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HEXVIX 85 mg POWDER AND SOLVENT FOR INTRAVESICAL SOLUTION

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About the medicine

How to use HEXVIX 85 mg POWDER AND SOLVENT FOR INTRAVESICAL SOLUTION

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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

Package Leaflet: Information for the Patient

HEXVIX 85 mg powder and solvent for intravesical solution

Hexaminolevulinate

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

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

Contents of the package leaflet:

  1. What is Hexvix and what is it used for
  2. What you need to know before you are given Hexvix
  3. How to use Hexvix
  4. Possible side effects
  5. Storage of Hexvix
  6. Package contents and further information.

1. What is Hexvix and what is it used for

This medicine is for diagnostic use only.

This medicine is used to help detect bladder cancer. It is given before your doctor uses a special device called a "cystoscope" that allows them to visualize the inside of your bladder. A cystoscope helps to visualize possible tumors and thus to eliminate abnormal cells, which glow in blue light after administration of Hexvix.

Doctor consultation

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2. What you need to know before you are given HEXVIX

Do not use Hexvix:

  • If you are allergic (hypersensitive) to the active substance or to any of the other ingredients of Hexvix, including the liquid used to dissolve it (see Section 6 Further information).
  • If you have porphyria (a rare and hereditary blood disease)

Warnings and precautions:

Consult your doctor or nurse before you start using Hexvix.

  • If you have a urinary tract infection or if you feel burning/stinging when urinating.
  • If you have recently undergone BCG therapy in the bladder.
  • If you have recently had bladder surgery.

These circumstances may cause local reactions in your bladder, which may make it difficult for your doctor to interpret what they see during the examination.

Other medicines and Hexvix:

Tell your doctor if you are taking or have recently taken other medicines, including those bought without a prescription.

Fertility, pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

Ask your doctor for advice about driving and using machines after taking Hexvix.

3. How to use Hexvix

Hexvix must be prepared and administered by qualified personnel. Hexvix is usually administered in a hospital or clinic.

Your doctor will give it to you in the following way:

  1. A small tube called a catheter will be inserted into your bladder.
  2. Your bladder will be emptied through this tube.
  3. Hexvix will be inserted into the bladder through this tube.
  4. Hexvix will remain inside your bladder for 60 minutes.
  5. After this time, the bladder will be emptied with the catheter.
  6. Your doctor will use a device called a cystoscope to examine your bladder.

If you use more Hexvix than you should

No side effects are expected to occur if the dwell time of Hexvix in the bladder is increased above 60 minutes or if the amount of Hexvix used is increased. If you are concerned about this, consult your doctor or nurse.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medicines, Hexvix can cause side effects, although not everybody gets them. There is a risk of possible side effects related to the technique (cystoscopy) used to examine your bladder. Generally, the use of Hexvix as a complementary method to standard cystoscopy for a more accurate diagnosis of bladder cancer is well tolerated. If side effects occur, they will be those typically associated with the examination technique, usually not serious or prolonged. The following side effects may occur after the examination procedure using this medicine:

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

  • Feeling sick (nausea), vomiting.
  • Diarrhea.
  • Constipation.
  • Muscle cramp or pain in and around the stomach (abdomen).
  • Pain or difficulty urinating.
  • Inability to empty the bladder (urinary retention).
  • Blood in the urine.
  • Pain after the examination (procedure).
  • Fever (high temperature)

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

  • Headache
  • Burning sensation when urinating (caused by infection or inflammation in the bladder).
  • Frequent need to urinate.
  • Blood poisoning (septicemia).
  • Difficulty sleeping or insomnia.
  • Pain in the tube called the urethra, through which urine passes.
  • Continuous feeling of needing to urinate (and urgently).
  • Increased white blood cell count, increased bilirubin (a yellow bile pigment) or liver enzyme concentrations, all of which should be observed in blood test results.
  • Decrease in the number of red blood cells in the body (anemia).
  • Inflammation of the glans penis (balanitis).
  • Back pain.
  • Gout.
  • Rash (skin eruption).
  • Itching (pruritus).

Frequency not known(cannot be estimated from the available data):

  • Anaphylactoid shock (drop in blood pressure, increased heart rate, skin rash)

Reporting of side effects

If you experience any side effects, consult your doctor, even if they are not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines Agency's website. www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Hexvix

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

Do not use this medicine after the expiry date which is stated on the outer packaging. The expiry date refers to the last day of the month.

Powder and solvent: the product does not require special storage conditions.

Solution (after mixing): store between 2°C and 8°C (in the refrigerator) for a maximum period of 2 hours.

Hospital staff must ensure that the product is stored and disposed of properly and that it is not used after the expiry date printed on the outer packaging.

6. Package contents and further information

Composition of Hexvix

?The active substance is hexaminolevulinate in the form of hydrochloride.

?The other ingredients are disodium phosphate, potassium dihydrogen phosphate, sodium chloride, hydrochloric acid, sodium hydroxide, and water for injections

Appearance of the product and package contents

  • Each package contains a vial of powder, white to beige or pale yellow in color, which contains 85 mg of the active substance hexaminolevulinate (as hydrochloride), and a pre-filled syringe, which contains 50 ml of a clear and colorless liquid for dissolving the powder.
  • The Hexvix powder is dissolved in 50 ml of the solution provided in the package. Once the powder is mixed with the solvent, a solution is obtained that contains 1.7 mg/ml of hexaminolevulinate, which corresponds to 8 mmol/l of hexaminolevulinate solution.

Marketing authorization holder and manufacturer:

Photocure ASA

Hoffsveien 4

NO-0275 Oslo,

Norway

You can ask for more information about this medicine by contacting the marketing authorization holder.

