মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

teva parenteral medicines, inc. - mesna (unii: nr7o1405q9) (2-mercaptoethanesulfonic acid - unii:vhd28s0h7f) - mesna 100 mg in 1 ml - mesna injection is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. limitation of use: mesna injection is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia. mesna is contraindicated in patients known to be hypersensitive to mesna or to any of the excipients [see warnings and precautions (5.1)]. risk summary mesna is used in combination with ifosfamide or other cytotoxic agents. ifosfamide can cause fetal harm when administered to a pregnant woman. refer to the ifosfamide prescribing information for more information on use during pregnancy. mesna injection contains the preservative benzyl alcohol. because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is unlikely [see warnings and precautions (5.3) and use in specific populations (8.4)]. the estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. all

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

teva parenteral medicines, inc. - epoprostenol sodium (unii: 4k04iq1of4) (epoprostenol - unii:dcr9z582x0) - epoprostenol 0.5 mg - epoprostenol sodium for injection is indicated for the treatment of pulmonary arterial hypertension (pah) (who group i) to improve exercise capacity. trials establishing effectiveness included predominantly (97%) patients with new york heart association (nyha) functional class iii-iv symptoms and etiologies of idiopathic or heritable pah (49%) or pah associated with connective tissue diseases (51%). epoprostenol is contraindicated in patients with heart failure caused by reduced left ventricular ejection fraction [see clinical studies ( 14.3)] . epoprostenol is contraindicated in patients with a hypersensitivity to the drug or any of its ingredients. risk summary limited published data from case series and case reports have not established an association with epoprostenol and major birth defects, miscarriage or adverse maternal or fetal outcomes when epoprostenol is used during pregnancy. there are risks to the mother and fetus from untreated pulmonary arterial hypertension (see clinical considerations) . in

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

teva parenteral medicines, inc. - ifosfamide (unii: um20qqm95y) (ifosfamide - unii:um20qqm95y) - ifosfamide 1 g in 20 ml - ifosfamide injection is indicated for use in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. it should be used in combination with mesna for prophylaxis of hemorrhagic cystitis. ifosfamide is contraindicated in patients with: - known hypersensitivity to administration of ifosfamide. - urinary outflow obstruction. ifosfamide can cause fetal harm when administered to a pregnant woman. fetal growth retardation and neonatal anemia have been reported following exposure to ifosfamide-containing chemotherapy regimens during pregnancy. animal studies indicate that ifosfamide is capable of causing gene mutations and chromosomal damage in vivo . in pregnant mice, resorptions increased and anomalies were present at day 19 after a 30 mg/m2 dose of ifosfamide was administered on day 11 of gestation. embryo-lethal effects were observed in rats following the administration of 54 mg/m2 doses of ifosfamide from the 6th through the 15th day of gestatio

