Lutrate depot mensual 3,75 mg polvo y disolvente para suspension de liberacion prolongada inyectable

Prospecto: information for the user

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

Leuprolide acetate

Read this prospectus carefully before starting to use the medicationbecause it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribedonlyto you and should not be given to other people even iftheyhave the same symptomsas you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospectus.See section 4.

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

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

3.How to use Lutrate Depot Monthly

4.Possible adverse effects

5.Storage of Lutrate Depot Monthly

6.Contents of the package and additional information

Lutrate Depot Monthly is a vial that contains a white powder, which is reconstituted in the form of a suspension for injection into a muscle.Lutrate Depot Monthly contains the active ingredient leuprorelina (also known asleuprolide), which belongs to a group of medications called gonadotropin-releasing hormone (LHRH) agonists, which are medications that reduce testosterone and estrogens (sex hormones).

Your doctor has prescribed Lutrate Depot Monthly for:

• The treatment of advanced prostate cancer in men.
• The treatment of locally advanced and localized hormone-dependent prostate tumors, in combination with radiation therapy.
• The treatment of endometriosis for a period of six months. It may be used alone or in combination with surgery.
• Treatment of uterine fibroids for a period of 6 months. This treatment may be used as a preoperative measure or as an adjunct to surgery or as an alternative definitive symptomatic treatment in perimenopausal women who do not wish to undergo surgery.
• Treatment of early-stage hormone-sensitive breast cancer in pre and perimenopausal women with a 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).

No use Lutrate Depot Mensual:

• If you are allergic (hypersensitive) to LHRH, LHRH agonists, or any of the other components of this medication (including those listed in section 6). An allergic reaction may manifest as 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 Mensual should not be used alone (in 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, planning to become pregnant, or breastfeeding.
• If you have abnormal vaginal bleeding that has not been discussed with your doctor.
• In pre- and perimenopausal women receiving Lutrate Depot Mensual for breast cancer:

Your estrogen levels must have been adequately suppressed with this medication before starting treatment with an aromatase inhibitor such as exemestane, and should be monitored every three months during combined treatment with leuprorelin 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 Mensual:

Immediately contact your doctor if you or your child experience severe headaches, visual problems, or tinnitus or buzzing.

Men and women

• If you believe you are experiencing an allergic reaction (shortness of breath, asthma, rhinitis, facial swelling, urticaria, skin rash), stop taking this medication and inform your doctor.
• Depression has been reported in patients taking leuprorelin acetate, which can be severe. If you are using leuprorelin acetate and feel depressed, inform your doctor.
• Inform your doctor if you have a risk of developing, or have, any of the following conditions, as you may need more frequent check-ups:

• Unexplained bleeding or bruising, or if you experience general discomfort. Although rare, these may be symptoms of changes in the number of red or white blood cells.
• Metabolic disease
• Heart problems or irregular heartbeator 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 gland tissue) have been described after initial administration of this type of medication in patients with pituitary adenoma.Pituitary apoplexy may manifest as sudden headache, meningism, visual disturbances, or altered vision, including blindness, and occasionally decreased level of consciousness.
• It may be necessary to monitor your liver function, as alterations of the liver and jaundice (yellowing of the eyes and skin) have been described with leuprorelin administration.
• Convulsions may occur in predisposed patients (patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors), in patients taking medications that can cause seizures, and to a lesser extent in patients without these characteristics.
• Severe skin reactions, including Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/NET), have been reported in association with leuprorelin. Discontinue the use of leuprorelin and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Only men

• • Inform your doctor if you have any heart or blood vessel disease or are being treated for it, including medications to control heart rhythm (arrhythmias). The risk of heart rhythm problems may increase when using leuprorelin acetate.
  • It is possible that your condition may worsen during the first weeks of treatment, but it should improve with continued treatment. Symptoms and signs include: temporary increase in testosterone levels (male hormone), hot flashes, bone pain, nervous system disorders (including depression) or urinary obstructions.
• Your doctor should be aware if you suffer from a bleeding 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 leuprorelin treatment.
• • Reduced bone density (fragile bones or thinner bones) has been described after leuprorelin administration. Your doctor may consider adding an anti-androgen to the treatment with leuprorelin acetate.Your doctor will be alert to detect the presence of inflammation of the veins (thrombophlebitis) and other signs of coagulation disorders and edema (swelling of the hands, feet, or ankles) that have a higher risk of occurring when adding anti-androgen treatment to leuprorelin acetate.
• Inform your doctor if you experience pressure on the spinal cord and/or urinary problems and/or hematuria (blood in the urine); in this case, your doctor will discuss the need for additional treatments to prevent neurological complications (e.g., tingling in the 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 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 disease or cardiovascular disease, and 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 leuprorelin.
• Consult your doctor, pharmacist, or nurse if you have fatty liver.
• During treatment, some blood tests should be performed to check if leuprorelin acetate is effective.
• You may experience a loss of interest in sex, hot flashes, and occasionally a reduction in testicle size and function.
• You may regain fertility when you stop treatment with leuprorelin acetate.
• Lutrate Depot Mensual may interfere with certain laboratory tests, so make sure your doctor knows that you are using this medication.