This medicine has been authorized with the trade name Hexvix in the following European Economic Area member states and in the United Kingdom (Northern Ireland):Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Iceland, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Slovenia, Spain, Sweden, and the United Kingdom (Northern Ireland).

Date of last revision of this package leaflet:January 2022

Detailed and up-to-date 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 only for healthcare professionals:

Handling instructions

Hexaminolevulinate may cause sensitization through skin contact.

All steps must be performed with sterile material and under aseptic conditions.

Reconstitution procedure: Hexvix powder and solvent for Hexvix in pre-filled syringe

Hand turning a cylindrical device with a needle inserted, curved arrow indicates the direction of rotation

  1. Fix the plunger rod to the rubber stopper of the syringe by turning the plunger to the right until it stops.
  1. Remove the syringe cap and save it for later use. Place a suitable needle for reconstitution on the syringe. Hold the syringe in a vertical position and carefully press the plunger upwards to eliminate air.

Hand holding syringe with clear liquid injecting into skin with needle inserted and angle visible

  1. Inject about 10 ml of the solvent into the powder vial. The vial should be about ¾ full.

Hand holding auto-injector with curved arrows indicating pressure and rotation of the device

  1. Without removing the needle from the vial, hold the powder vial and the syringe firmly and gently shake to ensure complete dissolution.

Hand holding syringe with needle inserted into skin showing plunger and transparent cylinder

  1. Withdraw all the dissolved solution from the powder vial into the syringe.

Hand holding syringe with needle inserted into skin showing angle of injection and direction of rotation

  1. Separate the empty vial from the syringe. Separate the needle from the syringe tip and discard it. Close the syringe with the cap. Gently mix the contents of the syringe.

Hexvix is now reconstituted and ready to use. The appearance of the reconstituted solution is a clear or slightly opalescent solution, and colorless to pale yellow.

Add two hours to the current time and write the resulting expiration time and date on the syringe label

This product is for single use only. Any remaining product should be discarded. No special requirements for disposal.

It has been demonstrated that the solution maintains its chemical and physical stability for a period of 2 hours at 2°C - 8°C. From a microbiological point of view, the product should be used immediately. If not, the storage times and conditions before use are the responsibility of the user and should not normally exceed 2 hours at 2°C - 8°C.

Online doctors for HEXVIX 85 mg POWDER AND SOLVENT FOR INTRAVESICAL SOLUTION

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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.

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Daniel Cichi

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Dr Daniel Cichi is a family medicine doctor with over 20 years of clinical experience. He provides online consultations for adults, supporting patients with acute symptoms, chronic conditions, and everyday health concerns that require timely medical guidance. His background includes work in emergency care, ambulance services, and family medicine, which allows him to assess symptoms quickly, identify warning signs, and help patients choose the safest next steps – whether that means home care, treatment adjustment, or in-person evaluation. Patients commonly consult Dr Daniel Cichi for: 

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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
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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.

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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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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:

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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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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: 

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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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Doctor

Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

Cardiology – Diagnosis and treatment of:

  • High blood pressure, blood pressure fluctuations, and cardiovascular risk prevention.
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  • EKG interpretation, lipid profile evaluation, cardiovascular risk assessment (heart attack, stroke).
  • Post-COVID-19 cardiac monitoring and care.
Endocrinology – Diabetes, thyroid, metabolism:
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  • Individual treatment plans including oral medications and insulin therapy.
  • GLP-1 therapy– modern pharmacological treatment for weight management and diabetes control, including drug selection, monitoring, and safety follow-up.
  • Thyroid disorders – hypothyroidism, hyperthyroidism, autoimmune thyroid diseases (Hashimoto’s, Graves’ disease).
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Gastroenterology – Digestive health:
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  • Stomach and intestinal conditions: gastritis, irritable bowel syndrome (IBS), indigestion.
  • Management of chronic digestive disorders and interpretation of tests (endoscopy, ultrasound, labs).
General internal medicine and preventive care:
  • Respiratory infections – cough, colds, bronchitis.
  • Lab test analysis, therapy adjustments, medication management.
  • Adult vaccinations – planning, contraindications assessment.
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Dr Biriukova combines internal medicine with specialist insight, offering clear explanations, personalised treatment plans, and comprehensive care tailored to each patient.
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Frequently Asked Questions

Is a prescription required for HEXVIX 85 mg POWDER AND SOLVENT FOR INTRAVESICAL SOLUTION?
HEXVIX 85 mg POWDER AND SOLVENT FOR INTRAVESICAL 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 HEXVIX 85 mg POWDER AND SOLVENT FOR INTRAVESICAL SOLUTION?
The active ingredient in HEXVIX 85 mg POWDER AND SOLVENT FOR INTRAVESICAL SOLUTION is hexaminolevulinate. This information helps identify medicines with the same composition but different brand names.
Who manufactures HEXVIX 85 mg POWDER AND SOLVENT FOR INTRAVESICAL SOLUTION?
HEXVIX 85 mg POWDER AND SOLVENT FOR INTRAVESICAL SOLUTION is manufactured by Photocure Asa. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of HEXVIX 85 mg POWDER AND SOLVENT FOR INTRAVESICAL 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 HEXVIX 85 mg POWDER AND SOLVENT FOR INTRAVESICAL 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 HEXVIX 85 mg POWDER AND SOLVENT FOR INTRAVESICAL SOLUTION?
Other medicines with the same active substance (hexaminolevulinate) include ANTICUDE, APULCO ACOMETH 0.3%/0.3%/0.3% MEDICINAL COMPRESSED GAS, APULCO COHE 0.28%/9.5% MEDICINAL COMPRESSED GAS. 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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