Bemfolа

INSTRUCTIONS for medical use of the medicinal product BEMFOLA

Composition:

Active substance: follitropin alfa*;

1 ml of solution contains 600 IU (44 mcg) of follitropin alfa;

one pre-filled pen contains:

75 IU (5.5 mcg) of follitropin alfa in 0.125 ml, or

150 IU (11 mcg) of follitropin alfa in 0.25 ml, or

225 IU (16.5 mcg) of follitropin alfa in 0.375 ml, or

300 IU (22 mcg) of follitropin alfa in 0.5 ml, or

450 IU (33 mcg) of follitropin alfa in 0.75 ml;

*recombinant human follicle-stimulating hormone (r-hFSH)

Excipients: sucrose; sodium hydrogen phosphate, dihydrate; sodium dihydrogen phosphate, dihydrate; L-methionine; poloxamer 188 / Pluronic F-68; phosphoric acid; water for injections.

Pharmaceutical form. Solution for injection in a pre-filled pen.

Main physicochemical properties: clear, colourless solution.

Pharmacotherapeutic group. Sex hormones and modulators of the reproductive system. Gonadotrophins and other ovulation stimulants. Gonadotrophins. ATC code G03G A05.

Pharmacological Properties

Pharmacodynamics.

Bemfola is a biosimilar medicinal product whose active substance is recombinant human follicle-stimulating hormone (r-hFSH), produced by genetic engineering using Chinese hamster ovary cells.

Mechanism of action

Follicle-stimulating hormone (FSH) and luteinizing hormone (LH) are secreted by the anterior pituitary in response to gonadotropin-releasing hormone (GnRH) and play complementary roles in follicular development and ovulation. FSH stimulates the development of ovarian follicles, while LH is involved in follicular development, steroidogenesis, and final maturation.

Pharmacodynamic effects

Serum levels of inhibin and estradiol (E2) increase after administration of r-hFSH, leading to subsequent induction of follicular development. The rise in serum inhibin occurs rapidly and can be observed as early as day 3 of r-hFSH treatment, whereas an increase in E2 levels takes longer and is typically observed only from day 4 of treatment. The total follicular volume begins to increase within 4–5 days of daily r-hFSH administration, and depending on the patient's response, maximal effect is generally achieved approximately 10 days after initiation of r-hFSH treatment.

Clinical efficacy and safety in women

In clinical studies, patients with severe deficiency of FSH and luteinizing hormone (LH) were defined by a serum level of endogenous LH <1.2 IU/L, as measured in a central laboratory. However, it should be noted that LH levels determined in different laboratories may vary.

In clinical studies comparing recombinant human FSH (r-hFSH) (follitropin alfa) with urinary FSH in assisted reproductive technology (ART) procedures (see Table 1) and in ovulation induction, follitropin alfa was shown to be more effective than urinary FSH, as demonstrated by a lower total dose and shorter treatment duration required to induce follicular maturation. The use of lower doses of follitropin alfa over a shorter treatment period in ART resulted in retrieval of a greater number of oocytes compared to urinary FSH.

Table 1

Results from study GF 8407 (a randomized, parallel-group study comparing the efficacy and safety of follitropin alfa and urinary FSH in assisted reproductive technology)

The difference between the two groups was statistically significant (p<0.05) for all listed criteria.

Clinical efficacy and safety in men

In men with FSH deficiency, concomitant administration of follitropin alfa and LH for at least 4 months promotes induction of spermatogenesis.

Pharmacokinetics.

There is no pharmacokinetic interaction between follitropin alfa and lutropin alfa when administered concomitantly.

Distribution

After intravenous administration, follitropin alfa is distributed in the extracellular fluid with an initial half-life of approximately 2 hours and is eliminated with a terminal half-life ranging from 14 to 17 hours. The volume of distribution at steady state ranges from 9 to 11 L.

After subcutaneous administration, the absolute bioavailability of follitropin alfa is 66%, and the apparent terminal half-life ranges from 24 to 59 hours. Dose proportionality after subcutaneous administration has been demonstrated up to 900 IU. Repeated administration of follitropin alfa results in a threefold increase in accumulation, reaching steady state within 3–4 days.

Elimination

Total clearance is 0.6 L/h, and approximately 12% of the administered dose of follitropin alfa is excreted in urine.

Clinical characteristics

Indications.

