Lutrate Depot Mensual 3,75 mg powder and solvent for prolonged-release injectable suspension: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Leuprorelin 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

What Lutrate Depot Monthly is and what it is used for
What you need to know before using Lutrate Depot Monthly
How to use Lutrate Depot Monthly
Possible side effects
How to store Lutrate Depot Monthly
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 into a suspension for intramuscular injection. Lutrate Depot Monthly contains the active substance leuprorelin (also known as leuprolide), which belongs to a group of medicines called gonadotropin-releasing hormone (GnRH) agonists, drugs 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 may be used alone or as combination therapy 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 women approaching menopause (perimenopausal women) who do not wish to undergo surgery.
Treatment of hormone-sensitive early-stage breast cancer in pre- and perimenopausal women at 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 of age, in boys under 10 years of age).

2. What you need to know before starting to 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 may present 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 (surgical removal of the testicles).
Lutrate Depot Monthly must not be used alone (as monotherapy) for the treatment of prostate cancer when the spinal cord is compressed or when 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 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 by this medicine 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 section “Warnings and precautions” below for further 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

Talk to 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, visual disturbances, or tinnitus (ringing in the ears).

Men and women

If you suspect you are experiencing an allergic reaction (shortness of breath, asthma, rhinitis, facial swelling, hives, or skin rash), stop taking this medicine and inform your doctor.
Cases of depression, which may be severe, have been reported in patients treated with leuprorelin acetate. If you are taking leuprorelin acetate and feel depressed, inform your doctor.
Inform your doctor if you have a risk of, or already suffer from, any of the following conditions, as you may require more frequent monitoring:
Unexplained bruising or bleeding, or if you feel generally unwell. Although rare, these may be symptoms of changes in red or white blood cell counts.
Metabolic disorders.
Heart problems or palpitations.
Diabetes.
Your doctor must be informed of any personal history of pituitary adenoma (a non-malignant tumor of the pituitary gland). Cases of pituitary apoplexy (partial loss of pituitary tissue) have been reported after initial administration of this type of medicine in patients with pituitary adenoma. Pituitary apoplexy may present as sudden headache, meningism, visual disturbances or altered vision, including blindness, and occasionally decreased level of consciousness.
Your liver function may need to be monitored, as liver disorders and jaundice (yellowing of the eyes and skin) have been reported with leuprorelin administration.
Seizures may occur in predisposed patients (those with a history of seizures, epilepsy, cerebrovascular disorders, or central nervous system abnormalities or tumors), in patients taking drugs that may cause seizures, and, less commonly, in patients without these risk factors.
Serious skin reactions, including Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), have been reported with leuprorelin. Discontinue leuprorelin and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Men only

- Inform your doctor if you have any heart or blood vessel conditions or are being treated for them, including medications to control heart rhythm (arrhythmias). The risk of heart rhythm problems may increase when leuprorelin acetate is used.
- Your condition may worsen during the first weeks of treatment, but should improve with continued therapy. Signs and symptoms include: a temporary rise in testosterone (male hormone), hot flushes, bone pain, nervous system disorders (including depression), or urinary obstruction.
Your doctor should know if you have a bleeding disorder, thrombocytopenia, or are taking anticoagulant medications.
Spinal fractures, paralysis, low blood pressure, and high blood pressure have been reported with leuprorelin treatment.
- Reduced bone density (fragile or thinner bones) has been reported after leuprorelin administration. Your doctor may consider adding an antiandrogen to leuprorelin acetate therapy. In such cases, your doctor will monitor for signs of venous inflammation (thrombophlebitis) and other signs of coagulation disorders and edema (swelling of hands, feet, or ankles), which are more likely when antiandrogen therapy is added to leuprorelin acetate.
Inform your doctor if you feel pressure on the spinal cord and/or have urinary disorders and/or hematuria (blood in urine); in such cases, 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 connecting 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 or cardiovascular disease, especially those with a history of congestive heart failure (a condition in which the heart cannot pump enough blood to the body), should be closely monitored during leuprorelin treatment.
Consult your doctor, pharmacist, or nurse if you have fatty liver.
Blood tests should be performed during treatment to monitor the effectiveness of leuprorelin acetate.
You may experience reduced interest in sexual activity, hot flushes, and occasionally a reduction in the size and function of the testicles.
Fertility may return after stopping leuprorelin acetate treatment.
Lutrate Depot Monthly may interfere with certain laboratory tests, so ensure your doctor knows you are taking this medicine.

