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QUADRAMET Injectable Solution

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About the medicine

How to use QUADRAMET Injectable Solution

Translated with AI

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

Package Leaflet: Information for the Patient

Quadramet 1.3 GBq/ml Solution for Injection

Samarium (153Sm) lexidronam pentasodium

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

  • Keep this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

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

1. What is Quadramet and what is it used for

Quadramet is a medicinal product for therapeutic use only.

This radiopharmaceutical is used for the treatment of bone pain caused by your disease.

Quadramet has a high affinity for bone tissue. Once injected, it concentrates in bone lesions. As Quadramet contains small amounts of a radioactive element, samarium 153, it delivers local radiation to bone lesions, allowing for a palliative effect on bone pain.

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2. What you need to know before you use Quadramet

Do not use Quadramet:

  • If you are allergic to ethylenediaminetetramethylene phosphonic acid (EDTMP), to similar compounds with phosphonates or to any of the other components of this medicinal product (listed in section 6).
  • If you are pregnant,
  • If you have received chemotherapy or external hemibody radiotherapy in the 6 weeks prior to administration of the medicinal product.

Warnings and precautions

Consult your doctor before starting to take Quadramet.

Your doctor will take blood samples from you every week for at least 8 weeks to measure your platelet count, red and white blood cell count, which may decrease slightly due to treatment.

In the 6 hours following administration of Quadramet, your doctor will instruct you to drink and urinate as frequently as possible. He will decide when you can leave the nuclear medicine department.

In case of urinary incontinence or urinary obstruction, a urinary catheter will be inserted for approximately 6 hours. In other patients, urine will be collected for at least 6 hours.

If you have reduced renal function, the amount of medicinal product to be administered will be adjusted.

Children and adolescents

QUADRAMET is not recommended for use in children under 18 years of age.

Use of Quadramet with other medicinal products

Tell your doctor if you are using, have recently used or might use any other medicinal products.

Pregnancy and lactation

If you are pregnant or breastfeeding, think you might be pregnant or plan to become pregnant, consult your doctor before using this medicinal product.

Quadramet must not be administered to pregnant women.

If administration of Quadramet to a breastfeeding woman is considered necessary, breastfeeding should be interrupted.

3. How to use Quadramet

Before administering Quadramet to you, your doctor will want to perform a special diagnostic examination (scintigraphy) to determine if you can benefit from Quadramet.

Posology

A single dose of 37 megabecquerels (the becquerel is the unit in which radioactivity is measured) of Quadramet per kilogram of body weight should be injected.

If you feel that the effect of Quadramet is too strong or too weak, consult your doctor or pharmacist.

Method and route of administration

Quadramet should be administered by slow injection into a vein.

Frequency of administration

The injection of this medicinal product is not performed on a regular or continuous basis. However, administration may be repeated after 8 weeks of the last injection, depending on the evolution of your disease.

Duration of treatment

You may leave the nuclear medicine department after undergoing dosimetric follow-up (usually within 6 hours after injection of Quadramet).

If you use more Quadramet than you should

As Quadramet is supplied in a single-dose vial, accidental overdose is unlikely.

The radiation dose received by the body can be limited by increasing fluid intake and urinating frequently.

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

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medicinal products, Quadramet can cause side effects, although not everybody gets them.

The side effects caused by the administration of Quadramet are related to a decrease in red and white blood cells and platelets. Cases of bleeding, some of them severe, have been reported.

For this reason, your blood counts will be strictly monitored during several weeks after the injection of Quadramet.

Exceptionally, you may notice a slight increase in bone pain a few days after the injection of Quadramet. Do not be alarmed; in this case, your pain medication will be slightly increased. It is a brief and moderate effect that will disappear within a few hours.

Adverse drug reactions such as nausea, vomiting, diarrhea, and sweating have been reported.

Hypersensitivity reactions, including rare cases of anaphylactic reaction after administration of Quadramet, have been reported.

In rare cases, the following adverse reactions have been observed: neuralgia, coagulation disorders, and cerebrovascular accidents. These effects were considered to be related to the progression of the disease.

If you experience back pain or sensitivity disorders, inform your doctor as soon as possible.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the national reporting system included in Annex V. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. Storage of Quadramet

Keep this medicinal product out of the sight and reach of children.

Do not use Quadramet after the expiry date stated on the pack.

Quadramet expires the day after the reference time of activity stated on the label.