Adult women

• Anovulation (including polycystic ovary syndrome (PCOS)) in women who have been found to be resistant to clomiphene citrate treatment.
• Stimulation of multiple follicular development in patients undergoing superovulation as part of assisted reproductive technologies (ART), such as in vitro fertilization (IVF), gamete intrafallopian transfer, and zygote intrafallopian transfer.
• Folitropin alfa in combination with luteinizing hormone (LH) preparations is indicated for follicular development stimulation in women with severe LH and FSH deficiency.

Adult men

• Folitropin alfa is indicated for stimulation of spermatogenesis in men with congenital or acquired hypogonadotropic hypogonadism, in combination with human chorionic gonadotropin (hCG) therapy.

Contraindications.

• Hypersensitivity to the active substance or to any of the excipients (see section "Composition");
• hypothalamic or pituitary tumors;
• ovarian enlargement or ovarian cysts not related to polycystic ovary syndrome and of unknown origin;
• gynecological bleeding of unknown origin;
• ovarian, uterine, or breast cancer.

Folitropin alfa must not be used in cases where a therapeutic response cannot be expected, such as:

• primary ovarian insufficiency;
• genital tract abnormalities incompatible with pregnancy;
• uterine fibroids incompatible with pregnancy;
• primary testicular insufficiency.

Interaction with other medicinal products and other forms of interaction.

Concomitant administration of folitropin alfa with other medicinal products used for ovulation induction (e.g., hCG, clomiphene citrate) may enhance the follicular response, whereas concomitant administration with gonadotropin-releasing hormone (GnRH) agonists or antagonists inducing pituitary desensitization may necessitate higher doses of folitropin alfa to achieve an adequate ovarian response. No other clinically significant drug interactions during folitropin alfa therapy have been reported.

Special precautions for use.

Traceability

In order to improve the traceability of biological medicinal products and reporting of suspected adverse reactions, healthcare professionals should clearly record the trade name and batch number of the administered preparation in the patient's medical record.

General recommendations

Since follitropin alfa has significant gonadotropic activity capable of causing adverse reactions ranging from mild to severe, it should be prescribed only by physicians who are well experienced in the management of infertility and its treatment.

Gonadotropin therapy requires time commitment from physicians and other healthcare professionals, as well as appropriate equipment for monitoring treatment. Safe and effective use of follitropin alfa in women requires regular monitoring of ovarian response by ultrasound, preferably combined with serial measurements of serum estradiol levels. Individual variability in response to FSH may occur; some patients may show poor response to FSH, while others may exhibit excessive response. For treatment of both women and men, the lowest effective dose of the preparation should be used according to the treatment objective.

Porphyria

Patients with porphyria or a family history of porphyria should be under close medical supervision during treatment with follitropin alfa. If early signs of porphyria develop or if the condition worsens, treatment discontinuation may be necessary.

Treatment of women

Prior to initiating treatment, infertility in the couple should be investigated and contraindications to pregnancy ruled out. In particular, patients should be evaluated for hypothyroidism, adrenal insufficiency, hyperprolactinemia, and appropriate specific therapy initiated if indicated.

During stimulation of follicular growth in the treatment of anovulatory infertility or assisted reproductive technology (ART) procedures, ovarian enlargement or ovarian hyperstimulation may occur. Adherence to recommended dosing and administration regimens of follitropin alfa, along with careful monitoring of therapy, will reduce the frequency of such events. Accurate interpretation of follicular development and maturation requires expertise in evaluating the relevant tests.

Clinical studies have shown increased ovarian sensitivity to follitropin alfa when co-administered with lutropin alfa. If an increase in FSH dose is considered necessary, dose adjustments should preferably be made at intervals of 7–14 days, with stepwise increments of 37.5–75 IU.

Direct comparison between follitropin alfa/LH and human menopausal gonadotropin (hMG) has not been conducted. Available data suggest that the ovulation rate achieved with follitropin alfa/LH is similar to that obtained with hMG.

Ovarian hyperstimulation syndrome (OHSS)

A predictable consequence of controlled ovarian stimulation is some degree of ovarian enlargement. This phenomenon, most commonly observed in women with polycystic ovary syndrome, usually resolves spontaneously without treatment.

In contrast to uncomplicated ovarian enlargement, OHSS is a syndrome that may progress in severity. It is characterized by marked ovarian enlargement, high serum sex steroid levels, and increased vascular permeability, which may lead to fluid accumulation in the peritoneal, pleural, and occasionally pericardial cavities.

