Label: information for the patient

Lutathera 370 MBq/ml infusion solution

lutetium (177Lu) oxodotreotide

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctoror another healthcare professionalwho will oversee the procedure.

• If you experience any adverse effects, consult your doctor, even if they are not listed in this label. See section 4.

What is Lutathera

Lutathera contains lutetium (177Lu) oxodotreotide. This medication is a single radioisotope for treatment purposes.

How is Lutathera used

Lutathera is used for the treatment of adults with certain tumors (gastroenteropancreatic neuroendocrine tumors), which cannot be completely eliminated from the body through surgery, have spread throughout the body (metastatic), or have stopped responding to their current treatment.

How Lutathera works

The tumor must have somatostatin receptors on the surface of its cells for the medication to be effective. Lutathera binds to these receptors and emits radiation directly into the tumor cells, causing their death.

The use of Lutathera involves exposure to a certain amount of radiation. Your doctor and the nuclear medicine physician have considered that the clinical benefit you will obtain from the procedure with the radiopharmaceutical outweighs the risk of radiation.

No use Lutathera

• if you are allergic to lutetium (177Lu) oxodotreotide or any of the other components of this medication (listed in section6).
• if you are pregnant, think you may be pregnant, or are not confirmed to be not pregnant
• if you have a severe kidney impairment

Warnings and precautions

Consult your doctor before starting to use Lutathera as it may cause:

• secondary blood cancer (myelodysplastic syndrome or acute leukemia), which may appear in rare cases several years after completing treatment with Lutathera.

Inform your doctor or another healthcare professional before or during treatment with Lutathera:

• if you have or have had weakness, fatigue, difficulty breathing, lack of concentration, infections, fever, bleeding, or have bruises more easily than normal or have difficulty stopping bleeding (signs and symptoms of myelosuppression),
• if you have had another type of cancer in the last 5years, bone metastases, or previous cancer treatment (chemotherapy) or radiation therapy,

• if you have or have had swelling of the feet and ankles, too much or too little urine, itching, or difficulty breathing (signs and symptoms of chronic kidney disease),
• if you have or have had yellow skin with itching, if the white of your eyes has turned yellow, nausea, vomiting, fatigue, loss of appetite, pain in the upper right side of your abdomen, dark or brown urine, or bleeding or bruises more easily than normal (signs and symptoms of liver disease),
• if you have difficulty breathing, weakness, numbness, chest pain, palpitations, or abnormal heart rhythm (signs and symptoms of high potassium levels in the blood, also known as hyperkalemia),
• if you have shortness of breath, weakness, numbness, chest pain, palpitations, or abnormal heart rhythm (signs and symptoms of heart failure),
• if your kidney or urinary tract did not develop correctly,
• if you have urinary incontinence.

Inform your doctor or another healthcare professional immediately if after starting treatment with Lutathera you experience any of the following:

• swelling of the face/throat and/or difficulty breathing (signs and symptoms of angioedema),
• redness, diarrhea, difficulty breathing with wheezing or cough, dizziness, or disorientation (signs and symptoms of hormonal neuroendocrine crisis) that may appear in the first 24hours after administration of Lutathera,
• if you feel tired, lose your appetite, notice changes in your heart rate, have difficulty thinking clearly (signs and symptoms of metabolic acidosis),
• if you have muscle cramps, muscle weakness, confusion, or difficulty breathing (signs and symptoms of tumor lysis syndrome).Lutathera (lutetium (177Lu) oxodotreotide) may cause tumor lysis syndrome, due to the rapid breakdown of tumor cells. This may lead to abnormal results in blood tests, irregular heartbeats, kidney failure, or seizures within a week of treatment. Your doctor will ask for a blood test to monitor this syndrome.

Unless your doctor has considered that the clinical benefit of treatment outweighs the possible risks, this medication will not be administered:

• if you have ever received external radiation therapy in more than 25% of your bone marrow,
• if you have a severe heart impairment,
• if you have a severe hematological impairment,
• if you have a severe liver impairment,
• if it appears that your tumor does not have a sufficient number of somatostatin receptors.

Before administration of Lutathera, you should

• drink plenty of water to urinate as often as possible during the first hours after infusion.

Children and adolescents

The safety and efficacy of this medication in children and adolescents under 18years have not been established. Talk to your doctor or nuclear medicine specialist if you are under 18years old.