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

teva parenteral medicines, inc. - hydromorphone hydrochloride (unii: l960up2krw) (hydromorphone - unii:q812464r06) - hydromorphone hydrochloride 10 mg in 1 ml - hydromorphone hydrochloride injection [high potency formulation (hpf)] is indicated for use in opioid-tolerant patients who require higher doses of opioids for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. patients considered opioid tolerant are those who are taking for one week or longer, around-the-clock medicine consisting of at least 60 mg oral morphine per day, or at least 25 mcg transdermal fentanyl per hour, or at least 30 mg oral oxycodone per day, or at least 8 g oral hydromorphone per day, or at least 25 mg oral oxymorphone per day, or at least 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid for one week or longer. patients must remain on around-the-clock opioids while administering hydromorphone hydrochloride injection [high potency formulation (hpf)]. limitations of use: because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see warnings and precautions (5.2)] , reserve hydromorphone hydrochloride injection [high potency formulation (hpf)] for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): hydromorphone hydrochloride injection [high potency formulation (hpf)] should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. hydromorphone hydrochloride injection [high potency formulation (hpf)] is contraindicated in patients with: hydromorphone hydrochloride injection [high potency formulation (hpf)] is contraindicated in patients who are not opioid tolerant [see warnings and precautions (5.1)] . risk summary use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see warnings and precautions (5.5) ] . there are no available data with hydromorphone hydrochloride injection in pregnant women to inform a drug-associated risk for major birth defects and miscarriage or adverse maternal outcomes. there are adverse outcomes reported with fetal exposure to opioid analgesics (see clinical considerations) . in animal reproduction studies, reduced postnatal survival of pups, and decreased body weight were noted following oral treatment of pregnant rats with hydromorphone during gestation and through lactation at doses 0.8 times the human daily dose of 24 mg/day (hdd), respectively. in published studies, neural tube defects were noted following subcutaneous injection of hydromorphone to pregnant hamsters at doses 6.4 times the hdd and soft tissue and skeletal abnormalities were noted following subcutaneous continuous infusion of 3 times the hdd to pregnant mice. no malformations were noted at 4 or 40.5 times the hdd in pregnant rats or rabbits, respectively [see data ]. based on animal data, advise pregnant women of the potential risk to a fetus. the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations fetal/neonatal adverse reactions use of opioid analgesics for an extended period of time during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight. the onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see warnings and precautions (5.5) ] . labor or delivery opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. an opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. hydromorphone hydrochloride injection [high potency formulation (hpf)] is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. opioid analgesics, including hydromorphone hydrochloride injection [high potency formulation (hpf)], can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. however, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. data animal data pregnant rats were treated with hydromorphone hydrochloride from gestation day 6 to 17 via oral gavage doses of 1, 5, or 10 mg/kg/day (0.4, 2, or 4 times the hdd of 24 mg based on body surface area, respectively). maternal toxicity was noted in all treatment groups (reduced food consumption and body weights in the two highest dose groups). there was no evidence of malformations or embryotoxicity reported. pregnant rabbits were treated with hydromorphone hydrochloride from gestation day 7 to 19 via oral gavage doses of 10, 25, or 50 mg/kg/day (8.1, 20.3, or 40.5 times the hdd of 24 mg based on body surface area, respectively). maternal toxicity was noted in the two highest dose groups (reduced food consumption and body weights). there was no evidence of malformations or embryotoxicity reported. in a published study, neural tube defects (exencephaly and cranioschisis) were noted following subcutaneous administration of hydromorphone hydrochloride (19 to 258 mg/kg) on gestation day 8 to pregnant hamsters (6.4 to 87.2 times the hdd of 24 mg/day based on body surface area). the findings cannot be clearly attributed to maternal toxicity. no neural tube defects were noted at 14 mg/kg (4.7 times the human daily dose of 24 mg/day). in a published study, cf-1 mice were treated subcutaneously with continuous infusion of 7.5, 15, or 30 mg/kg/day hydromorphone hydrochloride (1.5, 3, or 6.1 times the human daily dose of 24 mg based on body surface area) via implanted osmotic pumps during organogenesis (gestation days 7 to 10). soft tissue malformations (cryptorchidism, cleft palate, malformed ventricles and retina), and skeletal variations (split supraoccipital, checkerboard and split sternebrae, delayed ossification of the paws and ectopic ossification sites) were observed at doses 3 times the human dose of 24 mg/day based on body surface area. the findings cannot be clearly attributed to maternal toxicity. increased pup mortality and decreased pup body weights were noted at 0.8 and 2 times the human daily dose of 24 mg in a study in which pregnant rats were treated with hydromorphone hydrochloride from gestation day 7 to lactation day 20 via oral gavage doses of 0, 0.5, 2, or 5 mg/kg/day (0.2, 0.8, or 2 times the hdd of 24 mg based on body surface area, respectively). maternal toxicity (decreased food consumption and body weight gain) was also noted at the two highest doses tested. risk summary low levels of opioid analgesics have been detected in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for hydromorphone hydrochloride injection [high potency