For the use of a Registered Medical Practitioner, Hospital or Laboratory
Endogen-HP administered for 7 to 12 days produces ovarian follicular growth in women who do not have primary ovarian failure. Treatment with Endogen-
HP in most instances results only in follicular growth and maturation. When sufficient follicular maturation has occurred, hCG (Pubergen JO 7500 IU)must be given to induce ovulation.
Urofollitropin for Injection Pharmacokinetics For Subcutaneous / Intramuscular Injection only
Published clinical data reveals that there is a variation in AUC & Cmax depending on the route of administration. Pharmacokinetic data obtained by
SC & IM routes are not bioequivalent.
Each ampoule of sterile freeze-dried product contains:
The maximum plasma concentration of FSH was attained at 20.5 and 17.4
(As Highly Purified Human Follicle Stimulating Hormone)
hours following SC and IM single dose administration, respectively.
Mannitol I.P. 12 mgPotassium Dihydrogen orthophosphate B.P.
However, following multiple dosing, it was attained at approximately 10 hours
Dipotassium Hydrogen orthophosphate B.P.
following both routes of administration.
Reconstitute with 1 ml of Sodium Chloride injection(0.9% w/v) I.P. provided with this pack. Distribution
Each ampoule of sterile freeze-dried product contains:
Human tissue or organ distribution of FSH has not been studied
(As Highly Purified Human Follicle Stimulating Hormone)Mannitol I.P.
Metabolism of FSH has not been studied for in humans.
Potassium Dihydrogen orthophosphate B.P.
Dipotassium Hydrogen orthophosphate B.P.
Reconstitute with 1 ml of Sodium Chloride injection(0.9% w/v) I.P. provided with this pack.
Published clinical studies have demonstrated the mean elimination half-lives of FSH for SC and IM single dosing are 31.8 and 37 hours, respectively.
However, following multiple dosing (X 7 days) they are 20.6 and 15.2 hours for SC and IM, respectively.
Endogen-HP is a product containing a highly purified preparation of human follicle stimulating hormone (hFSH) extracted from the urine of
postmenopausal women. Human FSH consists of two non-covalently linked
Endogen-HP is not indicated in pediatric populations.
amino acids of which two are modified by attachment of carbohydrates. The
subunit has 111 amino acids of which two are modified by attachment of
Endogen-HP is not indicated in geriatric populations.
Endogen-HP is a sterile, lyophilized powder intended for subcutaneous (SC)
or intramuscular (IM) injection after reconstitution with Sodium Chloride 0.9% w/v Injection.
The safety and efficacy of Endogen-HP in renal and hepatic insufficiency have not been studied.
Indications & Usage Drug Interactions Ovulation Induction
No drug / drug interaction studies have been conducted for Endogen-HP in
Endogen-HP administered SC or IM in conjunction with hCG, (Pubergen JO
7500 IU) is indicated for ovulation induction in patients who have previously received pituitary suppression. Storage Conditions Multifollicular Development during ART
Store between 2 C - 8O C. Do not freeze.
Endogen-HP administered SC in conjunction with hCG is indicated for
Use Immediately after reconstitution.
multiple follicular development (controlled ovarian stimulation) during ART
After reconstitution of Endogen-HP, if the reconstituted solution is not used,
cycles in patients who have previously received pituitary suppression. Selection of Patients How Supplied
1.Before treatment with Endogen-HP is instituted, a thorough gynecologic
Box containing 1 Ampoule of sterile freeze-dried Highly Purified Urofollitropin
and endocrine evaluation must be performed. Except for those patients
75 IU + 1 Ampoule of Sodium chloride injection I.P.(0.9 %w/v).
enrolled in an in vitro fertilization program, this should include a hysterosalp in angiography (to rule out uterine and tubal pathology) and documentation of
Box containing 1 Ampoule of sterile freeze-dried Highly Purified
anovulation by means of basal body temperature, serial vaginal smears,
Urofollitropin 150 IU + 1 Ampoule of Sodium chloride injection I.P. (0.9 %w/v).
examination of cervical mucus, determination of serum (or urine)
progesterone, urinary pregnanediol and endometrial biopsy.
2.Primary ovarian failure should be excluded by the determination of
3.Careful examination should be made to rule out the presence of an early pregnancy.
4.Patients in late reproductive life have a greater predilection to endometrial
Gaganpahad, R.R. Dist. - 501 323, A.P., India
carcinoma as well as a higher incidence of anovulatory
disorders. Cervical dilation and curettage should always be done for
Careful monitoring of ovarian response can further minimize the risk of over
diagnosis before starting Endogen-HP therapy in such patients who
stimulation. If the ovaries are abnormally enlarged on the last day of Endogen
demonstrate abnormal uterine bleeding or other signs of endometrial
HP therapy, hCG should not be administered in the course of therapy; this will
reduce the chances of development of the Ovarian Hyperstimulation Syndrome. If severe OHSS occurs, treatment must be stopped and the
5.Evaluation of the husband's fertility potential should be included in the
Multiple pregnancies have occurred following treatment with Endogen-HP
Infertile patients with oligo-anovulation: The dose of Endogen-HP to
SC and IM. The patient and her partner should be advised of the potential risk
stimulate development of ovarian follicles must be individualized for each
of multiple births before starting treatment.
patient. The lowest dose consistent with achieving good results based on clinical experience and reported clinical data should be used. The
recommended initial dose of Endogen-HP for patients who have received
Hypersensitivity/anaphylactic reactions associated with follitropins for
GnRH agonist or antagonist pituitary suppression is 150 IU daily
injection, have been reported in some patients.