Other medications and Lutathera

Inform your doctor or nuclear medicine specialist if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications, as they may interfere with your treatment. This includes, in particular, somatostatin analogs or glucocorticoids (also known as corticosteroids). If you are taking somatostatin analogs, you may be asked to suspend treatment for a short period.

Consult with your doctor or pharmacist if you are unsure if your medication is one of those mentioned above.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or nuclear medicine specialist before using this medication.

Lutathera is contraindicated in pregnant women as ionizing radiation is hazardous to the fetus.Breastfeeding should be interrupted during treatment with this medication. Ifit is necessaryto administer Lutatheraduring breastfeeding, the mother will not continue breastfeeding.

You should inform your doctor and/or nuclear medicine specialist before administration of Lutathera if there is any possibility of pregnancy, if you have a delayed period, or if you are breastfeeding.

In case of doubt, it is essential to consult your nuclear medicine specialist or another healthcare professional who will oversee the procedure.

Female patients should use an effective contraceptive method during treatment with Lutathera and for 7months after completing treatment.

Male patients should use an effective contraceptive method during treatment with Lutathera and for 4months after completing treatment.

If you are a woman who may become pregnant, your doctor or another healthcare professional will check if you are pregnant and may perform a pregnancy test, if necessary, before starting treatment with Lutathera.

If you become pregnant or think you may be pregnant after starting treatment with Lutathera, inform your doctor and/or nuclear medicine specialist immediately.

The radiation from the medication may reduce your fertility. If you wish to have children after treatment, it is recommended that you undergo genetic counseling. Before treatment, you may be offered the possibility of cryopreserving sperm or eggs.

Driving and operating machinery

Lutathera is unlikely to affect your ability to drive and operate machinery. However, your general condition and possible side effects of treatment should be taken into account before driving or operating machinery.

Lutathera contains sodium

This medication contains up to 81.1mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 4% of the maximum daily sodium intake recommended for an adult.

There are strict guidelines for the use, handling, and disposal of radioactive medications. Lutathera will only be used in specially controlled areas. This medication will only be handled and administered by trained and qualified personnel to ensure safe use. Those individuals will take special care in the safe use of this medication and will inform you of their actions.

How much Lutathera you will receive

The recommended dose is 7,400 MBq (Megabecquerel, a unit used to express radioactivity) in a single infusion, which is administered approximately once every 8 weeks for a total of 4 times.

Administration of Lutathera and procedure

Lutathera is administered directly into a vein.

Due to the radiation emitted by this medication, you will need to remain isolated from other patients who are not receiving the same treatment during the administration procedure. The doctor or other healthcare professional will inform you when you can leave the controlled area of the hospital.

In addition to Lutathera, you will receive an infusion of amino acids to protect your kidneys. This may cause nausea and vomiting, and before starting treatment, you will also receive an injection of an antiemetic to help reduce these symptoms.

Duration of the administration procedure

Your nuclear medicine doctor or other healthcare professional will inform you of the usual duration of the procedure.

The Lutathera infusion lasts 30 ±10 minutes, but the total duration of the administration procedure will be approximately 5 hours. During administration, your doctor will monitor your condition periodically.

Monitoring of treatment

The treatment with Lutathera may affect your blood cells, liver, and kidneys (see section 4). Therefore, your doctor will ask you to undergo regular blood tests to ensure that you are suitable to receive this treatment and to detect any adverse effects as soon as possible. If necessary, your heart activity will also be checked before discharge from the hospital (with an electrocardiogram or ECG test). Based on the results, your doctor may decide to postpone, modify, or suspend your treatment with this medication if necessary.

After administration of Lutathera

You will be asked to drink enough water (e.g., 1 glass of water every hour) to allow you to urinate as often as possible on the day of the infusion and the following day, and to try to defecate every day to eliminate the medication from your body.

As this is a radioactive medication, you must follow the instructions below to minimize exposure to radiation from other people unless your doctor tells you otherwise.

Based on current knowledge and experience in this field and the properties of the medication, it is estimated that the risks to the health of people living with you and the general public are low.

Contact with other people living with you

You should limit close contact (less than 1 meter) with people living with you for 7 days after receiving Lutathera. You should sleep in a separate room from other people for 7 days after receiving Lutathera.

