LUTRATE DEPOT MENSUAL 3.75 mg POWDER AND SOLVENT FOR PROLONGED-RELEASE INJECTABLE SUSPENSION

Introduction

Package Leaflet: Information for the User

Lutrate Depot Monthly 3.75 mg powder and solvent for prolonged-release injectable suspension

Leuprolide acetate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Lutrate Depot Monthly is and what it is used for
2. What you need to know before you use Lutrate Depot Monthly
3. How to use Lutrate Depot Monthly
4. Possible side effects
5. Storage of Lutrate Depot Monthly
6. Contents of the pack and other information

1. What Lutrate Depot Monthly is and what it is used for

Lutrate Depot Monthly is a vial containing a white powder, which is reconstituted as a suspension for injection into a muscle. Lutrate Depot Monthly contains the active substance leuprolide (also known as leuprolide), which belongs to a group of medicines called gonadotropin-releasing hormone (LHRH) agonists, which are medicines that reduce testosterone and estrogen (sex hormones).

Your doctor has prescribed Lutrate Depot Monthly for:

• Treatment of advanced prostate cancer in men.
• Treatment of locally advanced and localized hormone-dependent prostate tumors, in combination with radiotherapy.
• Treatment of endometriosis for a period of six months. It can be used alone or as combination therapy with surgery.
• Treatment of uterine fibroids for a period of 6 months. This treatment can be used as a preoperative measure or as adjuvant therapy to surgery or as an alternative definitive symptomatic treatment in perimenopausal women who do not desire surgery.
• Treatment of hormone-sensitive breast cancer in early stages in pre- and perimenopausal women with high risk of recurrence.
• Treatment of advanced hormone-sensitive breast cancer in pre- and perimenopausal women.
• Preservation of ovarian function in premenopausal women with cancer who are receiving chemotherapy.
• In children: treatment of central precocious puberty (in girls under 9 years, in boys under 10 years).

2. What you need to know before you use Lutrate Depot Monthly

Do not use Lutrate Depot Monthly:

• If you are allergic (hypersensitive) to LHRH, LHRH agonists, or any of the other components of this medicine (listed in section 6). An allergic reaction can manifest as a skin rash, itching, difficulty breathing, or swelling of the face, lips, throat, or tongue.
• In men with prostate cancer:
• • If you have undergone orchiectomy (removal of the testicles).

• Lutrate Depot Monthly should not be used alone (as monotherapy) for the treatment of prostate cancer when the spinal cord is compressed or the cancer has spread to the spinal cord.

• In women:

• If you are pregnant, plan to become pregnant, or are breastfeeding.
• If you have abnormal vaginal bleeding that you have not discussed with your doctor.
• In pre- and perimenopausal women receiving Lutrate Depot Monthly for breast cancer:

Your estrogen levels must have been adequately suppressed with this medicine before starting treatment with an aromatase inhibitor such as exemestane, and must be monitored every three months during combined treatment with leuprolide and an aromatase inhibitor (see the "Warnings and precautions" section below for more information).

• In girls with central precocious puberty:

• if the girl to be treated is pregnant or breastfeeding.
• if the girl has undiagnosed vaginal bleeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lutrate Depot Monthly:

Contact your doctor immediately if you or your child experience severe or recurrent headaches, vision problems, or ringing in the ears.

Men and women

• If you think you are experiencing an allergic reaction (shortness of breath, asthma, rhinitis, swelling of the face, urticaria, skin rash), stop taking this medicine and inform your doctor.
• Depression has been reported in patients undergoing treatment with leuprolide acetate, which can be severe. If you are using leuprolide acetate and feel depressed, inform your doctor.
• Tell your doctor if you have a risk of or are suffering from any of the following diseases, as you may need more frequent check-ups:

• Bruises or unexplained bleeding or if you experience general discomfort. Although rare, these can be symptoms of changes in the number of red or white blood cells.
• Metabolic disease
• Heart problems or palpitations
• Diabetes.

