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08-15 Primovist® 0.25 mmol/mL BAYER MIDDLE EAST solution for injection prefilled syringe 1. WHAT PRIMOVIST IS AND WHAT IT IS USED FOR Primovist is a contrast medium for magnetic resonance imaging (MRI) of the liver. It is used in order to better recognise and diagnose possible changes in the liver. Liver abnormalities can be better assessed (number, size and distribution). Beyond that, the doctor can use Primovist to determine the type of a possible abnormality, consequently increasing the reliability of the diagnosis. The contrast agent is available as a solution for intravenous injection. This medicinal product is for diagnostic use only. MRI is a type of medical-diagnostic imaging process, that utilises a complex system of magnetic fields and radio waves to recognise and make visible water molecules in healthy and morbid tissue. 2. BEFORE YOU ARE GIVEN PRIMOVIST Do not use PRIMOVIST • if you are hypersensitive (allergic) to gadoxetic acid, disodium or one of the other components of Primovist. The other constituents are listed in section 6 ‘What Primovist contains’. Take special care with PRIMOVIST • if you have or have ever had an allergy (e.g. hay fever, hives) or asthma. • if you have ever had a reaction following the use of contrast agents. • if your kidney function is seriously impaired. There have been cases of nephrogenic systemic fibrosis (NSF) observed in patients with advanced renal malfunction following the administration of contrast agents containing gadolinium. NSF is a disease that causes thickening of the skin and of the connective tissue and can result in impaired mobility of joints, myasthenia or impaired function of the internal organs, which can be life threatening. • if you have a serious disease of the heart and blood vessels. • if your potassium values are low. • if you or a member of your family have ever had problems with the electrical activity of the heart, i.e. the heart‘s rhythm (Long QT syndrome) • if your heart‘s rhythm or your heart beat has ever changed after taking medicinal products If one of these criteria applies to you, inform your doctor before being given Primovist. Your doctor will then decide, whether the planned examination can take place or not. •A llergy-like, even severe reactions can result from the use of Primovist. Delayed reactions (after hours or days) cannot be ruled out (see section 4. ‘Possible side effects’). • Inform your doctor, if you wear a cardiac pacemaker or if you have implants or clips containing iron in your body. •T he use of Primovist in patients under 18 years of age is not recommended, since there are no clinical data available with respect to this age group. Using PRIMOVIST with other medicines Please inform your doctor, if you are taking or have recently taken any other medicines, even if they are nonprescription medicines. Of primary concern are: • b eta blockers, which are used for the treatment of high blood pressure and other heart diseases; •m edicines, that change the heart rhythm or the heart frequency (such as, amiodarone, sotalol); • r ifampicin or rifamycin, which are used in treating tuberculosis. Using PRIMOVIST with food and drink Since contrast agents, such as Primovist. can cause nausea and vomiting, you are advised not to eat anything for 2 hours prior to the examination. Pregnancy and breast-feeding Tell your doctor, if you are or could be pregnant, since Primovist should only be used during pregnancy, if it is compellingly necessary. BAYER-PRIMOVIST 0.25 mmol/mL - p.1/3 BAYER-PRIMOVIST 0.25 mmol/mL - p.2/3 Inform your doctor, if you are presently or intending to breast feed, since Primovist should only be used after careful examination in these circumstances. It is advisable for you to discontinue breast feeding for a period of 24 hours after the administration of Primovist. Important information about some of the ingredients of PRIMOVIST Primovist contains 82 mg sodium in each dose (based on the average dose for someone weighing 70 kg). Take this into consideration, if you are on a low-sodium diet. 3. HOW TO USE PRIMOVIST Using a small hollow needle, a doctor will inject Primovist into a vein, just before your MRI examination. After the injection, you will be monitored for at least 30 minutes. The dose of Primovist suitable for you depends on your body weight: 0.1 mL Primovist per kg body weight. Further information concerning the administration and handling of Primovist is located at the end of this leaflet. If you receive more Primovist than you should An overdose is unlikely. In the event of an overdose, your doctor will treat the symptoms, that arise as a consequence. 