Contact with children and/or pregnant women

After receiving Lutathera, it is strongly recommended that you limit close contact (less than 1 meter) with children and/or pregnant women to less than 15 minutes per day for 7 days. You should sleep in a separate room from children and/or pregnant women for 15 days after receiving Lutathera.

Use of toilets

It is strongly recommended that you defecate every day and, if necessary, use a laxative. Additionally, drink frequently and try to urinate as often as possible on the day of treatment and the following day. Follow the advice of your doctor or other healthcare professional regarding the amount of liquids you should drink.

Be especially careful to avoid contamination during the 7 days after treatment (applicable to all patients regardless of whether they are male or female):

• You should always sit down when using the toilet,
• It is essential to use toilet paper every time you use the toilet,
• Wash your hands thoroughly after using the toilet,
• Dispose of all wipes and toilet paper in the toilet immediately after use,
• Dispose of any materials containing bodily fluids, such as blood, urine, or feces, in the toilet. Items that cannot be disposed of in the toilet, such as dressings and bandages, should be placed in separate plastic waste bags (as recommended in the "Disposal Recommendations" section below).

Shower and laundry

During the first 7 days, take the following special precautions:

• Take a shower every day,
• Wash your underwear, pajamas, sheets, and clothing that contains sweat, blood, or urine separately from the rest of the laundry of other people in your home, using a standard washing cycle. It is not necessary to use bleach or perform extra rinses.

People with reduced mobility

People who need to stay in bed or have reduced mobility will receive assistance from a caregiver. It is recommended that when assistance is provided in the bathroom, the caregiver wear disposable gloves for 7 days after administration. Any medical equipment that may become contaminated with bodily fluids (e.g., catheters, colostomy bags, urinals, water bottles) should be emptied immediately into the toilet and cleaned afterwards. Caregivers who remove vomit, blood, urine, or feces should wear plastic gloves that should be disposed of in a separate plastic waste bag (see "Disposal Recommendations" below).

Disposal recommendations

All materials to be disposed of must be thrown away in a separate plastic waste bag that is used only for this purpose. Keep the waste bags separate from the rest of the trash and keep them out of reach of children and animals.

A hospital staff member will inform you how and when to dispose of these waste bags.

Hospitalization and emergency care

If you require emergency medical assistance or unplanned hospitalization within 3 months of treatment, you must inform healthcare professionals about the nature, date, and dose of your radioactive treatment. To facilitate this information, always carry your discharge report with you.

Travel

For at least 3 months after treatment, when traveling, always carry your discharge report with you.

Other precautions

Your nuclear medicine doctor or other healthcare professional will inform you if you need to take any special precautions after receiving this medication. Consult your doctor or nuclear medicine doctor if you have any doubts.

If you have received more Lutathera than you should

A single overdose is unlikely, as you will only receive a single controlled dose of Lutathera supervised by your nuclear medicine doctor or other healthcare professional. However, in the event of an overdose, you will receive the necessary treatment.

If you have any other questions about the use of Lutathera, ask your nuclear medicine doctor or other healthcare professional who supervises the procedure.

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

The side effects of Lutathera are mainly related to radioactivity.

The side effect that has been observed most frequently in patients treated with Lutathera is its effect on the bone marrow. This can lead to a decrease in different types of blood cells, mainly red blood cells (cells responsible for transporting oxygen from the lungs to different organs), platelets (special cells that help blood to clot), and other blood cells, such as white blood cells (which help to fight infections). This occurs in many patients and is often temporary. However, in rare cases, the decrease in blood cells can be long-lasting and/or permanent.

As a consequence, a decrease in different types of blood cells can put you at risk of bleeding, fatigue, difficulty breathing, and infection. If this occurs, your doctor may decide to postpone, modify, or suspend treatment.

Some side effects can be serious

If you experience any serious side effect,inform your doctor immediately:

Very common:can affect more than 1 in 10people

• Bleeding or appearance of bruises with ease or difficulty stopping bleeding (possible signs of low platelet count in blood) (thrombocytopenia)
• Infections with signs such as fever, sore throat, or ulcers in the mouth (possible signs of low white blood cell count) (lymphopenia)
• Fatigue, weakness, pale skin, or difficulty breathing (possible signs of low red blood cell count) (anemia)
• Fatigue, weakness, pale skin, difficulty breathing, bleeding, or bruises with ease or difficulty stopping bleeding, and infections with signs such as fever, chills, sore throat, or ulcers in the mouth (possible signs of low blood cell count) (pancytopenia)