• Your doctor should be informed of any personal clinical history of pituitary adenoma (non-malignant tumor of the pituitary gland). Cases of pituitary apoplexy (partial loss of pituitary tissue) have been described after the initial administration of this type of medicine to patients with pituitary adenoma. Pituitary apoplexy can manifest as sudden headache, meningism, vision disorders, or altered vision, including blindness, and occasionally a decrease in the level of consciousness.
• It is possible that your liver function will need to be monitored, as liver disorders and jaundice (yellowing of the eyes and skin) have been described with the administration of leuprolide.
• Seizures can occur in predisposed patients (patients with a history of seizures, epilepsy, cerebrovascular disorders, anomalies, or tumors of the central nervous system), in patients taking medications that can cause seizures, and to a lesser extent in patients who do not have these characteristics.
• Severe skin reactions, including Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), have been reported in association with leuprolide. Discontinue the use of leuprolide and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

Men only

• • Tell your doctor if you have any heart or blood vessel condition or are being treated for it, including medications to control heart rhythm (arrhythmias). The risk of heart rhythm problems may increase when using leuprolide acetate.
  • Your disease may worsen during the first few weeks of treatment, but it should improve with continued treatment. The signs and symptoms include: temporary increase in testosterone (male hormone), hot flashes, bone pain, nervous system disorders (including depression), or urinary obstruction.
• Your doctor should know if you have a coagulation disorder, thrombocytopenia, or if you are being treated with anticoagulants.
• Fracture of the spine, paralysis, low blood pressure, and high blood pressure have been described with leuprolide treatment.
• • A reduction in bone density (fragile or less dense bones) has been described after the administration of leuprolide. Your doctor may consider adding an antiandrogen to the treatment with leuprolide acetate. In this case, your doctor will be alert to detect the presence of vein inflammation (thrombophlebitis) and other signs of coagulation disorders and edema (swelling of hands, feet, or ankles) that are more likely to occur when antiandrogenic treatment is added to leuprolide acetate.
• Tell your doctor if you feel pressure on the spinal cord and/or experience urinary disorders and/or hematuria (blood in the urine); in such a case, your doctor will discuss the need for additional treatments to prevent neurological complications (e.g., tingling in hands and feet, paralysis) or urethral obstruction (the tube that connects the bladder to the outside of the body). You will be closely monitored during the first few weeks of treatment.
• Patients may experience metabolic changes (e.g., glucose intolerance or worsening of existing diabetes), weight changes, and cardiovascular disorders.
• Patients with metabolic or cardiovascular disease, especially those with a history of congestive heart failure (a condition in which the heart is no longer able to pump enough blood to the rest of the body), should be monitored during treatment with leuprolide.
• Consult your doctor, pharmacist, or nurse if you have fatty liver.
• During treatment, some blood tests will be performed to check if leuprolide acetate is effective.
• You may experience a loss of interest in sexual relations, hot flashes, and occasionally a reduction in the size and function of the testicles.
• You may become fertile again when treatment with leuprolide acetate is discontinued.
• Lutrate Depot Monthly may interfere with certain laboratory tests, so you should ensure that your doctor knows you are using this medicine.

Women only

• A decrease in bone density (fragile or less dense bones) has been reported with leuprolide, which is reversible after completing a six-month cycle of leuprolide acetate. If you have a higher risk of developing less dense bones (osteoporosis), you should inform your doctor before taking Lutrate Depot Monthly. Risk factors include:

• If you or a close family member has osteoporosis.
• If you drink excessive amounts of alcohol and/or smoke heavily.
• If you take medications for a prolonged period that can cause less dense bones, such as medications for epilepsy or steroids (e.g., hydrocortisone or prednisolone).

