270 mg I\/ml, 320 mg I\/ml solution <\/p>\n\n\n\n
for injection Visipaque is a contrast agent and is intended for diagnostic use only. It is used as an aid in disease determination.<\/p>\n\n\n\n It is given before an X-ray examination to make the X-ray image clearer.<\/p>\n\n\n\n Your doctor will tell you which part of your body will be examined. Talk to your doctor before receiving Visipaque if you:<\/p>\n\n\n\n You may experience a short-term disturbance in brain function called encephalopathy during or shortly after the contrast medium examination. Tell your doctor straight away if you notice any of the symptoms associated with this condition described in section 4.<\/p>\n\n\n\n If you are not sure if any of the above apply to you, talk to your doctor or nurse before you are given Visipaque.<\/a><\/p>\n\n\n\n Tell your doctor if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n Tell your doctor if you<\/p>\n\n\n\n You should do this because certain medicines can affect the effect of Visipaque and increase the risk of\u00a0side effects.<\/p>\n\n\n\n Tell your doctor if you are pregnant, if you think you may be pregnant or if you are trying to become pregnant. The examination will only be carried out if your doctor judges that the benefit is greater than the risk for both you and the child. If you have received Visipaque during pregnancy, it is recommended that the thyroid function of the newborn baby be monitored.<\/p>\n\n\n\n The amount of Visipaque excreted in breast milk is small and is not considered harmful to the baby. Breastfeeding can continue as usual after examination with Visipaque.<\/a><\/p>\n\n\n\n You should not drive or use machines for 24 hours after a brain scan (\u00a0intrathecal\u00a0use of Visipaque).\u00a0You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance.\u00a0One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or\u00a0side effects.\u00a0A description of these effects and\u00a0side effects\u00a0can be found in other sections.\u00a0Read all the information in this leaflet for guidance.\u00a0Discuss with a doctor or healthcare professional if you are unsure. Visipaque will always be given to you by a specially trained and qualified healthcare professional.<\/p>\n\n\n\n The recommended dose is:<\/strong><\/p>\n\n\n\n Visipaque is injected into a blood vessel before or during an X-ray or you may be asked to drink it.\u00a0For children, Visipaque can be given via the rectum.\u00a0The amount injected varies depending on the type of examination, user technique, and your age and weight.<\/p>\n\n\n\n After you have received Visipaque<\/strong><\/p>\n\n\n\n If you experience side effects during this time, contact your doctor immediately (see section 4 “Possible side effects”). This advice applies to all patients<\/strong> who have received Visipaque. If you are unsure about any of the above, ask your doctor.<\/p>\n\n\n\n Visipaque can be given in many different ways, a description of the most common ways of administration can be found below:<\/p>\n\n\n\n Injection into an artery or vein<\/strong><\/p>\n\n\n\n Visipaque is usually injected into a vein in the arm or leg. Sometimes it is given via a thin plastic tube ( catheter ), inserted into an artery usually in the arm or groin.<\/p>\n\n\n\n Injection into the spinal cord<\/strong><\/p>\n\n\n\n Visipaque is injected into the area around the spinal cord to see the spinal canal. You are then asked to follow the advice below:<\/p>\n\n\n\n The above advice\u00a0only applies<\/strong>\u00a0if you have received Visipaque\u00a0injected into the spine<\/strong>.\u00a0If you are unsure, consult your doctor.<\/p>\n\n\n\n Use in body cavities (body cavities) or joints<\/strong><\/p>\n\n\n\n Body cavities are, for example, the uterus, blood vessels, and bladder.\u00a0How and where Visipaqe is given varies.<\/p>\n\n\n\n Oral use as a drink<\/strong><\/p>\n\n\n\n When examining the esophagus, stomach\/stomach, or small intestine, Visipaque is given as a drink that can be diluted with water.<\/p>\n\n\n\n As you will be given Visipaque by trained healthcare professionals, overdose is unlikely.<\/a><\/p>\n\n\n\n Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n Allergic reactions<\/strong><\/p>\n\n\n\n If you have an allergic reaction while being examined at the hospital, tell your doctor or nurse immediately. Signs of an allergic reaction may include:<\/p>\n\n\n\n The above reactions may occur several hours or days after you receive Visipaque.