Common:can affect up to 1 in 10people

• Cancer of the bone marrow that produces malformed or non-functioning blood cells, with signs and symptoms of anemia, lymphopenia, neutropenia, and/or thrombocytopenia (myelodysplastic syndrome)
• Infections with signs such as fever, sore throat, or ulcers in the mouth (possible signs of low white blood cell count) (leukopenia and neutropenia)
• Weight gain, fatigue, hair loss, muscle weakness, feeling cold (possible signs of low thyroid activity) (secondary hypothyroidism)
• Excessive thirst, low urine production, weight loss, dry and inflamed skin, irritability (possible signs of dehydration)
• Transient and self-limiting loss of consciousness followed by spontaneous recovery (syncope)
• Irregular heartbeat (change in heart electrical activity) (prolonged QT interval on electrocardiogram)
• Dizziness, fainting (possible signs of low blood pressure) (hypotension)
• Urinating less frequently or much less urine than usual (possible signs of kidney problems) (renal insufficiency and acute kidney injury)

Rare:can affect up to 1 in 100people

• Sore throat, nasal secretion, difficulty or pain breathing, and fever (possible signs of respiratory tract infection)
• Cough, difficulty or pain breathing, wheezing, chest pain when breathing, fever (possible symptoms of lower respiratory tract infection) (pneumonia)
• Small, fluid-filled blisters that appear on red skin, possible signs of potentially serious viral infection (herpes zoster)
• Eye infection by virus (herpes zoster ophthalmicus)
• Staphylococcal infections
• Bloodstream presence of bacteria (streptococcal bacteremia)
• Persistent fatigue, frequent or severe infections, easy bleeding, weight loss (possible symptoms of bone marrow cancer) (acute myeloid leukemia, acute leukemia, and chronic myelomonocytic leukemia)
• Bone marrow cancer that produces malformed or non-functioning blood cells with signs and symptoms of anemia (refractory cytopenia with unilineage dysplasia)
• Anemia caused by kidney problems (nephrogenic anemia)
• Bone pain or fractures, fatigue, increased infections, changes in urination frequency, confusion, thirst, nausea or vomiting, weight loss (possible symptoms of bone marrow failure)
• Bleeding and/or bruises under the skin (possible signs of low platelet count in blood) (thrombocytopenic purpura)
• Eruption, itching, hives, shortness of breath, wheezing, or cough, dizziness, fainting, changes in levels of consciousness, hypotension with or without generalized mild itching, facial or throat swelling, bluish discoloration of lips, tongue, or skin (possible signs of severe allergic reaction) (hypersensitivity)
• Excessive thirst, high urine production, increased appetite with weight loss, fatigue (possible signs of high blood sugar) (diabetes mellitus)
• Facial redness, irritation, and rapid and sudden heat in the face that is sometimes confused with hot flashes, diarrhea, rapid heartbeat, wheezing, sudden drop in blood pressure (possible signs of carcinoid crisis)
• Nausea, sweating, weakness, dizziness, tremors, headache (possible signs of low blood sugar) (hypoglycemia)
• Shallow and rapid breathing, confusion, fatigue, headache, drowsiness, loss of appetite, jaundice, increased heart rate, possible signs of metabolic acidosis that occur when the body produces excessive acid or when the kidneys do not eliminate enough acid from the body (metabolic acidosis)
• Seeing, feeling, or hearing things that do not exist (hallucinations)
• Alteration of consciousness due to liver insufficiency (possible signs of hepatic encephalopathy)
• Pressure on spinal cord nerves that can be caused by a tumor or other damage (spinal cord compression)
• Irregular heartbeat (fibrillation)
• Oppressive and sudden chest pain, fatigue, irregular heartbeat (possible symptoms of heart attack) (myocardial infarction)
• Oppressive chest pain (possible symptom of heart problem) (angina pectoris)
• Cardiac collapse caused by a heart problem during which you may become short of breath, pale, experience cold sweat, and dry mouth (cardiogenic shock)
• Dizziness, fainting when standing up, drop in blood pressure when standing up (orthostatic hypotension)
• Swelling and redness of a vein (sign of phlebitis)
• Chest pain, cough, hiccups, rapid breathing (possible signs of fluid accumulation between lung and chest cavity layers) (pleural effusion)
• Abdominal swelling due to fluid accumulation (ascites)
• Constipation, swollen abdomen, abdominal pain (intestinal obstruction)
• Diarrhea, abdominal pain, fever (possible signs of colon inflammation) (colitis)
• Vomiting, belching, upper and lower abdominal pain with or without nausea and vomiting (possible signs of pancreatitis) (acute pancreatitis)
• Blood vomiting (hematemesis)
• Acute and painful abdominal swelling due to fluid accumulation (hemorrhagic ascites)
• Abdominal pain, general feeling of discomfort (ileus)
• Decrease in pancreatic enzyme levels in blood (decrease in pancreatic enzymes)
• Yellow skin and eyes, nausea, loss of appetite, dark urine (possible signs of liver problems) (hepatocellular injury)
• Yellow eyes or skin (possible signs of liver problems) (cholestasis)
• Liver congestion (hepatic congestion)
• Liver insufficiency (hepatic failure)
• Pre-renal acute insufficiency
• Death
• Clavicle fracture

