Tanzania - English - Tanzania Medicinces & Medical Devices Authority

gland pharma limited, india - heparin sodium - solution for injection - 5000

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gland pharma limited - phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - phenylephrine hydrochloride injection, 10 mg/ml, is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. none risk summary data from randomized controlled trials and meta-analyses with phenylephrine hydrochloride injection use in pregnant women during cesarean section have not established a drug-associated risk of major birth defects and miscarriage. these studies have not identified an adverse effect on maternal outcomes or infant apgar scores [see data] . there are no data on the use of phenylephrine during the first or second trimester. in animal reproduction and development studies in normotensive animals, evidence of fetal malformations was noted when phenylephrine was administered during organogenesis via a 1-hour infusion at 1.2 times the human daily dose (hdd) of 10 mg/60 kg/day. decreased pup weights were noted in offspring of pregnant rats treated with 2.9 times the hdd [see data]

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gland pharma limited - 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 approxim

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gland pharma limited - regadenoson (unii: 2xln4y044h) (regadenoson anhydrous - unii:7axv542lz4) - regadenoson injection  is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (mpi) in patients unable to undergo adequate exercise stress. do not administer regadenoson injection to patients with: ·       second- or third- degree av block, or ·       sinus node dysfunction  unless these patients have a functioning artificial pacemaker [see warnings and precautions (5.2) ]. risk summary there are no available data on regadenoson injection use in pregnant women to inform a drug-associated risk. in animal reproduction studies, adverse developmental outcomes were observed with the administration of regadenoson to pregnant rats and rabbits during organogenesis only at doses that produced maternal toxicity (see data ). in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data reproductive studies in rats showed that regadenoson dos

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gland pharma limited - etomidate (unii: z22628b598) (etomidate - unii:z22628b598) - etomidate 2 mg in 1 ml - etomidate injection, usp is indicated by intravenous injection for the induction of general anesthesia. when considering use of etomidate, the usefulness of its hemodynamic properties (see clinical pharmacology ) should be weighed against the high frequency of transient skeletal muscle movements (see adverse reactions ). intravenous etomidate is also indicated for the supplementation of subpotent anesthetic agents, such as nitrous oxide in oxygen, during maintenance of anesthesia for short operative procedures such as dilation and curettage or cervical conization. etomidate is contraindicated in patients whohave shown hypersensitivity to it.

