Інструкція із застосування EXVIX
Зміст інструкції
Hexvix 85mg powder and solvent for intravesical solution
Hexaminolevulinate
Read this leaflet carefully before you use 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
Contents of this leaflet:
- 1. What Hexvix is and what it is used for
- 2. What you need to know before you use Hexvix
- 3. How to use Hexvix
- 4. Possible side effects 5 How to store Hexvix
- 6. Contents of the pack and other information
1. What is Hexvix and what is it used for
This medicine is only for diagnostic use. This medicine is used to help detect
bladder cancer. Hexvix will be administered before the doctor begins the inspection of the
bladder with a special device called a “cystoscope”. The cystoscope helps doctors to
identify possible tumors and therefore to remove more abnormal cells, which are illuminated with blue light
after the administration of Hexvix.
2. What you need to know before using Hexvix
Do not use Hexvix
- if you are allergic (hypersensitive) to the active substance or to any other ingredient of HEXVIX including the liquid used to dissolve it (see section 6 Further information).
- if you suffer from porphyria (a rare hereditary blood disease).
Warnings and precautions
Before receiving Hexvix, consult your doctor:
- if you suspect you have a urinary tract infection or if you feel burning while urinating.
- if you have recently received BCG therapy for the bladder.
- if you have recently undergone bladder surgery. These situations could cause local reactions in the bladder that may make it more difficult for the doctor to interpret what is seen during the examination.
Use of other medicines:
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those
without a prescription.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor for advice before taking this medicine.
Driving and operating machinery
Consult your doctor for advice on driving or operating machinery after taking
Hexvix.
3. How to use Hexvix
Hexvix must be prepared and administered only by a healthcare professional specifically
trained.
As a rule, Hexvix is administered in hospital or in a clinic.
The doctor will administer Hexvix to you as follows:
- 1. They will insert a small tube called a “catheter” into your bladder.
- 2. Your bladder will be emptied through this tube.
- 3. Hexvix will be introduced into the bladder through the tube.
- 4. Hexvix will be left in the bladder for approximately 60 minutes.
- 5. The bladder will then be emptied through the tube.
- 6. Using a device (cystoscope), the doctor will inspect the bladder.
If you are given too much Hexvix
No adverse effects are expected if Hexvix remains in the bladder for more than 60 minutes or if more Hexvix than necessary is used. If you are concerned about this, contact your doctor or nursing staff.
4. Possible side effects
Like all medicines, Hexvix can cause side effects, although not everybody gets them.
There is a risk of side effects related to the technique (cystoscopy) used to
examine the bladder. The use of Hexvix as a supporting procedure to cystoscopy for a more accurate
diagnosis of bladder cancer is generally well tolerated. Any side effects are
generally associated with the standard exploratory technique, are not usually serious and do not last a
long time. The exploratory procedure with Hexvix may give the following side effects:
Common(affect 1 to 10 patients in 100):
- Headache.
- Nausea (feeling sick), vomiting.
- Diarrhoea.
- Constipation.
- Muscle spasms or pain around the stomach (abdomen).
- Pain, and difficulty in urination.
- Inability to empty the bladder (urinary retention).
- Presence of blood in the urine.
- Pain after the examination (procedure).
- Fever (high temperature).
Uncommon(affect 1 to 10 patients in 1,000):
- Burning sensation when passing urine (caused by inflammation or infection of the bladder).
- Frequent need to urinate.
- Blood infection (septicemia).
- Inability to sleep or difficulty falling asleep.
- Pain in the channel called “urethra”, through which urine passes.
- Feeling the need to urinate immediately (urgency).
- Increase in white blood cell count, increase in bilirubin concentration (yellow bile pigment) or increase in liver enzymes. All of this is visible from blood test results.
- Decrease in the number of red blood cells in the blood (anemia).
- Inflammation of the head of the penis (balanitis).
- Back pain.
- Gout.
- Skin rashes.