Women only

A decrease in bone density (bone fragility or less dense bones) has been reported with leuprorelin, which is reversible after completing a six-month cycle of leuprorelin acetate. If you are at higher risk of developing low bone density (osteoporosis), 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 over a long period that may cause bone loss, such as antiepileptic drugs or steroids (e.g., hydrocortisone or prednisolone).
Your condition may worsen initially during the first weeks of treatment, but should improve with continued therapy.
If you are a woman with submucosal fibroids (benign tumors in the muscle beneath the uterine lining), Lutrate Depot Monthly may cause severe bleeding as 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 must use a non-hormonal contraceptive method while receiving this medicine. Although Lutrate Depot Monthly stops menstruation, it is not a contraceptive in itself. If you are unsure, speak with your doctor.
If you are a woman and continue to have periods (menstruation) after starting leuprorelin treatment, inform your doctor.
If you are receiving this medicine for breast cancer treatment:
- Your doctor may assess your bone density and ovarian function before starting leuprorelin and monitor them throughout treatment.
- Lutrate Depot Monthly should be started at least 6–8 weeks before beginning treatment with an aromatase inhibitor and must continue throughout aromatase inhibitor therapy.
- If you have received chemotherapy, leuprorelin treatment should only begin after chemotherapy is completed and premenopausal status is confirmed.
- The recommended duration of treatment with Lutrate Depot Monthly in combination with other hormonal therapies 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, cardiac function, and blood glucose levels during treatment. If you have depression or a history of depression, inform your doctor so your depressive symptoms can also be monitored during leuprorelin treatment.
- If you are unsure about any of these points, speak with your doctor.

In children:

If a sterile abscess occurs at the injection site, your doctor will monitor hormone levels, as reduced absorption of leuprorelin at the injection site may occur.
If the child has a progressive brain tumor, the doctor will decide whether leuprorelin treatment is appropriate.
Serious skin reactions, including Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), have been reported with leuprorelin. Discontinue leuprorelin and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

In girls with central precocious puberty

After the first injection, vaginal bleeding (spotting) and vaginal discharge may occur 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 treatment ends, subsequent bone mass accumulation continues, and the peak bone mass in late adolescence does not appear to be altered by treatment.
After stopping treatment, slipping of the femoral epiphysis may occur. A possible cause of growth plate weakness is the reduced concentration of female sex hormones during treatment.

Use of Lutrate Depot Monthly with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Treatment with leuprorelin acetate may still be appropriate; your doctor will decide what is suitable for you.

Leuprorelin acetate may interfere with some 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 drug detoxification), moxifloxacin (an antibiotic), antipsychotics used to treat serious 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 leuprorelin acetate is excreted in breast milk; therefore, this medicine must not be administered to women or girls who are breastfeeding.

Driving and using machines

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

Lutrate Depot Monthly contains less 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 per dose unit. Polysorbates may cause allergic reactions. Inform your doctor if you or your child has any known allergies.

3. How to use Lutrate Depot Monthly

Dosage

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

Adults, including elderly patients:

The recommended dose of Lutrate Depot Monthly is one injection per month. The powder is reconstituted to form a suspension, which is administered as a single intramuscular injection (into a muscle) once monthly (approximately every 28–33 days).

The injection site should be rotated at regular intervals.

Lutrate Depot Monthly must be administered exclusively by the intramuscular route. It must not be administered by any other route.

The treatment regimen will be determined by your doctor.

If you have endometriosis or uterine fibroids, you will receive Lutrate Depot Monthly injections for a period of up to 6 months maximum.
If you have breast cancer, you will receive Lutrate Depot Monthly once a month in combination with tamoxifen or an aromatase inhibitor. Prior to initiating treatment with an aromatase inhibitor or tamoxifen, a minimum of two leuprorelin injections must have been administered, with an interval of one month between each injection.
If you are receiving Lutrate Depot Monthly to preserve ovarian function during chemotherapy, you will typically receive your first injection of this medication two weeks before starting chemotherapy, followed by monthly injections throughout the duration of your chemotherapy treatment.

Use in children:

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

Dosage adjustments must be individualized.

