Breast-feeding<\/em><\/p>\n\n\n\nIf you are breast-feeding or planning to breast-feed, talk to your doctor before using this medicine. Discuss with your doctor if you should continue breast-feeding or if you should stop breastfeeding for a period of 24 hours after receiving Clariscan.
<\/p>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
There is no information on the effects of Clariscan on the ability to drive. Take into account any side effects such as dizziness (symptoms of low blood pressure ) and nausea when driving or using machines. If you feel unwell after the examination, do not drive or use machines.
<\/p>\n\n\n\n
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or side effects.<\/p>\n\n\n\n
Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
<\/p>\n\n\n\n
3. How Clariscan is given<\/h2>\n\n\n\n
How to use Clariscan<\/strong><\/p>\n\n\n\nClariscan is given to you via intravenous injection.<\/p>\n\n\n\n
The procedure is performed in a hospital, clinic, or private practice.<\/p>\n\n\n\n
The staff knows what precautions must be taken during the examination.<\/p>\n\n\n\n
They also know what possible complications can occur.
<\/p>\n\n\n\n
During the examination, you will be monitored by a doctor.<\/p>\n\n\n\n
- A needle is left in your vein.<\/li>
- In this way, the doctor can inject suitable emergency medicines if needed.
<\/li><\/ul>\n\n\n\nIf you get an allergic reaction, the administration of Clariscan is stopped.
<\/p>\n\n\n\n
How much medicine will you get?<\/strong><\/p>\n\n\n\nThe doctor decides what dose to take and monitors the injection.
<\/p>\n\n\n\n
Patients with liver or kidney problems<\/strong><\/p>\n\n\n\nClariscan is not recommended for use in patients with severe kidney problems and patients who have recently had, or are expected to undergo, a liver transplant.
<\/p>\n\n\n\n
If your doctor still thinks you should get Clariscan:<\/p>\n\n\n\n
- You should only receive one dose of Clariscan during an MRI scan<\/li>
- and you should not receive any more injection in at least 7 days.<\/li><\/ul>\n\n\n\n
Use for newborns, infants, children, and adolescents<\/h2>\n\n\n\n
Clariscan should only be given to these patients after careful consideration by your doctor.<\/p>\n\n\n\n
If your doctor thinks your child should get Clariscan:<\/p>\n\n\n\n
\u2022 the child should only receive one dose of Clariscan, during an MRI scan<\/p>\n\n\n\n
\u2022 and the child should not receive another injection for at least 7 days.
<\/p>\n\n\n\n
Use of full-body MRI is not recommended for children under 6 months.<\/p>\n\n\n\n
Use for angiography is not recommended for children under 18 years of age.
<\/p>\n\n\n\n
Older<\/strong><\/p>\n\n\n\nIt is not necessary to adjust the dose if you are 65 years or older, but you will have to take a blood sample to examine how well your kidneys are working.
<\/p>\n\n\n\n
If you take more Clariscan than you should<\/h2>\n\n\n\n
It is very unlikely that you would get an overdose because you are being given Clariscan in a medical setting by a trained person.<\/p>\n\n\n\n
If you really get an overdose, Clariscan can be removed from your body by hemodialysis (blood purification).<\/p>\n\n\n\n
There is more information on use and handling for healthcare professionals at the end of this leaflet.<\/p>\n\n\n\n
If you have any further questions on the use of this product, ask your doctor.
<\/p>\n\n\n\n
4. Possible side effects<\/h2>\n\n\n\n
Like all medicines, this medicine can cause side effects, although not everybody gets them.
<\/p>\n\n\n\n
After receiving the medicine,<\/strong> you will be monitored for at least half an hour. Most side effects occur immediately, but sometimes side effects can be delayed. Some effects may occur up to seven days after Clariscan injection.