formulation (hpf)] and any potential adverse effects on the breastfed infant from hydromorphone hydrochloride injection [high potency formulation (hpf)] or from the underlying maternal condition. clinical considerations monitor infants exposed to hydromorphone hydrochloride injection [high potency formulation (hpf)] through breast milk for excess sedation and respiratory depression. withdrawal symptoms can occur in breastfed infants when maternal administration of hydromorphone is stopped, or when breast-feeding is stopped. infertility use of opioids for an extended period of time may cause reduced fertility in females and males of reproductive potential. it is not known whether these effects on fertility are reversible [see adverse reactions (6), clinical pharmacology (12.2), nonclinical toxicology (13.1)] . the safety and effectiveness of hydromorphone hydrochloride injection [high potency formulation (hpf)] in pediatric patients has not been established. elderly patients (aged 65 years or older) may have increased sensitivity to hydromorphone. in general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. titrate the dosage of hydromorphone hydrochloride injection [high potency formulation (hpf)] slowly in geriatric patients and monitor closely for signs of central nervous system and respiratory depression [see warnings and precautions (5.7) ] . hydromorphone is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. the pharmacokinetics of hydromorphone are affected by hepatic impairment. due to increased exposure of hydromorphone, patients with moderate hepatic impairment should be started at one-fourth to one-half the recommended starting dose depending on the degree of hepatic dysfunction and closely monitored during dose titration. the pharmacokinetics of hydromorphone in patients with severe hepatic impairment has not been studied. a further increase in cmax and auc of hydromorphone in this group is expected and should be taken into consideration when selecting a starting dose [see clinical pharmacology (12.3)] . the pharmacokinetics of hydromorphone are affected by renal impairment. start patients with renal impairment on one-fourth to one-half the usual starting dose depending on the degree of impairment. patients with renal impairment should be closely monitored during dose titration [see clinical pharmacology (12.3)] . hydromorphone hydrochloride injection [high potency formulation (hpf)] contains hydromorphone, which is a schedule ii controlled substance. hydromorphone hydrochloride injection [high potency formulation (hpf)] contains hydromorphone hydrochloride, a substance with high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction [see warnings and precautions (5.2)] . misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. misuse and abuse of hydromorphone hydrochloride injection [high potency formulation (hpf)] increases risk of overdose, which may lead to central nervous system and respiratory depression, hypotension, seizures, and death. the risk is increased with concurrent abuse of hydromorphone hydrochloride injection [high potency formulation (hpf)] with alcohol and/or other cns depressants. abuse of and addiction to opioids in some individuals may not be accompanied by concurrent tolerance and symptoms of physical dependence. in addition, abuse of opioids can occur in the absence of addiction. all patients treated with opioids require careful and frequent reevaluation for signs of misuse, abuse, and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. patients at high risk of hydromorphone hydrochloride injection [high potency formulation (hpf)] abuse include those with a history of prolonged use of any opioid, including products containing hydromorphone, those with a history of drug or alcohol abuse, or those who use hydromorphone hydrochloride injection [high potency formulation (hpf)] in combination with other abused drugs. "drug-seeking" behavior is very common in persons with substance use disorders. drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated "loss" of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating healthcare provider(s). "doctor shopping" (visiting multiple prescribers to obtain additional prescriptions) is common among people who abuse drugs and people with substance use disorder. preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with inadequate pain control. hydromorphone hydrochloride injection [high potency formulation (hpf)], like other opioids, can be diverted for nonmedical use into illicit channels of distribution. careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. risks specific to abuse of hydromorphone hydrochloride injection [high potency formulation (hpf)] abuse of hydromorphone hydrochloride injection [high potency formulation (hpf)] poses a risk of overdose and death. the risk is increased with concurrent use of hydromorphone hydrochloride injection [high potency formulation (hpf)] with alcohol and/or other cns depressants. parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and hiv. both tolerance and physical dependence can develop during use of opioid therapy. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). physical dependence is a state that develops as a result of a physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. withdrawal may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). physical dependence may not occur to a clinically significant degree until after several days to weeks of continued use. hydromorphone hydrochloride injection [high potency formulation (hpf)] should not be abruptly discontinued in a physically-dependent patient [see dosage and administration (2.6)] . if hydromorphone hydrochloride injection [high potency formulation (hpf)] is abruptly discontinued in a physically-dependent patient, a withdrawal syndrome may occur, typically characterized by restlessness, lacrimation, rhinorrhea, perspiration, chills, myalgia, and mydriasis. other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. infants born to mothers physically-dependent on opioids will also be physically-dependent and may exhibit respiratory difficulties and withdrawal signs [see use in specific populations (8.1)] .

