Highlights of prescribing information concurrent or recent. Kits of five vials of a and five vials of b are no longer available. This binding is independent of concentration and is not affected by the presence of phenytoin, doxorubicin, methotrexate, prednisone, prednisolone, heparin, or aspirin. Nasonex nasal spray 50 mcg is indicated for the treatment of nasal polyps in patients 18years of age and older. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for valtrex valacyclovir. Onsolis fentanyl buccal soluble film rationale for. Dec 17, 2018 mesnex mesna is a detoxifying agent to inhibit the hemorrhagic cystitis induced by ifosfamide. Highlights of prescribing information these highlights do not include all the information needed to use otrexup safely and effectively. Imitrex is not indicated for the prevention of migraine attacks. Prior to initial use of nasonex nasal spray, 50 mcg, the pump must be primed by actuating ten times or until a fine spray appears. Enhertu famtrastuzumab deruxtecannxki for injection, for intravenous use. Highlights of prescribing information these highlights do not include all theinformation needed to use xgevasafely and effectively.
September 2012 rabies immune globulin human hyper rab sd solven tdetergent treated description rabies immune globulin human hyper rab sd treated with solventdetergent is a colorless to pale yellow or pink sterile. Information for healthcare professionals on nitrostat nitroglycerin sublingual tablets, usp. These highlights do not include all the information needed to use. Xgevadenosumab injection, for subcutaneous use initial usapproval. Mesnex injection is given as intravenous bolus injections in a dosage equal to 20% of the ifosfamide dosage weight by weight ww at the time of ifosfamide administration and 4 and 8 hours after each dose of ifosfamide.
Apr 01, 2012 boxed warnings listed in the canadian package monograph for sativex include the possibility of adverse cardiovascular effects, mental function changes dizziness, changes in memory and perception, and drug dependence, as well as a warning to use cautiously in patients with a history of seizures. Sulfamethoxazole and trimethoprim oral suspension, usp is supplied in a purple grapeflavored suspension and in a pink cherryflavored suspension containing 200 mg sulfamethoxazole and 40 mg trimethoprim per 5 ml teaspoonful both packaged in 1 pint 473 ml bottles. The grapeflavored suspension is also available in 20 ml unit dose. Vial a contains bicisate dihydrochloride and a reducing agent vial a protect from light vial b contains a buffer solution. The most common laboratory abnormalities incidence. The active ingredient, mesna, is a synthetic sulfhydryl compound designated as sodium2mercaptoethane sulfonate with a molecular formula of c 2 h 5 nao 3 s 2 and a molecular weight of 164. It is supplied as a nonpyrogenic, sterile lyophilized powder for intravenous, intracavitary or intravesical administration, containing 15 mg and 30 mg of thiotepa. Thiotepa is a synthetic product with antitumor activity. For intravenous induction of anesthesia prior to the use of other general anesthetic agents 2.
Imovax rabies vaccine is approved for use in all age groups. Otrexup methotrexate injection, solution antares pharma, inc. Safety and effectiveness of imitrex tablets have not been established for cluster headache. Pba occurs secondary to a variety of otherwise unrelated neurologic conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing andor crying. Cipro package insert 720 the fda added a warning regarding the possibility of severe permanent nerve damage in 20 here is. Didrex benzphetamine hydrochloride this product information is intended only for residents of the united states.
Remove protective covering from the other end of the doubleended needle, taking care not to touch the exposed end. Vumerity diroximel fumarate delayedrelease capsules, for oral use. Rabies vaccine rx only imovax rabies rabies is transmitted by. Package insert thiotepa for injection, usp description thiotepa for injection is an ethyleniminetype compound. Highlights of prescribing information for intravenous. Highlights of prescribing information coadministration with. Tepezza teprotumumabtrbw for injection, for intravenous use. Sirturo is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in the treatment of adult and pediatric patients 12 to less than 18. Brevital sodium methohexital sodium injection, powder. Treat certain adults with severe, active rheumatoid arthritis, and children with active polyarticular juvenile idiopathic arthritis pjia, after treatment with other medicines including nonsteroidal antiinflammatory nsaids have. The imitrex package insert indicates that 34% of patients taking may experience a stiff neck as a side effect, and indeed when i saw my internist the next day, he had called glaxcowelcome the manufacturer of imitrex and found out it was a possible side effect.