<\/p>\n\n\n\n If it happens after you have left the hospital, go straight to the nearest emergency department. Serious allergic reactions may occur in an unknown number of users. Less serious allergic reactions may occur in up to 1 in 100 users.<\/p>\n\n\n\n Other unwanted effects you may experience are listed below. These depend on how or why you received Visipaque.<\/p>\n\n\n\n After injection\u00a0into an\u00a0artery\u00a0or vein<\/strong><\/p>\n\n\n\n Uncommon (may affect up to 1 in 100 users):<\/em><\/p>\n\n\n\n Rare (may affect up to 1 in 1,000 users)<\/em> :<\/p>\n\n\n\n Very rare (may affect up to 1 in 10,000 users, including isolated cases)<\/em> :<\/p>\n\n\n\n Has been reported (may occur in an unknown number of users <\/em>)<\/em> :<\/p>\n\n\n\n After injection\u00a0into the spine<\/strong><\/p>\n\n\n\n Uncommon (may affect up to 1 in 100 users)<\/em> :<\/p>\n\n\n\n Has been reported (may occur in an unknown number of users):<\/em><\/p>\n\n\n\n After use in body cavities<\/strong>\u00a0(such as the uterus and fallopian tubes)<\/p>\n\n\n\n Very common (may affect more than 1 in 10 users)<\/em> :<\/p>\n\n\n\n Common (may affect up to 1 in 10 users)<\/em> :<\/p>\n\n\n\n Has been reported (may occur in an unknown number of users):<\/em><\/p>\n\n\n\n After injection into joints<\/strong><\/p>\n\n\n\n Common <\/em>(may affect up to 1 in 10 users)<\/em> :<\/p>\n\n\n\n Has been reported (may occur in an unknown number of users):<\/em><\/p>\n\n\n\n After oral use as a drink<\/strong><\/p>\n\n\n\n Common <\/em>(may affect up to 1 in 10 users)<\/em> :<\/p>\n\n\n\n Uncommon (may affect up to 1 in 100 users)<\/em> :<\/p>\n\n\n\n Has been reported (may occur in an unknown number of users):<\/em><\/p>\n\n\n\n Reporting\u00a0side effects\u00a0If you experience\u00a0side effects, talk to a doctor or nurse.\u00a0This also applies to\u00a0side effects\u00a0that are not mentioned in this information.\u00a0You can also report\u00a0side effects\u00a0directly (see details below).\u00a0By reporting\u00a0side effects, you can contribute to increasing information about drug safety.<\/p>\n\n\n\n Store out of sight and reach of children.<\/p>\n\n\n\n Use before the expiry date stated on the label after EXP. The expiration date is the last day of the specified month.<\/p>\n\n\n\n Visipaque must not be frozen. Store in the outer carton. Light sensitive.<\/p>\n\n\n\n Can be heated and stored in a warming cabinet at 37\u00b0C for up to one month before use. The active substance is iodixanol.\u00a0Other ingredients are trometamol, sodium chloride, calcium chloride dihydrate, anhydrous\u00a0sodium\u00a0calcium edetate,\u00a0hydrochloric acid\u00a0(\u00a0pH\u00a0regulation), and water for injections.<\/p>\n\n\n\n Visipaque 270 mg I\/ml contains 550 mg iodixanol per ml (equivalent to 270 mg iodine per ml).<\/p>\n\n\n\n Visipaque 320 mg I\/ml contains 652 mg iodixanol per ml (equivalent to 320 mg iodine per ml).<\/a><\/p>\n\n\n\n Visipaque is a\u00a0solution for injection.\u00a0The product is a clear, colorless slightly yellow\u00a0aqueous solution.<\/p>\n\n\n\n Visipaque is supplied as:<\/p>\n\n\n\n 270 mg I\/ml solution for injection<\/strong><\/p>\n\n\n\n Glass bottle:<\/em> 10×20 ml, 10×50 ml, 10×75 ml, 10×100 ml, 6×200 ml and 6×500 ml<\/p>\n\n\n\n Polypropylene bottle (USB<\/em> ): 10×50 ml, 10×75 ml, 10×100 ml, 10×150 ml, 10×175 ml, 10×200 ml and 6×500 ml.<\/p>\n\n\n\n 320 mg I\/ml solution for injection<\/strong><\/p>\n\n\n\n
iodixanol<\/a><\/p>\n\n\n\nWhat Visipaque is and what it is used for<\/h2>\n\n\n\n
<\/a><\/p>\n\n\n\nWhat you need to know before you are given Visipaque<\/h2>\n\n\n\n
Do not use Visipaque<\/h2>\n\n\n\n
Warnings and precautions<\/h2>\n\n\n\n
Other medicines and Visipaque<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
Driving ability and use of machinery<\/h2>\n\n\n\n
<\/p>\n\n\n\nHow Visipaque is used<\/h2>\n\n\n\n
If you receive too many Visipaque<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
How to store Visipaque<\/h2>\n\n\n\n
<\/a><\/p>\n\n\n\nContents of the packaging and other information<\/h2>\n\n\n\n
Contents declaration<\/h2>\n\n\n\n
Appearance and package sizes of the medicine<\/h2>\n\n\n\n