<\/p>\n\n\n\nThere is a small risk that you may have an allergic reaction to Clariscan. <\/strong>Such reactions can be severe and in rare cases lead to shock<\/strong> (a very rare type of allergic reaction that can be life-threatening). The following symptoms may be the first signs of shock.<\/strong><\/p>\n\n\n\nTell your doctor or healthcare professional immediately if you experience any of the following symptoms<\/strong> – you may need urgent medical attention:<\/p>\n\n\n\n\u2022 swelling of the face, mouth, or throat which may make it difficult to swallow or breathe<\/p>\n\n\n\n
\u2022 swelling of the hands or feet<\/p>\n\n\n\n
\u2022 low blood pressure (feeling faint)<\/p>\n\n\n\n
\u2022 breathing difficulties including whistling\/wheezing<\/p>\n\n\n\n
\u2022 cough<\/p>\n\n\n\n
\u2022 itching<\/p>\n\n\n\n
\u2022 Runny nose<\/p>\n\n\n\n
\u2022 sneezing or eye irritation<\/p>\n\n\n\n
\u2022 red rash, severe itching ( hives )
<\/p>\n\n\n\n
Other side effects are<\/strong><\/p>\n\n\n\nTalk to your doctor if you experience any of the following side effects:
<\/p>\n\n\n\n
Very common (may affect more than 1 user in 10)<\/strong><\/p>\n\n\n\n- headache<\/li>
- stinging sensation<\/li><\/ul>\n\n\n\n
Common (may affect up to 1 in 10 people)<\/strong><\/p>\n\n\n\n- the feeling of heat or cold and\/or pain at the injection site<\/li>
- nausea, vomiting<\/li>
- redness, itching, and rash
<\/li><\/ul>\n\n\n\nUncommon (may affect up to 1 in 100 people)<\/strong><\/p>\n\n\n\n- allergic reactions<\/li><\/ul>\n\n\n\n
Rare (may affect up to 1 in 1,000 people)<\/strong><\/p>\n\n\n\n- unusual taste in the mouth<\/li>
- hives (red spots on the skin, severe itching )<\/li>
- increased sweating<\/li><\/ul>\n\n\n\n
Very rare (may affect up to 1 in 10,000 people)<\/strong><\/p>\n\n\n\n- worry or anxiety<\/li>
- coma , seizures, syncope (short-term loss of consciousness), weakness (dizziness and feeling that you are fainting), dizziness, odor disturbance (you often feel unpleasant odors), tremors<\/li>
- eye inflammation, red eyes, blurred vision, increased tear secretion, swollen eyes<\/li>
- cardiac arrest, faster or slower heartbeat, irregular heartbeat, palpitations, low or high blood pressure , dilation or relaxation of blood vessels (vasodilation) which can cause low blood pressure and slower heartbeat, pallor<\/li>
- sudden cessation of breathing (respiratory arrest), fluid in the lungs ( pulmonary edema ), difficulty breathing, feeling of tightness in the throat, wheezing, stuffy nose, sneezing, coughing, dryness in the throat<\/li>
- diarrhea, abdominal pain, increased salivation<\/li>
- eczema, other skin reactions (eg red rash)<\/li>
- muscle contractions, muscle weakness, back pain<\/li>
- feeling tired (general malaise or fatigue)<\/li>
- chest pain or discomfort in the chest<\/li>
- fever or chills<\/li>
- swelling of the face<\/li>
- swelling, reaction or discomfort at the injection site, redness and pain, leakage of the drug outside the blood vessels at the injection site may lead to inflammation tissue death of the skin, inflammation of a vein caused by a blood clot (superficial phlebitis )<\/li>
- decreased oxygen content in the blood<\/li><\/ul>\n\n\n\n
Has been reported (occurs in an unknown number of users)<\/strong><\/p>\n\n\n\nNitrogen systemic fibrosis
<\/p>\n\n\n\n
This is a disease that causes the skin to thicken and harden and can also affect soft parts and internal organs. This has most commonly occurred in patients receiving Clariscan with other contrast agents containing gadolinium.<\/p>\n\n\n\n
Tell your doctor if you notice any changes in the color or thickness of your skin on any part of your body as this may be a sign of the condition listed above.<\/p>\n\n\n\n
The following side effects have occurred with the use of similar contrast agents in MRI:<\/p>\n\n\n\n
destruction of your red blood cells ( hemolysis ), confusion, temporary blindness, eye pain, ringing in the ears ( tinnitus ), earache, asthma, dry mouth, bladder-like eczema of the skin, inability to control urine ( incontinence ), kidney damage, acute renal failure, changes in electrocardiography ( ECG ) measurements of your heart, changes in blood tests (increase in iron in the blood, increased bilirubin ), abnormal liver tests.