Severe OHSS may present with symptoms such as abdominal pain and distension, significant ovarian enlargement, weight gain, dyspnea, oliguria, and gastrointestinal symptoms including nausea, vomiting, and diarrhea. Clinical examination may reveal hypovolemia, hemoconcentration, electrolyte imbalances, ascites, hemoperitoneum, pleural effusions, hydrothorax, or acute respiratory distress syndrome. In rare cases, severe OHSS may be complicated by ovarian torsion and thromboembolic events such as pulmonary artery embolism, ischemic stroke, and myocardial infarction.

Independent risk factors for OHSS include young patient age, low body fat mass, polycystic ovary syndrome, high doses of exogenous gonadotropins, high or rapidly rising serum estradiol levels, previous episodes of OHSS, a large number of developing follicles, and a high number of oocytes retrieved in ART cycles.

Adherence to recommended dosing and administration regimens of follitropin alfa may minimize the risk of ovarian hyperstimulation (see sections "Dosage and administration" and "Adverse reactions"). Monitoring of stimulation cycles by ultrasound and serum estradiol measurements is recommended for early identification of relevant risk factors.

It is known that hCG plays a key role in initiating OHSS and that this syndrome may become more severe and prolonged if pregnancy occurs. Therefore, in the presence of signs of ovarian hyperstimulation, such as serum estradiol levels >5500 pg/mL (or >20200 pmol/L) and/or total number of follicles ≥40, administration of hCG should be withheld, and patients should be advised to abstain from sexual intercourse or use barrier contraception for at least 4 days. OHSS may rapidly progress (within 24 hours) and become a serious medical complication within a few days. It most commonly occurs after discontinuation of hormonal therapy and peaks approximately 7–10 days after treatment ends. Therefore, patients should remain under medical supervision for at least 2 weeks after hCG administration.

The incidence of hyperstimulation in ART procedures may be reduced by aspiration of all follicles prior to ovulation.

Mild or moderate forms of OHSS usually resolve spontaneously. In cases of severe OHSS, gonadotropin therapy should be discontinued if still ongoing, and the patient should be hospitalized and receive appropriate treatment.

Multiples pregnancy

The rate of multiple pregnancies following ovulation induction is higher than after natural conception. Most multiple pregnancies are twins. Multiple pregnancy, especially of higher order, carries an increased risk of adverse outcomes for mother, fetus, and newborn.

To reduce the risk of multiple pregnancy, careful monitoring of ovarian response is recommended.

In ART procedures, the risk of multiple pregnancy is primarily related to the number of embryos transferred, embryo quality, and patient age.

Patients should be informed about the potential risk of multiple pregnancy before starting treatment.

Pregnancy loss

In women undergoing follicular growth stimulation for ovulation induction or ART, the rate of pregnancy loss due to miscarriage or spontaneous abortion is higher than after natural conception.

Ectopic pregnancy

Women with a history of tubal disease are at risk of ectopic pregnancy, regardless of whether conception occurs spontaneously or following infertility treatment. The incidence of ectopic pregnancy after ART has been reported to be higher than in the general population.

Reproductive system neoplasms

Cases of both benign and malignant neoplasms of the ovaries and other reproductive organs have been reported in women who underwent various infertility treatments. It has not yet been established whether gonadotropin therapy increases the risk of such tumors in infertile women.

Congenital malformations

The incidence of congenital malformations after ART may be slightly higher than after spontaneous conception. This is believed to be due to parental health characteristics (e.g., maternal age, paternal sperm characteristics) and multiple pregnancies.

Thromboembolic complications

In women with recent or existing thromboembolic disorders or those with established risk factors for thromboembolic events (e.g., personal or family history), gonadotropin therapy may further increase the risk of exacerbation or occurrence of such events. In such patients, the benefit of gonadotropin use should be weighed against the existing risk of such complications. However, it should be noted that pregnancy itself and OHSS increase the risk of thromboembolic complications.

Treatment of men

Elevated endogenous FSH levels in patients indicate primary testicular failure. Such patients are unresponsive to treatment with follitropin alfa/hCG. Follitropin alfa should not be used when an effective response to treatment cannot be achieved.

To assess treatment response, semen analysis is recommended after 4–6 months of treatment initiation.