administered SC or IM for the first 5 days of treatment. Precautions
Based on clinical monitoring (including serum estradiol levels and vaginal ultrasound results) subsequent dosing should be adjusted according to
individual patient response. Adjustments in dose should not be made more frequently than once every 2 days and should not exceed more than 75 to
The combination of both estradiol levels and ultrasonography are useful for
150 IU per adjustment. The maximum daily dose of Endogen-HP should not
monitoring the growth and development of follicles, timing hCG
exceed 450 IU and in most cases dosing beyond 12 days is not
administration, as well as minimizing the risk of the Ovarian Hyperstimulation
Syndrome and multiple gestations. The clinical confirmation of ovulation, is determined by:
If patient response to Endogen-HP is appropriate, hCG 7500 IU units, Pubergen JO should be given 1 day following the last dose of Endogen-HP
.or the follicle attains a size greater than 18 mm. hCG should be withheld if the
serum estradiol is greater than 2000 pg/mL, if the ovaries are abnormally
c. Menstruation following the shift in basal body temperature.
enlarged or if abdominal pain occurs, and the patient should be advised to
When used in conjunction with indices of progesterone production,
refrain from intercourse. These precautions may reduce the risk of Ovarian
sonographic visualization of the ovaries will assist in determining if ovulation
Hyperstimulation Syndrome and multiple gestations. Patients should be
has occurred. Sonographic evidence of ovulation may include the following:
followed closely for at least 2 weeks after hCG administration. If there is inadequate follicle development or ovulation without subsequent pregnancy,
the course of treatment with Endogen-HP may be repeated.
b. Ovarian stigmata, andc. Collapsed follicle. Assisted Reproductive Technologies:
Because of the subjectivity of the various tests for the determination of
The recommended initial dose of Endogen-HP for patients undergoing IVF
follicular maturation and ovulation, it cannot be overemphasized that the
and donor egg patients who have received GnRH agonist or antagonist
physician should choose tests with which he/she is thoroughly familiar.
pituitary suppression is 225 IU daily administered SC for the first 5 days of treatment. Based on clinical monitoring (including serum estradiol levels and
Carcinogenesis and Mutagenesis
vaginal ultrasound results) subsequent dosing should be adjusted according to individual patient response. Adjustments in dose should not be made more
Long-term toxicity studies in animals and in vitro mutagenicity tests have not
frequently than once every 2 days and should not exceed more than 75 to
been performed to evaluate the carcinogenic potential of urofollitropin for
150 IU per adjustment. The maximum daily dose of Endogen-HP given
should not exceed 450 IU and in most cases dosing beyond 12 days is not
Pregnancy & Lactation
Endogen-HP should not be administered during pregnancy. It is not known
Once adequate follicular development is evident, highly purified hCG 7500
whether the drug is excreted in breast milk.
IU(Pubergen JO) should be administered to induce final follicular maturation in preparation for oocyte retrieval. The administration of hCG must be
withheld in cases where the ovaries are abnormally enlarged on the last day of therapy. This should reduce the chance of developing OHSS.
Safety and effectiveness in geriatric patients have not been established.
Gastrointestinal Nausea, Vomitting, Abdominal Pain
Aside from possible ovarian hyperstimulation and multiple gestations, little is
known concerning the consequences of acute overdosage with Endogen-
In susceptible individuals Ovarian Hyperstimulation Syndrome (OHSS)
Endogen-HP drug that should only be used by physicians who are thoroughly
Endogen-HP is contraindicated in women who have:
Ahigh FSH level indicating primary ovarian failure. Overstimulation of the Ovary During Endogen-HP Therapy
Uncontrolled thyroid and adrenal dysfunction.
Ovarian Enlargement: Mild to moderate uncomplicated ovarian enlargement
An organic intracranial lesion such as pituitary tumor.
which may be accompanied by abdominal distension and/or abdominal pain
The presence of any cause of infertility other than anovulation.
occurs in susceptible individuals treated with follitropin and hCG, and
Abnormal bleeding of undetermined origin.
generally regresses without treatment within two or three weeks. In order to
Ovarian cysts or enlargement not due to polycystic ovary syndrome.
Prior hypersensitivity to urofollitropins, purified.
minimize the hazard associated with the occasional abnormal ovarian 1
Endogen-HP is contraindicated in women who are pregnant and may
enlargement, which may occur withFSH - hCG therapy, the lowest dose (D5
cause fetal harm when administered to a pregnant woman. There are
consistent with expectation of good results should be used.
limited human data on the effects of Endogen-HP when administered
ANDREW B. SILVA, MD VIRGINIA HEAD AND NECK SURGEONS P.C. HERE’S WHAT TO DO IF A NOSE BLEED STARTS: Sit down or lay down with your head propped up on 2 or 3 pillows. Keep calm and remember many nose bleeds will stop all by themselves if you just rest for a few minutes. If you are driving or operating heavy or dangerous equipment stop. Put an ice pack on your nose . Get a thin washclot
Birthing Basics, LLC Class Syllabus Lisa-Marie Cook RNC-OB, BSN, ICCE, CD Cook CounterpressureSM This five hour long childbirth class is designed to provide the mother and father a comprehensive, informative session covering all aspects of childbirth beginning with the last trimester, covering labor and delivery and newborn childcare. Topics in labor and delivery include the newest evidence-based