• Your condition may worsen at the beginning during the first few weeks of treatment, but it should improve with continued treatment.
• If you are a woman with submucous fibroids (benign tumors in the muscle under the uterine lining), Lutrate Depot Monthly may cause severe bleeding when the fibroids break down. Contact your doctor immediately if you experience severe or unusual bleeding or pain.
• If you are a woman of childbearing age, you should use a non-hormonal contraceptive method while receiving this medicine. Although Lutrate Depot Monthly interrupts menstruation, it is not a contraceptive in itself. If you are unsure about this, talk to your doctor.
• If you are a woman and continue to have periods (menstruation) after starting treatment with leuprolide, you should inform your doctor.
• If you are receiving this medicine for the treatment of breast cancer:
• • Your doctor may evaluate your bone density and ovarian function before starting treatment with leuprolide and monitor your bone density and ovarian function during treatment.
  • Lutrate Depot Monthly should be started at least 6-8 weeks before starting treatment with an aromatase inhibitor and should continue throughout treatment with the aromatase inhibitor.
  • If you have received chemotherapy, treatment with leuprolide should only begin once chemotherapy has been completed and premenopausal status has been confirmed.
  • The recommended duration of treatment with Lutrate Depot Monthly in combination with other hormonal treatments for breast cancer is up to 5 years.
  • If you are administered leuprolide in combination with an aromatase inhibitor, your doctor may monitor your blood pressure, heart function, and blood glucose levels during treatment. If you have depression or a history of depression, inform your doctor so they can also monitor your symptoms of depression during treatment with leuprolide.
  • If you are unsure about any of these points, talk to your doctor.

In children:

• In the event of a sterile abscess at the injection site, your doctor will monitor your hormone levels, as there may be a reduction in the absorption of leuprolide at the injection site.
• If the child has a progressive brain tumor, the doctor will decide whether treatment with leuprolide is appropriate.
• Severe skin reactions, including Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), have been reported in association with leuprolide. Discontinue the use of leuprolide and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

In girls with central precocious puberty

• After the first injection, vaginal bleeding (spotting) and vaginal secretions may appear as a sign of hormonal withdrawal. Vaginal bleeding beyond the first/second month of treatment must be investigated.
• During treatment for central precocious puberty with this medicine, bone density may decrease. Despite this, after the end of treatment, the subsequent accumulation of bone mass is maintained, and the peak bone mass in late adolescence does not appear to be altered by treatment.
• After discontinuation of treatment, a slipping of the femoral epiphysis may occur. A possible cause of the weakness of the growth plate is the decrease in female sex hormone concentrations during treatment.

Using Lutrate Depot Monthly with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. It may still be suitable to use leuprolide acetate; your doctor will decide what is suitable for you.

Leuprolide acetate may interfere with certain medicines used to treat heart rhythm problems (e.g., quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of heart rhythm problems when used with other medicines (e.g., methadone (used for pain relief and detoxification from other medicines), moxifloxacin (an antibiotic), antipsychotics used to treat severe mental illnesses).

Pregnancy and breastfeeding

Lutrate Depot Monthly is contraindicated during pregnancy. Spontaneous abortions may occur if this medicine is administered during pregnancy.

It is unknown whether leuprolide acetate is excreted in breast milk; therefore, this medicine should not be administered to women or girls who are breastfeeding.

Driving and using machines

Visual disturbances and dizziness may occur during treatment. If you are affected, do not drive or operate machines.

Lutrate Depot Monthly containsless than 23 mg of sodium (1 mmol) per dose; this is essentially "sodium-free".

Lutrate Depot Monthly contains Polysorbate 80

This medicine contains 1 mg of polysorbate 80 in each dose unit. Polysorbates can cause allergic reactions. Inform your doctor if you or your child have any known allergies.

3. How to use Lutrate Depot Monthly

Dosage

Lutrate Depot Monthly should only be administered by your doctor or nurse. They will be responsible for preparing the product.

Adults, including the elderly:

The recommended dose of Lutrate Depot Monthly is one injection once a month. The powder is reconstituted to form a suspension that is administered as a single intramuscular injection (in a muscle) once a month (approximately every 28-33 days).

The injection site should be varied at regular intervals.

Lutrate Depot Monthly should only be administered intramuscularly. It should not be administered by any other route.

The treatment schedule will be decided by your doctor.

If you have endometriosis or uterine fibroids, you will be given an injection of Lutrate Depot Monthly for a period of up to 6 months.

If you have breast cancer, you will be given Lutrate Depot Monthly once a month in combination with tamoxifen or an aromatase inhibitor. Before starting treatment with an aromatase inhibitor or tamoxifen, you must have received at least two injections of leuprorelin with a one-month interval between each injection.