Otrexup is a singledose autoinjector containing a prescription medicine, methotrexate. Cipro package insert 720 the fda added a warning regarding the possibility of severe permanent nerve damage in 20 here is the page with their warning. Invert diluent vial over the concentrate vial, then insert free end of the needle through the concentrate vial stopper. Rationale of treatment physicians must evaluate each possible rabies exposure. Jul 24, 2019 brevital can be used in adults as follows. Imipramine pamoate may enhance the cns depressant effects of alcohol. Saxenda liraglutide injection, for subcutaneous use. Medication package size quantity limit axert almotriptan tablets 6 tablets 6. Onsolis has one indication, the management of breakthrough cancer pain in patients with malignancies, who are already receiving, and are tolerant to, opioid therapy for their underlying persistent cancer pain. Zonegran zonisamide package insert page 3 of 23 renal insufficiency. Highlights of prescribing information these highlights do not. Nitrostat is a stabilized sublingual compressed nitroglycerin tablet that contains. Rabies vaccine rx only imovax rabies rabies is transmitted. Dec 01, 2019 mesnex may be given on a fractionated dosing schedule of three bolus intravenous injections as outlined below.
For intravenous induction of anesthesia and as an adjunct to subpotent inhalational anesthetic agents such as nitrous oxide in oxygen for short surgical procedures. Single 300 mg zonisamide doses were administered to three groups of volunteers. Issued 102000 4 novantrone package insert 016609 mitoxantrone is 78% bound to plasma proteins in the observed concentration range of 26455 ngml. Oral tablets medication package size quantity limit. Benefix coagulation factorix recombinant rx only description. Neulasta pegfilgrastiminjection,for subcutaneous use initial u. Highlights of prescribing information neulasta safely and. I have updated this page with the newest cipro package insert. Home otrexup methotrexate injection, for subcutaneous use. Tracleer is a prescription medicine indicated for patients with certain types of pulmonary arterial hypertension pah, who group 1, which is high blood pressure in the vessels of the lungs.
Local or state public health officials should be consulted if questions arise about the need for. The previous text from this page with the package insert from 2009 is below. Highlights of prescribing information these highlights. Since imipramine pamoate may impair the mental andor physical abilities required for the performance of potentially hazardous tasks, such as operating an automobile or machinery, the patient should be cautioned accordingly. Group 1 was a healthy group with a creatinine clearance ranging from 70152 mlmin. Mesnex mesna is a detoxifying agent to inhibit the hemorrhagic cystitis induced by ifosfamide. Imovax rabies is a vaccine indicated for preexposure and postexposure prophylaxis against rabies. Imipramine pamoate capsules drugs lupin pharmaceuticals.
Full prescribing information 1 indications and usage nuedexta is indicated for the treatment of pseudobulbar affect pba. Mesnex fda prescribing information, side effects and uses. Sulfamethoxazole trimethoprim fda label suspension. Tracleer can improve your ability to exercise as measured by 6minute walk test and can slow the worsening of your physical condition and symptoms. Group 2 and group 3 had creatinine clearances ranging from 14. Highlights of prescribing information childpugh class b. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for parnate tranylcypromine. Highlights of prescribing information concurrent or. Prescribing information product monograph mandelamine methenamine mandelate tablets usp 500 mg urinary antibacterial 8250 decarie blvd, suite 110. All reported events are included except those already listed above, events unlikely to be drugrelated, and those too general to be informative. Determine if patients are taking drugs that could slow heart rate or atrioventricular conduction see warnings and. Ervebo ebola zaire vaccine, live suspension for intramuscular injection. Dobutrex pi marketed page 2 of 10 volume and decreased pulmonary artery wedge pressure are consistent with a shift in the ventricular function curve upward and to the left. Information commons 625 old peachtree road suwanee, ga 30024 circulation desk.
Nda 20080s036 package insert page 1 of 24 1 1 prescribing information 2 imitrex 3 sumatriptan succinate 4 injection 5 6 for subcutaneous use only. Highlights of prescribing information these highlights do not include all the information needed to. To administer, remove unit from package just before use. Brevital may be given by infusion or intermittent injection. Supplied in kits of two 2 vials of a and two 2 vials of b. Primitrex df sumatriptan succinate tablets usp 50 mg and 100 mg sumatriptan primitrex sumatriptan succinate injection 6 mg 0. Onsolis fentanyl buccal soluble film rationale for inclusion in pa program.
492 222 698 1056 635 684 635 242 178 41 40 532 623 1657 93 1205 1002 425 23 728 1443 509 459 538 59 724 1042 714 222 71 930 1403 1035 1471 241