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In both trials, the proportion of individuals gaining relief at 10 or 15 minutes was significantly greater among patients receiving 6 mg of Sumatriptan Succinate Injection compared with those who received placebo (see An estimate of the cumulative probability of a patient with a cluster headache obtaining relief after being treated with either sumatriptan succinate injection or placebo is presented in Figure 1.The plot was constructed with data from patients who either experienced relief or did not require (request) rescue medication within a period of 2 hours following treatment. Apprise patients of the importance of this follow-up Inform patients that anaphylactic reactions have occurred in patients receiving Sumatriptan Succinate Injection. Therefore, the use of Sumatriptan Succinate Injection in patients receiving MAO-A inhibitors is contraindicated Because their vasospastic effects may be additive, coadministration of Sumatriptan Succinate Injection and other 5‑HTCases of serotonin syndrome have been reported during coadministration of triptans and SSRIs, SNRIs, TCAs, and MAO inhibitors Data from a prospective pregnancy exposure registry and epidemiological studies of pregnant women have not detected an increased frequency of birth defects or a consistent pattern of birth defects among women exposed to sumatriptan compared with the general population In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. It may harm them.This Patient Information leaflet summarizes the most important information about Sumatriptan Succinate. There may be new information. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.Sumatriptan Succinate can cause dizziness, weakness, or drowsiness. Corneal opacities were seen at the lowest dose tested, 2 mg/kg/day, and were present after 1 month of treatment. ��ރh�����m�| �sD�"$�4�D�S���O�����U�Nh�9��. Protect from light.Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).Inform patients that Sumatriptan Succinate Injection may cause serious cardiovascular side effects such as myocardial infarction or stroke. �[�i0aq�x��}#[O˼� Heart problems may lead to death.Stop taking Sumatriptan Succinate and get emergency medical help right away if you have any of the following symptoms of a heart attack:Before taking Sumatriptan Succinate, tell your healthcare provider about all of your medical conditions, including if you:Tell your healthcare provider about all the medicines you take,What should I avoid while taking Sumatriptan Succinate?What are the possible side effects of Sumatriptan Succinate?Sumatriptan Succinate may cause serious side effects.How should I store Sumatriptan Succinate Injection?Keep Sumatriptan Succinate and all medicines out of the reach of children.General information about the safe and effective use of Sumatriptan SuccinateWhat are the ingredients in Sumatriptan Succinate Injection?Before you use the Sumatriptan Succinate Injection KitImportant Things to Know About Your Sumatriptan Succinate Injection KitDo not load the Pen until you are ready to give yourself an injection.Do not touch the Blue Button on top of the Pen (see Figure A) while you are loading the Pen.is broken or missing when you first open the Carrying Casepress the loaded Pen firmly against the skin so that the grey part of the barrel slides against the blue part until it cannot be pressed any further. }�T� � _rels/.rels �(� ��MN�0��H���}� �P�nRw�L�ib��v!�=�EC�U��=���͛�f0={����E ��tJ�F�k���Z���$�H6�����zL�Ql��,��(�M�?peKc�`������ %T��Kh�C&Ig/���P��|��������^��{-��Ƀ!��x�4$���z?G��O�)�8���.t;�9���,���WjfgQ�#�)�S�x��|��'KY} �� PK !
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