4. POSSIBLE SIDE EFFECTS Like all medicines, Primovist can cause side effects, although not everybody gets them. As can be found in other contrast agents, rare cases of allergy-like reactions can occur, in very rare cases, even severe reactions (shock), that require immediate medical treatment. The first signs of a severe reaction can take the form of slight swelling in the face, lips, tongue or throat, coughing, itching, runny nose, sneezing and hives (skin rash). Inform the MRI department staff immediately, if you experience any of these signs or have difficulty in breathing. Delayed reactions are also possible; these can occur anywhere from several hours to several days after the administration of Primovist. If you notice delayed reactions, inform your doctor or radiologist. Side effects, that were reported / actually occurred are listed below categorically according to their frequency: The adverse reactions listed under ‘uncommon’ refer to 1 to 10 in 1,000 patients. The adverse reactions listed under ‘rare’ refer to less than 1 in 1,000 patients. Adverse reactions, that were observed in clinical studies, prior to the marketing authorisation of Primovist: Uncommon Headaches Vertigo Sensations of numbness and tingling Dysgeusia (problems with the sense of taste) Olfactory dysfunction (problems with the sense of smell) Flushed face Rise in blood pressure Difficulties in breathing Vomiting Nausea (feeling sick) Skin rash Strong itching * Chest pain Reactions at the injection site** Sensation of heat Rare Dizziness (vertigo) Restlessness Trembling Strong and/or quickened heartbeat (palpitation) Arrhythmia (irregular heartbeat) (sign of a heart block) Dry mouth Mouth complaints Increased saliva formation Rash with blisters and splotchy skin Increased sweating Chills Back pain Feeling of uneasiness Generally not feeling well Tiredness Malaise * Strong itching (generalised itching, itchy eyes) **Reactions at the injection site (varying kinds), which includes the following terms: extravasation of the contrast agent and bleeding into the tissue surrounding the injection site, burning sensation at the injection site, sensation of cold at the injection site, irritation at the injection site, pain at the injection site Post-marketing spontaneous reporting of additional adverse reactions to Primovist: Accelerated heartbeat (tachycardia) and restlessness occurred in rare cases. Laboratory test results can change soon after the use of Primovist. If you have blood or urine samples taken, please inform the healthcare professionals that you recently underwent an examination using Primovist. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or radiologist. BAYER-PRIMOVIST 0.25 mmol/mL - p.3/3 5. STORING PRIMOVIST Do not store above 30°C. Keep out of the reach and sight of children. Do not use the medicinal product after the expiry date stated on the label. The expiry date refers to the last day of the month indicated. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. The following information is intended for medical or healthcare professionals only: • Before the injection Primovist is a clear, colourless to faintly yellow solution, which is free of visible particles. Visually examine prior to use, and do not use, if the solution exhibits any strong discolouration, if particles are present, or if the container is damaged. • Administration Administer Primovist undiluted as an intravenous bolus injection with a flow speed of approximately 6. FURTHER INFORMATION 2 mL per second. Afterwards, flush the intravenous cannula with physiological saline solution (9 mg/mL). What PRIMOVIST contains: he patient should lie down and remain under •T he active substance is gadoxetic acid, disodium - T observation for at least 30 minutes after the injection. 181.43 mg/mL, equivalent to 0.25 mmol/mL. o not mix Primovist with other medicinal products. • The other constituents are caloxetic acid, trisodi- - D Absolutely avoid intramuscular injection. um; trometamol, sodium hydroxide, hydrochloric acid and water for injection. • Handling 1 prefilled syringe with 5.0 mL solution contains Primovist is ready to use. Prepare the prefilled syringe for injection directly 907 mg gadoxetic acid, disodium salt. 1 prefilled syringe with 7.5 mL solution contains before the examination. Remove the tip cap only just before using the prefilled syringe. 1361 mg gadoxetic acid, disodium salt. 1 prefilled syringe with 10.0 mL solution contains 1 Any unused contrast-agent solution remaining from any one examination should be disposed of in 814 mg gadoxetic acid, disodium salt. accordance with local requirements. What PRIMOVIST looks like and contents of the 1. Open the package. pack: 2. Screw the plunger onto the syringe. Primovist is a clear, colourless to faintly yellow liq- 3. Break off the tip cap. uid, which is free of visible particles. The packs 4. Remove the tip cap. contain: 5. Remove the rubber stopper. 1, 5 or 10 prefilled syringes with 5.0 mL solution for 6. Remove the air from the syringe. injection (in 10-mL prefilled syringes) 1, 5 or 10 prefilled syringes with 7.5 mL solution for injection (in 10-mL prefilled syringes) 1, 5 or 10 prefilled syringes with 10.0 mL solution for injection (in 10-mL prefilled syringes) Not all pack sizes may be marketed. Manufacturer: Bayer Schering Pharma AG Müllerstrasse 178 D – 13342 Berlin, Deutschland Telephone: +49 30 468-1111 This leaflet was last approved in June 2008