When using an intravenous infusion pump, administer integrilin undiluted directly from the 100ml vial. Tepezza teprotumumabtrbw for injection, for intravenous use. Dose increase or reduction is recommended based on individual safety and tolerability. In combination with docetaxel, the recommended dose of xeloda is 1250 mgm twice daily for 2 weeks followed by a 7 day rest period, combined with docetaxel at 75 mgm2 as a 1hour iv infusion every 3 weeks 2. Highlights of prescribing information these highlights. If the disease is not metastatic, treatment is commonly given with the goal of cure. Center the spike within the circle on the stopper top. Gemzar vials contain no antimicrobial preservatives and are intended for single use only. Jun 01, 2015 cisplatin injection is a clear, lightyellow, sterile aqueous solution available in amber vials containing 1 mgml of cisplatin. Inlyta may cause fertility problems in males and females, which may affect your ability to have a child.
Docetaxel injection, usp requires no prior dilution with a diluent and is ready to add to the infusion solution. The recommended dose of angiomax is an intravenous iv bolus dose of 0. Daptacel diphtheria and tetanus toxoids and acellular pertussis. Development and use of standardised package inserts 1 purpose the purpose of this document is to define the criteria for developing standardised package inserts spis and for the use of an spi within the regulatory process. The stealth liposome carriers are composed of n carbonyl methoxypolyethylene glycol 20001,2distearoyl sn. Taxotere in combination with cisplatin and fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck scchn. A database developed with information extracted from. To order wgcc products, please contact your wholesaler or call customer service at 18884930861.
Working with pdf documents has never been this easy. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Saxenda liraglutide injection, for subcutaneous use. It is approved, effective on the date of this letter, for use as recommended in the enclosed agreedupon labeling text. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for taxotere docetaxel. 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. 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. Docetaxel fda prescribing information, side effects and uses.
Torisel temsirolimus injection worldwide fact sheet. Youll need to have adobe acrobat or abode reader installed to see or read pdf files. The product catalog provides you with a full listing of tevas brand and generic product lines. Highlights of prescribing information coadministration of. Highlights of prescribing information patients at risk. Integrilin should be given concomitantly with heparin dosed to achieve the following parameters. An instruction booklet for the preparation of drug suspension for injection is. Inlyta axitinib tablets 2ndline mrcc treatment safety.
The catalog displays all strengths and sizes along with the description, imprint code, ndc and photo for each product. Prescribing information hycamtin topotecan hydrochloride for injection for intravenous use warning hycamtin topotecan hydrochloride for injection should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. For the first cycle, the recommended total dose of besponsa for all patients is 1. If weight less than 70kg, 60unitskg bolus followed by infusion of 12unitskgh. Paclitaxel injection, usp is available in 30 mg 5 ml, 100 mg 16. This information is not intended as medical advice. Patients with combined abnormalities of transaminase and alkaline phosphatase should, in general, not be treated with taxotere. Save money on your ifosfamide injection prescription by switching to tevas fdaapproved generic version.
Follow applicable special handling and disposal procedures. Doxil package insert draft 5 alza confidential date revised. Determine if patients are taking drugs that could slow heart rate or atrioventricular conduction see warnings and. Mesnex may be given on a fractionated dosing schedule of three bolus intravenous injections as outlined below. This change in the insert requirements was influenced by the approximate 300,000 mishaps occurring each year relating to misleading information collected from the package inserts by health care providers 25. In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which. Docetaxel clinical pharmacology mechanism of action.
Tell your healthcare provider about all the medicines you take, including prescription and overthecounter medicines, vitamins, and herbal supplements. A comparison is considered statistically significant if the pvalue is sep 23, 2019 paclitaxel injection, usp is a clear, colorless to slightly yellow viscous solution. A comparison is considered statistically significant if the pvalue is prescribing information. Mesnex mesna is a detoxifying agent to inhibit the hemorrhagic cystitis induced by ifosfamide. Abraxane is 125 mgm2 intravenously over 3040 minutes on days 1, 8 and 15 of each 28day cycle. You can resize the object, but you cant edit it after you insert it. Highlights of prescribing information patients at risk of. In 2006 the fda established a new set of rules for pharmaceuticals companies to follow when putting together a package insert. Pdf architect standard is exceptionally userfriendly and is an ideal alternative to. Tell your healthcare provider about all the medicines you take, including prescription and overthecounter medicines, vitamins, and. Administer integrilinby volume according to patient weightsee table1.
