the package insert of the medicine Puregon. Active principles Folitrofina Beta Injetavel.
PUREGON is indicated for the treatment of female infertility in the following situations: * anovulation (including disease policistíca ovarian) in women who were non-responsive to treatment with clomiphene citrate: ovarian hyperstimulation controlled to induce the development of multiple follicles in programs of assisted reproduction (for example, in vitro fertilization/embryo transfer (FIV/TE) and transfer intratubária of gametes or zygotes (GIFT/ZIFT), and intracytoplasmic espermetozóide (ICSI).
How it works?
After the intramuscular administration or the subcutaneous of PUREGON, maximum levels of FSH are reached within about 12 hours. Due to the extended release, and to the half-life of elimination is relatively high, about 40 hours, the FSH levels remain high for 24-48 hours. Even so, due to the half-life of elimination is relatively long, the concentrations of FSH in plasma are approximately 1.5-2.5 times higher after repeated administration than after single administration, which contributes to achieve the therapeutic concentrations. There are no differences in pharmacologically significant between subcutaneous administration and intramuscular of PUREGON. As the FSHrec and biochemically very similar to the FSH endogenous human, it is distributed, metabolized and excreted the same way.
When should I not use?
PUREGON is contraindicated in cases of: tumors of the ovary, breast, uterus, pituitary and hypothalamus; pregnancy and lactation; vaginal bleeding not diagnosed; hypersensitivity to any of the substances of PUREGON; bankruptcy primary ovarian; ovarian cysts or ovaries, increased, non-related with polycystic liver disease ovarian; mal-formations of the õrgãos sexual incompatible with pregnancy; uterine fibroids incompatible with pregnancy.
How to use?
There are large variations in inter-and intra-individual response of the ovaries to gonadotrofínas exogenous, so it is impossible to establish a dosing regimen to be uniform. Therefore, the adjustment should be done individually, depending on the response of the ovary. For this it is necessary to do the monitoring through ultrasounds and through the dosage level estrogenic and (or) clinical evaluation of the level estrogenic. After pituitary desensitization induced by a GnRH agonist, a higher dose of PUREGON may be needed to achieve a response ovarian proper. Clinical experience with PUREGON is based on up to 3 treatment cycles in both indications. The experience with IVF indicates the success rate of treatment, remains stable during the first 4 attempts and gradually declines thereafter. Anovulation: In general it is recommended a treatment scheme sequential. It is usually initiated with daily administration of 75 IU of FSH, the dose that must be maintained during 5-7 days. If it is not detected a response of the ovaries, the dose should be increased gradually until the estrogen levels start to increase. It is considered to be a great speed increase on the order of 40% – 100% a day. Then the effective daily dose is maintained until reaching the conditions of pre-ovulation. The conditions pre-ovulatórias are achieved when there is evidence that ultrasonographic of a dominant follicle of at least 18 mm in diameter and (or) when the levels of estradiol plasma level of 300-900 body weight/ml (1.000-3.000 pmol/l) are identified. The administration of PUREGON is then stopped and can induce ovulation. administering human chorionic gonadotropin (hCG) at a dose of 5,000-10,000 IU. If the levels of estrôgenos increase very quickly, more than twice a day, during 2 or 3 consecutive days, the daily dose should be decreased. As the follicles of over 14 mm may produce pregnancy, multiple follicles, pre-ovulatory with more than 14 mm increase the risk of multiple pregnancy. In this case, you must suspend the hCG in order to avoid multiple pregnancies. Hyperstimulation controlled ovarian in programs of assisted reproduction: Several stimulation protocols can be employed. A starting dose of 150-225 IU is recommended for the first four days of stimulation. From this point on the dose should be adjusted individually, based on the response to ovarian. Clinical studies have shown that dosages of maintenance, ranging from 75-375 IU for six to twelve days are sufficient, while treatments longer may be required, PUREGON can be used alone or in combination with agonist GnRH to prevent the luteinização premature. In the latter case, a total dose of treatment, the greater may be required. The maturation of the follicles is monitored by ultrasonography and by plasma levels of estrogens. When evaluating ultrasound indicates the presence of at least three follicles of 16-20 mm, and the response of estradiol is good [plasma levels of about 300-400 body weight/ml (1000-3.000 pmol/l) for each follicle with a diameter greater than 18 mm], is the induction of the final phase of follicular maturation by administering hCG at a dose of 5,000-10,000 IU. The recovery of oocytes is performed after 34 to 35 hours a.
What are the evils that can cause me?
The ovarian hyperstimulation unwanted can be observed in 5% of patients treated with PUREGON. Symptoms characteristic of these conditions have already been described (see Precautions and warnings). The use of PUREGON by both via IM or SC, can lead to reactions at the site of application such as burning, pain, erythema, swelling and itching, the majority of which are of light intensity. Reactions generalised have not been observed. Formation of antibodies antifolitrofina beta or proteins derived from the host cell has not been reported during therapy. A slight increase of the risk of ectopic pregnancy and multiple pregnancy has been observed. In rare circumstances, arterial thromboembolism has been associated with therapy with menotrofina/human chorionic gonadotropin. This can occur with the treatment PUREGON/hCG therapy.
Warnings and Precautions
what should I know before using?
