Highlights of prescribing information when cobicistat, a. Zantac and zantac maximum strength nonprescription tablets page 5 of 35 if the administration of ranitidine is considered to be necessary, its use requires that the potential benefits be weighed against possible hazards to the patient and to the fetus. Your doctor may decide that subcutaneous injections can be given at home. Fludara 50mg powder for solution for injection or infusion. Manufacturing cmc label is not available on this site. Package insert thiotepa for injection, usp description thiotepa for injection is an ethyleniminetype compound. Terms of access to pfizer s safety data sheets for its products pfizer develops safety data sheets sdss for our products to help our employer customers occupational health and safety specialists. Precautions section in the package insert and to raise caution by a dear.
Identification of the substancepreparation and the companyundertaking material name. Toxicological information the toxicological effects of this product have not been thoroughly studied. Doxorubicin adriamycin or epirubicin ellence cyclophosphamide cytoxan, neosar altretamine hmm, hexalen carmustine bcnu, bicnu 250mgm 2 cisplatin cddp, platinol, platinolaq 50mgm 2. Unopened vials of zanosar should be stored at refrigeration temperatures 2 to 8c and protected from light preferably stored in carton vial. Altretamine is the generic name for the trade drug name hexalen. One ml of reconstituted solution contains 25 mg fludarabine phosphate. Zanosar 1 g, powder for concentrate for solution for infusion emc.
Emetogenic potential of antineoplastic agents high risk 90% frequency without antiemetics ac combination. Zanosar information, side effects, warnings and recalls. The effect of zetia on cardiovascular morbidity and mortality has not been determined. In some cases, health care professionals may use the trade name hexalen or other names hexamethylmelamine or hmm when referring to the generic drug name altretamine. Doxorubicin consists of a naphthacenequinone nucleus linked through a glycosidic bond at ring atom 7 to an amino sugar, daunosamine. Zanosar sterile powder should be administered intravenously by rapid injection or shortprolonged infusion. Zetia has not been studied in fredrickson type i, iii, iv, and v dyslipidemias.
Package insert in vitro diagnostic medical device the kit has been manufactured according to ec directive 9879ec as an in vitro diagnostic medical device and it has been designed for professional. Zanosar streptozocin should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. This change in the insert requirements was influenced by the approximate. Morphine sulfate er is a pain medicine that slowly releases morphine over an extended period of time. Streptozocin has been reported to prolong the elimination halflife of doxorubicin and.
Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for truvada emtricitabine tenofovir. Hiv1 is the virus that causes acquired immune deficiency syndrome aids. Dose modifications are at the discretion of the treating provider based on package insert and diarrhea severity. Pharmaceuticals and medical devices safety information pmda. Although it has been administered intraarterially, this is not. Exposure to light is a concern with numerous medications due to the potential for photodegradation or other chemical reactions that affect drug stability. Zanosar streptozocin sterile powder prescribing information. The product catalog provides you with a full listing of tevas brand and generic product lines. Mar 18, 2019 fludara 50 mg powder for solution for injection or infusion. This emedtv segment provides an indepth look at this prescription drug, including its effects, possible side effects, dosing information, and more.
Doxorubicin is a cytotoxic anthracycline antibiotic isolated from cultures of streptomyces peucetius var. Highlights of prescribing information these highlights do not. The catalog displays all strengths and sizes along with the description, imprint code, ndc and photo for each product. Many patients treated with zanosar have experienced renal toxicity as evidenced by azotemia, anuria, hypophosphatemia, glycosuria and renal tubular acidosis. Zanosar should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic. Zanosar should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Dailymed zanosar streptozocin powder, for solution. The catalog displays all strengths and sizes along with the description, imprint code, ndc and photo for each. If zarxio is given at home, see the detailed instructions for use within the prescribing information on how to prepare. Tevas generic of zanosar streptozocin sterile powder.