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. Infusion reactions and cardiopulmonary arrest 1 indications and usage 1. Highlights of prescribing information posterior reversible. Docetaxel injection this product information is intended only for residents of the united states. For the 2 x 5 ml syringe package, the contents of both syringes must be injected to receive the 500 mg. Angiomax bivalirudin for injection is contraindicated in patients with active major bleeding and hypersensitivity e.
Highlights of prescribing information these highlights do not. Talk to your healthcare provider if this is a concern for you. Add a pdf to your office file office support microsoft office support. Etopophos etoposide phosphate for injection is an antineoplastic agent which is available for intravenous infusion as a sterile lyophile in singledose vials containing etoposide phosphate equivalent to 100 mg etoposide, 32. An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic. Neutropenia do not administer abraxane therapy to patients who have baseline neutrophil counts of less than 1,500 cellsmm3. Tarceva is not recommended for use in combination with platinumbased chemotherapy see clinical studies 14. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for adrucil fluorouracil. Dose modifications for vectibix concerning dermatologic toxicity are provided see dosage and administration 2. Pdfarchitect insert module insert pages hyperlinks pdf page. Following 3 hour infusions of 175 mg m2, mean terminal half life was estimated to be 9. Dosage adjustment is recommended for these patients see dosage and administration. Ferrlecit sodium ferric gluconate complex in sucrose injection, for intravenous use initial u. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are.
Withhold abraxane for grade 34 peripheral neuropathy. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available. Toxic deaths, hepatotoxicity, neutropenia, hypersensitivity reactions, and fluid retention 1 indications and usage 1. Monitor hepatic function at baseline and prior to each dose. The recommended dose of jevtana is based on calculation of the body surface area bsa, and is 20 mgm. Target aptt 50 to 70seconds if weight greaterthan or equal to 70kg, 5000unitbolus followed by infusion of unitsh. The information in this site is intended to provide balanced, scientific and evidencebased answers to unsolicited medical questions. The recommended dose of angiomax is an intravenous iv bolus dose of. How to add and organize pages in a pdf adobe acrobat dc. Click select to convert the file into pdf format and insert it into the document. Highlights of prescribing information these highlights do not include all the information needed to use ferrlecit safely and effectively. Plasma clearance in patients with hepatic impairment serum bilirubin levels between 1. Get emergency help right away if you get symptoms such as chest pain, shortness of breath, racing heartbeat, swelling in lower legs, feet and abdomen, feel lightheaded or faint, tiredness, nausea, vomiting, or sweat a lot. For full prescribing information including indications, contraindications, warnings, precautions and adverse events, please see the appropriate package insert.
Taxotere docetaxel injection concentrate warning taxotere docetaxel injection concentrate should be administered under the supervision of a qualified physician experienced in the use of antineoplastic agents. Resume abraxane and carboplatin at reduced doses see table 2 when peripheral neuropathy improves to grade 1 or completely resolves see warnings and precautions 5. Risk of hepatotoxicity, liver failure and death has occurred. Angiomax is intended for use with aspirin 300325 mg daily and has been studied only in patients receiving concomitant aspirin. These highlights do not include all the information needed to use. Docetaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions. It is a bittertasting white powder consisting of crystalline and amorphous particles freely soluble in methanol, acetone and acetic acid and practically insoluble in water. Cycle 1 is 3 weeks in duration, but may be extended to 4 weeks if the patient achieves a complete remission cr or complete remission with. The mechanism of action of doxorubicin hcl is thought to be related to its ability to bind dna and inhibit nucleic acid synthesis. Docetaxel injection in combination with cisplatin and fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck scchn. Hemlibra emicizumabkxwh injection, for subcutaneous use.
Refer to the full prescribing information of coadministeredpalbociclib, abemaciclib, or ribociclib for dose modification guidelines in the event of toxicities, for use with concomitant medications, and other relevant safety information. Doxil package insert draft 4 alza confidential date revised. Xeloda tablets should be swallowed whole with water within 30 minutes after a meal. Sandostatin lar depot is available in singleuse kits for injectable suspension containing a 6ml vial of 10 mg, 20 mg, or 30 mg strength, a syringe containing 2 ml of diluent, one vial adapter, and one sterile 1. If the disease is metastatic, treatment is not commonly given with the goal of cure.
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