Sodium content

The medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially "sodium-free".

Use during pregnancy or breastfeeding.

Pregnancy

There are no indications for the use of follitropin alfa during pregnancy. Data from a limited number of cases (fewer than 300) of exposure during pregnancy suggest no increased risk of congenital malformations or fetotoxic/neonatal toxic effects of follitropin alfa.

Teratogenic effects were not observed in animal studies. However, clinical data are insufficient to exclude a teratogenic effect of follitropin alfa when used during pregnancy.

Breastfeeding

Follitropin alfa is not indicated for use during breastfeeding.

Fertility

Follitropin alfa is indicated for the treatment of infertility (see section "Indications").

Ability to influence the speed of reaction when driving vehicles or operating machinery.

Follitropin alfa has no effect or has a negligible effect on the ability to drive vehicles or operate machinery.

Method of Administration and Dosage

Treatment with follitropin alfa should be initiated under the supervision of a physician experienced in the management of infertility.

Patients should be provided with the necessary number of pre-filled pens required for the treatment course and trained properly in their correct use for administering the prescribed dose.

Dosage

Dosage recommendations for follitropin alfa are the same as for urinary FSH. Clinical evaluation of follitrop alfa indicates that its daily dosage, administration schedule, and treatment monitoring process should not differ from those used for urinary FSH preparations. It is recommended to follow the proposed initial doses of the drug as outlined below.

Comparative clinical studies have shown that when follitropin alfa is used compared to urinary FSH, patients require a lower total dose over a shorter treatment period. Therefore, it is considered appropriate to use a lower total dose of follitropin alfa than that typically used with urinary FSH therapy. This allows not only for optimizing treatment but also for reducing the risk of ovarian hyperstimulation (see section "Pharmacodynamics").

Women with anovulation, including polycystic ovary syndrome

Follitropin alfa is administered as a course of daily injections. In women with regular menstrual cycles, treatment should begin within the first 7 days of the menstrual cycle.

The usual treatment regimen starts with daily administration of 75 to 150 IU FSH. If necessary, the dose may be increased by 37.5 or 75 IU at intervals of 7 or (preferably) 14 days to achieve adequate, but not excessive, ovarian response. Treatment should be individualized based on the patient's response, assessed by ultrasound evaluation of follicular size and/or serum estrogen levels. The maximum daily dose generally does not exceed 225 IU FSH. If the patient does not respond adequately after 4 weeks of treatment, this treatment cycle should be discontinued, further evaluation performed, and treatment restarted in the next cycle with a higher initial dose than used in the previous cycle.

After achieving optimal follicular response, a single dose of 250 mcg recombinant human chorionic gonadotropin alfa (r-hCG) or 5000–10000 IU hCG should be administered 24–48 hours after the last injection of follitropin alfa. Patients are advised to have intercourse on the day of hCG administration and the following day. Alternatively, intrauterine insemination may be performed.

If excessive ovarian response occurs, treatment should be discontinued and hCG administration withheld (see section "Special Warnings and Precautions for Use"). In the subsequent cycle, treatment should be restarted with a lower FSH dose than that used in the previous cycle.

Ovarian stimulation for multiple follicular development in women undergoing ovarian stimulation prior to in vitro fertilization (IVF) or other assisted reproductive technologies

The commonly used regimen for controlled ovarian hyperstimulation involves daily administration of 150 to 225 IU of follitropin alfa, starting on day 2 or 3 of the cycle. Treatment continues until adequate follicular development is achieved, as assessed by serum estradiol levels and/or ultrasound monitoring. The dose should be adjusted according to the patient's response but generally should not exceed 450 IU daily. Adequate follicular development is typically achieved by approximately day 10 of treatment (range: 5 to 20 days).

For induction of final follicular maturation, a single injection of 250 mcg r-hCG or 5000–10000 IU hCG is administered 24–48 hours after the last injection of follitropin alfa.

To prevent a premature surge in endogenous luteinizing hormone (LH) and to control basal LH levels, pituitary suppression with gonadotropin-releasing hormone (GnRH) agonists or antagonists is usually employed. In a standard treatment protocol, administration of follitropin alfa begins approximately 2 weeks after starting the agonist, and both are administered concurrently until adequate follicular development is achieved. For example, after 2 weeks of agonist therapy, administration of 150–225 IU follitropin alfa is initiated and continued for the first 7 days, with subsequent dose adjustments based on ovarian response.

