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DRUGS & SUPPLEMENTS
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How old is patient? |
Eema-FSH® is a gonadotropin indicated for:
Prior to initiation of treatment with Eema-FSH®:
Prior to initiation of treatment with Eema-FSH®:
Ovulation Induction
Assisted Reproductive Technology (ART) (2.3)
The dosing scheme is stepwise and is individualized for each woman .
Discourage intercourse when the risk for OHSS is increased .
The recommended dosing scheme for patients undergoing IVF follows a stepwise approach and is individualized for each woman. The recommended initial dose of Eema-FSH® for women who have received a GnRH agonist for pituitary suppression is 225 International Units. Eema-FSH® may be administered together with MENOPUR® (menotropins for injection, USP), and the total initial dose when the products are combined should not exceed 225 International Units (150 International Units of Eema-FSH® and 75 International Units of MENOPUR® or 75 International Units of Eema-FSH® and 150 International Units of MENOPUR®).
Lyophilized powder for Injection containing 82.5 International Units of FSH, to deliver 75 International Units of FSH after reconstituting with the diluent, supplied in sterile vials with diluent vials and Q-Cap® vial adapters.
Lyophilized powder for injection: containing 82.5 International Units of FSH, to deliver 75 International Units FSH after reconstituting, supplied as lyophilized powder in sterile vials with diluent vials. (3)
Eema-FSH® is contraindicated in women who exhibit:
Eema-FSH® may cause fetal harm when administered to a pregnant woman . Eema-FSH® is contraindicated in women who are pregnant. If this drug is used during pregnancy, or if the woman becomes pregnant while taking this drug, the woman should be apprised of the potential hazard to a fetus.
Eema-FSH® is contraindicated in women who exhibit:
Eema-FSH® should only be used by physicians who are experienced in infertility treatment. Eema-FSH® contains gonadotropic substances capable of causing in women, Ovarian Hyperstimulation Syndrome [OHSS] with or without pulmonary or vascular complications and multiple births . Gonadotropin therapy requires the availability of appropriate monitoring facilities . Use the lowest effective dose.
Hypersensitivity/anaphylactic reactions associated with urofollitropins for injection, purified administration have been reported in some patients. These reactions presented as generalized urticaria, facial edema, angioneurotic edema, and/or dyspnea suggestive of laryngeal edema. The relationship of these symptoms to uncharacterized urinary proteins is uncertain.
In order to minimize the hazard associated with abnormal ovarian enlargement that may occur with Eema-FSH® therapy, the lowest effective dose should be used . Use of ultrasound monitoring of ovarian response and/or measurement of serum estradiol levels is important to minimize the risk of ovarian stimulation .
If the ovaries are abnormally enlarged on the last day of Eema-FSH® therapy, hCG should not be administered in order to reduce the chances of development of the Ovarian Hyperstimulation Syndrome . Prohibit intercourse in women with significant ovarian enlargement because of the danger of hemoperitoneum resulting from rupture of ovarian cysts .
OHSS: OHSS is a medical event distinct from uncomplicated ovarian enlargement. OHSS may progress rapidly to become a serious medical event. It is characterized by an apparent dramatic increase in vascular permeability, which can result in a rapid accumulation of fluid in the peritoneal cavity, thorax, and potentially, the pericardium. The early warning signs of development of OHSS are severe pelvic pain, nausea, vomiting, and weight gain. Abdominal pain, abdominal distension, gastrointestinal symptoms including nausea, vomiting and diarrhea, severe ovarian enlargement, weight gain, dyspnea, and oliguria have been reported with OHSS. Clinical evaluation may reveal hypovolemia, hemoconcentration, electrolyte imbalances, ascites, hemoperitoneum, pleural effusions, hydrothorax, acute pulmonary distress, and thromboembolic events . Transient liver function test abnormalities suggestive of hepatic dysfunction, which may be accompanied by morphologic changes on liver biopsy, have been reported in association with OHSS.
OHSS occurs after treatment has been discontinued and reaches its maximum at about 7 to 10 days after treatment. Usually, OHSS resolves spontaneously with the onset of menses. If there is evidence that OHSS may be developing prior to hCG administration , the hCG must be withheld.
