1.0 mmol / ml injection solution
Gadobutrol
1. What Gadovist is and what it is used for
Gadovist is a contrast enhancer used for diagnostic magnetic resonance imaging (MRI) of the brain, spine, and blood vessels. Gadovist may also make it easier for the doctor to check if known or suspected changes in the liver and kidneys are benign or malignant.
Gadovist can also be used in MRI of abnormalities in other body regions. Gadovist makes it easier to see abnormal structures and changes and makes it easier to distinguish between healthy and diseased tissue. It is used for adults and children of all ages.
How Gadovist works
MRI is a form of medical imaging technology based on the behavior of water molecules in normal and abnormal tissue. The technology is based on an intricate system of magnets and radio waves. Computers record the activity and transfer it to visible images.
Gadovist is given as an injection in a friend. This medicine is for diagnostic purposes only and will only be given by healthcare professionals with experience in clinical MRI.
2. What you need to know before you get Gadovist
DO NOT use Gadovist if you
- is allergic to gadobutrol or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor before getting Gadovist about you
- have or have had allergies (eg hay fever, hives ) or asthma
- previously experienced a reaction when you received a contrast agent
- has very weak kidney function
- suffer from a condition in the brain that causes seizures or if you suffer from other diseases of the central nervous system
- have pacemakers in the heart or any other implant or metal clips that contain iron in the body.
Your doctor will determine if the scheduled examination is possible or not.
- Allergy-like reactions leading to heart problems, difficulty breathing or skin reactions may occur after using Gadovist. Serious reactions are possible. Most of these reactions occur within half an hour after receiving Gadovist. Therefore, you will be kept under observation after the examination. Delayed reactions have been observed (after hours or days) (see section 4).
Kidneys / Liver
Tell your doctor about
- your kidneys are not functioning normally.
- you have recently undergone or are soon expected to undergo a liver transplant.
Doctors may decide to take a blood test to check how your kidneys are working before deciding to use Gadovist, especially if you are 65 years of age or older.
Newborns and infants
Because the kidney function in newborns up to 4 weeks of age and infants up to 1 year of age is not fully developed, Gadovist will only be used after careful consideration by your doctor.
Other drugs and Gadovist
Tell your doctor or pharmacist if you have recently taken or might take any other medicines.
Pregnancy and breastfeeding
Consult a doctor before taking any medicine.
- Pregnancy
You must tell your doctor if you think you are or may become pregnant as Gadovist should not be used during pregnancy unless clearly necessary. - Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Your doctor will discuss with you whether you should continue or stop breast-feeding for a period of 24 hours after receiving Gadovist.
Gadovist contains sodium
This medicine contains less than 23 mg sodium per dose (based on an average dose per person of 70 kg), ie the medicine is almost ‘sodium-free.
Driving and using machines
Gadovist does not affect the ability to drive or use machines.
3. How Gadovist is given
Healthcare professionals inject Gadovist into a vein using a thin needle. Your MRI scan can start immediately.
You will be under observation for at least 30 minutes after injection one.
Dosage
The dose you receive depends on your body weight and the area of the MRI scan.
For adults, a single injection of 0.1 ml Gadovist per kg body weight is generally sufficient (for a person weighing 70 kg this means a dose of 7 ml), however, an additional injection of up to 0.2 ml per kg body weight may be given within 30 minutes after the first injection. A total of 0.3 ml Gadovist can be given per kg body weight.
Further information on how to administer and manage Gadovist is provided at the end of this leaflet.
Dosage in special patient groups The
use of Gadovist is not recommended for patients with severe kidney problems and for patients who have recently had or are expected to undergo a liver transplant. If, after all, use is necessary, you should only receive a dose of Gadovist during an examination and you should not receive a second injection before at least 7 days have passed.
Newborns, infants, children, and adolescents
For children of all ages (including newborns and infants), the recommended dose is 0.1 ml Gadovist per kg body weight for all indications (see section 1).
As renal function is not fully developed in newborns up to 4 weeks of age and infants up to 1 year of age, Gadovist should only be used after careful consideration by your doctor. Newborns and infants should only be given Gadovist as a single dose in a study. If the test with Gadovist needs to be repeated, it can only be done 7 days after the first injection.
Elderly
It is not necessary to adjust the dose if you are 65 years of age or older but you may need a blood test to check how well your kidneys are working.
If you have received too much Gadovist
Overdose is unlikely. If overdose still occurs, the doctor will treat any symptoms and may then use dialysis to remove Gadovist from the body.
There is no evidence to suggest that this prevents the development of nephrogenic systemic fibrosis (NSF, see section 4) and it should not be used to treat the condition. In some cases, your heart will be checked.
If you have any further questions on the use of this product, ask your doctor or radiologist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most serious adverse reactions are (which in some cases have been fatal or life-threatening) are:
- The heart stops beating (cardiac arrest) and severe allergic (anaphylactic) reactions (such as respiratory arrest and shock ).
In addition, the following side effects have been life-threatening or fatal in some cases:
- Shortness of breath ( dyspnoea ) and unconsciousness, severe allergic-like reactions, dangerous fall in blood pressure that can lead to collapse, respiratory arrest, fluid in the lungs, swelling of the mouth and throat and low blood pressure .
