Tanzania - English - Tanzania Medicinces & Medical Devices Authority

cadila pharmaceuticals limited, india - cemiplimab - powder for solution for injection - 150 mg/vial

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

cadila pharmaceuticals limited, india - bevacizumab - solution for injection/concentrate for solution for infusion - 400 mg/16 ml

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

cadila pharmaceuticals limited, india - bevacizumab - solution for injection/concentrate for solution for infusion - 100 mg/4ml

United States - English - NLM (National Library of Medicine)

cadila pharmaceuticals limited - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine extended-release tablets are indicated for the treatment of major depressive disorder (mdd). efficacy of venlafaxine in mdd was shown in both short-term trials and a longer-term trial in mdd [see clinical studies (14.1)] . a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. venlafaxine extended-release tablets are indicated for the treatment of social anxiety disorder (sad), also known as social phobia, as defined in dsm-iv. social anxiety disorder (dsm-iv) is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. the feared situations are avoided or endured with intense anxiety or distress. the avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is a marked distress about having the phobias. lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment. efficacy of venlafaxine extended release in the treatment of sad was established in short-term sad trials [see clinical studies (14.2)] . the use of maoi’s intended to treat psychiatric disorders with venlafaxine extended-release tablets or within 7 days of stopping treatment with venlafaxine extended-release tablets are contraindicated because of an increased risk of serotonin syndrome. the use of venlafaxine extended-release tablets within 14 days of stopping, an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administrations (2.6) and warnings and precautions (5.2)] . starting venlafaxine extended-release tablets in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see dosage and administrations   (2.7) and warnings and precautions (5.2)] . based on data from published observational studies, exposure to snris, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see warnings and precautions (5.13) and clinical considerations].   teratogenic effects        venlafaxine did not cause malformations in offspring of rats or rabbits given doses up to 2.5 times (rat) or 4 times (rabbit) the maximum recommended human daily dose on a mg/m2 basis.  however, in rats, there was a decrease in pup weight, an increase in stillborn pups, and an increase in pup deaths during the first 5 days of lactation, when dosing began during pregnancy and continued until weaning. the cause of these deaths is not known. these effects occurred at 2.5 times (mg/m2 ) the maximum human daily dose. the no effect dose for rat pup mortality was 0.25 times the human dose on a mg/m2 basis. there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. non-teratogenic effects neonates exposed to venlafaxine hydrochloride extended-release capsules, other snris (serotonin and norepinephrine reuptake inhibitors), or ssris (selective serotonin reuptake inhibitors), late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. such complications can arise immediately upon delivery. reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. these features are consistent with either a direct toxic effect of ssris and snris or, possibly, a drug discontinuation syndrome. it should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [see warnings and precautions (5.2)] . when treating a pregnant woman with venlafaxine extended-release tablets during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. maternal adverse reactions exposure to venlafaxine extended release tablets in mid to late pregnancy may increase the risk of preeclampsia, and exposure to venlafaxine extended release tablets in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see warnings and precautions (5.13)]. the effect of venlafaxine on labor and delivery in humans is unknown. venlafaxine and odv have been reported to be excreted in human milk. because of the potential for serious adverse reactions in nursing infants from venlafaxine extended-release tablets, 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. safety and effectiveness in the pediatric population have not been established [see boxed warning and warnings and precautions (5.1)] . two placebo-controlled trials in 766 pediatric patients with mdd and two placebo-controlled trials in another disorder in 793 pediatric patients have been conducted with venlafaxine hydrochloride extended-release capsules, and the data were not sufficient to support a claim for use in pediatric patients. anyone considering the use of venlafaxine extended-release tablets in a child or