The presence of endocrinopatias non-gonadal, non-controlled (for example: disorders of the thyroid, adrenal, and pituitary) should be deleted. In cases of pregnancy produced by the induction of ovulation with preparations gonadotróficas, there is an increased risk of occur multiple pregnancy. There have been reported cases of hypersensitivity to the PUREGON, but the possibility exists that responses anaphylactic. The first injection of PUREGON should only be performed under medical supervision direct. Once that infertile women submitted to assisted reproduction, and particularly IVF, often have abnormalities tubárias, the frequency of ectopic pregnancy can be increased. Therefore, it is important to carry out an ultrasound examination at an early stage to confirm whether pregnancy is intra-uterine. The rates of miscarriage in women undergoing assisted reproduction techniques are higher than in the normal population. Hyperstimulation is not-desired. During the treatment should perform an ultrasonographic evaluation of follicular development and to determine the levels of estrogens prior to treatment and at regular intervals during the same, because the levels of estrogens can increase very quickly, more than twice a day, during 2 or 3 days in a row and, possibly, reaches values exceedingly high. If the hyperstimulation unwanted (not as part of ovarian hyperstimulation controlled in programs of assisted reproduction), must immediately suspend the administration of PUREGON. In this case, pregnancy should be avoided and should not be administered the hCG, because it can induce, in addition to ovulation multiple, the syndrome of ovarian hyperstimulation. The clinical symptoms of the syndrome of ovarian hyperstimulation moderate are abdominal pain, nausea, diarrhea and mild to moderate increase ovaries and ovarian cysts. In rare cases, can occur the syndrome of hiperestirnulação ovarian serious, that you can reach to trigger a critical situation. It is characterized by cístos ovarian-large (prone to rupture), ascites, often hydrothorax and weight gain. In rare situations, processes, thromboembolic arterial have been associated with therapy with gonadotrofínas. This can also happen with PUREGON/hCG therapy.
what to do if someone use a larger amount than is recommended?
there are No data on acute toxicity of PUREGON in humans, but acute toxicity of PUREGON the use of preparations with gonadotrofína urinary, in animal studies, proved to be very low. It was demonstrated that a very high dosage maintained for more than a day may lead to hyperstimulation of the ovaries.
Vial containing sphere liofílizada (or liosfera) + 1-ml ampoule with diluent PUREGON 50, 100 and 150 IU: Packaging with 1 ampoule with liosfera + 1 ampoule with diluent; packages of 5 ampoules with liosfera + 5 ampoules with diluent.
AKZO NOBEL Ltda. Division Organon
The joint use of PUREGON and clomiphene citrate can improve the response follicular. After the desensitization pituitary, through the use of an agonist GnRH, can be necessária a larger dose of PUREGON to produce a response follicular appropriate.
Folitrofina beta injectable (FSHrec human)
Composition Each ampoule with liosfera contains: Folitrofina beta 50, 100, 150 IU. Each ampoule diluent contains: sodium Chloride 4.5 mg.
PUREGON contains folitrofina beta (FSHrec human) produced by the technique of recombinant DNA, using hamster ovary cells chinese. The sequence of amino acids-primary is identical to that of human FSH natural. There are small differences in the structure of the chain of carbohydrates. FSH is indispensable in the growth and follicular maturation and in the production of steroids gonadal. In women, the amount of FSH is crucial in the beginning and in the maintenance of follicular development and, in consequence, in the time they take to mature and in the number of follicles that reach maturity, Therefore, PUREGON can be used to stimulate the follicular development and the production of steroids in selected cases of changes of the gonadal function. In addition, PUREGON can be used to promote multiple follicular development in programs of assisted reproduction (for example, in vitro fertilization) embryo transfer (FIV/TE), transfer intratubária of gamatas or zygotes (GIFT/ZIFT), and intracytoplasmic sperm injection (ICSI)]. Treatment with PUREGON is generally followed by administration of hCG to induce the final phase of follicular maturation, resumption of a cheesy and rupture of the follicle.
Administration and Mode of Use
PUREGON should be reconstituted with the diluent that is supplied. The reconstituted solution should be administered immediately. To prevent injections painful and prevent the reflux at the site of the injection, the solution of PUREGON should be slowly administered intramuscularly or subcutaneously. The site of the subcutaneous injection should be varied to prevent lipoatrophy. Any reconstituted solution not used should be seized. Injections subcutaneous of PUREGON can be administered by patient or partner, provided that the necessary instructions may be given by the doctor. The self-administration of PUREGON should only be performed by patients as well motivated, adequately trained and with access to expert advice. To use PUREGON correctly follow the following instructions:
1. Break the upper part of the ampoule diluent, firmly holding the bottle in one hand and pressing with the thumb of the other hand the upper part of the bulb, while it promotes a bending of this part to the back with your other finger. Repeat the procedure with the bulb with the liosfera.
2. Aspirate the contents of the ampoule-diluent with a syringe (not included).
3. Put the diluent in the ampoule with the liosfera of PUREGON.
4. Aspirate the solution recontituída of PUREGON with the same syringe.
5. The needle used for the operations will not be used for the injection, therefore changing the needle for another sterile needle
6. Gently tap with the fingers on the syringe and press the plunger, with the needle pointed upward, to force the output of the air until a drop appears at the tip of the needle.
7. Clean approximately 2 cm around the point wave the needle will be introduced, introduce the needle at a 90 degree angle relative to the surface of the skin and press the plunger slowly
8. Clean approximately 2 cm around the point where the needle will be introduced, to introduce the needle in the base of the skin clamped at an angle of 45 degrees relative to the surface of the skin and press the plunger slowly.
Use During Pregnancy and Lactation
PUREGON should not be used during pregnancy and lactation.
Akzo Nobel Ltda.
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