Store in a freezer at -10°C to -20°C in the original package.

Quadramet should be used within 6 hours after thawing. Do not refreeze after thawing.

The label on the medicinal product states the appropriate storage conditions and the expiry date for the batch of the medicinal product. Hospital staff will ensure that the product is stored correctly and not administered after the expiry date stated.

Storage procedures must comply with national regulations on radioactive materials.

6. Contents of the pack and other information

Composition of Quadramet

The active substance is samarium (153Sm) lexidronam pentasodium.

Each ml of solution contains 1.3 GBq/ml of Samarium (153Sm) lexidronam pentasodium on the reference date (corresponding to 20 - 80 µg/ml of samarium per vial).

The other components are total EDTMP (as EDTMP.H2O), sodium calcium EDTMP salt (as Ca), total sodium (as Na), water for injections.

Appearance of Quadramet and contents of the pack

Quadramet is a solution for injection.

This medicinal product is a clear, colorless to pale amber solution filled in a 15 ml type I glass vial, closed with a natural rubber/butyl rubber stopper coated with teflon and an aluminum cap.

Each vial contains 1.5 ml (2 GBq on the reference date) to 3.1 ml (4 GBq on the reference date) of solution for injection.

Marketing authorization holder and manufacturer

CIS bio international

Boîte Postale 32

F-91192 Gif-sur-Yvette cedex

France

Date of last revision of this leaflet: {MM/AAAA}

Detailed information on this medicinal product is available on the European Medicines Agency (EMEA) website http://www.ema.europa.eu/

This information is intended only for healthcare professionals:For detailed information, refer to the Summary of Product Characteristics of QUADRAMET. In order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical, the Summary of Product Characteristics of Quadramet is included as a separate document in the product packaging.

Consult the Summary of Product Characteristics (which must be included in the packaging)

Online doctors for QUADRAMET Injectable Solution

Discuss questions about QUADRAMET Injectable Solution, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Doctor

Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

  • fever, chills, fatigue and viral symptoms
  • cough, sore throat, nasal congestion, breathing discomfort
  • bronchitis and mild asthma flare-ups
  • nausea, diarrhoea, abdominal pain, digestive infections
  • rashes, allergic reactions, redness, insect bites
  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
  • stress-related symptoms, sleep disturbances
  • questions about test results and treatment plans
  • management of chronic conditions in stable phases
Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

  • Advanced Trauma Life Support (ATLS)
  • Basic and Advanced Cardiac Life Support (BLS/ACLS)
  • Pediatric Advanced Life Support (PALS)
  • Prehospital Trauma Life Support (PHTLS)
  • eFAST and critical care transthoracic echocardiography
  • aviation medicine
He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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€58
5.0 (3)
Doctor

Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques.

For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance.

Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults.

In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions.

Patients commonly seek his care for:

  • seasonal and perennial allergies
  • allergic rhinitis and chronic nasal symptoms
  • asthma and breathing difficulties
  • food and medication allergies
  • urticaria, atopic dermatitis and skin reactions
  • recurrent infections in children
  • sports-related health questions
  • general family medicine concerns
Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.
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€80
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Doctor

Lina Travkina

Family medicine 13 years exp.

Dr. Lina Travkina is a licensed family and preventive medicine doctor based in Italy. She provides online consultations for adults and children, supporting patients across all stages of care – from acute symptom management to long-term health monitoring and prevention.

Areas of medical care include:

  • Respiratory conditions: colds, flu, acute and chronic bronchitis, mild to moderate pneumonia, bronchial asthma.
  • ENT and eye conditions: sinusitis, tonsillitis, pharyngitis, otitis, infectious and allergic conjunctivitis.
  • Digestive issues: gastritis, acid reflux (GERD), IBS, dyspepsia, bloating, constipation, diarrhoea, functional bowel symptoms, intestinal infections.
  • Urological and infectious diseases: acute and recurrent cystitis, bladder and kidney infections, prevention of recurrent UTIs, asymptomatic bacteriuria.
  • Chronic conditions: hypertension, diabetes, hypercholesterolemia, metabolic syndrome, thyroid disorders, excess weight.
  • Neurological and general symptoms: headache, migraine, dizziness, fatigue, sleep disturbances, reduced concentration, anxiety, asthenia.
  • Chronic pain support: back, neck, joint, and muscle pain, tension syndromes, pain associated with osteochondrosis and chronic conditions.

