1.0 mmol \/ ml injection solution
Gadobutrol<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
How Gadovist works<\/strong><\/p>\n\n\n\n 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.<\/p>\n\n\n\n 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. Talk to your doctor before getting Gadovist about you<\/p>\n\n\n\n Your doctor will determine if the scheduled examination is possible or not.<\/p>\n\n\n\n Kidneys \/ Liver<\/strong><\/p>\n\n\n\n Tell your doctor about<\/p>\n\n\n\n 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.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n Tell your doctor or pharmacist if you have recently taken or might take any other medicines.<\/p>\n\n\n\n Consult a doctor before taking any medicine.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n Gadovist does not affect the ability to drive or use machines.<\/p>\n\n\n\n Healthcare professionals inject Gadovist into a vein using a thin needle. Your MRI scan can start immediately. Dosage<\/strong> For adults<\/strong>, 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.<\/p>\n\n\n\n Further information on how to administer and manage Gadovist is provided at the end of this leaflet.<\/p>\n\n\n\n Dosage in special patient groups The<\/strong> Newborns, infants, children, and adolescents<\/strong><\/p>\n\n\n\n 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).<\/p>\n\n\n\n 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.<\/p>\n\n\n\n Elderly<\/strong> Overdose is unlikely. If overdose still occurs, the doctor will treat any symptoms and may then use dialysis to remove Gadovist from the body.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n If you have any further questions on the use of this product, ask your doctor or radiologist.<\/p>\n\n\n\n Like all medicines, this medicine can cause side effects, although not everybody gets them.<\/p>\n\n\n\n The most serious adverse reactions are<\/strong> (which in some cases have been fatal or life-threatening) are:<\/p>\n\n\n\n In addition, the following side effects have been life-threatening or fatal<\/strong> in some cases:<\/p>\n\n\n\n In rare cases<\/strong><\/p>\n\n\n\n If you experience:<\/p>\n\n\n\n tell the staff of the MRI department immediately. <\/strong>These may be the first signs that a serious reaction<\/strong> is developing. Your examination may need to be stopped and you may need other treatment.<\/p>\n\n\n\n Delayed allergy-like reactions<\/strong> 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.<\/p>\n\n\n\n The most common side effects were<\/strong> observed (may affect 5 or more in 1000) are:<\/p>\n\n\n\n Most of these side effects are mild to moderate.<\/p>\n\n\n\n Listed below are the possible side effects are<\/strong> observed in clinical trials<\/strong> before the approval of Gadovist according to how common they are. The following categories are used:<\/p>\n\n\n\n Common<\/strong> (may affect up to 1 in 10 people)<\/p>\n\n\n\n Uncommon<\/strong> (may affect up to 1 in 100 people)<\/p>\n\n\n\n The frequency of the following allergic reactions is unknown:<\/p>\n\n\n\n Rare<\/strong> (may affect up to 1 in 1000 people)<\/p>\n\n\n\n Additional side effects reported after the approval of Gadovist without known frequency<\/strong> (cannot be calculated from the available data):<\/p>\n\n\n\n Variations in renal function tests (eg elevated serum creatinine ) have been observed after administration of Gadovist.<\/p>\n\n\n\n Reporting of side effects<\/em><\/p>\n\n\n\n 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.<\/p>\n\n\n\n Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n Chemical, physical and microbiological stability during use has been demonstrated for 24 hours at 20-25 \u00b0 C. From a microbiological point of view, the drug should be used immediately.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n The active substance<\/strong> is gadobutrol.<\/p>\n\n\n\n 1 ml solution for injection contains 604.72 mg gadobutrol (equivalent to 1.0 mmol gadobutrol containing 157.25 mg gadolinium).<\/p>\n\n\n\n 1 vial of 2 ml contains 1209.44 mg gadobutrol,<\/p>\n\n\n\n 1 vial of 7.5 ml contains 4535.4 mg gadobutrol, 1 vial of 65 ml contains 39306.8 mg Gadobutrol.<\/p>\n\n\n\n
<\/p>\n\n\n\n2. What you need to know before you get Gadovist<\/h2>\n\n\n\n
DO NOT use Gadovist if you<\/h2>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Newborns and infants<\/h2>\n\n\n\n
Other drugs and Gadovist<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
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.<\/li>
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.<\/li><\/ul>\n\n\n\nGadovist contains sodium<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
3. How Gadovist is given<\/h2>\n\n\n\n
You will be under observation for at least 30 minutes after injection one.<\/p>\n\n\n\n
The dose you receive depends on your body weight and the area of \u200b\u200bthe MRI scan.<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
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.<\/p>\n\n\n\nIf you have received too much Gadovist<\/h2>\n\n\n\n
4. Possible side effects<\/h2>\n\n\n\n
5. How to store Gadovist<\/h2>\n\n\n\n
6. Contents of the packaging and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n
1 vial of 15 ml contains 9070.8 mg gadobutrol,
1 vial of 30 ml contains 18141.6 mg gadobutrol.<\/p>\n\n\n\n