Cases of OHSS are more common, more severe and more protracted if pregnancy occurs. OHSS develops rapidly; therefore patients should be followed for at least two weeks after hCG administration.
If severe OHSS occurs, gonadotropins, including hCG, must be stopped and consideration should be given as to whether the woman needs be hospitalized. Treatment is primarily symptomatic and overall should consist of bed rest, fluid and electrolyte management, and analgesics (if needed). Because the use of diuretics can accentuate the diminished intravascular volume, diuretics should be avoided except in the late phase of resolution as described below. The management of OHSS may be divided into three phases as follows:
Management should be directed at preventing hemoconcentration due to loss of intravascular volume to the third space and minimizing the risk of thromboembolic phenomena and kidney damage. Fluid intake and output, weight, hematocrit, serum and urinary electrolytes, urine specific gravity, BUN and creatinine, total proteins with albumin: globulin ratio, coagulation studies, electrocardiogram to monitor for hyperkalemia, and abdominal girth should be thoroughly assessed daily or more often based on the clinical need. Treatment, consisting of limited intravenous fluids, electrolytes, human serum albumin, is intended to normalize electrolytes while maintaining an acceptable but somewhat reduced intravascular volume. Full correction of the intravascular volume deficit may lead to an unacceptable increase in the amount of third space fluid accumulation.
After the acute phase is successfully managed as above, excessive fluid accumulation in the third space should be limited by instituting severe potassium, sodium, and fluid restriction.
As third space fluid returns to the intravascular compartment, a fall in hematocrit and increasing urinary output are observed in the absence of any increase in intake. Peripheral and/or pulmonary edema may result if the kidneys are unable to excrete third space fluid as rapidly as it is mobilized. Diuretics may be indicated during the resolution phase, if necessary, to combat pulmonary edema.
Do not remove ascitic, pleural, and pericardial fluid unless there is the necessity to relieve symptoms such as pulmonary distress or cardiac tamponade.
OHSS increases the risk of injury to the ovary. Pelvic examination or intercourse may cause rupture of an ovarian cyst, which may result in hemoperitoneum, and should be avoided.
If bleeding occurs and requires surgical intervention, the clinical objective should be to control the bleeding and retain as much ovarian tissue as possible. A physician experienced in the management of this syndrome, or who is experienced in the management of fluid and electrolyte imbalances, should be consulted.
In a clinical study of induction of ovulation indication, 6 of 72 (8.33%) Eema-FSH® treated women developed OHSS and 2 were classified as severe. In a clinical study for the development of multiple follicles as part of an IVF cycle, 3 of 60 women treated with Eema-FSH® developed OHSS and 1 was classified as severe.
Serious pulmonary conditions have been reported in women treated with gonadotropins. In addition, thromboembolic events both in association with, and separate from, the Ovarian Hyperstimulation Syndrome have been reported in women treated with gonadotropins. Intravascular thrombosis and embolism, which may originate in venous or arterial vessels, can result in reduced blood flow to critical organs or the extremities. Women with generally recognized risk factors for thrombosis, such as personal or family history, severe obesity, or thrombophilia, may have an increased risk of venous or arterial thromboembolic events during or following treatment with gonadotropins. Sequelae of such reactions have included venous thrombophlebitis, pulmonary embolism, pulmonary infarction, cerebral vascular occlusion (stroke), and arterial occlusion resulting in loss of limb and rarely in myocardial infarctions. In rare cases, pulmonary complications and/or thromboembolic events have resulted in death. In women with recognized risk factors, the benefits of ovulation induction and assisted reproductive technology need to be weighed against the risks. Pregnancy also carries an increased risk of thrombosis.
Ovarian torsion has been reported after treatment with gonadotropins. This may be related to OHSS, pregnancy, previous abdominal surgery, past history of ovarian torsion, previous or current ovarian cyst and polycystic ovaries. Damage to the ovary due to reduced blood supply can be limited by early diagnosis and immediate detorsion.
