do this now. So, turn the knob until your prescribed dose appears in the window. If you accidentally scrolled through the dose prescribed for you, then turn the handle all the way, and then press the handle, without losing a single drop. Having established the dose of the drug prescribed to you by your doctor, treat the skin and insert the needle into the subcutaneous fold. By pressing the handle, inject the marked dose, after which for several seconds without removing the syringe from the skin and making sure that the window on the syringe shows 0. After the injection, remove the needle from, close the handle and place it out of reach of children. You can use the started cartridge as long as there is enough drug for one injection. You will use a disposable needle every day and set the appropriate dose of the drug injected.
Puregon®
Treatment with Puregon® should be started under the supervision of a physician experienced in the treatment of infertility.
The dose should be adjusted individually depending on the response of the ovaries, under ultrasound control and estradiol concentration.
Puregon® is effective with a lower total dose and shorter treatment time required for maturation compared to FSH obtained from urine, which minimizes the risk of developing ovarian hyperstimulation.
Overall experience in the treatment of infertility by in vitro fertilization indicates that success is most likely during the first 4 courses of therapy and gradually decreases thereafter.
During anovulation
A sequential treatment regimen is recommended, starting with daily administration of 50 IU of Puregon® for at least 7 days. In the absence of an ovarian response, the daily dose is gradually increased until follicular growth and/or an increase in plasma estradiol concentration is achieved, indicating that an optimal pharmacodynamic response has been achieved. A daily increase in plasma estradiol concentration by 40-100% is considered optimal.
The daily dose thus obtained is then maintained until the preovulation state is achieved. 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 a plasma extradiol concentration of 300-900 picograms/ml (1000-3000 pmol/l).
Typically, 7-14 days of treatment are required to achieve this state.
After this, the administration of the drug is stopped and ovulation is induced by administering hCG. If the number of follicles is too large or the estradiol concentration increases too quickly, i.e. more than 2 times per day for 2-3 consecutive days, then the daily dose should be reduced. Since each follicle with a diameter greater than 14 mm is preovulatory, the presence of several follicles with a diameter greater 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 induction of superovulation during artificial insemination
Various stimulation schemes are used. For at least the first 4 days, it is recommended to administer 150-225 IU of the drug. After this, the dose can be selected individually, based on the reaction of the ovaries. Clinical studies have shown that a maintenance dose of 75-375 IU for 6-12 days is usually sufficient, but in some cases longer treatment may be required.
Puregon® can be used either alone or in combination with a GnRH agonist or antagonist to prevent premature peak ovulation. When using GnRH analogues, higher total doses of Puregon® may be required.
The reaction of the ovaries is monitored by ultrasound and determination of the concentration of estradiol in plasma. If there are at least 3 follicles with a diameter of 16-20 mm (according to ultrasound) and there is a good ovarian response (estradiol concentration in blood plasma 300-400 picograms/ml (1000-1300 pmol/l) for each follicle with a diameter of more than 18 mm), induce the final phase of follicle maturation by administering hCG. After 34-35 hours, oocytes are aspirated.
Rules for using the drug
To prevent pain during injection and to minimize leakage of the drug from the injection site, the solution should be administered slowly IM and SC. It is necessary to alternate sites of subcutaneous injection to avoid the development of fatty atrophy. Unused solution should be destroyed.
Subcutaneous injections of Puregon® can be carried out by the woman herself or her partner, who has received detailed instructions from the doctor. Self-administration of the drug is permissible only for patients who have good skills and a constant opportunity to consult with a specialist.
The drug is produced in cartridges
, intended for administration using
the Puregon Pen injector pen.
In this case, the drug is administered subcutaneously.
When using the Puregon Pen injector pen, it must be taken into account that the pen is a precise device that releases the dose set on it. It has been shown that using an injector pen delivers 18% more FSH than using a syringe. This may be significant, in particular, when changing an injector pen to a regular syringe, and vice versa, in the same treatment cycle. Some dose adjustment is especially necessary when switching from a syringe to a pen to avoid an unacceptable increase in the administered dose.
The drug is available in bottles
, intended for administration using
a syringe
.
Step 1 - Preparing the syringe
To administer the drug, disposable sterile syringes and needles should be used. The volume of the syringe must be small enough to deliver the prescribed dose accurately. If the solution is opaque or contains mechanical inclusions, it cannot be used. The contents of the bottle should be used immediately after piercing the rubber stopper. The solution remaining after a single use is discarded. First, remove the valve from the bottle cap. Place the needle on the syringe and pierce the rubber stopper of the bottle with the needle. Draw the solution into the syringe and replace the needle with an injection needle. Holding the syringe with the needle up, gently tap it on the side to displace air bubbles into the upper part of the syringe, then press the piston until the air is completely removed, until only the Puregon® solution remains in the syringe. If necessary, additional pressure on the piston is used to set the volume of the solution intended for administration.
Stage 2 - Injection site
The most suitable place for subcutaneous injection is the abdominal area around the navel with mobile skin and a layer of fatty tissue. With each injection, you should change the injection site slightly. The drug can be injected into other areas of the body.
Stage 3 - Preparing the injection site
To reduce discomfort when inserting a needle, you can make several claps at the site of the intended injection. Hands should be washed and the injection site should be wiped with a disinfectant solution (for example, 0.5% chlorhexidine) to remove surface bacteria. Apply approximately 6 cm around the point where the needle will enter and wait about a minute for the disinfectant solution to dry.
Step 4 - Inserting the needle
Pull the skin back a little. With your other hand, insert the needle at a 90° angle under the surface of the skin.
Step 5 - Checking the correct needle position
When the needle is positioned correctly, the piston is quite difficult to return.
Blood seeping into the syringe indicates that the needle has pierced a vein or artery. In this case, remove the syringe, cover the injection site with a swab containing disinfectant liquid 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 step 1, using a new needle and syringe, and a new bottle of the drug.
Stage 6 - Introduction of the solution
Lower the plunger slowly and gradually to ensure proper injection of the solution without damaging the skin tissue.
Stage 7
—
Removing the syringe
Quickly remove the syringe, cover the injection site with a swab containing disinfectant liquid and apply pressure. Gently massaging this area (with constant pressure) will help distribute the Puregon® solution and help avoid discomfort.