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gland pharma limited - posaconazole (unii: 6tk1g07bhz) (posaconazole - unii:6tk1g07bhz) - posaconazole injection is indicated for the treatment of invasive aspergillosis in adults and pediatric patients 13 years of age and older. posaconazole injection is indicated for the prophylaxis of invasive aspergillus and candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (hsct) recipients with graft-versus-host disease (gvhd) or those with hematologic malignancies with prolonged neutropenia from chemotherapy [see clinical studies (14.1)] as follows: - posaconazole injection: adults and pediatric patients 2 years of age and older posaconazole is contraindicated in persons with known hypersensitivity to posaconazole or other azole antifungal agents. posaconazole is contraindicated with sirolimus. concomitant administration of posaconazole with sirolimus increases the sirolimus blood concentrations by approximately 9-fold and can result in sirolimus toxicity [see drug interactions (7.1) and clinical pharmacology (12.3) ]. posaconazole is contraindicated with cyp3a4 substrates that prolong the qt interval. concomitant administration of posaconazole with the cyp3a4 substrates, pimozide and quinidine may result in increased plasma concentrations of these drugs, leading to qtc prolongation and cases of torsades de pointes [see warnings and precautions (5.2) and drug interactions (7.2) ]. coadministration with the hmg-coa reductase inhibitors that are primarily metabolized through cyp3a4 (e.g., atorvastatin, lovastatin, and simvastatin) is contraindicated since increased plasma concentration of these drugs can lead to rhabdomyolysis [see drug interactions (7.3) and clinical pharmacology (12.3) ]. posaconazole may increase the plasma concentrations of ergot alkaloids (ergotamine and dihydroergotamine) which may lead to ergotism [see drug interactions (7.4) ]. coadministration of posaconazole with venetoclax at initiation and during the ramp-up phase is contraindicated in patients with chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll) due to the potential for increased risk of tumor lysis syndrome [see warnings and precautions (5.10) and drug interactions (7.16) ]. risk summary based on findings from animal data, posaconazole may cause fetal harm when administered to pregnant women. available data for use of posaconazole in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, skeletal malformations (cranial malformations and missing ribs) and maternal toxicity (reduced food consumption and reduced body weight gain) were observed when posaconazole was dosed orally to pregnant rats during organogenesis at doses ≥1.4 times the 400 mg twice daily oral suspension regimen based on steady-state plasma concentrations of posaconazole in healthy volunteers. in pregnant rabbits dosed orally during organogenesis, increased resorptions, reduced litter size, and reduced body weight gain of females were seen at doses 5 times the exposure achieved with the 400 mg twice daily oral suspension regimen. doses of ≥ 3 times the clinical exposure caused an increase in resorptions in these rabbits (see data ). based on animal data, advise pregnant women of the potential risk to a fetus. the estimated 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. data animal data posaconazole resulted in maternal toxicity (reduced food consumption and reduced body weight gain) and skeletal malformations (cranial malformations and missing ribs) when given orally to pregnant rats during organogenesis (gestational days 6 through 15) at doses ≥27 mg/kg (≥1.4 times the 400 mg twice daily oral suspension regimen based on steady-state plasma concentrations of drug in healthy volunteers). the no-effect dose for malformations and maternal toxicity in rats was 9 mg/kg, which is 0.7 times the exposure achieved with the 400 mg twice daily oral suspension regimen. no malformations were seen in rabbits dosed during organogenesis (gestational days 7 through 19) at doses up to 80 mg/kg (5 times the exposure achieved with the 400 mg twice daily oral suspension regimen). in the rabbit, the no-effect dose was 20 mg/kg, while high doses of 40 mg/kg and 80 mg/kg (3 or 5 times the clinical exposure) caused an increase in resorptions. in rabbits dosed at 80 mg/kg, a reduction in body weight gain of females and a reduction in litter size were seen. risk summary there are no data on the presence of posaconazole in human milk, the effects on the breastfed infant, or the effects on milk production. posaconazole is excreted in the milk of lactating rats. when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for posaconazole and any potential adverse effects on the breastfed child from posaconazole or from the underlying maternal condition. the safety and effectiveness of posaconazole injection for the prophylaxis of invasive aspergillus and candida infections have been established in pediatric patients aged 2 and older who are at high risk of developing these infections due to being severely immunocompromised, such as hsct recipients with gvhd or those with hematologic malignancies with prolonged neutropenia from chemotherapy. the safety and effectiveness of posaconazole injection for the treatment of invasive aspergillosis have been established in pediatric patients aged 13 years and older. use of posaconazole in these age groups is supported by evidence from adequate and well-controlled studies of posaconazole in adult and pediatric patients and additional pharmacokinetic and safety data in pediatric patients 2 years of age and older [see adverse reactions (6.1), clinical pharmacology (12.3) and clinical studies (14) ]. the safety and effectiveness of posaconazole have not been established in pediatric patients younger than 2 years of age. no overall differences in the safety of posaconazole injection was observed between geriatric patients and younger adult patients in the clinical trials; therefore, no dosage adjustment is recommended for any formulation of posaconazole in geriatric patients. no clinically meaningful differences in the pharmacokinetics of posaconazole were observed in geriatric patients compared to younger adult patients during clinical trials [see clinical pharmacology (12.3) ]. of the 279 patients treated with posaconazole injection in the posaconazole injection study, 52 (19%) were greater than 65 years of age. of the 230 patients treated with noxafil® (posaconazole) delayed-release tablets , 38 (17%) were greater than 65 years of age. of the 605 patients randomized to noxafil® (posaconazole) oral suspension in noxafil oral suspension study 1 and study 2, 63 (10%) were ≥65 years of age. of the 288 patients randomized to posaconazole injection/  noxafil® (posaconazole) delayed-release tablets in the aspergillosis treatment study, 85 (29%) were ≥65 years of age. no overall differences in the pharmacokinetics and safety were observed between elderly and young subjects during clinical trials, but greater sensitivity of some older individuals cannot be ruled out. posaconazole injection should be avoided in patients with moderate or severe renal impairment (egfr <50 ml/min), unless an assessment of the benefit/risk to the patient justifies the use of posaconazole injection. in patients with moderate or severe renal impairment (egfr <50 ml/min), receiving the posaconazole injection, accumulation of the intravenous vehicle, sbecd, is expected to occur. serum creatinine levels should be closely monitored in these patients, and, if increases occur, consideration should be given to changing to oral posaconazole therapy [see dosage and administration (2.9) and warnings and precautions (5.5) ]. after a single oral dose of noxafil® oral suspension 400 mg, the mean auc was 43%, 27%, and 21% higher in subjects with mild (child-pugh class a, n=6), moderate (child-pugh class b, n=6), or severe (child-pugh class c, n=6) hepatic impairment, respectively, compared to subjects with normal hepatic function (n=18). compared to subjects with normal hepatic function, the mean cmax was 1% higher, 40 % higher, and 34% lower in subjects with mild, moderate, or severe hepatic impairment, respectively. the mean apparent oral clearance (cl/f) was reduced by 18%, 36%, and 28% in subjects with mild, moderate, or severe hepatic impairment, respectively, compared to subjects with normal hepatic function. the elimination half-life (t½) was 27 hours, 39 hours, 27 hours, and 43 hours in subjects with normal hepatic function and mild, moderate, or severe hepatic impairment, respectively. it is recommended that no dose adjustment of posaconazole injection is needed in patients with mild to severe hepatic impairment (child-pugh class a, b, or c) [see dosage and administration (2) and warnings and precautions (5.4) ]. however, a specific study has not been conducted with posaconazole injection. the pharmacokinetics of posaconazole are comparable in males and females. no adjustment in the dosage of posaconazole injection is necessary based on gender. the pharmacokinetic profile of posaconazole is not significantly affected by race. no adjustment in the dosage of posaconazole injection is necessary based on race. pharmacokinetic modeling suggests that patients weighing greater than 120 kg may have lower posaconazole plasma drug exposure. it is, therefore, suggested to closely monitor for breakthrough fungal infections [see clinical pharmacology (12.3)].