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

teva parenteral medicines, inc. - octreotide acetate (unii: 75r0u2568i) (octreotide - unii:rwm8ccw8gp) - octreotide 50 ug in 1 ml - octreotide acetate injection is indicated to reduce blood levels of growth hormone (gh) and insulin growth factor-1 (igf-1; somatomedin c) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. the goal is to achieve normalization of gh and igf-1 (somatomedin c) levels (see dosage and administration ). in patients with acromegaly, octreotide acetate injection reduces gh to within normal ranges in 50% of patients and reduces igf-1 (somatomedin c) to within normal ranges in 50% to 60% of patients. since the effects of pituitary irradiation may not become maximal for several years, adjunctive therapy with octreotide acetate injection to reduce blood levels of gh and igf-1 (somatomedin c) offers potential benefit before the effects of irradiation are manifested.  improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trials

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teva parenteral medicines, inc. - topotecan hydrochloride (unii: 956s425zcy) (topotecan - unii:7m7ykx2n15) - topotecan injection, as a single agent, is indicated for the treatment of patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy. topotecan injection, as a single agent, is indicated for the treatment of patients with small cell lung cancer (sclc) with platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy. topotecan injection, in combination with cisplatin, is indicated for the treatment of patients with stage iv-b, recurrent, or persistent cervical cancer not amenable to curative treatment. topotecan injection is contraindicated in patients who have a history of severe hypersensitivity reactions to topotecan. reactions have included anaphylactoid reactions [see adverse reactions (6.2)]. risk summary based on animal data and its mechanism of action, topotecan injection can cause fetal harm when administered to a pregnant woman. there are no available clinical data on the use of topotecan in pregnancy. to

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

teva parenteral medicines, inc. - norepinephrine bitartrate (unii: ify5pe3zrw) (norepinephrine - unii:x4w3enh1cv) - norepinephrine bitartrate injection is indicated to raise blood pressure in adult patients with severe, acute hypotension. none. risk summary limited published data consisting of a small number of case reports and multiple small trials involving the use of norepinephrine in pregnant women at the time of delivery have not identified an increased risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks to the mother and fetus from hypotension associated with septic shock, myocardial infarction and stroke which are medical emergencies in pregnancy and can be fatal if left untreated (see clinical considerations ). in animal reproduction studies, using high doses of intravenous norepinephrine resulted in lowered maternal placental blood flow. clinical relevance to changes in the human fetus is unknown since the average maintenance dose is ten times lower (see data ). increased fetal reabsorptions were observed in pregnant hamsters after receiving daily injections at approxima

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teva parenteral medicines, inc. - bleomycin sulfate (unii: 7dp3ntv15t) (bleomycin - unii:40s1vhn69b) - bleomycin 15 [usp'u] - bleomycin for injection should be considered a palliative treatment. it has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents: head and neck (including mouth, tongue, tonsil, nasopharynx, oropharynx, sinus, palate, lip, buccal mucosa, gingivae, epiglottis, skin, larynx), penis, cervix, and vulva. the response to bleomycin is poorer in patients with previously irradiated head and neck cancer. hodgkin's disease, non-hodgkin's lymphoma. embryonal cell, choriocarcinoma, and teratocarcinoma. bleomycin for injection has also been shown to be useful in the management of: bleomycin for injection is effective as a sclerosing agent for the treatment of malignant pleural effusion and prevention of recurrent pleural effusions. bleomycin is contraindicated in patients who have demonstrated a hypersensitive or an idiosyncratic reaction to it.

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teva parenteral medicines, inc. - palonosetron hydrochloride (unii: 23310d4i19) (palonosetron - unii:5d06587d6r) - palonosetron 0.25 mg in 5 ml - palonosetron hydrochloride injection is indicated in adults for prevention of: - acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (mec). - acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (hec). - postoperative nausea and vomiting (ponv) for up to 24 hours following surgery. efficacy beyond 24 hours has not been demonstrated. as with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. in patients where nausea and vomiting must be avoided during the postoperative period, palonosetron hydrochloride injection is recommended even where the incidence of postoperative nausea and/or vomiting is low. palonosetron hydrochloride injection is indicated in pediatric patients 1 month to less than 17 years of age for prevention of: - acute nausea and vomiting associated with initial

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

teva parenteral medicines, inc. - romidepsin (unii: cx3t89xqbk) (romidepsin - unii:cx3t89xqbk) - romidepsin injection is indicated for the treatment of cutaneous t-cell lymphoma (ctcl) in adult patients who have received at least one prior systemic therapy. none. risk summary based on its mechanism of action and findings from animal studies, romidepsin injection can cause embryo-fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on romidepsin use in pregnant women to inform a drug associated risk of major birth defects and miscarriage. in an animal reproductive study, romidepsin was embryocidal and caused adverse developmental outcomes including embryo-fetal toxicity and malformations at exposures below those in patients at the recommended dose (see data) . advise pregnant women of the potential risk to a fetus and to avoid becoming pregnant while receiving romidepsin and for at least 1 month after the last dose. the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a backgrou