The recommended starting dose depends on body weight:

Children with body weight equal to or greater than 20 kg

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

Children with body weight less than 20 kg

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

Unless otherwise directed by your doctor, 1 ml of Lutrate Depot Monthly (1.88 mg of leuprorelin acetate) should be administered once monthly as a single intramuscular injection. The remaining suspension must 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 blood testing.

The duration of treatment depends on clinical symptoms at the start or during treatment and is decided jointly by the treating physician, the legal guardian, and, when appropriate, the child. Your doctor will assess the child's bone age at regular intervals.

In girls with bone age over 12 years and boys with bone age over 13 years, your doctor will consider discontinuing treatment, based on the clinical effects in your child.

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

Treatment is long-term and individually adjusted. Please coordinate with your doctor to ensure that Lutrate Depot Monthly is administered as precisely as possible at regular monthly intervals. An occasional delay in the injection date of a few days (30 ± 2 days) 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 intended, inform your doctor immediately so that appropriate measures can be taken.

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

If you forget to use Lutrate Depot Monthly

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

For women only: If you miss an injection of Lutrate Depot Monthly, intermenstrual bleeding or ovulation may occur, with a possibility of conception. If you think you might be pregnant, you must stop using this medication and contact your doctor immediately.

If you stop using Lutrate Depot Monthly

Since medical treatment involves long-term administration of Lutrate Depot Monthly, discontinuation of treatment may lead to a worsening of disease-related symptoms. Therefore, do not stop treatment prematurely without your doctor's approval.

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

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

4. Possible adverse effects

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

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

sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, skin rash or itching (especially if affecting the whole body).
Frequency not known (frequency cannot be estimated from available data):
- If you notice circular or target-shaped, reddish, non-elevated skin lesions on the trunk, often with central blisters, skin peeling, or ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome/toxic epidermal necrolysis).
- Skin redness and itchy rash (toxic skin eruption).
- A skin reaction causing pimples or red spots 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 adverse effects have been reported:

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

Hot flushes and injection site reactions.

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

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

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

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

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

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

Lung inflammation, lung 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 adverse effects of Lutrate Depot Monthly are related to decreased estrogen levels. Estrogen levels return to normal after stopping treatment. Common adverse effects may include hot flushes, mood changes, depression, and vaginal dryness. As may naturally occur when women reach menopause, this medicine may cause a slight reduction in bone thickness. Vaginal bleeding may occur during treatment.

The following adverse effects have been reported:

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

Difficulty sleeping, headache, or hot flushes.

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 disturbances, strong heartbeat, diarrhea, vomiting, abnormalities in liver 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 or platelet count, allergic reactions (including rash, itching, hives, or a severe allergic reaction causing 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), abnormalities in liver function, vertebral fractures, seizures, less dense bones, vaginal bleeding, lung inflammation, or lung 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 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 medicines called GnRH analogues (gonadotropin-releasing hormone analogues) have 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 flushes, excessive sweating, difficulty sleeping, depression, decreased libido, vaginal dryness, pain during or after sexual 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, formation of blood clots in a blood vessel.

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

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

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

Changes in ECG (prolongation of QT interval).

Children

In the initial phase of treatment, there is a short-term increase in sex hormone levels, followed by a drop into the prepubertal range. Because of this, adverse effects may occur especially at the beginning of treatment.

The following adverse effects have been reported:

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

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

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

General allergic reactions (fever, skin rash, itching), severe allergic reactions causing difficulty breathing or dizziness.

As with other medicines in this class: if you have an existing pituitary lesion, there may be an increased 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 intracranial pressure around the brain characterized by headaches, diplopia and other visual symptoms, tinnitus or ringing in one or both ears).

Notes:

Generally, the occurrence of vaginal bleeding during continued treatment (after any 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 of adverse effects:

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

5. Storage of Lutrate Depot Monthly

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

Keep this medicine out of the sight and reach of children.

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

Do not use this medicine after the expiry date stated on the packaging, vial, and prefilled syringe after “EXP”. The syringe has the same expiry date as the vial. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lutrate Depot Monthly

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

The other components are: polysorbate 80, mannitol (E-421), sodium carboxymethylcellulose (E-466), triethyl citrate, and poly(DL-lactide-co-glycolide) (PLGA).

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

Appearance of the medicine and contents of the pack

Each pack contains one 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 Authorisation 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 medicine is authorised in the Member States of the European Economic Area under the following names:

Spain: Lutrate Depot Mensual 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 most recent review of this leaflet: February 2025.