Unknown frequency:cannot be estimated from available data

• Swelling of the face/gagging and/or difficulty breathing (possible signs and symptoms of angioedema)

Other possible side effects

Other side effects include those listed below. If those side effects become serious, inform your doctor or another healthcare professional.

Very common:can affect more than 1 in 10people

• Loss of appetite
• Nausea
• Vomiting
• Fatigue (fatigue)

Common:can affect up to 1 in 10people

• Excessive thirst, high urine production, increased appetite with weight loss (possible signs of high blood sugar) (hyperglycemia)
• Sleep disturbance
• Dizziness
• Alteration in sense of taste (dysgeusia)
• Headache
• Sensation of having little energy, fatigue (lethargy)
• Headache, dizziness (possible signs of high blood pressure) (hypertension)
• Redness and hot flashes
• Shortness of breath, difficulty breathing (dyspnea)
• Swelling, feeling of fullness in the abdomen
• Diarrhea
• Abdominal pain
• Constipation
• Upper abdominal pain
• Indigestion, pain or discomfort in the middle to upper part of the stomach (dyspepsia)
• Abdominal pain, nausea (gastritis)
• Yellow skin and eyes, possible signs of high levels of bile pigment (bilirubin) in the blood
• Hair loss (alopecia)
• Pain in muscles, bones, or joints
• Muscle spasms
• Blood in urine
• Anomalous results of urine analysis (presence of serum proteins)
• Reactions in the skin such as redness and swelling and pain at the injection site
• Swollen hands, ankles, or feet (peripheral edema)
• Pain at the injection site
• Chills
• Fatigue, chills, sore throat, joint or muscle pain (pseudogripal illness)

Rare:can affect up to 1 in 100people

• Eye secretion with itching, redness, and swelling (possible signs of conjunctivitis)
• Frequent and painful urination (possible signs of bladder inflammation) (cystitis)
• Symptoms of the flu such as fatigue, chills, sore throat, muscle or joint pain (influenza)
• Weight gain, fatigue, hair loss, muscle weakness, feeling cold (possible signs of low thyroid activity) (hypothyroidism)
• Bone and joint pain, excessive urination, abdominal pain, weakness, fatigue (possible signs of hyperparathyroidism) (hyperparathyroidism)
• Nausea, difficulty breathing, irregular heartbeat, cloudy urine, fatigue, and/or joint pain associated with abnormal laboratory values - high levels of potassium, uric acid, and phosphorus, and low levels of calcium in the blood (possible signs of tumor cell lysis) (tumor lysis syndrome)
• Excessive anxiety, problems (anxiety)
• Disorientation
• Sensation similar to ants crawling on the skin (paresthesia)
• Sensation of tingling (pinching, burning, itching, or numbness) (paresthesia)
• Distorted sense of smell (parosmia)
• Drowsiness (somnolence)
• Eye problems
• Dizziness, feeling of spinning (vertigo)
• Irregular heartbeat (palpitations)
• Redness and/or heat in the face (due to vasodilation)
• Cold hands and feet
• Pale skin (pallor)
• Sore throat (oropharyngeal pain)
• Increased sputum
• Sensation of choking
• Dry mouth
• Flatulence
• Abdominal pain
• Ulcers in the mouth with inflammation of the gums (stomatitis)
• Red, bright blood in stool (hematochezia)
• Abdominal discomfort
• Bleeding from the anus (hemorrhage rectal)
• Black stool (melena)
• Lower abdominal pain
• Eruption
• Dry skin
• Swelling of the face
• Excessive sweating (hyperhidrosis)
• Generalized itching (pruritus)
• Anomalous results of urine analysis (presence of white blood cells)
• Involuntary urine loss (incontinence)
• Results of analysis indicating kidney problems (decrease in glomerular filtration rate)
• Kidney problems
• Renal insufficiency
• Unusual, swollen, or lump-like skin at the injection site (injection site nodule)
• Fatigue, chest discomfort, palpitations (possible signs of heart problems) (chest discomfort)
• Chest pain
• Fever (pyrexia)
• General feeling of discomfort (discomfort)
• Pain
• Abnormal sensation
• Weight loss
• Physical disability