Article 54c requires that all excipients must be declared on the labeling if the medicinal product is an injectable, a topical, or an eye preparation the european guide for the label. The recommended dose is 3 mgm 2 given intravenously, as a single short, intravenous infusion. What zanosar is and what it is used for pharmacotherapeutic group it is a cytotoxic medicine, which means that it inhibits the growth of certain cells. Streptozocin has been reported to prolong the elimination halflife of doxorubicin and may lead to. Every year, thousands of americans are prescribed zanosar by their doctors as part of their treatment for pancreatic cancer.
Zanosar is available as a sterile, pale yellow, freezedried preparation for. Zanosar streptozocin dosing, indications, interactions. The authors make no claims of the accuracy of the information contained herein. Truvada emtricitabine tenofovir fda package insert. Thiotepa is a synthetic product with antitumor activity. Zanosar fda prescribing information, side effects and uses. Zanosar streptozocin sterile powder package insert rx only warning zanosar should be administered under the. It is supplied as a nonpyrogenic, sterile lyophilized powder for intravenous, intracavitary or intravesical administration, containing 15 mg and 30 mg of thiotepa. Zarxio injections can be given by a doctor or nurse under your skin subcutaneous injections or by intravenous iv infusions. Hiv1 is the virus that causes acquired immune deficiency. Fludara 50 mg powder for solution for injection or infusion. In some cases, health care professionals may use the trade name.
The passage of h 2 antagonists through breast milk is documented, with an. Terms of access to pfizer s safety data sheets for its products pfizer develops safety data sheets sdss for our products to help our employer customers occupational health and safety specialists assure workplace safety and comply with applicable laws. Doxorubicin fda prescribing information, side effects and uses. 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. Tomudex summary of product characteristics smpc emc.
A patient need not be hospitalized but should have access to a facility with laboratory and supportive resources sufficient to monitor drug tolerance and to protect and maintain a patient compromised by drug toxicity. Package insert in vitro diagnostic medical device the kit has been manufactured according to ec directive 9879ec as an in vitro diagnostic medical device and it has been designed for professional use in specialized clinical and research laboratories. Hexamethylmelamine and hmm are other names for altretamine. Zanosar is available as a sterile, pale yellow, freezedried preparation for intravenous administration. A case of streptozocin monotherapy for unresectable duodenal. Stable if stored in accordance with information listed on the product insert. Doxorubicin adriamycin or epirubicin ellence cyclophosphamide. Capitals indicate lifethreatening, underlines indicate most frequent. Zanosar streptozocin powder, for solution dailymed. In the near future we will link the name of all these drugs. The dose of raltitrexed is calculated on the basis of the body surface area.
These elevations in transaminases were generally asymptomatic, not associated with cholestasis, and returned to. Drugs which may cause diarrhea in 30% or more of patients include. Chemotherapy with streptozocin stz in combination with 5fu or doxorubicin dox represents a standard of care for patients with metastatic pancreatic neuroendocrine neoplasms. Zanosar streptozocin sterile powder package insert rx only warning zanosar should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Pdf excipient selection in parenteral formulation development. In 2006 the fda established a new set of rules for pharmaceuticals companies to follow when putting together a package insert. Zanosar streptozocin powder, for solution teva parenteral. Your doctor may decide that subcutaneous injections can be given at home by you or your caregiver. Oncology intravenous iv dilution parenteral agents. Although it has been administered intraarterially, this is not recommended pending further evaluation of the possibility that adverse renal effects may be evoked more rapidly by this route of administration. Zanosar reference guide for safe and effective use from the american society of. Zanosar streptozocin powder, for solution teva parenteral medicines, inc.
Zanosar 1 g, powder for concentrate for solution for infusion summary of product characteristics smpc by intrapharm laboratories limited. Each vial of zanosar contains 1 g of the active ingredient streptozocin 2deoxy2 methylnitrosoaminocarbonylamino. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for zebeta bisoprolol. It is supplied as a nonpyrogenic, sterile lyophilized powder for intravenous, intracavitary or.
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