Frequency not known
- Anaphylactoid shock (low blood pressure, increased heart rate, skin rash)
If any of these side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through
the national reporting system at http://www.agenziafarmaco.gov.it/content/come-
segnalare-una-sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the safety of
this medicine.
5. How to store Hexvix
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging.
The expiry date refers to the last day of the month.
Powder and solvent: the product does not require any special storage conditions.
Solution (after mixing): store at 2°C – 8°C (in refrigerator) for no more than 2 hours.
Hospital personnel will be responsible for storing and disposing of the product correctly, ensuring that the
product is not used after the expiry date indicated on the outer packaging.
6. Content of the pack and other information
What Hexvix contains
- The active ingredient is hexaminolevulinate hydrochloride.
- The excipients are: disodium phosphate dihydrate, dipotassium hydrogen phosphate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.
Description of the appearance of Hexvix and contents of the pack
- Each pack consists of a vial of powder with an appearance ranging from white to off-white or pale yellow, containing 85 mg of the active ingredient hexaminolevulinate and a pre-filled syringe with or without the Mini-Spike transfer device, containing 50 ml of clear and colorless liquid, for dissolving the powder.
- Hexvix powder is dissolved with the 50 ml of solution provided with the pack. Mixing the powder and solvent results in a solution of 1.7 mg/ml of hexaminolevulinate, equivalent to an hexaminolevulinate solution of 8 mmol/l.
Marketing Authorisation Holder and Manufacturer
Photocure ASA,
Hoffsveien 4
NO 0275 Oslo
Norway
This medicinal product is authorised with the name Hexvix in the following Member States
of the European Economic Area: Austria, Belgium, Cyprus, Czech Republic, Denmark,
Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Iceland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia,
Spain, United Kingdom
This leaflet was last updated
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The following information is intended exclusively for healthcare professionals:
Instructions for handling
Hexaminolevulinate may cause skin sensitization upon contact.
All steps of the procedure must be performed with sterile instruments and under aseptic conditions.
Reconstitution procedure A: Powder and Solvent (for Hexvix) in pre-filled syringe
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Reconstitution procedure B: Powder and Solvent (for Hexvix) in pre-filled syringe with
Mini-Spike transfer device



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slightly opalescent and ranges from colorless to pale yellow .
Add 2 hours to the reconstitution time and write the resulting expiry date and time on the
syringe label.
For single use only. Discard unused product. No special precautions for
disposal.
The solution is chemically and physically stable for 2 hours if stored at temperatures
between 2°C and 8°C. From a microbiological point of view, the product must be used
immediately. If not used immediately, the storage times after
opening and storage conditions before use are the responsibility of the user
and generally should not exceed 2 hours at 2-8°C.

- Країна реєстрації
- Лікарська формаPowder and solvent for injectable solution, 85 MG
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до EXVIXЛікарська форма: Oral solution, 75MG/10MLДіюча речовина: 13C-мочевинаВиробник: AB ANALITICA S.R.L.Потрібен рецептЛікарська форма: Powder for oral solution, 75 MGДіюча речовина: 13C-мочевинаВиробник: RICHEN EUROPE S.R.L.Рецепт не потрібенЛікарська форма: Soluble tablet, 100 MGДіюча речовина: 13C-мочевинаВиробник: ALFASIGMA S.P.A.Рецепт не потрібен
Аналоги EXVIX в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог EXVIX у Іспанія
Лікарі онлайн щодо EXVIX
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на EXVIX онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
Оберіть лікаря або ми призначимо
Оберіть спеціаліста або ми підберемо найближчого доступного лікаря.
Лікар розглядає ваш випадок
Зазвичай протягом 30 хвилин. Може ставити уточнювальні запитання в чаті.
Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
EXVIX потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
EXVIX виробляється компанією PHOTOCURE ASA. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування EXVIX з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати EXVIX у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною () включають BREATQUALITY-UBT, KITREDIKI UBT KIT, EXPIROBAKTER. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
























