Examples of using Optimark in English and their translations into German
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Haemodialysis shortly after Optimark administration may be useful at removing Optimark from the body.
Breast-feeding should be discontinued for at least 24 hours after the administration of Optimark.
Before you receive Optimark, you will need to have a blood test to check how well your kidneys are working.
Pregnancy and breast-feeding Tell your doctor ifyou are pregnant and ask your doctor or pharmacist for advice before you are given Optimark.
Optimark has been studied in children of 2 years and older with a similar safety profile as shown in the adult population.
Patients who have moderateproblems with their kidneys should only receive Optimark if their doctor has carefully balanced the benefits and risks of using it.
Optimark 500 micromol/ml solution for injection in pre-filled syringe Optimark 500 micromol/ml solution for injection in vial.
The European Commission granted amarketing authorisation valid throughout the European Union for OptiMARK to Tyco Healthcare Deutschland GmbH on 23 July 2007.
Therefore, Optimark must not be used in patients who have had or are undergoing liver transplantation and in neonates.
Special warnings and precautions for use As withany paramagnetic contrast agent, enhancement of MRI with Optimark may impair the visualization of existing lesions.
Optimark has been studied in children of 2 years and older with a similar safety profile as shown in the adult population.
The required dose should be administered by hand to children to avoid overdosage by mistake.Neonates and infants Optimark should not be used in children below the age of two years.
Optimark has been studied in children of 2 years and older with a similar safety profile as shown in the adult population.
The risk for development of NSF in patients with moderate renal impairment(GFR 30-59 ml/min/1.73 m2) is unknown;therefore, Optimark should only be used after careful risk-benefit evaluation in patients with moderate renal impairment.
Therefore, Optimark must not be used in patients who have had or are undergoing liver transplantation and in neonates see section 4.3.
The most common side effects with OptiMARK(seen in between 1 and 10 patients in 100) are dizziness, headaches, dysgeusia(taste disturbances) and feeling hot.
OptiMARK is not recommended for use in children below 2 years of age, because of a lack of information on safety and effectiveness in this group.
The elimination of Optimark in dogs younger than 3 months of age was significantly delayed because of immature renal function and resulted in a high systemic exposure to Optimark.
Optimark must not be used in people who are hypersensitive(allergic) to gadoversetamide, any of the other ingredients or other medicines containing gadolinium.
If you are given more Optimark than you should have been If too much Optimark was injected it is unlikely that it will do you much harm, as much higher doses did not lead to any problems when some people received them.
Optimark is not recommended for use in children below the age of two years because the safety, efficacy, and impact of immature kidney function have not been studied in this age group.
In Optimark, the gadolinium is attached to another chemical so that the metal is not released in the body but stays‘trapped' until it is eliminated from the body in the urine.
Optimark is contraindicated in patients with severe renal impairment(GFR< 30ml/ min/ 1.73m2), and those who have had or are undergoing liver transplantation see section 4.4.
Do not use Optimark if you are allergic(hypersensitive) to the active substance gadoversetamide or to any of the other ingredients of Optimark, or to other gadolinium contrast agents.
Optimark has been studied in four main studies involving a total of 804 patients who had or were thought to have abnormalities in the brain or spine(two studies in 401 patients) or in the liver two studies in 403 patients.
OptiMARK has been studied in four main studies involving a total of 804 adults who had, or were thought to have abnormalities in the brain or spine(two studies in 401 patients) or in the liver two 7 Westferry Circus, Canary Wharf, London E14 4HB.
Optimark is contraindicated in patients with severe renal impairment(GFR< 30 ml/min/1.73 m2) and/or acute renal injury and in patients who have had liver transplantation or in patients in the perioperative liver transplantation period.
Take special care with Optimark Diagnostic procedures involving the use of contrast agents should be conducted under supervision of a physician with the prerequisite training and a thorough knowledge of the procedure to be performed.
You should not be given Optimark if you suffer from severe kidney impairment, or if you are a liver transplant patient as use of Optimark in patients with these conditions has been associated with a disease called Nephrogenic Systemic fibrosis NSF.
The company that markets Optimark will ensure that all healthcare professionals who are expected to use this medicine are informed that it should not be used in children below 2 years as the effect of the medicine in this age group, such as its effect on immature kidneys, has not been studied.