Ascor is supplied as a pharmacy bulk package pbp which is intended for dispensing of single doses to multiple patients in a pharmacy admixture program and is restricted to the preparation of admixtures for infusion. Zoladex is indicated for the management of endometriosis, including pain relief and reducing endometrial lesions, for 6 months of therapy. Prefilled syringe, 1 dose 1 per package ndc 000502 this package not for sale. This supplemental new drug application proposes changes in the format of the pravachol package insert in response to the physicians labeling rule plr. Neulasta pegfilgrastiminjection,for subcutaneous use initial u. Lipitor is a prescription medicine that lowers cholesterol in your blood. Crestor is an hmg coa reductase inhibitor indicated for.
In patients without alternative, viable treatment options, cardiac monitoring is recommended. 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. In patients taking cyclosporine, therapy should be limited to 20 mg of pravastatin sodium once daily see warnings and precautions 5. Vials may be held up to 12 months upon removal from refrigeration to room temperature storage conditions 20c to 25c 68f to 77f. Novolin n fda prescribing information, side effects and uses. Please see important safety information, medication guide, instructions for use, and full prescribing information on this website. See full prescribing information for complete boxed warning. Each pharmacy bulk package contains vancomycin hydrochloride equivalent to 5 grams of vancomycin base. Administer cerenia injectable solution intravenously over 12 minutes or subcutaneously at 1 mgkg 0. Hepatotoxicity has been observed in clinical trials and postmarketing experience. Highlights of prescribing information these highlights do. Nardil should not be used in patients who are hypersensitive to the drug or its ingredients, with pheochromocytoma, congestive heart failure, severe renal impairment or renal disease, a history of liver disease, or abnormal liver function tests.
Coadministration of amiodarone with sovaldi is not recommended. Pba occurs secondary to a variety of otherwise unrelated neurologic conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing andor crying. Each vial contains 10 mg of pentostatin and 50 mg of mannitol, usp. Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Highlights of prescribing information coadministration with. Lovenox between 15 minutes before and 30 minutes after the start of. Strattera is indicated as an integral part of a total treatment program for adhd that may include other measures psychological, educational, social for patients with this syndrome. Highlights of prescribing information warnings and precautions these highlights do not include all the information needed to use skeletal muscle effects e. Tilt the upright vial and insert a syringe with appropriately sized needle into the bottom corner of the vial and remove 4ml of the reconstituted solution. Hemlibra emicizumabkxwh injection, for subcutaneous use. Reduce the risk of mi, stroke, revascularization procedures, and angina in adult patients without chd, but with multiple risk factors. Engerixb is indicated for immunization against infection. It lowers the ldlc bad cholesterol and triglycerides in your blood. The ph of the final product is maintained between 7.
It is a cloudy or milky suspension of human insulin with protamine and zinc. Full prescribing information 1 indications and usage nuedexta is indicated for the treatment of pseudobulbar affect pba. Prescribers are advised to consult the package insert of any medication administered concomitantly with hormonal contraceptives. Highlights of prescribing information these highlights. The incidence of syncopal episodes is approximately 1% in patients. In general, treatment with norvasc was welltolerated at doses up to 10 mg da ily. Sandimmune cyclosporine should be administered with adrenal corticosteroids but not with other immunosuppressive agents. Full prescribing information 1 indications and usage havrix is indicated for active immunization against disease caused by hepatitis a virus hav. If previously receiving 60 mg daily dose, resume treatment at 40 mg daily.
Highlights of prescribing information palmarplantar. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for diflucan fluconazole. Updated january 2015 page 1 package insert template for atorvastatin tablet brand or product name product name tablet 10mg product name tablet 20mg product name tablet 40mg product name tablet 80mg name and strength of active substances. Ninlaro 4 mg capsules contain 4 mg of ixazomib equivalent to 5.
Highlights of prescribing information nss are frequent nss. Highlights of prescribing information childpugh class b. Sustol granisetron extendedrelease injection for hcps. For prevention of vomiting in dogs 4 months of age and older caused by emetogenic medications or chemotherapeutic agents. Engerixb can be given on either dosing schedule 0, 1, and 6 months or 0, 1, 2, and 12 months. Mavyret is indicated for the treatment of adult and pediatric patients 12 years and older or weighing at least 45 kg with hcv genotype 1 infection, who previously have been treated with a regimen containing an hcv ns5a inhibitor or an ns34a protease inhibitor, but not both. If contact lenses are worn, they should be removed prior to the administration of the emulsion.
Zoladex is also approved to thin the lining of the uterus i. Highlights of prescribing information neulasta safely and. Highlights of prescribing information these highlights do not include all the information needed to use esbriet safely and effectively. Hydrea is an antimetabolite indicated for the treatment of. Dec 17, 2018 mesnex mesna is a detoxifying agent to inhibit the hemorrhagic cystitis induced by ifosfamide. Use only in a suitable iso class 5 work area such as a laminar flow hood or an equivalent clean air compounding area. When possible, interrupt therapy with brilinta for fivedays prior to surgery that has a major risk of bleeding. Sandimmune soft gelatin capsules cyclosporine capsules, usp and sandimmune oral solution. Tablets and injectable solution animal safety antiemetic. Sustol is indicated for prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of mec or ac combination chemotherapy. The reconstituted vial contains 20 mgml dalbavancin as a clear, colorless to yellow solution. Harvoni is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis c virus hcv see dosage and administration 2.