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gland pharma limited - dexrazoxane hydrochloride (unii: 5346058q7s) (dexrazoxane - unii:048l81261f) - dexrazoxane 500 mg in 50 ml - dexrazoxane for injection is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumor control. do not use with the initiation of doxorubicin therapy [see warnings and precautions (5.2)]. do not use dexrazoxane for injection with non-anthracycline chemotherapy regimens. pregnancy category d risk summary dexrazoxane for injection can cause fetal harm when administered to pregnant women. dexrazoxane administration resulted in maternal toxicity, embryotoxicity and teratogenicity in rats and rabbits at doses significantly lower than the clinically recommended dose. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see warnings and precautions (5.5)]. animal data dexrazoxane resulted in maternal toxicity in rats at doses of ≥2 mg/kg (1/40 the human dose on a mg/m2 basis) and embryotoxicity and teratogenicity at 8 mg/kg (approximately 1/10 the human dose on a mg/m2 basis) when given daily to pregnant rats during the period of organogenesis. teratogenic effects in the rat included imperforate anus, microphthalmia, and anophthalmia. in offspring allowed to develop to maturity, fertility was impaired in the male and female rats treated in utero during organogenesis at 8 mg/kg. in rabbits, doses of ≥5 mg/kg (approximately 1/10 the human dose on a mg/m2 basis) daily during the period of organogenesis caused maternal toxicity and doses of 20 mg/kg (1/2 the human dose on a mg/m2 basis) were embryotoxic and teratogenic. teratogenic effects in the rabbit included several skeletal malformations such as short tail, rib and thoracic malformations, and soft tissue variations including subcutaneous, eye and cardiac hemorrhagic areas, as well as agenesis of the gallbladder and of the intermediate lobe of the lung. it is not known whether dexrazoxane or its metabolites are excreted in human milk. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from dexrazoxane, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. the safety and effectiveness of dexrazoxane in pediatric patients have not been established [see warnings and precautions (5.4)]. clinical studies of dexrazoxane for injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, 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. contraception dexrazoxane for injection can cause fetal harm when administered during pregnancy.  advise female patients of reproductive potential to use highly effective contraception during treatment [see use in specific populations (8.1)]. greater exposure to dexrazoxane may occur in patients with compromised renal function. reduce the dexrazoxane for injection dose by 50% in patients with creatinine clearance values <40 ml/min [see dosage and administration (2.2) and clinical pharmacology (12.3)].

