85 mg Powder and liquid for intravesical solution
hexaminolevulinate

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or nurse.
  • If you get any side effects , talk to your doctor or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about:
1. WHAT HEXVIX IS AND WHAT IT IS USED FOR
2. BEFORE YOU USE HEXVIX
3. HOW TO USE HEXVIX
4. POSSIBLE SIDE EFFECTS
5. STORING HEXVIX
6. FURTHER INFORMATION

1. WHAT HEXVIX IS AND WHAT IT IS USED FOR

This medicine is for diagnostic purposes only.

This medicine is used to help diagnose bladder cancer. It is given to you before your doctor uses a special instrument called a cystoscope to look inside your bladder. A cystoscope is used to help you see any tumors that light up in blue light after administration of Hexvix. The abnormal cells can thus be removed.

2. BEFORE YOU USE HEXVIX

Do not use Hexvix

  • if you are allergic to the active substance or to any of the other ingredients of this medicine, including the liquid used to dissolve it in (listed in section 6).
  • if you have porphyria (a rare, inherited blood disorder).

Warnings and cautions

Tell your doctor before taking Hexvix:

  • If you have a urinary tract infection or a burning sensation when urinating.
  • If you have recently received a BCG treatment (weakened tubercle bacteria injected into the bladder).
  • If you have recently undergone bladder surgery.

These conditions can cause local reactions in the bladder, which can make it difficult for your doctor to interpret the results of the test.

Taking other medicines

Tell your doctor or pharmacist if you have recently taken or might take any other medicines.

Pregnancy, breastfeeding and fertility

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

Driving and using machines

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. HOW TO USE HEXVIX

Hexvix is ​​prepared and given to you by specially trained and authorized staff.

  • Hexvix is ​​usually given in a hospital or doctor’s office.

Your doctor will give it to you as follows:

  1. A narrow tube called a catheter is placed in the bladder.
  2. Your bladder is emptied through the hose.
  3. Hexvix is ​​inserted into the bladder through the tube.
  4. Hexvix is ​​kept inside the bladder for about 60 minutes.
  5. Your bladder is then emptied through the tube.
  6. Your doctor will use an instrument (cystoscope) to examine the inside of your bladder .

If you receive more Hexvix than you should

If Hexvix is ​​kept in the bladder for longer than 60 minutes or if more Hexvix is ​​used than usual, no side effects are expected. Talk to your doctor or nurse if you are worried about this.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them. There is a risk of side effects related to the examination technique ( cystoscopy ) used to see the inside of the bladder. The use of Hexvix as a complementary procedure to standard cystoscopy for a more accurate diagnosis of your bladder cancer is usually well tolerated. If side effects occur, these are expected to be related to the examination technique and are usually not serious and do not last long. The following side effects may occur after the examination procedure when using this medicine:

Common (affects 1 to 10 users in 100):

  • Headache.
  • Nausea, vomiting.
  • Diarrhea.
  • Constipation.
  • Muscle cramps or pain in or near the abdomen.
  • Pain when emptying the bladder or difficulty throwing water.
  • Inability to empty bladder ( urinary retention ).
  • Blood in the urine.
  • Pain after the examination.
  • Fever.

Uncommon (affects 1 to 10 users in 1000):

  • Burning sensation when throwing water (caused by inflammation or infection of the bladder).
  • Need to throw water more often.
  • Blood poisoning.
  • Insomnia or difficulty falling asleep.
  • Pain in the urethra.
  • Feeling you have to urinate immediately (urinary incontinence).
  • Increased white blood cell count , increased levels of bilirubin (the yellow pigment in the bile) or liver enzymes. These side effects are seen in blood test results.
  • Decreased red blood cell count ( anemia ).
  • Inflammation of the glans (balanitis).
  • Back pain.
  • Gout .
  • Rash.

No known frequency (can not be calculated from the available data)

  • Anaphylactic shock (drop in blood pressure, increased heart rate, rash).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

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 carton after EXP. Expiration date is the last day of the specified month.

Powder and liquid: No special precautions for storage.
Solution (after mixing ): Store in a refrigerator (2ºC –8ºC), the solution should be used within 2 hours.

The medical staff ensures that the medicine is stored and disposed of correctly and is not used after the expiry date on the carton.

6. FURTHER INFORMATION

Content declaration

  • The active substance is hexaminolevulinate.
  • The other ingredients are disodium phosphate dihydrate, potassium dihydrogen phosphate, sodium chloride, hydrochloric acid , sodium hydroxide and water for injections.

What the medicine looks like and contents of the pack

  • Each pack consists of a vial with white to off-white or light yellow powder containing 85 mg of active substance hexaminolevulinate and a prefilled syringe with or without a Mini Spike containing 50 mL of clear colorless liquid for dissolving the powder.
  • Hexvix powder is dissolved in the 50 ml liquid that comes with the package. When powder and liquid have been mixed, a solution containing hexaminolevulinate 1.7 mg / ml is obtained, which corresponds to hexaminolevulinate 8 mmol / l solution.

Marketing Authorization Holder and Manufacturer

Photocure ASA
Hoffsveien 4
NO-0275 Oslo
Norway

Muhammad Nadeem

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