adolescent must balance the potential risks with the clinical need. although no studies have been designed to primarily assess impact of venlafaxine hydrochloride extended-release capsules on the growth, development, and maturation of children and adolescents, the studies that have been done suggest that venlafaxine extended-release tablets may adversely affect weight and height [see warnings and precautions (5.7, 5.8, and 5.9)] . should the decision be made to treat a pediatric patient with venlafaxine extended-release tablets, regular monitoring of weight and height is recommended during treatment, particularly if it is to be continued long term. the safety of venlafaxine extended-release tablets treatment for pediatric patients has not been systematically assessed for chronic treatment longer than six months in duration. in the studies conducted in pediatric patients (ages 6 to 17), the occurrence of blood pressure and cholesterol increases considered to be clinically relevant in pediatric patients was similar to that observed in adult patients. consequently, the precautions for adults apply to pediatric patients [see warnings and precautions (5.3 and 5.14)] . approximately 4% (14/357) and 2% (6/277) of patients treated with venlafaxine hydrochloride extended-release capsules in placebo-controlled premarketing major depressive disorder and social anxiety disorder trials, respectively, were 65 years of age or over. of 2,897 patients treated with venlafaxine hydrochloride immediate-release tablets in premarketing phase major depressive disorder studies, 12% (357) were 65 years of age or over. no overall differences in effectiveness or safety were observed between geriatric patients and younger patients, and other reported clinical experience generally has not identified differences in response between the elderly and younger patients. however, greater sensitivity of some older individuals cannot be ruled out. ssris and snris, including venlafaxine hydrochloride extended-release capsules have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [see warnings and precautions (5.11)] . the pharmacokinetics of venlafaxine and odv are not substantially altered in the elderly [see clinical pharmacology (12.3)] . no dose adjustment is recommended for the elderly on the basis of age alone, although other clinical circumstances, some of which may be more common in the elderly, such as renal or hepatic impairment, may warrant a dose reduction [see dosage and administration (2.3)] . in patients with cirrhosis of the liver, the clearances of venlafaxine and its active metabolite (odv) were decreased, thus prolonging the elimination half-lives of these substances. a large degree of intersubject variability was noted. [see clinical pharmacology (12.3)]. a lower dose and individualization of dosing may be necessary [see dosage and administration (2.3)] . venlafaxine extended-release tablets, like all drugs effective in the treatment of major depressive disorder, should be used with caution in such patients. in patients with renal impairment (gfr = 10 to 70 ml/min), the clearances of venlafaxine and its active metabolites were decreased, thus prolonging the elimination half-lives of these substances [see clinical pharmacology (12.3)] . it is recommended that the total daily dose be reduced by 25% to 50% in patients with renal impairment. because there was much individual variability in clearance between patients with renal impairment, individualization of dosage may be desirable in some patients. in patients undergoing hemodialysis, it is recommended that the total daily dose be reduced by 50%. [see dosage and administration (2.3)]. venlafaxine extended-release tablets, like all drugs effective in the treatment of major depressive disorder, should be used with caution in such patients. venlafaxine extended-release tablets (venlafaxine hydrochloride) are not a controlled substance. while venlafaxine has not been systematically studied in clinical trials for its potential for abuse, there was no indication of drug-seeking behavior in the clinical trials. however, it is not possible to predict on the basis of premarketing experience the extent to which a cns active drug will be misused, diverted, and/or abused once marketed. consequently, physicians should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of venlafaxine (e.g., development of tolerance, incrementations of dose, drug-seeking behavior). in vitro studies revealed that venlafaxine has virtually no affinity for opiate, benzodiazepine, phencyclidine (pcp), or n-methyl-d-aspartic acid (nmda) receptors. venlafaxine was not found to have any significant cns stimulant activity in rodents. in primate drug discrimination studies, venlafaxine showed no significant stimulant or depressant abuse liability. discontinuation effects have been reported in patients receiving venlafaxine [see dosage and administration (2.4) and warnings and precautions (5.5)] .

