Ireland - English - HPRA (Health Products Regulatory Authority)

omrix biopharmaceuticals s.a. - human clottable protein human alpha thrombin calcium chloride dihydrate tranexamic acid - solution for sealant

Canada - English - Health Canada

omrix biopharmaceuticals ltd - thrombin (human); fibrinogen (human); calcium chloride - kit - 1200unit; 60.0mg; 6.2mg - thrombin (human) 1200unit; fibrinogen (human) 60.0mg; calcium chloride 6.2mg - hemostatics

Canada - English - Health Canada

omrix biopharmaceuticals ltd - fibrinogen (human); thrombin (human) - solution - 90mg; 1200unit - fibrinogen (human) 90mg; thrombin (human) 1200unit - hemostatics

European Union - English - EMA (European Medicines Agency)

omrix biopharmaceuticals n. v. - human fibrinogen, human thrombin - hemostasis, surgical - antihemorrhagics - evicel is used as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis.evicel is also indicated as suture support for haemostasis in vascular surgery.

United States - English - NLM (National Library of Medicine)

nextwave pharmaceuticals, inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 20 mg - quillichew er is indicated for the treatment of attention deficit hyperactivity disorder (adhd) [see clinical studies (14)] . quillichew er is contraindicated in patients known to be hypersensitive to methylphenidate, or other components of quillichew er. hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other methylphenidate products [see adverse reactions (6.2)] . quillichew er is contraindicated during concomitant treatment with monoamine oxidase inhibitors (maois), and also within 14 days following discontinuation of treatment with a monoamine oxidase inhibitor (maoi), because of the risk of hypertensive crisis [see drug interactions (7.1)]. risk summary there are limited published studies and small case series that report on the use of methylphenidate in pregnant women; however, the data are insufficient to inform any drug-associated risks. there are clinical considerations [see clinical considerations]. no teratogenic effects were obser

United States - English - NLM (National Library of Medicine)

nextwave pharmaceuticals, inc - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - quillichew er is indicated for the treatment of attention deficit hyperactivity disorder (adhd) [see clinical studies ( 14 ) ]. quillichew er is contraindicated in patients known to be hypersensitive to methylphenidate, or other components of quillichew er. hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other methylphenidate products [see adverse reactions ( 6.2 ) ] . quillichew er is contraindicated during concomitant treatment with monoamine oxidase inhibitors (maois), and also within 14 days following discontinuation of treatment with a monoamine oxidase inhibitor (maoi), because of the risk of hypertensive crisis [see drug interactions ( 7.1 ) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for psychostimulants at 1-866-961-2388 o

United States - English - NLM (National Library of Medicine)

nextwave pharmaceuticals, inc - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 300 mg in 60 ml - quillivant xr is indicated for the treatment of attention deficit hyperactivity disorder (adhd) [see clinical studies (14)] . quillivant xr is contraindicated in patients known to be hypersensitive to methylphenidate, or other components of quillivant xr. hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other methylphenidate products [see adverse reactions (6.2)] . quillivant xr is contraindicated during treatment with monoamine oxidase inhibitors (maois), and also within 14 days following discontinuation of treatment with a monoamine oxidase inhibitor (maoi), because of the risk of hypertensive crisis [see drug interactions (7.1)]. risk summary there are limited published studies and small case series that report on the use of methylphenidate in pregnant women; however, the data are insufficient to inform any drug-associated risks. there are clinical considerations [see clinical considerations]. no teratogenic effects were observed in embry