If you are given Lutrate Depot Monthly to preserve ovarian function while receiving chemotherapy, you will normally be given an injection of this medication two weeks before starting chemotherapy and then every month during the duration of your chemotherapy treatment.

Use in children:

Treatment of children should be under the general supervision of a pediatric endocrinologist.

Dose adjustment should be done individually.

The recommended initial dose depends on body weight:

1. Children with a body weight of 20 kg or more

Unless your doctor tells you otherwise, 2 ml of Lutrate Depot Monthly (3.75 mg of leuprorelin acetate) should be administered once a month as a single intramuscular injection.

1. Children with a body weight of less than 20 kg

Taking into account the clinical activity of central precocious puberty in these rare cases, the following procedure should be followed:

Unless your doctor tells you otherwise, 1 ml of Lutrate Depot Monthly (1.88 mg of leuprorelin acetate) should be administered once a month as a single intramuscular injection. The rest of the suspension should be discarded. Your doctor will monitor the child's weight gain.

Depending on the progression of central precocious puberty, your doctor may increase the dose if inadequate suppression is observed (e.g., vaginal bleeding). Your doctor will determine the minimum effective dose through a blood test.

The duration of treatment depends on the clinical symptoms at the start of treatment or during treatment and is decided jointly between the treating doctor, the legal guardian, and, if appropriate, the child being treated. Your doctor will determine the child's bone age at regular intervals.

In girls with bone maturation of more than 12 years and boys with bone maturation of more than 13 years, your doctor will assess stopping treatment based on the clinical effects on your child.

In girls, pregnancy should be ruled out before starting treatment. Generally, pregnancy cannot be excluded during treatment. In these cases, consult your doctor.

Treatment is long-term and is adjusted individually. Please agree with your doctor that the administration of Lutrate Depot Monthly is done as precisely as possible at regular monthly intervals. An exceptional delay of the injection date by a few days (30 ± 2 days) does not affect the outcome of the treatment.

If you use more Lutrate Depot Monthly than you should

This is unlikely, as the doctor or nurse will know what the correct dose is. Nevertheless, if you suspect that you have received more medication than you should, inform your doctor immediately so that the necessary measures can be taken.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount administered.

If you forget to use Lutrate Depot Monthly

It is essential that you do not miss a dose of Lutrate Depot Monthly. As soon as you realize that you have missed an injection, contact your doctor, who will administer the next injection.

Only for women:if you forget an injection of Lutrate Depot Monthly, intermenstrual bleeding or ovulation with the possibility of conception may occur. If you think you may be pregnant, you should stop using this medication and contact your doctor immediately.

If you stop treatment with Lutrate Depot Monthly

Since medical treatment involves the administration of Lutrate Depot Monthly for a long period, stopping treatment may result in a worsening of symptoms related to the disease. Therefore, you should not stop treatment prematurely without your doctor's permission.

If you are given Lutrate Depot Monthly for the treatment of breast cancer, you should not stop treatment with this medication while taking an aromatase inhibitor or tamoxifen. If you are going to stop treatment with leuprorelin, your treatment with an aromatase inhibitor should also be stopped within one month of the last injection of Lutrate Depot Monthly.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Tell your doctor immediately if you notice any of the following symptoms:

• You experience wheezing, difficulty breathing, swelling of the eyelids, face, or lips, skin rash, or itching (especially if it affects your whole body) suddenly.
• Frequency not known (frequency cannot be estimated from available data):
• • You notice circular or target-shaped red spots on your trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome/toxic epidermal necrolysis).
  • Redness of the skin and rash with itching (toxic skin eruption).
  • A skin reaction that causes spots or red patches on the skin, which can look like a target, with a dark red center surrounded by lighter red rings (erythema multiforme).

During the first few weeks of treatment, a temporary worsening of your condition may occur, but it should improve with continued treatment.

Men

The following side effects have been reported:

Very common (may affect more than 1 in 10 people):

Hot flashes and reactions at the injection site.