Only women

• Reduced bone density (fragile bones or thinner bones) has been reported with leuprorelin, which is reversible after completing a six-month cycle of leuprorelin acetate. If you have a higher risk of developing thinner bones (osteoporosis), inform your doctor before taking Lutrate Depot Mensual. 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 may cause thinner bones, for example, medications for epilepsy or steroids (such as hydrocortisone or prednisolone).

• Your condition may worsen initially during the first weeks of treatment, but it should improve with continued treatment.
• If you are a woman with submucosal fibroids (benign tumors in the muscle beneath the uterine lining), Lutrate Depot Mensual may cause severe bleeding when the fibroids degenerate. Contact your doctor immediately if you experience severe or unusual bleeding or pain.
• If you are a fertile woman, you should use a non-hormonal contraceptive method while receiving this medication. Although Lutrate Depot Mensual stops menstruation, it is not a contraceptive in itself. If you are unsure, discuss this with your doctor.
• If you continue to have periods (menstruation) after starting treatment with leuprorelin, inform your doctor.
• If you are receiving this medication for breast cancer:
• • Your doctor may evaluate your bone density and ovarian function before starting treatment with leuprorelin and monitor your bone density and ovarian function during the entire treatment.
  • Lutrate Depot Mensual should be initiated at least 6-8 weeks before starting treatment with an aromatase inhibitor and should continue during the entire treatment with the aromatase inhibitor.
  • If you have received chemotherapy, treatment with leuprorelin should only begin once you have completed chemotherapy and your premenopausal state has been confirmed.
  • The recommended duration of treatment with Lutrate Depot Mensual in combination with other hormonal treatments for breast cancer is up to 5 years.
  • If you are receiving leuprorelin 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 monitor your depression symptoms during treatment with leuprorelin.
  • If you are unsure about any of these points, discuss them with your doctor.

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 leuprorelin absorption at the injection site.
• If the child has a progressive brain tumor, the doctor will decide if treatment with leuprorelin is appropriate.
• Severe skin reactions, including Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/NET), have been reported in association with leuprorelin. Discontinue the use of leuprorelin and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

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 treatmentshould be investigated.
• During treatment for central precocious puberty with this medication, bone density may decrease. Despite this, after treatment is completed, 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 treatment withdrawal, 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.

Use of Lutrate Depot Mensual with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. It may still be suitable to continue treatment with leuprorelin acetate; your doctor will decide what is best for you.

Leuprorelin acetate may interfere with some medications 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 medications (e.g., methadone (used for pain relief and detoxification of other medications), moxifloxacino (an antibiotic), and antipsychotics used to treat severe mental illnesses).

Pregnancy and lactation

Lutrate Depot Mensual is contraindicated during pregnancy. Spontaneous abortions may occur if this medication is administered during pregnancy.

It is unknown whether leuprorelin acetate is excreted in breast milk, therefore, this medication should not be administered to women or girls during lactation.

Driving and operating machinery

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

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

Lutrate Depot Mensual contains Polisorbato 80

This medication contains 1 mg of polisorbate 80 in each dose. Polysorbates may cause allergic reactions. Inform your doctor if you have or your child has any known allergies.

Dosage

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

Adults including elderly:

The recommended dose of Lutrate Depot Monthly is one injection per 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 via intramuscular injection. It should not be administered by any other route.

The treatment regimen will be decided by your doctor

If you have endometriosis or uterine fibroids, you will be administered a Lutrate Depot Monthly injection for a period of up to 6 months at most

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

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

Use in children:

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

The dose adjustment should be made individually.

The recommended starting 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) are administered once a month as a single intramuscular injection.

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

Considering the clinical activity of central precocious puberty in these rare cases, the following should be done:

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 remaining suspension should be discarded. Your doctor will monitor the child's weight gain.

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 will be 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 a bone age of over 12 years and boys with a bone age of over 13 years, your doctor will evaluate whether to stop treatment based on the clinical effects in the child.

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

The treatment is of long duration and is adjusted individually. Please agree with your doctor that the administration of Lutrate Depot Monthly should be carried out as precisely as possible at regular intervals of one month. An occasional delay of a few days (30 ± 2 days) in the injection date does not affect the treatment outcome.

If you use more Lutrate Depot Monthly than you should

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

For 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 not to miss a dose of Lutrate Depot Monthly.As soon as you know that you have missed an injection, contact your doctor, who will administer the next injection.

