LOCAMETZ 25 micrograms RADIOPHARMACEUTICAL
How to use LOCAMETZ 25 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Patient Information Leaflet
Locametz25microgramsradio-pharmaceutical preparation kit
gozetotida
This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
- Keep this leaflet, you may need to read it again.
- If you have any further questions, ask your nuclear medicine doctor who will be supervising the procedure.
- If you get any side effects, talk to your nuclear medicine doctor, even if you think they are not serious.
Contents of the pack:
- What is Locametz and what is it used for
- What you need to know before you are given Locametz
- How Locametz is given
- Possible side effects
- Storage of Locametz
- Contents of the pack and other information
1. What is Locametz and what is it used for
What is Locametz
This medicine is a radiopharmaceutical for diagnostic use only.
Locametz contains a substance called gozetotida. Before it can be used, the gozetotida (powder in the vial) is combined with a radioactive substance called gallium-68 to produce a solution of gallium (68Ga)-gozetotida (this procedure is called radiolabelling).
What Locametz is used for
After radiolabelling with gallium-68, Locametz is used in a medical imaging procedure called positron emission tomography (PET) to detect certain types of cancer cells with a protein called prostate-specific membrane antigen (PSMA) in adults with prostate cancer. This is done:
- to find out if the prostate cancer has spread to the lymph nodes and other tissues outside the prostate, before initial curative therapy (e.g. therapy that involves surgical removal of the prostate, radiotherapy)
- to identify cancer cells when there is a suspicion of recurrence of prostate cancer in patients who have received initial curative therapy
- to find out if patients with metastatic castration-resistant prostate cancer may be suitable for PSMA-targeted treatment
How Locametz works
When given to the patient, the gallium (68Ga)-gozetotida binds to cancer cells that have PSMA on their surface and makes them visible to the nuclear medicine doctor during the PET imaging procedure. This provides valuable information about the disease to the doctor and the nuclear medicine doctor.
The use of gallium (68Ga)-gozetotida involves exposure to radioactivity. The doctor and the nuclear medicine doctor have considered that the clinical benefit you will get from the procedure with the radiopharmaceutical outweighs the risk of radiation.
If you have any questions about how Locametz works or why it has been prescribed for you, ask your nuclear medicine doctor.
2. What you need to know before you are given Locametz
Locametz must not be given to you
- if you are allergic to gozetotida or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Before receiving Locametz, tell your nuclear medicine doctor if you have any other type of cancer, as this may affect the interpretation of the images.
The use of Locametz involves exposure to small amounts of radioactivity. Repeated exposure to radiation may increase the risk of cancer. Your nuclear medicine doctor will explain the necessary radiation protection measures (see section 3).
Before administration of Locametz, you must
- Drink plenty of water to stay hydrated and urinate just before starting the PET imaging procedure, and as frequently as possible during the first few hours after administration.
Children and adolescents
This medicine must not be given to children or adolescents under 18 years because there are no data available for this age group.
Pregnancy and breastfeeding
Locametz is not indicated for use in women. All radiopharmaceuticals, including Locametz, have the potential to cause harm to the fetus.
Driving and using machines
It is considered unlikely that Locametz will affect your ability to drive and use machines.
Locametz contains sodium
This medicine contains 28.97 mg of sodium (the main component of cooking/table salt) per injection. This is equivalent to 1.5% of the maximum recommended daily intake of sodium for an adult.
3. How Locametz is given
There are strict rules for the use, handling, and disposal of radiopharmaceuticals. Locametz will only be used in special controlled areas. This radiopharmaceutical will only be handled and administered by trained and qualified personnel who are authorized to use it safely. These people will take special care in the safe use of this radiopharmaceutical and will inform you of their actions.
The nuclear medicine doctor supervising the procedure will decide the amount of Locametz to be used in your case. This will be the minimum amount necessary to obtain the desired information.