Highlights of prescribing information these highlights do not include all the information needed to use sutent safely and effectively. In vivo, nilutamide interacts with the androgen receptor and prevents the normal androgenic response. Aseptically transfer the required dose of reconstituted dalbavancin solution. The usual duration of lovenox therapy is 8 days or until hospital discharge. Lipitor is an hmgcoa reductase inhibitor indicated as an adjunct therapy to diet to. Mesnex fda prescribing information, side effects and uses. Lipitor is for adults and children over 10 whose cholesterol does not come down enough with exercise and a lowfat diet alone. Since grapefruit juice is known to inhibit cyp3amediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of amiodarone, do not drink grapefruit juice during treatment. Page 2 of 21 full prescribing information 1 indications and usage 1. Highlights of prescribing information these highlights do not include all the information needed to use pravachol safely and effectively. Nexavar tablets are round, biconvex, red filmcoated tablets, debossed with the bayer cross on.
Determine if patients are taking drugs that could slow heart rate or atrioventricular conduction see warnings and. Abraxane is indicated for the firstline treatment of locally advanced or metastatic nonsmall cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. Sep 23, 2019 this package contains five 5 novolin n penfill 3 ml cartridges. Sarclisa isatuximabirfc injection, for intravenous use.
Remove protective covering from the other end of the doubleended needle, taking care not to touch the exposed end. Vaprisol has not been shown to be effective for the treatment of. Human secretin is a gastrointestinal peptide hormone produced by cells in the duodenum in response to acidification. Each entericcoated tablet contains pantoprazole sodium sesquihydrate equivalent to 20 mg pantoprazole and is sugar free. Havrix is approved for use in persons 12 months of age and older. Norvasc amlodipine besylate tablets are formulated as white tablets equivalent to 2. Norvasc has been evaluated for safety in more than 11,000 patients in u. Hepatotoxicity see full prescribing information for complete boxed warning. Light orange gelatin capsule imprinted with takeda on the cap and 4 mg on the body in black ink.
Drug treatment is not intended for use in the patient who exhibits symptoms secondary to. Prazoloc 20 entericcoated tablets prazoloc 40 entericcoated tablets composition. Tablets containing sorafenib tosylate 274 mg equivalent to 200 mg of sorafenib. Jakafi is indicated for treatment of intermediate or highrisk myelofibrosis mf, including primary mf, postpolycythemia vera mf and postessential thrombocythemia mf in adults. Vaprisol conivaptan hydrochloride injection, for intravenous use initial u. Vancomycin hydrochloride is an offwhite to tan colored lyophilized powder. It is slightly soluble in water and sparingly soluble in ethanol.
Highlights of prescribing information 3 prs 16 weeks 16. It is approved, effective on the date of this letter, for use as recommended in the enclosed, agreedupon labeling text. Invert diluent vial over the concentrate vial, then insert free end of the needle through the concentrate vial stopper. Dec 14, 2009 contains inactivated ndc codes ndc codes. Vumerity diroximel fumarate delayedrelease capsules, for oral use. Highlights of prescribing information initial dose of. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.
For the 2 x 5 ml syringe package, the contents of both syringes must be injected to receive the 500 mg. Emcyt estramustine phosphate sodium capsules description. In controlled clinical trials directly comparing norvasc n1730. Esbriet pirfenidone capsules and filmcoated tablets, for oral use initial u. Based on efficacy and tolerability, dose may be increased to a maximum of 75 mg once. Hepatotoxicity may be severe, and in some cases fatal. Since grapefruit juice is known to inhibit cyp3amediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of amiodarone, do not drink grapefruit juice during treatment with oral amiodarone see drug interactions 7. Although the pravachol 10 mg tablets are no longer available, pravastatin 10 mg tablets are available. Novolin n is commonly known as nph, human insulin isophane suspension recombinant dna origin.
Dec 01, 2019 mesnex may be given on a fractionated dosing schedule of three bolus intravenous injections as outlined below. Actemra tocilizumab injection, for intravenous or subcutaneous use. It is not known whether other progestinonly contraceptives, such as implants and injectables, are adequate methods of contraception during acitretin therapy. The concentration of this product is 100 units of insulin per milliliter. Nipent pentostatin for injection is supplied as a sterile, apyrogenic, lyophilized powder in singledose vials for intravenous administration. Ferrlecit sodium ferric gluconate complex in sucrose injection, for intravenous use initial u. Reduce the risk of mi and stroke in adult patients with type 2 diabetes without chd, but with multiple risk factors. Primary immunization should be administered at least 2 weeks prior to expected exposure to hav. Nexavar tablets are round, biconvex, red filmcoated tablets, debossed with the bayer cross on one side and 200 on the other side. Yasmin should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed. See cerenia tablets package insert for complete prescribing information. Patients with decreased tear production typically should not wear contact lenses.
Highlights of prescribing information these highlights do not include all the information needed to use ferrlecit safely and effectively. In vitro, nilutamide blocks the effects of testosterone at the androgen receptor level. Emcyt capsules are white and opaque, each containing estramustine phosphate sodium as the disodium salt monohydrate equivalent to 140 mg estramustine phosphate, for oral administration. Neulasta pegfilgrastim injection,for subcutaneous use initial u. Highlights of prescribing information these highlights do not.
Restasis should not be administered while wearing contact lenses. The reconstituted solution must be further diluted in 250ml of 0. When possible, interrupt therapy with brilinta for fivedays prior to. When reconstituted as directed each 10 ml contains 500 mg and each 20 ml contains 1 gram. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended see warnings and precautions 5. Ninlaro ixazomib capsules, for oral use hepatotoxicity. Download the chirhostim human secretin for injection package insert in pdf form chirho stim human secretin for injection description. The recommended tukysa dose reductions and dosage modifications for adverse reactions are provided in. Lenses may be reinserted 15 minutes following administration of restasis ophthalmic emulsion. Most adverse reactions reported during therapy with norvasc were of mild or moderate severity.
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