Multi-fetal gestation and births have been reported with all gonadotropin therapy including therapy with Eema-FSH®.
In a controlled study of 72 patients undergoing induction of ovulation, 66.7% of pregnancies of women treated with subcutaneous Eema-FSH® were multiples, while 28.6% of pregnancies in women treated with intramuscular Eema-FSH® were multiples.
In a controlled study of 60 patients undergoing IVF, 34.8% of pregnancies of women treated with subcutaneous Eema-FSH® were multiples.
Before beginning treatment with Eema-FSH®, advise the woman and her partner of the potential risk of multi-fetal gestation and birth.
The incidence of congenital malformations after some ART [specifically in vitro fertilization or intracytoplasmic sperm injection (ICSI)] may be slightly higher than after spontaneous conception. This slightly higher incidence is thought to be related to differences in parental characteristics (e.g., maternal age, maternal and paternal genetic background, sperm characteristics) and to the higher incidence of multi-fetal gestations after IVF or ICSI. There are no indications that the use of gonadotropins during IVF or ICSI is associated with an increased risk of congenital malformations.
Since infertile women undergoing ART often have tubal abnormalities, the incidence of ectopic pregnancy may be increased. Early confirmation of intrauterine pregnancy should be determined by β-hCG testing and transvaginal ultrasound.
The risk of spontaneous abortion is increased with gonadotropin products. However, causality has not been established. The increased risk may be a factor of the underlying infertility.
There have been infrequent reports of ovarian neoplasms, both benign and malignant, in women who have had multiple drug therapy for controlled ovarian stimulation; however, a causal relationship has not been established.
In most instances, treatment of women with Eema-FSH® will result only in follicular growth and maturation. In the absence of an endogenous LH surge, hCG is given when monitoring of the woman indicates that sufficient follicular development has occurred. This may be estimated by ultrasound alone or in combination with measurement of serum estradiol levels. The combination of both ultrasound and serum estradiol measurement are useful for monitoring follicular growth and maturation, timing of the ovulatory trigger, detecting ovarian enlargement and minimizing the risk of the Ovarian Hyperstimulation Syndrome and multiple gestation.
The clinical confirmation of ovulation is obtained by direct or indirect indices of progesterone production as well as sonographic evidence of ovulation.
Direct or indirect indices of progesterone production:
Sonographic evidence of ovulation:
The following serious adverse reactions are discussed elsewhere in the labeling:
To report SUSPECTED ADVERSE REACTIONS, contact Ferring Pharmaceuticals Inc. at 1-888-FERRING (1-888-337-7464) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice.
The safety of Eema-FSH® was examined in four clinical studies that enrolled a total of 222 women who received Eema-FSH®.
Ovulation Induction
In a randomized, multi-center, active controlled study, a total of 72 women received Eema-FSH® (35 in a subcutaneous administration arm and 37 in an intramuscular administration arm) for induction of ovulation. Adverse reactions occurring at an incidence of ≥2% incidence in women receiving Eema-FSH® are shown in Table 1.
All Patients with Adverse Events ≥ 2% | ||
---|---|---|
Adverse Events (%) | Eema-FSH® subcutaneous | Eema-FSH® intramuscular |
N=35 | N=37 | |
Genitourinary/Reproductive | ||
OHSS | 4 (11.4) | 2 (5.4) |
Vaginal Hemorrhage | 3 (8.6) | 0 (0.0) |
Ovarian Disorder (Pain, Cyst) | 1 (2.9) | 3 (8.1) |
Urinary tract infection | 0 | 1 (2.7) |
Cervix disorder | 1 (2.9) | 0 |
Gastrointestinal | ||
Nausea | 2 (5.7) | 0 (0.0) |
Enlarged Abdomen | 1 (2.9) | 1 (2.7) |
Abdominal Pain | 1 (2.9) | 2 (5.4) |
Vomiting | 0 | 1 (2.7) |
Constipation | 0 | 1 (2.7) |
Diarrhea | 0 | 1 (2.7) |
Metabolic/Nutritional | ||
Dehydration | 0 | 1 (2.7) |
Weight gain | 1 (2.9) | 0 |
Skin/Appendages | ||
Acne | 1 (2.9) | 0 |
Exfoliative dermatitis | 0 | 1 (2.7) |
Other Body Systems | ||
Headache | 4 (11.4) | 3 (8.1) |
Pain | 2 (5.7) | 0 (0.0) |
Neck pain | 0 | 1 (2.7) |
Respiratory Disorder | 2 (5.7) | 0 (0.0) |
Hot Flashes | 2 (5.7) | 0 (0.0) |
Fever | 0 | 1 (2.7) |
Hypertension | 0 | 1 (2.7) |
Emotional lability | 0 | 1 (2.7) |
Depression | 0 | 1 (2.7) |
Accidental injury | 0 | 1 (2.7) |
Assisted Reproductive Technology
Three studies examined the safety profile of Eema-FSH® in ART. A total of 150 women received treatment with Eema-FSH® in these studies. Adverse reactions occurring at an incidence of ≥2% incidence for this integrative assessment are presented in Table 2.