<\/p>\n\n\n\n
Reporting of side effects<\/em><\/p>\n\n\n\nIf you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. <\/p>\n\n\n\n
5. How to store Clariscan<\/h2>\n\n\n\n
Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n
Vials (s): No special precautions for storage.<\/p>\n\n\n\n
Pre-filled syringes: Do not freeze.<\/p>\n\n\n\n
Do not use this medicine after the expiry date which is stated on the vial, vial, or pre-filled syringe and on the carton after \u201cEXP\u201d. The expiration date is the last day of the specified month.<\/p>\n\n\n\n
Chemical and physical in-use stability has been demonstrated for 48 hours at room temperature. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 – 8 \u00b0 C, unless handled under controlled and validated aseptic conditions.
<\/p>\n\n\n\n
6. Contents of the packaging and other information<\/h2>\n\n\n\nContent declaration<\/h2>\n\n\n\n
Content declaration<\/strong><\/p>\n\n\n\n– The active substance is gadoteric acid. One milliliter of solution for injectioncontains 279.32 mg of gadoteric acid (as meglumine salt), equivalent to 0.5 mmol of gadoteric acid.<\/p>\n\n\n\n
– The other ingredients are meglumine, tetraxetane (DOTA) and water for injections. <\/p>\n\n\n\n
What the medicine looks like and the contents of the pack<\/h2>\n\n\n\n
Clariscan is a clear, colorless to pale yellow solution for intravenous injection.
<\/p>\n\n\n\n
Clariscan is available in the following pack sizes:<\/p>\n\n\n\n
Glass vials (type 1, clear), filled with 5, 10, 15, and 20 ml.<\/p>\n\n\n\n
Pre-filled syringes filled with 10, 15, and 20 ml.<\/p>\n\n\n\n
Glass bottles (type 1, transparent) and plastic bottles, filled with 50 and 100 ml.
<\/p>\n\n\n\n
All packaging types are available in one-pack or in 10-pack.<\/p>\n\n\n\n
Not all pack sizes may be marketed.<\/p>\n\n\n\n
Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n
GE Healthcare AS<\/p>\n\n\n\n
Nycoveien 1-2<\/p>\n\n\n\n
PO Box 4220 Nydalen<\/p>\n\n\n\n
NO-0401 OSLO<\/p>\n\n\n\n
Norway
<\/p>\n\n\n\n
Local representative: <\/p>\n\n\n\n
GE Healthcare AB<\/p>\n\n\n\n
Box 90<\/p>\n\n\n\n
182 11 Danderyd<\/p>\n\n\n\n
<\/p>\n","protected":false},"excerpt":{"rendered":"
Clariscan contains the active substance gadoteric acid. It belongs to a group of medicines called “contrast agents” for magnetic resonance imaging (MRI).<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"cybocfi_hide_featured_image":"","footnotes":""},"categories":[2203,2200],"tags":[7064,7067,7066,5226,5229,5228,2215,2212,7065],"class_list":["post-6843","post","type-post","status-publish","format-standard","hentry","category-c","category-medicines","tag-clariscan","tag-clariscan-injection","tag-clariscan-side-effects","tag-gadoteric-acid","tag-gadoteric-acid-injection","tag-gadoteric-acid-side-effects","tag-injection","tag-medicine","tag-what-is-clariscan"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/6843","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/comments?post=6843"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/6843\/revisions"}],"predecessor-version":[{"id":11394,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/6843\/revisions\/11394"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=6843"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=6843"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=6843"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}