Overall IVF experience indicates that treatment success rates remain relatively stable during the first four attempts and then gradually decline.

Women with severe deficiency of LH and FSH

In women with hypogonadotropic hypogonadism characterized by deficient LH and FSH secretion, the goal of therapy with follitropin alfa in combination with a luteinizing hormone (LH) preparation is to stimulate follicular development followed by final oocyte maturation after administration of human chorionic gonadotropin (hCG). Follitropin alfa is administered as a course of daily injections concomitantly with lutropin alfa. If the patient has amenorrhea and low endogenous estrogen secretion, treatment may be initiated at any time.

The recommended treatment regimen starts with daily administration of 75 IU lutropin alfa together with 75–150 IU FSH. Treatment should be individualized based on the patient's response, assessed by ultrasound evaluation of follicular size and serum estrogen levels.

If an increase in FSH dose is considered necessary, it should preferably be adjusted every 7–14 days, with incremental increases of 37.5 to 75 IU. The duration of stimulation may be extended up to 5 weeks within a single treatment cycle.

After achieving optimal follicular response, a single dose of 250 mcg r-hCG or 5000–10000 IU hCG should be administered 24–48 hours after the last injection of follitropin alfa and lutropin alfa. Patients are advised to have intercourse on the day of hCG administration and the following day. Alternatively, intrauterine insemination or another medically assisted reproductive procedure may be performed based on the physician's clinical judgment.

Luteal phase support should be considered, as deficiency of substances with luteotropic activity (LH/hCG) after ovulation may lead to premature luteal phase deficiency.

If excessive ovarian response occurs, treatment should be discontinued and hCG administration withheld. In the subsequent treatment cycle, a lower FSH dose than that used in the previous cycle should be used (see section "Special Warnings and Precautions for Use").

Men with hypogonadotropic hypogonadism

Follitropin alfa is administered at a dose of 150 IU three times weekly, in combination with hCG, for at least 4 months. If no response is observed after this period, combination therapy may be continued. Clinical experience indicates that, if necessary to achieve spermatogenesis, treatment may be continued for at least 18 months.

Special Patient Populations

Elderly patients

There are no relevant indications for the use of follitropin alfa in elderly patients. The safety and efficacy of follitropin alfa in this population have not been established.

Patients with renal or hepatic impairment

The safety, efficacy, and pharmacokinetic profile of follitropin alfa in patients with renal or hepatic impairment have not been established.

Method of Administration

The medicinal product Bemfola is intended for subcutaneous administration. The injection should be administered daily at the same time.

The first injection should be performed under direct medical supervision. Self-administration may be carried out only by well-motivated and adequately trained patients who have access to medical advice if needed. The injection site should be rotated daily.

The pre-filled pen containing a single-dose cartridge of Bemfola is intended for single use only. Therefore, patients must receive clear instructions to avoid incorrect use of the single-use device.

INSTRUCTIONS FOR SELF-ADMINISTRATION OF BEMFOLA USING THE PRE-FILLED PEN

Warning: Please read the instructions carefully before self-administering the pre-filled pen with Bemfola. Do not follow instructions from sources other than this product information or your physician, as this may compromise the correct use of the pre-filled pen and your treatment.

1. How to use the pre-filled pen with Bemfola
   • Read the instructions completely before using the pre-filled pen.
   • Each pre-filled pen is intended for your personal use only; do not allow others to use it.
   • The numbers displayed on the pre-filled pen indicate the dose of the drug in international units (IU). Your doctor will tell you how many IU you need to inject daily.
   • Your doctor/pharmacist will inform you how many pre-filled pens with Bemfola you will need for the complete treatment course.
   • Administer your injection daily at the same time.
2. Before using the pre-filled pen
3. 1. Remove the pen from the refrigerator
   • Remove one of your pens from the refrigerator 5–10 minutes before use.
   • Do not use the product if it has been frozen.
4. 2. Wash your hands
   • Wash your hands with warm water and soap and dry them thoroughly.
   • It is important that your hands and all materials used in preparing the pen are as clean as possible.
5. 3. Choose a clean area
   • A suitable location may be a clean table or other surface.
6. Preparing the pre-filled pen for injection

Components of the pre-filled pen

Children.

There are no appropriate indications for the use of follitropin alfa in pediatric patients.

Overdose.

Symptoms of follitropin alfa overdose are unknown; however, there is a possibility of developing ovarian hyperstimulation syndrome (see section "Special precautions").

Adverse Reactions

Summary of Safety Profile

The most commonly reported adverse reactions are headache, ovarian cysts, and injection site reactions (e.g., pain, erythema, hematoma, swelling, and/or irritation at the injection site).

Mild or moderate ovarian hyperstimulation syndrome (OHSS) has been frequently reported and should be considered an inherent risk of the stimulation procedure. Severe forms of OHSS are uncommon (see section "Special Warnings and Precautions for Use").

Thromboembolic events have been reported very rarely (see section "Special Warnings and Precautions for Use").

The following frequency categories are used to classify adverse reactions:

Very common (≥ 1/10, occurs in more than 1 in 10 individuals).

Common (≥ 1/100 to < 1/10, occurs in up to 1 in 10 individuals).

Uncommon (≥ 1/1000 to < 1/100, occurs in up to 1 in 100 individuals).

Rare (≥ 1/10,000 to < 1/1000, occurs in up to 1 in 1000 individuals).

Very rare (< 1/10,000, occurs in less than 1 in 10,000 individuals).

Treatment of Women

Immune System Disorders

Rare: Hypersensitivity reactions ranging from mild to severe, including anaphylactic reactions and shock.

Nervous System Disorders

Very common: Headache.

Vascular Disorders

Rare: Thromboembolism (both associated with OHSS and occurring independently).

Respiratory, Thoracic and Mediastinal Disorders

Rare: Exacerbation or worsening of asthma.

Gastrointestinal Disorders

Common: Abdominal pain, sensation of abdominal distension and discomfort, nausea, vomiting, diarrhea.

Reproductive and Breast Disorders

Very common: Ovarian cysts.

Common: Mild to moderate OHSS (including associated symptoms).

Uncommon: Severe OHSS (including associated symptoms) (see section "Special Warnings and Precautions for Use").

Rare: Complications of severe OHSS.

General Disorders and Administration Site Reactions

Very common: Injection site reactions (e.g., pain, erythema, hematoma, swelling, and/or irritation at the injection site).

Treatment of Men

Immune System Disorders

Rare: Hypersensitivity reactions ranging from mild to severe, including anaphylactic reactions and shock.

Respiratory, Thoracic and Mediastinal Disorders

Rare: Exacerbation or worsening of asthma.

Skin and Subcutaneous Tissue Disorders

Common: Acne.

Reproductive and Breast Disorders

Common: Gynecomastia, varicocele.

General Disorders and Administration Site Reactions

Very common: Injection site reactions (e.g., pain, erythema, hematoma, swelling, and/or irritation at the injection site).

Laboratory and Instrumental Findings

Common: Increase in body weight.

Reporting of Suspected Adverse Reactions

Reporting suspected adverse reactions after marketing authorization is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals, patients, and their legal representatives are encouraged to report all suspected adverse reactions and lack of efficacy through the Automated Information System for Pharmacovigilance at: https://aisf.dec.gov.ua.

Healthcare professionals should ensure that the brand name and batch number of the medicinal product are included in the report of a suspected adverse reaction.

Shelf Life. 3 years.

After opening, the medicinal product should be administered immediately.

Do not use after the expiry date stated on the packaging.

Storage Conditions.

Store in a refrigerator (2–8 °C). Do not freeze.

Prior to first use, the closed medicinal product may be stored outside the refrigerator at a temperature not exceeding 25 °C for up to 3 months without re-refrigeration during its shelf life. The medicinal product must be discarded if not used within 3 months.

Keep in the original packaging to protect from light.

Keep out of the reach of children.

Incompatibilities.

Not applicable.

Packaging.

0.125 ml, 0.25 ml, 0.375 ml, 0.50 ml, or 0.75 ml of solution for injection in a glass cartridge with a rubber plunger and rubber disc sealed with an aluminum cap, housed in a delivery pen. Packs of 1, 5, or 10 pre-filled pens with single-use needles (1, 5, or 10 respectively) and alcohol-impregnated wipes (1, 5, or 10 respectively), together with instructions for medical use, in a cardboard box.

Prescription Status.

Prescription only.

Manufacturer.

JSC "Gedeon Richter".

Manufacturer's Address and Place of Business.

H-1103 Budapest, Demrédi út 19-21, Hungary.