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

If you interrupt treatment with Lutrate Depot Monthly

Since medical treatment involves the administration ofLutrate Depot Monthlyfor a long period of time, interrupting treatment may result in an aggravation of symptoms related to the disease. Therefore, do not interrupt treatment prematurely without your doctor's permission.

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

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

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

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

• Experience wheezing, difficulty breathing, swelling of the eyelids, face, or lips, skin rash, or itching (especially if it affects the entire body) suddenly.
• Unknown frequency (frequency cannot be estimated from available data):
• • If you notice circular or target-shaped patches on the trunk, red and not elevated, often with central blisters, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome/toxic epidermal necrolysis).
  • Redness of the skin and itchy rash (toxic skin eruption).
  • A skin reaction that causes pimples or red patches on the skin, which may resemble a target, with a dark red center surrounded by lighter red rings (erythema multiforme).

During the first 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 described:

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 sweating, cold sweats, fatigue, headache, pyrexia (elevated 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 (inflammation), hematomas (bruising), mood changes, and depression in prolonged treatments with leuprorelin.

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

Swelling of the breasts, breast pain, dizziness, weakness, sleep disturbances, lower abdominal pain, diarrhea, nausea, vomiting, sensation of cold and heat, restlessness, fever, jaundice (yellowing of the eyes and skin), liver enzyme abnormalities, anorexia, elevated cholesterol, joint pain, muscle spasms, hand and foot pain, decreased libido, mood changes, urinary retention, frequent urination, urinary incontinence, swelling around the eyes, ejaculation dysfunction, hyperlipidemia (elevated blood lipid levels), pruritus (itching), urticaria (skin rash), mood changes, depression in short-term treatments with leuprorelin, and reactions at the injection site such as swelling, wounds, and bleeding.

Unknown (frequency cannot be estimated from available data):

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

Pulmonary inflammation, pulmonary disease.

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

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 appear 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 described:

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, paresthesia (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 (which include 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), visual disturbances, palpitations, diarrhea, vomiting, abnormalities in liver values in blood tests, hair loss, muscle pain, fever, chills, or fatigue.

Unknown (frequency cannot be estimated from available data):

Blood tests may show anemia (low red blood cell count), low white blood cell count, or 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, pulmonary embolism, high or low blood pressure, jaundice (yellowing of the skin), liver function abnormalities, spinal fracture, seizures, less dense bones, or vaginal bleeding, pulmonary inflammation, or pulmonary disease.

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

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

The following side effects have been observed when a similar class of medications called GnRH analogs (GnRH hormone-releasing hormone analogs) has been used for breast cancer treatment 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 sex, urinary incontinence, increased blood pressure.

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

Diabetes, high blood sugar (hyperglycemia), pain, hematomas, 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):

Brain hemorrhage, 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 temporary increase in sex hormone levels, followed by a drop in values within the prepubertal range. As a result, side effects may occur, especially at the beginning of treatment.

The following side effects have been described:

Common (may affect up to1 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.

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

Unknown (frequency cannot be estimated from available data):

Seizures, pulmonary inflammation, pulmonary disease.

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

Notes:

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

Reporting side effects:

If you experience side effects, consult your doctor or pharmacist, even if they do not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Keepthis medicationout of the sight and reach of children.

Do not store at a temperature above 25°C. Do not freeze.

Do not use this medication after the expiration date that appears on the packaging, vial, and preloaded syringe after “CAD”. 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 must be administered immediately.

Medicationsshould not be disposed of through drains or in the trash. Dispose of the packaging and medications you do not need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you do not need. By doing so, you will help protect the environment.

Composition of Lutrate Depot Monthly

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

The other components are: polisorbate 80, mannitol (E-421), sodium carmelose (E-466), triethyl citrate, and poly(DL-lactide-co-glycolide) (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 contents of the package

Each package 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.

Holder of the marketing authorization and responsible for manufacturing

GP-PHARM, S.A.

Pol. Ind.Els Vinyets – Els Fogars Sector 2

Carretera comarcal 244, km22

08777 Sant Quintí de Mediona

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:February 2025.

Other sources of information

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (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 components of the kit).

You should follow aseptic technique during the reconstitution procedure.

Use only the solvent included in the commercial kit.

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

This medicine is for single use only. Any remaining suspension must be discarded.

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

The package contains:

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

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

1 (one) sterile, single-use device for reconstituting the product, including 1 (one) single-use sterile needle.

Instructions for use

Include in the lid of the tray containing the components of the Medicinal Product Kit

Lutrate Depot – Instructions for use

Read carefully before administering the product

Reconstituteimmediately before administering by single intramuscular injection

Use only the solvent included in the commercial kit.

Product intended for single use only.

Any remaining suspension must be discarded.