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gland pharma limited - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - fluorouracil 50 mg in 1 ml - fluorouracil is indicated for the treatment of patients with: 1.1 adenocarcinoma of the colon and rectum 1.2 adenocarcinoma of the breast 1.3 gastric adenocarcinoma 1.4 pancreatic adenocarcinoma  none. pregnancy category d risk summary  there are no adequate and well-controlled studies with fluorouracil in pregnant women. based on its mechanism of action, fluorouracil can cause fetal harm when administered to a pregnant woman. administration of fluorouracil to rats and mice during selected periods of organogenesis, at doses lower than a human dose of 12 mg/kg, caused embryolethality and teratogenicity. malformations included cleft palate and skeletal defects. in monkeys, maternal doses of fluorouracil higher than an approximate human dose of 12 mg/kg resulted in abortion. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to a fetus [see clinical pharmacology (12.1)].  animal data  malformations including cleft palate, skeletal defects and deformed appendages (paws and tails) were observed when fluorouracil was administered by intraperitoneal injection to mice at doses at or above 10 mg/kg (approximately 0.06 times a human dose of 12 mg/kg on a mg/m2 basis) for 4 days during the period of organogenesis. similar results were observed in hamsters administered fluorouracil intramuscularly at doses lower than those administered in commonly used clinical treatment regimens. in rats, administration of fluorouracil by intraperitoneal injection at doses greater than 15 mg/kg (approximately 0.2 times a human dose of 12 mg/kg on a mg/m2  basis) for a single day during organogenesis resulted in delays in growth and malformations including microanophthalmos. in monkeys, administration of fluorouracil during organogenesis at doses approximately equal to a human dose of 12 mg/kg on a mg/m2  basis resulted in abortion; at a 50% lower dose, resorptions and decreased fetal body weights were reported. it is not known whether fluorouracil or its metabolites are present in human milk. because many drugs are present in human milk and because of the potential for serious adverse reactions in nursing infants from fluorouracil, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. the safety and effectiveness in pediatric patients have not been established. reported clinical experience has not identified differences in safety or effectiveness between the elderly and younger patients. contraception females based on its mechanism of action, fluorouracil can cause fetal harm when administered to a pregnant woman. advise females of reproductive potential to use effective contraception during treatment with fluorouracil and for up to 3 months following cessation of therapy [see use in specific populations (8.1)]. males fluorouracil may damage spermatozoa. advise males with female partners of reproductive potential to use effective contraception during and for 3 months following cessation of therapy with fluorouracil [see nonclinical toxicology (13.1)].   infertility females advise females of reproductive potential that, based on animal data, fertility may be impaired while receiving fluorouracil [see nonclinical toxicology (13.1)].   males advise males of reproductive potential that, based on animal data, fertility may be impaired while receiving fluorouracil [see nonclinical toxicology (13.1)].

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gland pharma limited - temsirolimus (unii: 624kn6gm2t) (temsirolimus - unii:624kn6gm2t) - temsirolimus injection is indicated for the treatment of advanced renal cell carcinoma. temsirolimus injection is contraindicated in patients with bilirubin >1.5×uln [see warnings and precautions (5.2) ]. risk summary based on findings in animal studies and its mechanism of action, temsirolimus can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)]. although there are no data on the use of temsirolimus injection in pregnant women, there are limited data on the use of sirolimus, the active metabolite of temsirolimus, during pregnancy; however, these data are insufficient to inform a drug-associated risk of adverse developmental outcomes. in animal reproductive studies, oral daily administration of temsirolimus to pregnant rats and rabbits during organogenesis caused adverse embryo-fetal effects at approximately 0.04 and 0.12 times the auc in patients at the recommended dose, respectively (see data). advise pregnant women of the potential hazard to a fetus. the est

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gland pharma limited - decitabine (unii: 776b62cq27) (decitabine - unii:776b62cq27) - decitabine for injection is indicated for treatment of adult patients with myelodysplastic syndromes (mds) including previously treated and untreated, de novo and secondary mds of all french-american-british subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk international prognostic scoring system groups. risk summary based on findings from human data, animal studies, and the mechanism of action, decitabine can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1) and nonclinical toxicology (13.1)] . limited published data on decitabine use throughout the first trimester during pregnancy describe adverse developmental outcomes including major birth defects (structural abnormalities). in animal reproduction studies, administration of decitabine to pregnant mice and rats duri