In rare cases
- Allergic-like reactions (hypersensitivity and anaphylaxis ) may occur, including severe reactions ( shock ) that may require immediate medical attention.
If you experience:
- swelling of the face, lips, tongue or throat
- coughing and sneezing
- breathing difficulties
- itching
- Runny nose
- hives
tell the staff of the MRI department immediately. These may be the first signs that a serious reaction is developing. Your examination may need to be stopped and you may need other treatment.
Delayed allergy-like reactions have been observed in rare cases. These have occurred several hours or days after Gadovist was given. If this happens to you, tell your doctor or radiologist immediately.
The most common side effects were observed (may affect 5 or more in 1000) are:
- headache, nausea and dizziness.
Most of these side effects are mild to moderate.
Listed below are the possible side effects are observed in clinical trials before the approval of Gadovist according to how common they are. The following categories are used:
Common (may affect up to 1 in 10 people)
- headache
- nausea
Uncommon (may affect up to 1 in 100 people)
- allergy-like reactions, e.g.
- low blood pressure
- hives
- swelling of the face
- swelling ( edema ) of the eyelids
- redness
The frequency of the following allergic reactions is unknown:
- severe allergic reactions ( anaphylactic shock )
- dangerous drop in blood pressure that can lead to collapse ( shock )
- respiratory arrest
- fluid in the lungs
- difficulty breathing ( bronchospasm )
- bluish discoloration of the lips
- swelling of the mouth and throat
- swelling of the throat
- increased blood pressure
- chest pain
- swelling of the face, throat, mouth, lips and / or tongue ( angioedema )
- eye inflammation ( conjunctivitis )
- increased sweating
- cough
- sneezing
- burning sensation
- pallor
- dizziness, disturbed taste, numbness and tingling
- shortness of breath ( dyspnoea )
- vomiting
- redness ( erythema )
- itching ( pruritus , also general itching )
- rash (including rash in general), small flat red spots [ macular rash ], small, raised demarcated wounds [ papular rash ] and itchy rash
- various reactions at the injection site (eg leakage to surrounding tissue , burning, feeling of cold or heat, redness , rash, pain or bruising)
- hot flashes
Rare (may affect up to 1 in 1000 people)
- fainting
- cramps
- disturbed sense of smell
- fast pulse
- palpitation
- dry mouth
- malaise ( malaise )
- feeling cold
Additional side effects reported after the approval of Gadovist without known frequency (cannot be calculated from the available data):
- cardiac arrest
- There have been reports of nephrogenic systemic fibrosis – NSF (which causes thickening of the skin and which can also affect soft tissues and internal organs).
Variations in renal function tests (eg elevated serum creatinine ) have been observed after administration of Gadovist.
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. How to store Gadovist
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 and carton after EXP. dat / EXP. The expiration date is the last day of the specified month. No special storage instructions.
Chemical, physical and microbiological stability during use has been demonstrated for 24 hours at 20-25 ° C. From a microbiological point of view, the drug should be used immediately.
This medicine is a clear, colorless, or pale yellow solution. Do not use this medicine if you notice severe discoloration, see particles, or if the packaging appears to be defective.
Medicines should not be disposed of via wastewater or household waste. Healthcare professionals will discard the medicine when it is no longer in use. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
The active substance is gadobutrol.
1 ml solution for injection contains 604.72 mg gadobutrol (equivalent to 1.0 mmol gadobutrol containing 157.25 mg gadolinium).
1 vial of 2 ml contains 1209.44 mg gadobutrol,
1 vial of 7.5 ml contains 4535.4 mg gadobutrol,
1 vial of 15 ml contains 9070.8 mg gadobutrol,
1 vial of 30 ml contains 18141.6 mg gadobutrol.
1 vial of 65 ml contains 39306.8 mg Gadobutrol.
The other ingredients are calcobutrol sodium (see the end of section 2), trometamol, hydrochloric acid 1 N, and water for injections.
What the medicine looks like and contents of the pack
Gadovist is a clear, colorless, or light yellow solution for injection.
The packages contain:
- 1 or 3 vials with 2 ml solution for injection .
- 1 or 10 vials of 7.5, 15 or 30 ml solution for injection .
- 1 or 10 infusion vials with 65 ml solution for injection (in 100 ml vials).
Hospital packaging:
- 3 vials with 2 ml solution for injection .
- 10 vials of 7.5, 15 or 30 ml solution for injection .
- 10 vials of 65 ml solution for injection .
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Bayer AB
Box 606
SE-169 26 Solna
Manufacturer
Bayer AG
Müllerstrasse 178
133 53 Berlin
Germany
This medicinal product is authorized under the European Economic Area under the names:
| Austria, Germany | Gadovist 1.0 mmol / ml solution for injection |
| Belgium, Cyprus, Denmark, Estonia, Finland, Greece, Italy, Luxembourg, Norway, Portugal, Sweden | Gadovist |
| France | GADOVIST 1.0 mmol / mL, injectable solution |
| Croatia | Gadovist 1.0 mmol / ml otopina for injection in strains / ulcers |
| Ireland | Gadovist 1.0 mmol / ml solution for injection |
| Netherlands | Gadovist 1.0 mmol / ml solution for injection |
| Spain | Gadovist 1 mmol / ml injectable solution in vial |
| Great Britain, Malta | Gadovist 1.0 mmol / ml solution for injection |