During treatment with Lutathera, you may also experience side effects from abnormal results of blood tests that can provide your doctor with information about the functioning of certain parts of your body.

Common:can affect up to 1 in 10people

• Elevated levels of the following enzymes:

• Gamma-glutamyl transferase, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase in blood

• Elevated creatinine levels in blood
• Low levels of magnesium and sodium in blood

Rare:can affect up to 1 in 100people

• Elevated levels of the following enzymes:

• Creatine phosphokinase in blood that may indicate muscle damage such as heart muscle damage

• Lactate dehydrogenase in blood that provides information about the health of certain organs

• Low levels of potassium, phosphorus, calcium, and albumin in blood
• High levels of sodium, calcium, urea, hemoglobin A1c, catecholamines, and C-reactive protein in blood
• Low levels of red blood cells (decrease in hematocrit)
• Presence of proteins in urine

During treatment with Lutathera, it is possible that you will also undergo medical/ surgical procedures.

Common:

• Blood transfusion

Rare:

• Drainage of peritoneal cavity fluid, the space between the abdominal wall and organs (peritoneal cavity drainage)
• Filtration of your blood to remove from your body harmful waste products, excess salt, and water (dialysis)
• Implantation of a stent
• Drainage of abscesses
• Insertion of a gastrointestinal tube
• Collection of stem cells from your spinal cord (bone marrow extraction)
• Removal of polyps from the inside of the colon, also known as the large intestine (polypectomy)

Reporting side effects

If you experience any type of side effect, consult your doctor or nuclear medicine doctor, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through thenational notification system includedin theAppendix V.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

This medication does not need to be stored by the patient. This medication is stored under the responsibility of the specialist in suitable facilities. Storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

The following information is intended solely for the specialist:

• Keep this medication out of the sight and reach of children.
• Do not use Lutathera after the expiration date and time that appears on the label after CAD.
• Store below 25°C. Do not freeze.
• Store in the original packaging to protect against ionizing radiation (lead shielding).

Lutathera Composition

• The active principle is lutetium (177Lu) oxodotreotide. One ml of infusion solution contains 370MBq of lutetium (177Lu) oxodotreotide on the date and time of calibration.
• The other components are: acetic acid, sodium acetate, gentisic acid, ascorbic acid, pentetic acid, sodium chloride, sodium hydroxide, water for injection (see section2 “Lutathera contains sodium”).

Appearance of the product and contents of the container

Lutathera is a transparent, colorless to slightly yellowish infusion solution, supplied in a colorless type I glass vial, closed with a bromobutyl rubber stopper and sealed with an aluminum seal.

One vial contains a volume of solution varying from 20.5 to 25.0ml, corresponding to an activity of 7400MBq on the date and time of infusion.

The vial is enclosed within a lead container for protection.

Marketing Authorization Holder

Advanced Accelerator Applications

8-10 Rue Henri Sainte-Claire Deville

92500 Rueil-Malmaison

France

Responsible Person

Advanced Accelerator Applications Ibérica, S.L.U.

Polígono Industrial la Cuesta – Sector 3

Parcelas 1 and 2 La Almunia de Doña Godina

50100 Zaragoza

Spain

Advanced Accelerator Applications (Italy) S.r.l

Via Ribes 5

10010

Colleretto Giacosa (TO)

Italy

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of this leaflet

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

---------------------------------------------------------------------------------------------------------------------------This information is intended for healthcare professionals only:

The full technical dossier of Lutathera is included as a separate document in the product packaging, with the aim of providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please refer to the technical dossier.