0.5 mg kit for radioactive drug 
exametazim

Read all of this leaflet carefully before you are given 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.

– If you get any side effects, talk to your doctor. This also applies to any side effectsnot mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Ceretec Stabilised is and what it is used for 
2. What you need to know before you are given Ceretec Stabilised 
3. How to use Ceretec Stabilised 
4. Possible side effects 
5. How to store Ceretec Stabilised 
6. Contents of the packaging and other information 

1. What Ceretec Stabilized is and what it is used for

This medicine is a radioactive medicine that is intended for diagnostic use only (to identify disease). Ceretec Stabilized contains an active substance called exametazim and is used to prepare a radioactive injection of technetium ( 99m Tc). Technetium ( 99mTc) is a radioactive substance that allows you to produce images of specific organs in the body with the help of a special camera. The image obtained can give the doctor valuable information about the structure and function of a specific organ or the location of, for example, a tumor.

Ceretec Stabilized is used in tests to see how much blood is flowing through the brain. This can be important to know for example:

  • if you have a disease of the central nervous system
  • if you are going to have surgery for epilepsy
  • if your doctor suspects you have dementia.

Using Ceretec Stabilized means that you are exposed to small amounts of radioactive radiation. Your doctor believes that the clinical benefit of using radioactive medicine outweighs the risks of radiation.

What you need to know before you are given Ceretec Stabilized

Ceretec Stabilised should not be used:

– if you are allergic to exametazim or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to the doctor responsible for the examination before you are given Ceretec Stabilized.

Take special care with Ceretec Stabilized:


• if you are pregnant or think you may be pregnant. 
• if you are breast-feeding. 
• if you are prescribed a low-salt diet.

Before the examination

Drink plenty of fluids before the test so that you can urinate frequently during the first hours after the test so that the medicine leaves the body quickly.

Children

Ceretec Stabilized is not recommended for use in children.

Other medicines and Ceretec Stabilized

Tell your doctor if you are taking, have recently taken, or might take any other medicines. These may affect the interpretation of the images, although it has not been reported that other drugs affect the function of Ceretec Stabilized.

Pregnancy and breastfeeding

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

You must tell your doctor before you are given this medicine if you are pregnant, have missed a period or if you are breast-feeding. If you are unsure, it is important that you consult the doctor who is supervising the examination.

If you are pregnant

If you are pregnant, your doctor will only give you this medicine if the benefits are significantly expected to outweigh the risks.

If you are breast-feeding

Breast-feeding is not recommended when using this medicine. Discuss with your doctor when you can start breastfeeding again after using this medicine.

Driving and using machines

There is no indication that Ceretec Stabilized would affect the ability to drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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.

Ceretec Stabilized contains sodium

Ceretec Stabilized contains 1.77 mg sodium per dose ( vial ). This should be considered by patients on a low-salt diet.

How to use Ceretec Stabilized

There are strict regulations on how radioactive drugs should be used, handled, and disposed of. Ceretec Stabilized will only be used in specially controlled locations. This medicine will only be handled and given to you by people who are trained and qualified to use it safely. These people make sure that the medicine is used in a risk-free way and keep you informed of what is happening.

Use of Ceretec Stabilized and how the study is performed

Dose

The doctor supervising the examination will decide which dose of Ceretec Stabilized to use in your case. It will be the minimum amount required to obtain the desired information. The amount usually recommended for an adult is 555 – 1110 MBq for an examination of the brain ( scintigraphy ). Megabecquerel (MBq) is a device used to express radioactivity.

One injection is sufficient for your doctor to perform the examination.  

Ceretec is always given in a hospital or clinic by trained staff.

The staff will provide you with the necessary information about the survey.

During the survey:

Your doctor will tell you how long the examination is expected to take.

After the examination:

  • urinate frequently for the drug to leave the body.
  • Avoid close contact with young children and pregnant women for 12 hours after injection.

Your doctor will inform you if you need to take any special measures after receiving this medicine. Contact your doctor if you have any questions.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact a doctor immediately or see a hospital if you get the following side effect:

Allergic reactions

Tell your doctor immediately if you experience any of the following when you are examined at a hospital or clinic, it may be a sign of a severe allergic reaction:

  • skin rash, itching, feeling hot,
  • swelling of the face, swollen lips, eyelids, face or tongue
  • breathing difficulties

If this happens after you leave the hospital or clinic, you should immediately go to the emergency department at the nearest hospital.

Other side effects ( affects an unknown number of users):

Headache, dizziness, numbness, hot flashes, nausea, vomiting, malaise, weakness, fatigue.

This radioactive medicine emits small amounts of ionizing radiation with very little risk of cancer and hereditary defects.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Ceretec Stabilised

You do not need to store this medicine. Healthcare professionals are responsible for storing medicine in suitable premises. Storage of radioactive medicines takes place in accordance with national regulations on radioactive materials.

The following information is intended for healthcare professionals only:

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 label after EXP:.

Do not store above 25 ° C. Do not freeze.

Injected within 6 hours after reconstitution.

6. Contents of the packaging and other information

Content declaration

  • The active substance is exametazim. Each bottle contains 500 micrograms of exametazime.
  • The other ingredients are sodium chloride, tin chloride dihydrate, cobalt dichloride hexahydrate, water for injections.

What the medicine looks like and the contents of the pack

Ceretec Stabilized is a white powder in a glass bottle closed with a chlorobutyl rubber stopper and a metal cap and a cobalt stabilization solution delivered in a glass bottle with a chlorobutyl rubber stopper and a metal cap.

Pack sizes:

The packages contain 2 or 5 bottles of each component.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

GE Healthcare AS

POBox 4220 Nydalen

NO-0401 Oslo

Norway

Manufacturer:

GE Healthcare AS

Nycoveien 1

NO-0485 Oslo, Norway

Contact your local marketing authorization representative to find out more about this medicine:

GE Healthcare AB

Box 90

182 11 Danderyd

Tel: 08-559 504 00

Muhammad Nadeem

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