All Patients with Adverse Events ≥ 2% | |
---|---|
Adverse Events (%) | Eema-FSH® subcutaneous |
N=150 | |
Genitourinary/Reproductive | |
Vaginal hemorrhage | 7 (4.7) |
Post retrieval pain | 12 (8.0) |
Pelvic pain/cramps | 10 (6.7) |
OHSS | 9 (6.0) |
Uterine spasms | 4 (2.7) |
Vaginal spotting | 4 (2.7) |
Urinary tract infection | 5 (3.3) |
Ovarian disorder | 3 (2.0) |
Breast tenderness | 3 (2.0) |
Vaginal Discharge | 4 (2.7) |
Infection fungal | 3 (2.0) |
Gastrointestinal | |
Abdominal cramps | 21 (14.0) |
Nausea | 13 (8.7) |
Abdominal pain | 7 (4.7) |
Abdominal fullness/enlargement | 10 (6.7) |
Constipation | 3 (2.0) |
Other Body Systems | |
Headache | 19 (12.7) |
Pain | 8 (5.3) |
Rash | 4 (2.7) |
Respiratory disorder | 6 (4.0) |
Sinusitis | 3 (2.0) |
Injection site reaction | 6 (4.0) |
Hot flash | 6 (4.0) |
Emotional lability | 3 (2.0) |
The following adverse reactions have been reported during postmarketing use of gonadotropins. Because these reactions were reported voluntarily from a population of uncertain size, the frequency or a causal relationship to Eema-FSH® cannot be reliably determined.
No drug/drug interaction studies in humans have been conducted for Eema-FSH®.
No drug/drug interaction studies have been conducted for Eema-FSH® in humans (7)
Teratogenic effects
Pregnancy Category X .
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in the nursing infant from Eema-FSH®, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Safety and effectiveness in pediatric patients have not been established.
Safety and effectiveness in women with renal and hepatic sufficiency have not been established.
Aside from possible ovarian hyperstimulation and multiple gestations , little is known concerning the consequences of acute overdosage with Eema-FSH®.
Eema-FSH® is a product containing a highly purified preparation of human follicle stimulating hormone (hFSH) extracted from the urine of postmenopausal women. Human FSH is a gonadotropin and consists of two non-covalently linked glycoproteins designated as the α and β subunits. The α subunit has 92 amino acids of which two are modified by attachment of carbohydrates. The β subunit has 111 amino acids of which two are modified by attachment of carbohydrates.
Eema-FSH® is a sterile, lyophilized powder intended for subcutaneous or intramuscular injection after reconstitution with sterile 0.9% Sodium Chloride Injection, USP. Each vial of Eema-FSH® contains 82.5 International Units (IU) of Follicle Stimulating Hormone (FSH) activity, 23 mg Lactose Monohydrate, 0.005 mg Polysorbate 20, and Sodium Phosphate buffer (Sodium Phosphate dibasic, Heptahydrate and Phosphoric acid) for pH adjustments, which, when reconstituted with diluent, will deliver 75 International Units of FSH. Eema-FSH® contains up to 2% luteinizing hormone (LH) activity based on bioassay. Human Chorionic Gonadotropin (hCG) is not detected in Eema-FSH®. When stored at 3° to 25°C, up to 40% of the α-subunits may be oxidized.