Additional care areas:

  • Preventive consultations and check-up planning.
  • Medical advice and follow-up consultations.
  • Test interpretation and diagnostic guidance.
  • Structured support for undiagnosed complaints.
  • Second opinion on diagnoses and treatment plans.
  • Nutritional and lifestyle support for vitamin deficiencies, anaemia, metabolic issues.
  • Post-operative recovery support and pain management.
  • Preconception counselling and postpartum support.
  • Immunity support and strategies to reduce frequency of infections.

Dr. Travkina combines evidence-based medicine with an attentive, personalised approach. Her consultations focus not only on treatment, but also on prevention, recovery, and long-term wellbeing.

If during the consultation it becomes clear that your case requires in-person assessment or specialised care outside of her scope, the session will be terminated and the payment fully refunded.

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€70
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Doctor

Alina Tsurkan

Family medicine 13 years exp.

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

Dr. Tsurkan supports patients with a wide range of health issues, including:

  • Respiratory infections: cold, flu, bronchitis, pneumonia, and lingering coughs.
  • ENT conditions: sinusitis, tonsillitis, otitis (ear infections), sore throat, allergic rhinitis.
  • Eye conditions: allergic or infectious conjunctivitis, red eyes, irritation.
  • Digestive issues: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), constipation, bloating, nausea.
  • Urinary and reproductive health: urinary tract infections (UTIs), cystitis, prevention of recurrent infections.
  • Chronic diseases: hypertension, elevated cholesterol, weight management.
  • Neurological complaints: headaches, migraines, sleep disturbances, fatigue, general weakness.
  • Children’s health: fever, infections, digestive issues, follow-ups, vaccination guidance.

She also provides:

  • IMT medical certificates for driving licence exchange in Portugal.
  • Personalised preventive care and wellness consultations.
  • Interpretation of test results and medical reports.
  • Follow-up care and medication review.
  • Support in managing multiple coexisting conditions.
  • Remote prescription management and medical documentation.

Dr. Tsurkan’s approach is evidence-based and holistic. She works closely with each patient to develop an individualised care plan that addresses both symptoms and root causes. Her goal is to empower patients to take control of their health and maintain well-being through lifestyle adjustments, routine check-ups, and early intervention.

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€55
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Doctor

Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

  • Acute and chronic pain: headaches, muscle and joint pain, back pain, abdominal pain, postoperative pain. Identifying the cause, selecting treatment, and creating a care plan.
  • Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions.
  • Pre- and postoperative care: risk assessment, decision-making support, follow-up after surgery, rehabilitation strategies.
  • General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries.
  • Injuries and trauma: bruises, fractures, sprains, soft tissue damage, wound care, dressing, referral when in-person care is required.
  • Oncological surgery: diagnosis review, treatment planning, and long-term follow-up.
  • Obesity treatment and weight management: a medical approach to weight loss, including assessment of underlying causes, evaluation of comorbidities, development of a personalised plan (nutrition, physical activity, pharmacotherapy if needed), and ongoing progress monitoring.
  • Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data.
  • Second opinions and medical navigation: clarifying diagnoses, reviewing current treatment plans, helping patients choose the best course of action.

Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
  • Member of the German Society of Surgeons (BDC).
  • Certified in radiological diagnostics and robotic surgery.
  • Active participant in international medical conferences and research.

Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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€50

Frequently Asked Questions

Is a prescription required for QUADRAMET Injectable Solution?
QUADRAMET Injectable Solution 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 QUADRAMET Injectable Solution?
The active ingredient in QUADRAMET Injectable Solution is samarium (153Sm) lexidronam. This information helps identify medicines with the same composition but different brand names.
Who manufactures QUADRAMET Injectable Solution?
QUADRAMET Injectable Solution is manufactured by Cis Bio International. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of QUADRAMET Injectable Solution 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 QUADRAMET Injectable Solution is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to QUADRAMET Injectable Solution?
Other medicines with the same active substance (samarium (153Sm) lexidronam) include ERBIUM CITRATE (169Er) colloidal CIS BIO INTERNACIONAL 111 MBq/ML INJECTABLE SUSPENSION, Yttrium Citrate (90 Y) Colloidal CIS BIO INTERNATIONAL 37-370 MBq/ml Injectable Suspension, SODIUM IODIDE (I131) CURIUM PHARMA SPAIN 37-7400 MBq CAPSULES. 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.
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