The recommended amount to be administered is usually 1.8-2.2 MBq (megabecquerel, the unit used to express radioactivity) per kilogram of body weight, with a minimum of 111 MBq and a maximum of 259 MBq.
Administration of Locametz and performance of the procedure
After reconstitution and radiolabelling, Locametz is administered as a slow injection into a vein. You will undergo a PET scan between 50 and 100 minutes after receiving Locametz.
Duration of the procedure
Your nuclear medicine doctor will inform you of the usual duration of the procedure.
After administration of Locametz, you should
- Continue to drink plenty of water to stay hydrated and urinate as frequently as possible to eliminate the radiopharmaceutical from your body.
Your nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine. If you have any questions, ask your nuclear medicine doctor.
If you have been given too much Locametz
An overdose of Locametz is unlikely because you will only receive a single dose that is precisely controlled by the nuclear medicine doctor supervising the procedure. However, in the event of an overdose, you will receive the necessary treatment. You may be asked to drink and urinate frequently to eliminate the radiopharmaceutical from your body.
If you have any other questions about the use of Locametz, ask the nuclear medicine doctor supervising the procedure.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects include the following listed below. If these side effects become serious, inform your nuclear medicine doctor.
Common(may affect up to 1 in 10 people)
- fatigue
Uncommon(may affect up to 1 in 100 people)
- nausea
- constipation
- vomiting
- diarrhea
- dry mouth
- reactions at the injection site, such as bruising, itching, and warmth
- chills
This radiopharmaceutical emits low levels of ionizing radiation associated with a minor risk of cancer and genetic abnormalities.
Reporting of side effects
If you experience any side effects, talk to your nuclear medicine doctor, even if you think they are not serious. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Locametz
You will not need to store this medicine. This medicine is stored under the responsibility of the specialist in suitable facilities. The storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.
The following information is intended for healthcare professionals only:
- Locametz should not be used after the expiry date stated on the packaging and label after EXP. The expiry date is the last day of the month stated.
- Before reconstitution, store below 25°C.
- After reconstitution and radiolabelling, store upright below 30°C. Use within 6 hours.
6. Contents of the pack and other information
Composition of Locametz
- The active substance is gozetotida. One vial contains 25 micrograms of gozetotida. The other ingredients are: gentisic acid, sodium acetate trihydrate, and sodium chloride (see "Locametz contains sodium" in section 2).
Appearance and pack contents of Locametz
Locametz is a multidose radiopharmaceutical preparation kit that contains a vial of white lyophilized powder (powder for solution for injection).
Gallium-68 is not part of the preparation kit.
After reconstitution and radiolabelling, Locametz contains a sterile solution for injection of gallium (68Ga)-gozetotida with an activity of up to 1369 MBq.
After reconstitution, the solution for injection of gallium (68Ga)-gozetotida also contains hydrochloric acid.
Pack size: 1 vial.
Marketing authorisation holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland
Manufacturer
Advanced Accelerator Applications (Italy) S.R.L.