The in vivo biological activity of Eema-FSH for injection, purified is determined by using reference standards calibrated against the First International Standard for follicle-stimulating hormone, (FSH, Eema-FSH), Urinary, Human for Bioassay, National Institute for Biological Standards and Control (NIBSC) at its 46th meeting in 1995.
FSH is a glycoprotein that is acidic and water-soluble.
Eema-FSH® has been mixed in vitro with MENOPUR® with no evidence of aggregation.
Therapeutic class: Infertility
Eema-FSH® administered for 7 to 12 days produces ovarian follicular growth in women who do not have primary ovarian failure. Treatment with Eema-FSH® in most instances results only in follicular growth and maturation. When sufficient follicular maturation has occurred, hCG must be given to induce ovulation.
Single doses of 225 International Units and multiple daily doses (7 days) of 150 International Units of Eema-FSH® were administered to healthy volunteer female subjects while their endogenous FSH was suppressed. Sixteen subjects received Eema-FSH® subcutaneously and 12 received the drug intramuscularly. Serum FSH concentrations were determined. Based on the steady state ratio of FSH Cmax and AUC, subcutaneous and intramuscular administration of Eema-FSH® were not bioequivalent. Multiple doses of Eema-FSH® intramuscular resulted in Cmax and AUC of 77.7% and 81.8% compared to multiple doses of Eema-FSH® subcutaneous. The FSH pharmacokinetic parameters for single and multiple dose Eema-FSH®, administered subcutaneously and intramuscularly are in Table 3.
Single Dose (225 IU) | Multiple Dose × 7 (150 IU) | |||
---|---|---|---|---|
PK Parameters | Subcutaneous | Intramuscular | Subcutaneous | Intramuscular |
Cmax (mIU/mL) | 6.0 (1.7) | 8.8 (4.5) | 14.8 (2.9) | 11.5 (2.9) |
Tmax (hrs) | 20.5 (7.7) | 17.4 (12.2) | 9.6 (2.1) | 11.3 (8.4) |
AUCobs (mIU∙hr/mL) | 379 (111) | 331 (179) | 234.7 (77.0) | 192.1 (52.3) |
t1/2 (hrs) | 31.8 | 37 | 20.6 | 15.2 |
Absorption
The subcutaneous route of administration trends toward greater bioavailability than the IM route for single and multiple doses of Eema-FSH®.
Distribution
Human tissue or organ distribution of FSH has not been studied for Eema-FSH®.
Metabolism
Metabolism of FSH has not been studied for Eema-FSH® in humans.
Elimination
The mean elimination half-lives of FSH for subcutaneous and intramuscular single dosing are 31.8 and 37 hours, respectively. However, following multiple dosing (× 7 days) they are 20.6 and 15.2 hours for SC and IM, respectively.
Long-term toxicity studies in animals and in vitro mutagenicity tests have not been performed to evaluate the carcinogenic potential of Eema-FSH for injection, purified.
The efficacy of Eema-FSH® was examined in two clinical studies, one for in-vitro fertilization and one for ovulation induction (OI).
In the randomized, multi-center, active-controlled, ovulation induction study, women underwent pituitary suppression with a GnRH agonist before being randomized to subcutaneously administered Eema-FSH® , intramuscularly-administered Eema-FSH®, or a subcutaneously administered commercial recombinant FSH product. A total of 111 oligo-anovulatory women were randomized to both treatment arms, of which 72 received Eema-FSH®, starting at a dose of 150 International Units daily for 5 days. Subsequently each woman received individual titration of the Eema-FSH® dose from 75 to 450 International Units daily based on ultrasound and estradiol (E2) levels. The total duration of dosing did not exceed 12 days. Results for the Intent-To-Treat Population are summarized in Table 4.