Common (may affect up to 1 in 10 people):

Nocturnal sweats, cold sweats, fatigue, headache, pyrexia (increased body temperature), increased appetite, erectile dysfunction, hyperhidrosis (excessive sweating), asthenia (lack or loss of strength), back pain, and reactions at the injection site such as pain, irritation, discomfort, erythema (redness of the skin), swelling (increased size or inflammation), hematoma (bruising), mood changes, and depression during prolonged treatment with leuprorelin.

Uncommon (may affect up to 1 in 100 people):

Breast swelling, breast pain, dizziness, weakness, sleep disorders, lower abdominal pain, diarrhea, nausea, vomiting, feeling of cold and heat, restlessness, fever, yellowing of the eyes and skin (jaundice), alteration of liver enzymes, anorexia, high cholesterol, joint pain, muscle spasms, pain in hands and feet, decreased sexual desire, mood changes, urinary retention, frequent urination, urinary incontinence, swelling around the eyes, ejaculation disorder, hyperlipidemia (high levels of lipids in the blood), pruritus (itching), urticaria (skin rash), mood changes, depression during short-term treatment with leuprorelin, and reactions at the injection site such as swelling, wounds, and bleeding.

Not known (frequency cannot be estimated from available data):

Cardiac disorders: changes in the ECG (prolongation of the QT interval).

Lung inflammation, lung disease.

Idiopathic intracranial hypertension (increased pressure around the brain characterized by headaches, double vision, and other visual symptoms, ringing in the ears or tinnitus).

Women

Many of the side effects of Lutrate Depot Monthly are related to the decrease in estrogen levels. Estrogen levels return to normal after stopping treatment. Common side effects that may occur include hot flashes, mood changes, depression, and vaginal dryness. As can happen naturally when women reach menopause, this medication may cause a small reduction in bone density. Vaginal bleeding may occur during treatment.

The following side effects have been reported:

Very common (may affect more than 1 in 10 people):

Difficulty sleeping, headache, or hot flashes.

Common (may affect up to 1 in 10 people):

Weight changes, mood changes, depression, tingling in hands or feet, dizziness, nausea, joint pain, muscle weakness, breast tenderness, changes in breast size, vaginal dryness, swelling of the ankles, or skin reactions at the injection site (including skin hardening, redness, pain, abscesses, swelling, nodules, ulcers, and skin damage).

Uncommon (may affect up to 1 in 100 people):

Loss of appetite, changes in blood lipids (cholesterol), vision changes, strong heartbeat, diarrhea, vomiting, abnormal liver values in blood tests, hair loss, muscle pain, fever, chills, or fatigue.

Not known (frequency cannot be estimated from available data):

Blood tests may show anemia (low red blood cell count), low white blood cell count, or low platelet count, allergic reactions (including symptoms of rash, itching, hives, or a severe allergic reaction that causes difficulty breathing or dizziness), changes in blood sugar levels, paralysis, blood clots in the lungs, high or low blood pressure, jaundice (yellowing of the skin), liver function abnormalities, spinal fracture, seizures, less dense bones, or vaginal bleeding, lung inflammation, or lung disease.

Idiopathic intracranial hypertension (increased pressure around the brain characterized by headaches, double vision, and other visual symptoms, ringing in the ears or tinnitus).

Side effects when used for the treatment of breast cancer in combination with tamoxifen or an aromatase inhibitor

The following side effects have been observed when a similar class of medications called GnRH analogs (gonadotropin-releasing hormone analogs) has been used for breast cancer in combination with tamoxifen or an aromatase inhibitor:

Very common (may affect more than 1 in 10 people):

Nausea, feeling very tired, joint and muscle pain, osteoporosis, hot flashes, excessive sweating, difficulty sleeping, depression, decreased libido, vaginal dryness, pain during or after intercourse, urinary incontinence, increased blood pressure.

Common (may affect up to 1 in 10 people):

Diabetes, high blood sugar levels (hyperglycemia), pain, bruising, redness, and swelling at the injection site, allergic reaction, bone fractures, blood clots in a blood vessel.

Uncommon (may affect up to 1 in 100 people):

Bleeding in the brain, lack of blood flow to the brain or heart.