United States - English - NLM (National Library of Medicine)

cadila pharmaceuticals limited - tizanidine hydrochloride (unii: b53e3nmy5c) (tizanidine - unii:6ai06c00gw) - tizanidine is indicated for the management of spasticity. because of the short duration of therapeutic effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important [see dosage and administration (2.1)]. tizanidine is contraindicated in patients taking potent inhibitors of cyp1a2, such as fluvoxamine or ciprofloxacin [see drug interactions (7.1, 7.2)]. risk summary there are no adequate data on the developmental risk associated with use of tizanidine in pregnant women. in animal studies, administration of tizanidine during pregnancy resulted in developmental toxicity (embryofetal and postnatal offspring mortality and growth deficits) at doses less than those used clinically, which were not associated with maternal toxicity (see animal data ). 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. the bac

United States - English - NLM (National Library of Medicine)

cadila pharmaceuticals limited - nateglinide (unii: 41x3pwk4o2) (nateglinide - unii:41x3pwk4o2) - nateglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use : nateglinide tablets should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. nateglinide is contraindicated in patients with a history of hypersensitivity to nateglinide or its inactive ingredients. risk summary  the available data from published literature and the applicant’s pharmacovigilance with use of nateglinide in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . nateglinide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in animal reproduction studies, there was no teratogenicity in rats and rabbits administer

United States - English - NLM (National Library of Medicine)

cadila pharmaceuticals limited - paroxetine hydrochloride hemihydrate (unii: x2els050d8) (paroxetine - unii:41vrh5220h) - paroxetine extended-release tablets are indicated in adults for the treatment of: • major depressive disorder (mdd) • panic disorder (pd) • social anxiety disorder (sad) • premenstrual dysphoric disorder (pmdd) paroxetine extended-release tablets are contraindicated in patients: • taking, or within 14 days of stopping, maois (including the maois linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome      [see warnings and precautions (5.2), drug interactions (7)] . • taking thioridazine because of risk of qt prolongation [see warnings and precautions (5.3), drug interactions (7)] . • taking pimozide because of risk of qt prolongation [see warnings and precautions (5.3), drug interactions (7)]. • with known hypersensitivity (e.g., anaphylaxis, angioedema, stevens-johnson syndrome) to paroxetine or to any of the inactive ingredients in paroxetine extended-release tablets [see adverse reactions (6.1, 6.2)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for antidepressants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/antidepressants/. risk summary based on data from published observational studies, exposure to ssris, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see warnings and precautions (5.5) and clinical considerations] . paroxetine extended-release tablets are associated with a less than 2-fold increase in cardiovascular malformations when administered to a pregnant woman during the first trimester. while individual epidemiological studies on the association between paroxetine use and cardiovascular malformations have reported inconsistent findings, some meta-analyses of epidemiological studies have identified an increased risk of cardiovascular malformations (see data ). there are risks of persistent pulmonary hypertension of the newborn (pphn) (see data ) and/or poor neonatal adaptation with exposure to selective serotonin reuptake inhibitors (ssris), including paroxetine extended-release tablets, during pregnancy. there also are risks associated with untreated depression in pregnancy (see clinical considerations ). for women who intend to become pregnant or who are in their first trimester of pregnancy, paroxetine should be initiated only after consideration of the other available treatment options. no evidence of treatment related malformations was observed in animal reproduction studies, when paroxetine was administered during the period of organogenesis at doses up to 50 mg/kg/day in rats and 6 mg/kg/day in rabbits. these doses are approximately 6 (rat) and less than 2 (rabbit) times the maximum recommended human dose (mrhd – 75 mg) on an mg/m2 basis. when paroxetine was administered to female rats during the last trimester of gestation and continued through lactation, there was an increase in the number of pup deaths during the first four days of lactation. this effect occurred at a dose of 1 mg/kg/day which is less than the mrhd on an mg/m2 basis ( see data) . the estimated background risks of major birth defects and miscarriage for the indicated populations are unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the us 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 disease-associated maternal and/or embryo/fetal risk women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants. this finding is from a prospective longitudinal study of 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. consider the risks of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. maternal adverse reactions use of paroxetine extended-release tablets in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see warnings and precautions (5.5)] . fetal/neonatal adverse reactions neonates exposed to paroxetine extended-release tablets and other ssris late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. such complications can arise immediately upon delivery. reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremors, jitteriness, irritability, and constant crying. these findings are consistent with either a direct toxic effect of ssris or possibly a drug discontinuation syndrome. it should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [see warnings and precautions (5.4)] . data human data published epidemiological studies on the association between first trimester paroxetine use and cardiovascular malformations have reported inconsistent results; however, meta-analyses of population-based cohort studies published between 1996-2017 indicate a less than 2-fold increased risk for overall cardiovascular malformations. specific cardiac malformations identified in two meta-analyses include approximately 2 to 2.5-fold increased risk for right ventricular outflow tract defects. one meta-analysis also identified an increased risk (less than 2- fold) for bulbus cordis anomalies and anomalies of cardiac septal closure, and an increased risk for atrial septal defects (pooled or 2.38, 95% ci 1.14-4.97). important limitations of the studies included in these meta-analyses include potential confounding by indication, depression severity, and potential exposure misclassification. exposure to ssris, particularly later in pregnancy, may have an increased risk for pphn. pphn occurs in 1-2 per 1000 live births in the general population and is associated with substantial neonatal morbidity and mortality. animal data reproduction studies were performed at doses up to 50 mg/kg/day in rats and 6 mg/kg/day in rabbits administered during organogenesis. these doses are approximately 6 (rat) and less than 2 (rabbit) times the maximum recommended human dose (mrhd – 75 mg) on an mg/m2 basis. these studies have revealed no evidence of malformations. however, in rats, there was an increase in pup deaths during the first 4 days of lactation when dosing occurred during the last trimester of gestation and continued throughout lactation. this effect occurred at a dose of 1 mg/kg/day which is less than the mrhd on an mg/m2 basis. the no-effect dose for rat pup mortality was not determined. the cause of these deaths is not known. risk summary data from the published literature report the presence of paroxetine in human milk (see data). there are reports of agitation, irritability, poor feeding and poor weight gain in infants exposed to paroxetine through breast milk (see clinical considerations) . there are no data on the effects of paroxetine on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for paroxetine extended-release tablets and any potential adverse effects on the breastfed infant from paroxetine extended-release tablets or the underlying maternal condition. clinical considerations  infants exposed to paroxetine extended-release tablets should be monitored for agitation, irritability, poor feeding and poor weight gain. data published literature suggests the presence of paroxetine in human milk with relative infant doses ranging between 0.4% to 2.2%, and a milk: plasma ratio of <1. no significant amounts were detected in the plasma of infants after breastfeeding. infertility male based on findings from clinical studies, paroxetine may affect sperm quality which may impair fertility; it is not known if this effect is reversible [see nonclinical toxicology (13.1) ]. the safety and effectiveness of paroxetine extended-release tablets in pediatric patients have not been established [see boxed warning, warnings and precautions (5.1)]. three placebo-controlled trials in 752 pediatric patients with mdd have been conducted with immediate-release paroxetine, and effectiveness was not established in pediatric patients. decreased appetite and weight loss have been observed in association with the use of ssris. in placebo-controlled clinical trials conducted with pediatric patients, the following adverse reactions were reported in at least 2% of pediatric patients treated with immediate-release paroxetine hydrochloride and at a rate at least twice that for pediatric patients receiving placebo: emotional lability (including self-harm, suicidal thoughts, attempted suicide, crying, and mood fluctuations), hostility, decreased appetite, tremor, sweating, hyperkinesia, and agitation. adverse reactions upon discontinuation of treatment with immediate-release paroxetine hydrochloride in the pediatric clinical trials that included a taper phase regimen, which occurred in at least 2% of patients and at a rate at least twice that of placebo, were: emotional lability (including suicidal ideation, suicide attempt, mood changes, and tearfulness), nervousness, dizziness, nausea, and abdominal pain. ssris and snris, including paroxetine extended-release tablets, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [see warnings and precautions (5.9)]. in premarketing clinical trials with immediate-release paroxetine hydrochloride, 17% of paroxetine treated patients (approximately 700) were 65 years or older. pharmacokinetic studies revealed a decreased clearance in the elderly, and a lower starting dose is recommended; however, no overall differences in safety or effectiveness were observed between these subjects and younger subjects [see dosage and administration (2.5), clinical pharmacology (12.3)]. increased plasma concentrations of paroxetine occur in patients with renal and hepatic impairment. the initial dosage of paroxetine extended-release tablets should be reduced in patients with severe renal impairment and patients with severe hepatic impairment [see dosage and administration (2.5) and clinical pharmacology (12.3)].

United States - English - NLM (National Library of Medicine)

cadila pharmaceuticals limited - rosuvastatin calcium (unii: 83mvu38m7q) (rosuvastatin - unii:413kh5zj73) - rosuvastatin 5 mg - pediatric use information for patients 7 to 17 years of age is approved for astrazeneca’s crestor (rosuvastatin calcium) tablets. however, due to astrazeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. rosuvastatin calcium tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. rosuvastatin calcium tablets are indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (type iii hyperlipoproteinemia). rosuvastatin calcium tablets are indicated as adjunctive therapy to other lipid-lowering treatments (e.g., ldl apheresis) or alone if such treatments are unavailable to reduce ldl-c, total-c, and apob in adult patients with homozygous familial hypercholesterolemia. rosuvastatin calcium tablets have not been studied in fredrickson type i and v dyslipidemias.   rosuvastatin calcium tablets are contraindicated in the following conditions: - patients with a know

United States - English - NLM (National Library of Medicine)

cadila pharmaceuticals limited - raloxifene hydrochloride (unii: 4f86w47br6) (raloxifene - unii:yx9162eo3i) - raloxifene hydrochloride is indicated for the treatment and prevention of osteoporosis in postmenopausal women [see clinical studies (14.1, 14.2)] .  raloxifene hydrochloride is indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis [see clinical studies (14.3)] . raloxifene hydrochloride is indicated for the reduction in risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer [see clinical studies (14.4)] . the effect in the reduction in the incidence of breast cancer was shown in a study of postmenopausal women at high risk for breast cancer with a 5-year planned duration with a median follow-up of 4.3 years [see clinical studies (14.4)] . twenty-seven percent of the participants received drug for 5 years. the long-term effects and the recommended length of treatment are not known. high risk of breast cancer is defined as at least one breast biopsy showing lobular carcinoma in situ (lcis) or atypical hyperpl

United States - English - NLM (National Library of Medicine)

cadila pharmaceuticals limited - rivastigmine tartrate (unii: 9iy2357jpe) (rivastigmine - unii:pki06m3iw0) - rivastigmine 1.5 mg - rivastigmine tartrate capsules, usp are indicated for the treatment of mild-to-moderate dementia of the alzheimer's type (ad). rivastigmine tartrate capsules, usp are indicated for the treatment of mild-to-moderate dementia associated with parkinson's disease (pd).  rivastigmine tartrate capsules are contraindicated in patients with: • known hypersensitivity to rivastigmine, other carbamate derivatives or other components of the formulation [see description (11)]. • a previous history of application site reaction with rivastigmine transdermal patch suggestive of allergic contact dermatitis, in the absence of negative allergy testing [see warnings and precautions (5.2)]. isolated cases of generalized skin reactions have been described in postmarketing experience [see adverse reactions (6.2)]. risk summary there are no adequate data on the developmental risks associated with the use of rivastigmine tartrate in pregnant women. in animals, no adverse effects on embryo-fetal development were obs