Eema-FSH® Subcutaneous | Eema-FSH® Intramuscular | |
---|---|---|
Parameter | N=35 | N=37 |
Ovulation (%) | 24 (68.6) | 26 (70.3) |
Received hCG (%) | 25 (71.4) | 28 (75.7) |
Mean Peak Serum E2 (pg/mL) (SD) | 976.5 (680.6) | 893.2 (815.2) |
Chemical Pregnancy (%) | 11 (31.4) | 8 (21.6) |
Clinical Pregnancy (%) | 9 (25.7) | 7 (18.9) |
Continuing Pregnancy (%) | 9 (25.7) | 7 (18.9) |
Pts. w/Live Births (%) | 9 (25.7) | 6 (16.2) |
In the randomized, multi-center, active-controlled, IVF study, women underwent pituitary suppression with a GnRH agonist before being randomized to subcutaneously administered Eema-FSH® or a subcutaneously administered commercial recombinant FSH product. A total of 120 patients were randomized to both treatment arms, of which 60 received Eema-FSH®, starting at a dose of 225 International Units daily for 5 days. Subsequently each woman received individual titration of the dose from 75 to 450 International Units daily based on ultrasound and estradiol (E2) levels. The total duration of dosing did not exceed 12 days. Results are summarized in Table 5 for the Intent-To-Treat population.
Eema-FSH® subcutaneous | |
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Parameter | n=60 |
Mean Total Oocytes Retrieved Per Patient (SD) | 11.8 (6.3) |
Mean Mature Oocytes Retrieved Per Patient (SD) | 9.0 (5.7) |
Patients with Oocyte Retrieval (%) | 57 (95.0) |
Patients with Embryo Transfer (%) | 57 (95.0) |
Patients with Chemical Pregnancy (%) | 28 (46.6) |
Patients with Clinical Pregnancy (%) | 25 (41.7) |
Patients with Continuing Pregnancy (%) | 23 (38.3) |
Eema-FSH® is supplied in a sterile, lyophilized, single dose vial containing 82.5 International Units of FSH, to deliver 75 International Units FSH after reconstituting with the diluent.
Each vial is available with an accompanying vial of sterile diluent containing 2 mL of 0.9% Sodium Chloride Injection, USP.
75 International Units FSH activity, supplied as:
NDC 55566-8505-6: Box of 5 vials + 5 vials diluent + 5 Q-Cap® vial adaptors.
Lyophilized powder may be stored refrigerated or at room temperature (3° to 25° C/37° to 77°F). Protect from light. Use immediately after reconstitution. Discard unused material.
See FDA-approved patient labeling
Instruct women on the correct usage and dosing of MENOPUR® . Caution women not to change the dosage or the schedule of administration unless she is told to do so by her healthcare provider.
Prior to beginning therapy with Eema-FSH®, inform women about the time commitment and monitoring procedures necessary for treatment.
Inform the woman that if she misses or forgets to take a dose of Eema-FSH®, the next dose should not be doubled and she should call her healthcare provider for further dosing instructions.
Inform women regarding the risks of OHSS and OHSS-associated symptoms including lung and blood vessel problems and ovarian torsion with the use of Eema-FSH®.
Inform women regarding the risk of multi-fetal gestation and birth with the use of Eema-FSH® .
Vials of sterile diluent of 0.9% Sodium Chloride Injection, USP, manufactured for Ferring Pharmaceuticals Inc.
MANUFACTURED FOR:
Step 1. Preparing your Eema-FSH® or Eema-FSH® mixed with MENOPUR®.
If your healthcare provider tells you to use more than 1 vial of Eema-FSH® or tells you to mix your Eema-FSH® with MENOPUR® in the same syringe:
Step 2. Removing the Q-Cap® and adding your needle for injection.
Your healthcare provider will tell you what needle you should use for your injection.
Step 3. Prepare Injection site for Eema-FSH® or with Eema-FSH® mixed with MENOPUR®.
Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
MANUFACTURED FOR:
FERRING PHARMACEUTICALS INC.
PARSIPPANY, NJ 07054
Revised: July 2015
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Depending on the reaction of the Eema-FSH after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Eema-FSH not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Eema-FSH addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology