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The article will provide instructions for using Buserelin. What kind of drug is this?

Spray "Buserelin" is a medication for intranasal use, an analogue of gonadotropin-releasing hormone produced by the hypothalamus. It is used in the treatment of hormone-dependent pathologies of the reproductive system, for example, uterine fibroids, endometrial hyperplasia, since these diseases develop due to excess estrogen in the blood. Nasal spray "Buserelin" suppresses the functions of the ovaries, as a result of which the spread of pathological processes is suspended. Treatment begins on the first day of menstruation by injecting 150 mcg of a medicinal solution into each nostril three times a day. In addition, a nasal spray is prescribed for IVF - 150 mcg four times a day.

The instructions for “Buserelin” for injection indicate that the medication is an antitumor drug. It is produced in bottles containing lyophilisate for preparing a special suspension. The injection is given intramuscularly once a month. This use is due to the fact that this drug has a prolonged effect and completely suppresses the production of sex hormones that stimulate the growth of tumors.

Forms of release of the drug

In accordance with the instructions for use, the Buserelin spray is produced in plastic bottles equipped with a special dispenser, in the form of a colorless, odorless liquid complete with a pump stopper.

Lyophilisate "Buserelin-Depot" for intramuscular injections of prolonged action is available in the form of a white powder, sometimes with a slight yellowish tint. The package contains a special solvent - a clear, colorless liquid. The resulting suspension is homogeneous, white with a slight yellowish tint, and is contained in darkened glass bottles. The kit also includes: solvent, syringe, needles (2 pcs.) and alcohol swabs (2 pcs.).

Release forms and varieties of Buserelin

It is immediately worth noting that this drug can have a completely suppressive effect on the functioning of the reproductive system of the female body.

Therefore, this should be taken into account when treating endometriotic lesions of the uterine cavity, especially in the fertile period, when the woman is still planning to conceive a child in the future.

If a woman does not plan to have more children, then the drug Buserelin is an excellent option for combating such pathological processes in the reproductive system of the female organs. The drug Buserelin Depot, especially during the period of premenopausal changes, will help eliminate the main symptoms of endometriotic lesions, and also stop the further growth of pathological tissues of the functional layer of the endometrium.

This drug can have a specific effect on the condition of the entire body. Therefore, it should be used only as prescribed by a qualified specialist and in accordance with the developed treatment regimen. Only the right approach to treatment can guarantee positive dynamics in the therapeutic treatment of endometriosis.

The severity of the manifestation of endometrioid symptoms directly depends on the level of estrogen content: the higher their concentration, the stronger the manifestation of endometriosis. The drug Buserelin is designed specifically to suppress hypothalamic releasing factor processes and reduce estrogen production both in the fertile period and in premenopause. Basically, medical specialists use the following types of Buserelin:

• Buserelin Long;
• Buserelin Depot;
• Goserelin;
• Buserelin Acetate is a nasal spray.

Any type of this remedy has a lasting effect.

But as medical practice shows, the best effect is observed when using the original medication: Buserelin Depot.

This drug is available in two pharmacological forms:

1. In powder form for the preparation of solution for injection.
2. In the form of a nasal spray.

Methods of using the drug are described in detail in the attached annotation to the drug.

As the main active ingredient, the drug contains Buserelin acetate and additional trace elements.

The cost of this drug is quite high and varies depending on the form of release of this medicine. So, for example, if you purchase a nasal spray, it can cost around 1,000 rubles, but an ampoule with a powdered preparation for preparing a solution and a special device for administering the injection will cost around 4,500 rubles.

Composition of the medical product

According to the instructions for Buserelin, one bottle of spray contains:

• main substance - buserelin acetate - 2.1 mg;
• additional substances - benzalkonium chloride - 0.1 mg, purified water - 1 ml.

One bottle contains 3.75 mg of buserelin, the active ingredient.

The additional ingredients are:

• 2 mg - polysorbate 80;
• 85 mg - mannitol;
• 30 mg - carmellose sodium;
• 200 mg - copolymer of DL-lactic and glycolic acids.

0.8% mannitol solution and water for injection - solvent.

Pharmacokinetics

Buserelin is a synthetic analogue of natural GnRH that binds to receptors in the cells of the anterior pituitary gland, causing a temporary increase in the levels of all sex hormones.

The use of the drug in therapeutic doses leads to a complete blockade of the gonadotropic function of the pituitary gland, inhibits the release of FSH and LH, as a result of which there is a suppression of the production of sex hormones in the ovaries, as well as a decrease in the concentration of the hormone estradiol in the blood up to postmenopausal levels.

When this medication is used intranasally, its substances are completely absorbed through the nasal mucosa.

This substance can be excreted in breast milk in small quantities.

Lyophilisate Buserelin-long FS composition

Composition per bottle: Active substance: Buserelin acetate - 3.93 mg, in terms of buserelin - 3.75 mg Excipients: DL-lactic and glycolic acid copolymer - 200 mg, D-mannitol - 85 mg, carmellose sodium - 30 mg, polysorbate-80 - 2 mg

Description: lyophilized powder (fragile lyophilisate) or porous mass compacted into a tablet, white or white with a slight yellowish tint.

Solvent in ampoule: mannitol, solution 0.8%

Composition per 1 ml: D-mannitol - 8.0 mg, water for injection - up to 1.0 ml

Description: transparent colorless liquid

Reconstituted suspension: by adding solvent and shaking, a homogeneous suspension of white or white with a slight yellowish tint is formed; when standing, the suspension settles, but easily resuspends when shaken; the suspension should flow freely into the syringe through needle No. 0840.

Pharmacotherapeutic group of the drug: antitumor agent, gonadotropin-releasing hormone (GnRH) analogue.

CodeATX: L02AE01

Pharmacological properties: Pharmacodynamics Synthetic analogue of endogenous gonadotropin-releasing hormone (GnRH). Buserelin competitively binds to the receptors of the cells of the anterior pituitary gland, causing a short-term increase in the level of sex hormones in the blood plasma, which subsequently leads to a complete reversible blockade of the gonadotropic function of the pituitary gland, thus inhibiting the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH).

As a result, there is a suppression of the synthesis of sex hormones in the gonads, which is manifested by a decrease in the concentration of estradiol in the blood plasma to post-menopausal values ​​in women and a decrease in testosterone content to a post-castration level in men. After the first administration of buserelin, by day 21 in men, testosterone concentration decreases to the post-castration level (characteristic of the orchidectomy state), i.e. pharmacological castration is caused. And in women, the concentration of estradiol decreases to a level corresponding to oophorectomy or postmenopause.

The concentration of testosterone and estradiol remains reduced throughout the entire period of treatment, carried out every 28 days, which leads to growth inhibition and reversal of hormone-dependent tumors. After cessation of treatment, physiological hormone secretion is restored.

Pharmacokinetics: High bioavailability. The maximum plasma concentration is reached approximately 2-3 hours after intramuscular administration and remains at a level sufficient to inhibit the synthesis of gonadotropins by the pituitary gland for at least 4 weeks.

Indications for use

As the instructions for “Buserelin” indicate, the drug is used for hormone-dependent diseases of the reproductive system, which are caused by relative or absolute hyperestrogenism. These include:

1. Endometriosis, including in the postoperative period.
2. Uterine fibroids.
3. Hyperplastic processes in the endometrium.
4. Infertility therapy, including in vitro fertilization.

This is what it says in the instructions for use. Reviews and analogues for “Buserelin” will be presented below.

Overdose

When treating uterine fibroids, endometriosis, endometrial hyperplasia, Buserelin is prescribed intranasally at a dose of 150 mcg in each nostril every 6-8 hours. Treatment usually begins on the first or second day of the cycle.

To suppress the reproductive system in the treatment of infertility through in vitro fertilization, Buserelin is prescribed 150 mcg in each nostril four times a day from the middle of the luteal phase of the cycle until a dose of human chorionic gonadotropin is administered, which induces ovulation.

The suspension (Buserelin Depot and Buserelin Long) is intended for intramuscular administration.

The suspension of this drug is used for:

• Endometriosis, endometrial hyperplasia - 3.75 mg every four weeks, starting from the first five days of the cycle. The duration of treatment is 4-6 months;
• Uterine fibroids - 3.75 mg every 4 weeks. The drug is prescribed three months before surgery, in other cases the duration of therapy is 6 months;
• In vitro fertilization - on the second day of the cycle at a dose of 3.75 mg;
• Hormone-dependent prostate cancer - 3.75 mg every 4 weeks.

The drug can also be administered subcutaneously. At the beginning of treatment, Buserelin is administered 3 times a day, 500 mcg every 8 hours, for 7 days. On the eighth day they switch to intranasal use of the drug.

The implant is inserted subcutaneously into the lateral surface of the abdomen once every two months.

Reviews for Buserelin do not contain indications of cases of overdose with drugs containing this drug.

To date, no cases of drug overdose have been recorded. Such situations are unlikely because the shots are given once every four weeks. During this time, the drug accumulates, but does not lead to systemic changes in organs and tissues. If you get injections from a specialist, there is no risk of administering a larger dose than required.

Directions for use and dosage

When treating symptoms of endometriosis, hyperplastic phenomena of the endometrium and uterine fibroids, the drug is administered into the nasal passages after the procedure of cleansing them at a dosage of 900 mcg/day.

A single dose of the drug when pressing the pump is approximately 150 mcg.

The daily dosage of the medication is administered in equal portions several times a day, one injection into each nasal passage at regular intervals.

Treatment with the drug "Buserelin" should begin on the first or second day of the menstrual cycle and continue continuously for six months.

When treating infertility using in vitro fertilization techniques, the drug is administered intranasally, one press into each nostril at regular intervals. The daily dosage should not exceed 1200 mcg.

What else does the instructions for use for Buserelin tell us?

The medication in this case is prescribed at the beginning of the follicular or mid-luteal phase of the menstrual cycle that precedes stimulation of egg production.

After about two weeks, when estradiol in the blood of patients decreases by at least half of the initial level, as well as in the absence of an ovarian cyst and the thickness of the endometrial layer is no more than 5 mm, they begin to stimulate superovulation with gonadotropic hormones under ultrasound monitoring and control of estradiol levels in the blood.

If necessary, the dosage of the medication can be adjusted.

The instructions for Buserelin injections confirm that the drug is intended for intramuscular administration.

Therapy for hormone-dependent prostate cancer involves intramuscular injections at a dose of 3.75 mg, prescribed every month.

Treatment of hyperplastic changes in the endometrium and endometriosis - 3.75 mg once by intramuscular injection every month. The start of therapy is combined with the first 5 days of the menstrual cycle. The course is from 4 to 6 months.

Treatment of uterine fibroids is carried out with a dosage of 3.75 mg of the active component, which is administered once intramuscularly every month. Instructions for use for Buserelin 3.75 mg recommend that therapy be carried out in the first 5 days of the menstrual cycle. The course before surgery is 3 months, sometimes 6 months.

When treating infertility in an IVF program, a single dose of medication is determined - 3.75 mg. The injection is carried out at the beginning of the follicular phase (on the second day of the cycle) or at the end of the luteal phase (21–24 days of the cycle) before stimulation.

Only an experienced medical professional can prepare the suspension. The prepared solution should be used immediately after preparation.

Buserelin-Long instructions for use

INSTRUCTIONS for use of the drug Buserelin-long

Composition Lyophilisate for the preparation of a suspension for intramuscular administration of prolonged action, containing 3.75 mg of buserelin.

Pharmacological action Pharmacotherapeutic group: antitumor agent, gonadotropin-releasing hormone (GnRH) analogue.

Buserelin-long, indications for use Hormone-dependent prostate cancer; Mammary cancer; Endometriosis (pre- and postoperative periods); Uterine fibroids; Hyperplastic processes of the endometrium; Treatment of infertility (during an in vitro fertilization (IVF) program).

Contraindications Pregnancy; Lactation period; Hypersensitivity to the components of the drug

Method of administration and dosage For hormone-dependent prostate cancer, Buserelin-long is administered at a dose of 3.75 mg (1 injection) intramuscularly (IM) every 4 weeks. In the treatment of endometriosis and endometrial hyperplastic processes, the drug is administered in a dose of 3.75 mg intramuscularly once every 4 weeks. Treatment should begin in the first five days of the menstrual cycle. Duration of treatment is 4 - 6 months. When treating uterine fibroids, Buserelin-long is administered at a dose of 3.75 mg intramuscularly once every 4 weeks. Treatment should begin in the first five days of the menstrual cycle. Duration of treatment – ​​3 months before surgery, in other cases – 6 months; 2 When treating infertility using in vitro fertilization (IVF), Buserelin-long is administered in a dose of 3.75 mg (1 injection) intramuscularly once at the beginning of the follicular phase (on the 2nd day of the menstrual cycle) or in the middle of the luteal phase (21 - 24 days ) menstrual cycle preceding stimulation. After blockade of pituitary function, confirmed by a decrease in the concentration of estrogen in the blood serum by at least 50% of the initial level (usually determined 12 - 15 days after injection of Buserelin-long), in the absence of ovarian cysts (according to ultrasound), the thickness of the endometrium is not more than 5 mm, stimulation of superovulation begins with gonadotropic hormones under ultrasound monitoring and control of the level of estradiol in the blood serum.

Side effects Allergic reactions: urticaria, skin hyperemia, rarely - angioedema. From the central nervous system: frequent mood swings, sleep disturbances, depression, headache. From the musculoskeletal system: with long-term use - bone demineralization, which is a risk of developing osteoporosis. In women - headache, depression, sweating and changes in libido, dryness of the vaginal mucosa, pain in the lower abdomen, rarely - menstrual bleeding (during the first weeks of treatment). In men, during the treatment of prostate cancer - during the first 2 - 3 weeks after the first injection, buserelin can cause exacerbation and progression of the underlying disease (associated with stimulation of the synthesis of gonadotropins and, accordingly, testosterone), gynecomastia, possible hot flashes, increased sweating and decreased potency (rarely requires discontinuation of therapy), transient increase in the concentration of androgens in the blood, urinary retention, “renal edema” - swelling of the face, eyelids, legs; muscle weakness in the lower extremities. When patients with prostate cancer begin treatment, they may experience a temporary increase in bone pain; in this case, symptomatic therapy should be carried out. Isolated cases of ureteral obstruction and spinal cord compression have been noted. Other: in isolated cases (the cause-and-effect relationship has not been clearly established) - pulmonary embolism, dyspeptic disorders.

Special instructions In women Patients with any form of depression during treatment with the drug should be under close medical supervision. Ovulation induction should be performed under strict medical supervision. In the initial stage of treatment with the drug, the development of ovarian cysts is possible. 5 Before starting treatment, it is recommended to exclude pregnancy and stop taking hormonal contraceptives, however, during the first two months of using the drug, it is necessary to use other (non-hormonal) methods of contraception. After cessation of treatment, ovarian function is restored. The first menstruation resumes after 3 months. In men In order to effectively prevent possible side effects in the first phase of the drug's action, it is necessary to use antiandrogens two weeks before the first injection of Buserelin-long and for two weeks after the first injection.

INFLUENCE ON THE ABILITY TO DRIVE A CAR AND OTHER MECHANISMS Care should be taken when prescribing the drug to patients engaged in potentially hazardous activities that require increased attention and speed of mental and motor reactions.

Drug interactions The simultaneous use of Buserelin-long with drugs containing sex hormones (for example, in ovulation induction mode) may contribute to the occurrence of ovarian hyperstimulation syndrome. With simultaneous use, Buserelin-long may reduce the effectiveness of hypoglycemic agents.

Overdose Currently, no cases of overdose have been reported.

Storage conditions: In a dry place, protected from light, at a temperature not exceeding 25°C. Keep out of the reach of children.

Adverse reactions

According to the instructions, “Buserelin” is generally well tolerated by patients, but sometimes some specific reactions of the body occur, which include:

1. Nervous system reactions: cephalalgia, dizziness, increased nervousness, fatigue, sleep disturbances, severe drowsiness, impaired memory and attention span, emotional instability, the onset of depression or the complication of its course.
2. Sense organ reactions: hearing and vision impairment (blurred vision), tinnitus, feeling of pressure on the eyeball.
3. Reactions of the endocrine system: “flushes” of blood to the face and upper chest, increased sweating, vaginal dryness, decreased libido, pain in the lower abdomen, decreased bone mineralization, menstrual-like bleeding (usually in the first weeks of treatment).
4. Reactions of the cardiovascular system: increased heart rate, increased blood pressure (especially in patients with arterial hypertension).
5. Allergic manifestations: skin itching, urticaria, redness of the skin, bronchospasm, angioedema, anaphylactic shock.
6. Reactions of the digestive system: dyspepsia, increased thirst, changes in stool, loss of appetite, decrease or increase in fat mass.
7. Laboratory indicators: decreased glucose tolerance, changes in the lipid spectrum, hyperglycemia, increased transaminase activity, thrombocytopenia, hyperbilirubinemia or leukopenia.
8. Other reactions: nosebleeds, swelling of the lower extremities, pulmonary embolism, increased or decreased hair growth on the body and head, pain in the back and joints.
9. Local reactions: symptoms of irritation of the nasopharyngeal mucosa, pain and dryness in the nose. This is confirmed by the instructions for use for Buserelin injections, as well as for the nasal spray.

Side effects

From the nervous system and sensory organs: headache (with intranasal administration), mood lability, sleep disturbance, depression, symptoms of eye irritation (when wearing contact lenses).

From the gastrointestinal tract: changes in appetite, nausea, vomiting.

From the genitourinary system: decreased libido, impotence, vaginal dryness, ovarian cysts, pain in the lower abdomen, menstrual bleeding.

Allergic reactions: urticaria, skin hyperemia, angioedema.

Other: hot flashes, irritation of the nasal mucosa and nosebleeds (with intranasal administration), increased sweating (with intranasal administration), acne, dry skin and mucous membranes, demineralization of bones, gynecomastia, thrombosis, swelling of the feet and ankle joints; symptoms associated with an increase in testosterone levels in the blood at the beginning of therapy (bone pain, numbness or tingling sensation in the hands or feet, difficulty urinating, weakness in the legs).

According to reviews, Buserelin, as a rule, does not cause significant side effects. If adverse reactions occur after Buserelin, they are reversible and are not a reason to discontinue the drug.

Side effects after Buserelin appear:

• Urticaria, irritation of the nasal mucosa, skin hyperemia, in rare cases, angioedema;
• Frequent mood swings, depression, sleep disturbances, headaches, “hot flashes” to the facial skin, increased sweating, decreased libido, vaginal dryness, bone demineralization, abdominal pain, menstrual-like bleeding – in women;
• Exacerbation and progression of prostate cancer in the first 2-3 weeks after the first injection; impotence, urinary retention, gynecomastia, ossalgia, renal edema, lymphostasis, muscle weakness in the legs - in men.

In addition, nausea, vomiting, and changes in appetite may occur after Buserelin.

While taking the drug, the following side effects from different systems and organs may develop:

• urticaria, redness of the skin, angioedema;
• frequent mood swings, sleep disturbances, headaches, depression;
• bone demineralization, osteoporosis;
• sweating, decreased libido, menstrual-like bleeding;
• dyseptic disorders;
• exacerbation of the disease in men, gynecomastia, flushing of the face, decreased potency, urinary retention;
• swelling of the eyelids, face, legs, muscle weakness, increased bone pain;
• ureteral obstruction, spinal cord compression, pulmonary embolism.

Very often, at the beginning of a course of treatment, headaches, dizziness, tinnitus, and memory loss are noted. Side effects from the gastrointestinal tract, such as dyspeptic disorders, loss of appetite, and weight gain, are less common. In 7% of cases, myasthenia gravis, vaginal dryness, and urinary retention were noted.

Contraindications for use

This medication is strictly contraindicated for use by pregnant women, women during lactation, as well as in cases of hypersensitivity to the substances included in its composition.

The drug "Buserelin" should be used with some caution in case of diabetes mellitus, hypotension, arterial hypertension, depressive and neurological disorders.

Patients with any form of depression should be under the supervision of specialists during therapy with this medication.

Ovulation induction must also be carried out under appropriate supervision. At the initial stage of treatment, the formation of cysts on the ovaries is possible.

An additional course of treatment is usually started after a thorough assessment of the balance between the expected benefit and the potential risk of osteoporosis.

Patients using contact lenses may experience signs of irritation of the eye mucosa. The instructions for the Buserelin spray indicate that with intranasal methods of using this drug, irritation of the inner surface of the nose is possible, and in some cases, minor nosebleeds may occur.

The medication is approved for use for rhinitis, but before injecting the solution into the nasal passages, they should be thoroughly cleaned.

The use of the medical product “Buserelin” in combination with surgical methods of treating endometriosis reduces pathological lesions in size and their blood supply, and relieves inflammation. As a result, the operation time is significantly reduced, and postoperative treatment is more successful. In addition, the incidence of postoperative relapses is significantly reduced and the formation of adhesions is reduced.

Before starting treatment with this drug, it is recommended to exclude pregnancy and stop using hormonal contraceptives, and at first, non-hormonal contraceptive methods should be used when taking the medication. This information is contained in the instructions for Buserelin injections.

Injection method of using Buserelin

Buserelin in injection form is used only through intramuscular administration. Before carrying out the procedure, it is necessary to properly prepare the solution for administering the injection. The solution preparation scheme is described in detail in the attached annotation, but it is still better to administer the injection drug in a medical facility.

The duration of this treatment method usually varies from three to six months.

The injection is given once a month. Many representatives of the fair sex note the tangible convenience of such treatment for serious pathology, rather than spraying a nasal spray three times daily.

Basically, all medical specialists note the high effectiveness of this drug in the treatment of endometriotic lesions of the uterine cavity. At the time of therapy, the development of endometriosis is observed to stop. But after stopping the drug, the pathological process of the endometrium may worsen again. Therefore, it is better to take Buserelin in combination with other medications prescribed by your doctor.

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special instructions

Women should rule out pregnancy, including ectopic pregnancy, before starting to use this medication, and for men, to effectively prevent negative effects at the very beginning of treatment, antiandrogens should be prescribed 14 days before the initial Buserelin injection and for 14 days after it. If there are signs of decreased potency, you should consult a doctor to adjust therapeutic methods or stop taking Buserelin. The instructions will give all the explanations.

Effect on concentration

The drug significantly reduces the speed of mental and motor reactions, so you should be especially careful when driving vehicles and complex machinery. In addition, during therapy, caution should be exercised when performing work that requires increased attention and speed of nervous reactions. This is what the instructions for the Buserelin nasal spray describe.

Use against endometriosis

The drug is very effective in treating this disease. Endometriosis is currently diagnosed in approximately 10% of women after thirty years of age. This pathology is estrogen-dependent, and clinical manifestations directly depend on the degree of involvement of nearby organs in the disease process. To treat the disease, it is necessary to suppress the secretion of estrogen, so it is advisable to use gonadotropin-releasing hormone analogues, one of which is Buserelin spray. The instructions indicate that the drug significantly reduces or leads to complete disappearance of signs of endometriosis, and prevents relapses of the disease for a long period after stopping taking this medication. However, the medicine does not completely cure endometriosis; after a while, some patients may experience a relapse. The most radical solution to this problem is surgery with concomitant drug therapy.

Men are prescribed the drug for prostate cancer, and women are prescribed for the development of endometriosis, breast cancer, uterine fibroids and hyperplastic processes in the endometrium. Treatment should begin in the first few days of menstruation. At the beginning of therapy, an exacerbation of the underlying disease is possible, but subsequently the functions of the ovaries are suppressed, and the hormone-dependent disease is suspended.

Are there any analogues to Buserelin Depot injections? The instructions do not contain such information.

Analog drugs

On the modern pharmaceutical market there is a large selection of drugs similar in action to the drug “Buserelin”, but their use in each individual case requires the appointment of a qualified specialist, since such drugs are serious hormonal treatments for special diseases, the treatment of which is exclusively the prerogative of a doctor.

Thus, analogues of this medication are:

• "Welbin";
• "Jevtana";
• "Andropharm";
• "Casodex";
• "Hongwan";
• "Novantron";
• "Diferelin";
• "Estradurine";
• "Bikulid";
• "Cyproterone-Teva";
• "Areklok";
• "Adriblastin";
• "Depo-Provera";
• "Flucinom";
• "Kalumid";
• "Leuprorelin";
• "Bicalutamide-Teva";
• "Indigal";
• "Sinestrol";
• "Vantas";
• "Endoxan";
• "Zoladex";
• "Sindroxocin";
• "Decapeptyl";
• "Navelbine";
• "Eligard";
• "Flutazine";
• "Zitiga";
• "Goserelin";
• "Chlorrtrianizen".

Analogues of the drug "Buserelin-depot" are represented by the following drugs:

• "Decapeptyl".
• "Eligard".
• Zoladex.
• "Decapeptyl Depot"
• Lucrine Depot.
• "Diferelin."