Rare (may affect up to 1 in 1000 people):

Changes in the ECG (prolongation of the QT interval).

Children

In the initial phase of treatment, there is a short-term increase in sex hormone levels, followed by a decrease in values within the prepubertal range. Due to this, side effects may occur, especially at the start of treatment.

The following side effects have been reported:

Common (may affect up to 1 in 10 patients):

Mood changes, headache, abdominal pain/cramps, nausea/vomiting, acne, vaginal bleeding, spotting, vaginal discharge, reactions at the injection site.

Very rare (may affect up to 1 in 10,000 people):

Generalized allergic reactions (fever, skin rash, itching), severe allergic reactions that cause difficulty breathing or dizziness.

As with other medications in this class: if you have an existing pituitary lesion, there may be a higher risk of bleeding in the area, which could cause permanent damage.

Not known (frequency cannot be estimated from available data):

Seizures, lung inflammation, lung disease.

Idiopathic intracranial hypertension (increased pressure around the brain characterized by headaches, double vision, and other visual symptoms, ringing in the ears or tinnitus).

Notes:

Generally, the occurrence of vaginal bleeding during continued treatment (after the possible withdrawal bleeding in the first month of treatment) should be evaluated as a potential sign of underdosing. If vaginal bleeding occurs, inform your doctor.

Reporting side effects:

If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Lutrate Depot Monthly

Your doctor or pharmacist will know how to store Lutrate Depot Monthly.

Keep this medication out of sight and reach of children.

Do not store above 25°C. Do not freeze.

Do not use this medication after the expiration date shown on the packaging, vial, and prefilled syringe after "EXP". The syringe has the same expiration date as the vial. The expiration date is the last day of the month indicated.

Once reconstituted with the solvent, the suspension should be administered immediately.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Lutrate Depot Monthly

The active ingredient is leuprorelin acetate. Each vial contains 3.75 mg of leuprorelin acetate.

The other components are: polysorbate 80, mannitol (E-421), sodium carmellose (E-466), triethyl citrate, and poly(DL-lactic-co-glycolic acid) (PLGA).

The solvent contains (pre-filled syringe): mannitol, water for injectable preparations, sodium hydroxide (for pH adjustment), and hydrochloric acid (for pH adjustment).

Appearance of the Product and Container Contents

Each container contains a vial with 3.75 mg of leuprorelin acetate, a pre-filled syringe with 2 ml of solvent, an adapter system, and a sterile 20G needle.

Marketing Authorization Holder and Manufacturer

GP-PHARM, S.A.

Pol. Ind. Els Vinyets – Els Fogars Sector 2

Carretera comarcal 244, km22

08777 Sant Quintí de Mediona

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain: Lutrate Depot Monthly 3.75 mg powder and solvent for prolonged-release injectable suspension

France: Zeulide 3.75 mg powder and solvent for prolonged-release injectable suspension

Date of the Last Revision of this Leaflet:February 2025.

Other Sources of Information

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

This information is intended solely for healthcare professionals.

How to Prepare the Injection?

IMPORTANT: Read carefully before administering the product (the Instructions for Use are also included in the tray containing the kit components).

Aseptic technique should be followed during the reconstitution procedure.

Use only the solvent included in the commercial kit.

Once mixed, the product should be administered immediately. By single intramuscular injection.

This medicinal product is for single use only. Any remaining suspension should be discarded.

Check the contents of the kit and ensure that it includes everything mentioned in the leaflet.

The Container Contains:

1 (one) vial of Lutrate Depot Monthly 3.75 mg (leuprorelin acetate) powder for injectable suspension.

1 (one) pre-filled syringe containing the solvent for the suspension (0.8% mannitol injectable solution)

1 (one) single-use sterile reconstitution device, including 1 (one) single-use sterile needle.

Instructions for Use

To be included in the cover of the tray containing the kit components

Lutrate Depot – Instructions for Use

Read carefully before administering the product

Reconstitute immediately before administration by single intramuscular injection

Use only the solvent included in the commercial kit.

Product intended for single injection only.

Any remaining suspension should be discarded.