0.5 mg preparation kit for radioactive drug-human albumin in colloidal particles
What Nanocoll is and what it is used for
Nanocoll is a radioactive medicine for diagnostic purposes only. This medicine does not treat your illness.
Nanocoll is used to prepare a radioactive injection of technetium ( 99m Tc). Technetium ( 99m Tc) 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.
You can get Nanocoll for:
- examination of bone marrow a
- to detect inflammation in areas other than the abdomen
- examination of the lymphatic system , i.a. in connection with the investigation of malignant melanoma and breast cancer
Using Nanocoll exposes you to small amounts of radioactive radiation. Your doctor and the doctor responsible for the examination have assessed that the benefits of the radioactive medicine outweigh the risks of the radiation.
What you need to know before you get Nanocoll
Do not use Nanocoll
- if you are allergic to human albumin, or any of the other ingredients of this medicine (listed in section 6).
- for imaging of the lymphatic system that includes the pelvic area if you are pregnant or think you may be pregnant.
Warnings and cautions
Talk to your doctor or nurse before receiving Nanocoll if you
- is pregnant or thinks you may be pregnant
- ammar
- have a blockage in your lymphatic system
- have impaired renal or hepatic function
Before administering Nanocoll you should:
- drink plenty of water before the test to be able to urinate as often as possible during the first hours after the test
Children and young people
Talk to your doctor if you are under 18 years of age.
Other drugs and Nanocoll
Tell your doctor if you are taking, have recently taken, or might take any other medicines. Some medicines may affect the interpretation of the images.
If you are having an examination of your lymphatic system, tell your doctor if you are taking any of the following medicines, as they may affect the results of the examination:
- Medicines given in hospital for X-rays or imaging (iodine-containing contrast medium).
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 taking this medicine.
You must tell your doctor before receiving Nanocoll if there is a possibility that you are pregnant, if you have not had a period or if you are breastfeeding. If you are unsure, you must talk to your doctor.
If you are pregnant
Your doctor will only use this medicine if the benefit is considered greater than the risk. You should not be given Nanocoll for an examination of the lymphatic system (which includes the pelvis) if you are pregnant or think you may be pregnant, as this may affect your baby.
If you are breast-feeding
You should not breastfeed if you are being given Nanocoll as small amounts of radioactivity may pass into your breast milk. If you are breastfeeding, your doctor may wait until you have finished breastfeeding before giving you Nanocoll. If it is not possible to wait, your doctor will ask you to:
- stop breastfeeding for 24 hours after injection one, and
- pump out the breast milk and discard it.
Your doctor will tell you when you can start breastfeeding again.
Driving and using machines
Nanocoll is unlikely to affect your ability to drive or use machines.
Nanocoll contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per vial, ie essentially ‘sodium-free’.
How to use Nanocoll
There are strict rules on the use, handling, and disposal of radioactive drugs. Nanocoll will only be used in specially controlled locations. The medicine will only be handled and given to you by people who have education and expertise in how to use it safely. These people will take special care for the safe use of the medicine and will inform you about the measures they are taking.
- Nanocoll will always be used in a hospital or clinic.
- The staff will inform you about everything you need to know for safe use.
Your doctor will decide which dose to use in your case. Dose one will be the minimum amount needed to obtain the desired information.
Adults
The recommended dose for adults is between 5-500 MBq (megabecquerel, the device used to express radioactivity), depending on the study to be performed.
Use for children and adolescents
The amount used for children and adolescents will be adjusted according to the child’s weight.
How Nanocoll is given and conducting the survey
Depending on the test to be performed, the dose may be:
- given as one or more injections
- injected into a vein ( intravenously ), under the skin ( subcutaneously ), in tumor one or in the area around tumor one before imaging is performed
After injection, you should drink something and be asked to urinate immediately before the examination.
The picture can be taken immediately or up to 60 minutes after injection, depending on the examination. Additional injection and more pictures may be needed.
Duration of the survey
Your doctor will tell you how long the examination is expected to take.
After receiving Nanocoll, you should:
- avoid close contact with young children and pregnant women for 24 hours after injection ,
- urinate frequently to remove the drug from the body.
Your doctor will tell you if you need to take any special measures after receiving this medicine. Contact your doctor if you have any questions.
If you take more Nanocoll than you should
Overdose is almost impossible because your dose is carefully monitored by your doctor. In the event of an overdose, you will receive treatment.
If you have any further questions on the use of this product, ask your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor or nurse immediately if you experience any of the following when you are examined at a hospital or clinic:
- skin rash, itching or feeling hot
- swelling of the face, difficulty breathing
- fainting (unconsciousness), dizziness
This may be a sign of an allergic reaction that may be severe (occurs in an unknown number of users).
If this happens after you leave the hospital or clinic, you should immediately go to the emergency department at the nearest hospital.
This radioactive medicine emits small amounts of ionizing radiation with a very low risk of cancer and hereditary disorders.
How to store Nanocoll
You do not need to store this medicine. A specialist is responsible for storing this medicine in a suitable place. Storage of radioactive medicines takes place following national regulations on radioactive materials.
The following information is intended for specialist use only.
Do not use this medicine after the expiry date which is stated on the label after EXP. day. The expiration date is the last day of the specified month.
Contents of the pack and other information
Content declaration
The active substance is human albumin in colloidal particles. Each bottle of Nanocoll contains 0.5 mg of human albumin in colloidal particles
The other ingredients are tin chloride dihydrate, anhydrous glucose, poloxamer, dibasic and anhydrous sodium phosphate, anhydrous sodium phytate, and nitrogen.
What the medicine looks like and contents of the pack
Nanocoll is a preparation kit for radioactive drugs.
Each preparation kit contains 5 vials on a polystyrene tray and package leaflet, packed in cardboard.
Marketing Authorization Holder and Manufacturer
GE Healthcare Srl
Via Galeno, 36
20126 Milano
Italy
Manufacturer:
GIPHARMA SRL
Via Cosentino
13040 Saluggia (VC)
Italy
Local representative:
GE Healthcare AB
Box 90
Vendevägen 89
182 11 Danderyd