Via Crescentino snc
13040 Saluggia (VC)
Italy
You can request more information about this medicine from the local representative of the marketing authorisation holder:
België/Belgique/Belgien Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11 | Lietuva SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16 50 |
| Luxembourg/Luxemburg Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11 |
Ceská republika Novartis s.r.o. Tel: +420 225 775 111 | Magyarország Novartis Hungária Kft. Tel.: +36 1 457 65 00 |
Danmark Novartis Sverige AB Tel: +46 8 732 32 00 | Malta Novartis Pharma Services Inc. Tel: +356 2122 2872 |
Deutschland Novartis Pharma GmbH Tel: +49 911 273 0 | Nederland Novartis Pharma B.V. Tel: +31 88 04 52 111 |
Eesti SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 810 | Norge Novartis Sverige AB Tlf: +46 8 732 32 00 |
Ελλáδα ΒΙΟΚΟΣΜΟΣ ΑΕΒΕ Τηλ: +30 22920 63900 or Novartis (Hellas) A.E.B.E. Τηλ: +30 210 281 17 12 | Österreich Novartis Pharma GmbH Tel: +43 1 86 6570 |
España Advanced Accelerator Applications Ibérica, S.L.U. Tel: +34 97 6600 126 | Polska Advanced Accelerator Applications Polska Sp. z o.o. Tel.: +48 22 275 56 47 |
France Advanced Accelerator Applications Tél: +33 1 55 47 63 00 | Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Tel: +351 21 000 8600 |
Hrvatska Novartis Hrvatska d.o.o. Tel. +385 1 6274 220 | România Novartis Pharma Services Romania SRL Tel: +40 21 31299 01 |
Ireland Novartis Ireland Limited Tel: +353 1 260 12 55 | Slovenija Novartis Pharma Services Inc. Tel: +386 1 300 75 50 |
Ísland Novartis Sverige AB Sími: +46 8 732 32 00 | Slovenská republika Novartis Slovakia s.r.o. Tel: +421 2 5542 5439 |
Italia Novartis Farma S.p.A. Tel: +39 02 96 54 1 | Suomi/Finland Novartis Sverige AB Puh/Tel: +46 8 732 32 00 |
Κúπρος ΒΙΟΚΟΣΜΟΣ ΑΕΒΕ Τηλ: +30 22920 63900 or Novartis Pharma Services Inc. Τηλ: +357 22 690 690 | Sverige Novartis Sverige AB Tel: +46 8 732 32 00 |
Latvija SIA Novartis Baltics Tel: +371 67 887 070 |
Date of last revision of this leaflet
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
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This information is intended for healthcare professionals only:
The full summary of product characteristics of Locametz 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 consult the summary of product characteristics.
-
- Country of registration
- Dosage formRADIOPHARMACEUTICAL, 25 micrograms
- ATC codeV09IX14
- Active substance
- Prescription requiredYes
- Manufacturer
- CompositionACETATO DE SODIO TRIHIDRATO (78 mg mg), CLORURO DE SODIO (40 mg mg)
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to LOCAMETZ 25 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATIONDosage form: RADIOPHARMACEUTICAL, 25 microgramsActive substance: gallium (68Ga) gozetotideManufacturer: Telix InnovationsPrescription requiredDosage form: RADIOPHARMACEUTICAL, 10 microgramsActive substance: gallium (68Ga) gozetotideManufacturer: Billev Pharma ApsPrescription requiredDosage form: INJECTABLE, 74 MBq iobenguane (123I)Active substance: iobenguane (123I)Manufacturer: Ge Healthcare Bio-Sciences, S.A.U.Prescription required
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Frequently Asked Questions
Is a prescription required for LOCAMETZ 25 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION?
LOCAMETZ 25 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in LOCAMETZ 25 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION?
The active ingredient in LOCAMETZ 25 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION is gallium (68Ga) gozetotide. This information helps identify medicines with the same composition but different brand names.
Who manufactures LOCAMETZ 25 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION?
LOCAMETZ 25 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION is manufactured by Novartis Europharm Limited. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of LOCAMETZ 25 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether LOCAMETZ 25 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
How to buy LOCAMETZ 25 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION in Spain?
Spain has a well-developed healthcare infrastructure across major cities such as Madrid, Barcelona, Valencia, and Seville. Pharmacies are widely available and operate under strict regulations, ensuring access to prescribed medications.
You can buy LOCAMETZ 25 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION in Madrid, Barcelona, Seville, or Valencia at any local pharmacy with a valid prescription.
To obtain a prescription, you can use Oladoctor:
What are the alternatives to LOCAMETZ 25 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION?
Other medicines with the same active substance (gallium (68Ga) gozetotide) include ILLUCCIX 25 MICROGRAMS RADIOPHARMACEUTICAL PREPARATION KIT, ISOPROTRACE 10 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION, ADREVIEW 74 MBq/ml INJECTABLE SOLUTION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