Other sources of information

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

This information is intended for healthcare professionals only.

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).

An aseptic technique must be followed during the reconstitution procedure.

Use only the solvent provided in the 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 all items listed in the leaflet are included.

The pack 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 (injectable mannitol 0.8% solution).

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

1		Completely remove the snap-off cap from the top of the vial so that the rubber stopper is fully exposed. Confirm that no parts of the snap-off cap remain on the vial.
2		Place the vial upright on a flat surface. Remove the blister cover containing the vial adapter (MIXJECT). Do not remove the vial adapter from the blister. Firmly place the blister containing the vial adapter onto the top of the vial, piercing the rubber stopper in a completely vertical position. Gently press downward until you feel it click into place.
3		Attach the white piece to the syringe until you feel it click into place. Unscrew the syringe cap counterclockwise. Then, remove the blister from the MIXJECT adapter system.
4		Connect the syringe to the adapter system by screwing it clockwise into the side opening of the adapter. To ensure a tight seal, gently screw the syringe until it stops.
5		While holding the syringe and vial firmly together in an upright position, slowly push the plunger of the syringe to transfer all the solvent into the vial.
6		With the syringe still attached to the vial, gently shake the vial for approximately one minute until a uniform milky suspension is obtained. To prevent separation of the suspension, proceed with the following steps without interruption.
7		Rotate the MIXJECT adapter system so that the vial is on top. Hold the MIXJECT adapter system firmly by the syringe and slowly pull back the plunger to transfer the contents of the vial into the syringe. Some product may accumulate or deposit on the vial wall. This is normal.
8		Disconnect the syringe from the MIXJECT adapter system. To do this, hold the syringe firmly and rotate the vial clockwise (holding it by the plastic cap of the adapter system).
9		Keep the syringe IN AN UPRIGHT POSITION. With the other hand, remove the needle cap by pulling it upward. Slightly press the plunger to expel air from the syringe. The syringe containing the product is now ready for immediate administration.
10		Administer the intramuscular injection by inserting the needle at a 90-degree angle into the gluteal muscle. Ensure that the entire product is injected. Injection sites should be alternated.

Instructions for Use

To be included on the lid of the tray containing the components of the Medication Kit

Lutrate Depot – Instructions for Use

Read carefully before administering the product

Reconstitute immediately before administration by single intramuscular injection.

Use only the solvent provided in the commercial kit.

This product is intended for single injection only.

Any remaining suspension must be discarded.

1		Completely remove the flip-off cap from the top of the vial so that the rubber stopper is exposed. Confirm that no parts of the flip-off cap remain on the vial.
2		Place the vial upright on a flat surface. Remove the blister cover protecting the vial adapter (MIXJECT). Do not remove the vial adapter from the blister. Firmly place the blister containing the vial adapter onto the top of the vial, piercing the stopper with the adapter in a fully vertical position. Gently press downward until you feel it snap into place.
3		Attach the white piece to the syringe until you feel it click into place. Then unscrew the syringe's rigid cap counterclockwise. Afterwards, remove the blister from the MIXJECT adapter system.
4		Connect the syringe to the adapter system by screwing it clockwise into the side opening of the MIXJECT adapter. To ensure a tight seal, gently screw the syringe until it stops.
5		While holding the syringe and vial firmly together in an upright position, slowly push the plunger of the syringe to transfer all the solvent into the vial.
6		With the syringe still attached to the vial, gently shake the vial for approximately one minute until a uniform milky suspension is obtained. To prevent separation of the suspension, proceed with the following steps without interruption.
7		Rotate the MIXJECT adapter system so that the vial is on top. Firmly hold the MIXJECT adapter by the syringe and slowly pull back the plunger to transfer the contents of the vial into the syringe. Some of the product may accumulate or deposit on the walls of the vial. This is normal.
8		Disconnect the syringe from the MIXJECT adapter system by firmly holding the syringe and rotating the vial clockwise (holding it by the plastic cap of the adapter system).
9		Keep the syringe IN AN UPRIGHT POSITION. With the other hand, remove the needle cap by pulling it upward. Gently press the plunger to expel any air from the syringe. The syringe containing the product is now ready for immediate administration.
10		Administer the intramuscular injection by inserting the needle at a 90-degree angle into the gluteal muscle. Ensure that the entire product is injected. Injection sites should be alternated.