Australija - engleski - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - mycophenolate mofetil, quantity: 250 mg - capsule, hard - excipient ingredients: povidone; titanium dioxide; iron oxide yellow; iron oxide red; croscarmellose sodium; gelatin; pregelatinised maize starch; indigo carmine; magnesium stearate - cellcept is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. cellcept is indicated for the prophylaxis of organ rejection in paediatric patients (2 to 18 years) receiving allogeneic renal transplants.

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

legacy pharma inc. - atropa belladonna (unii: wqz3g9pf0h) (atropa belladonna - unii:wqz3g9pf0h), opium (unii: 37m3mz001l) (opium - unii:37m3mz001l) - belladonna and opium suppositories are indicated for the management of ureteral spasm pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. belladonna and opium suppositories are used for relief of moderate to severe pain associated with ureteral spasm not responsive to non-narcotic analgesics and to space intervals between injections of opiates.  belladonna and opium suppositories are for rectal use only. limitations of use because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see warnings and precautions (5.1) ], reserve belladonna and opium suppositories  for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: - have not been tolerated, or are not expected to be tolerated - have not provided adequate analgesia, or are not expected to provide adequate analgesic not recommended for use in children 12 years of age and under belladonna and opium suppositor

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

bryant ranch prepack - atropa belladonna (unii: wqz3g9pf0h) (atropa belladonna - unii:wqz3g9pf0h), opium (unii: 37m3mz001l) (opium - unii:37m3mz001l) - belladonna and opium suppositories are indicated for the management of ureteral spasm pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see warnings and precautions (5.1) ], reserve belladonna and opium suppositories for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: risk summary prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. there are no available data with belladonna and opium suppositories in pregnant women to inform a drug associated risk for major birth defects and miscarriage. clinical considerations fetal/neonatal adverse reactions prolonged use of opioid analgesics 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 (5.3) ]. belladonna refers to plant alkaloids that contain anticholinergic agents such as atropine. atropine used in human pregnancies has not been associated with birth defects or adverse fetal effects although the drug readily crosses the placenta. use during pregnancy may increase risk of respiratory abnormalities, hypospadias, and eye or ear malformations but causal relationship is unclear. the collaborative perinatal project found no relationship between first trimester use of atropine and birth defects in the offspring but found an increase in birth defects in general in the offspring of pregnancies where the mother had taken belladonna. there was no relationship to any particular syndrome of anomalies. a statistically significant (although weak) association was discovered between congenital anomalies and maternal use of belladonna. a study was conducted based on the infants of 554 women who took belladonna during the first four months of pregnancy. the study was conducted in the collaborative perinatal project and showed that belladonna is unlikely to cause minor congenital abnormalities. the estimated maximum risk is most likely less than 3% if maternal belladonna is used early in pregnancy.1 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. belladonna and opium suppositories is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. opioid analgesics, including belladonna and opium suppositories, 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. risk summary the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for belladonna and opium suppositories and any potential adverse effects on the breastfed infant from belladonna and opium suppositories or from the underlying maternal condition. clinical considerations infants exposed to belladonna and opium suppositories through breast milk should be monitored for excess sedation and respiratory depression. withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped. infertility chronic use of opioids 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 (6.1)]. the safety and effectiveness of belladonna and opium suppositories in pediatric patients have not been established. elderly patients (aged 65 years or older) may have increased sensitivity to belladonna and opium. 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 belladonna and opium suppositories slowly in geriatric patients [see warnings and precautions (5.2) ]. belladonna and opium suppositories contains opium, a schedule ii controlled substance. belladonna and opium suppositories contains opium, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol. belladonna and opium suppositories can be abused and is subject to misuse, addiction, and criminal diversion [see warnings and precautions (5.1) ]. all patients treated with opioids require careful monitoring for signs of abuse and addiction, since use of opioid analgesic products carries the risk of addiction even under appropriate medical use. prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal. “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 health care provider(s). “doctor shopping” (visiting multiple prescribers) to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction. preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control. abuse and addiction are separate and distinct from physical dependence and tolerance. health care providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. in addition, abuse of opioids can occur in the absence of true addiction. belladonna and opium suppositories, like other opioids, can be diverted for non-medical 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 re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. risks specific to abuse of belladonna and opium suppositories belladonna and opium suppositories are for rectal use only. abuse of belladonna and opium suppositories poses a risk of overdose and death. the risk is increased with concurrent abuse of belladonna and opium suppositories with alcohol and other central nervous system 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 chronic opioid therapy. tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects. physical dependence results in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug. withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene), mixed agonist/antagonist analgesics (pentazocine, butorphanol, nalbuphine), or partial agonists (buprenorphine). physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage. belladonna and opium suppositories should not be abruptly discontinued [see dosage and administration (2.4) ]. if belladonna and opium suppositories is abruptly discontinued in a physically-dependent patient, a withdrawal syndrome may occur. some or all of the following can characterize this syndrome: restlessness, lacrimation, rhinorrhea, yawning, 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) ].

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

bryant ranch prepack - atropa belladonna (unii: wqz3g9pf0h) (atropa belladonna - unii:wqz3g9pf0h), opium (unii: 37m3mz001l) (opium - unii:37m3mz001l) - belladonna and opium suppositories are indicated for the management of ureteral spasm pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see warnings and precautions (5.1) ], reserve belladonna and opium suppositories for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: risk summary prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. there are no available data with belladonna and opium suppositories in pregnant women to inform a drug associated risk for major birth defects and miscarriage. clinical considerations fetal/neonatal adverse reactions prolonged use of opioid analgesics 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 (5.3) ]. belladonna refers to plant alkaloids that contain anticholinergic agents such as atropine. atropine used in human pregnancies has not been associated with birth defects or adverse fetal effects although the drug readily crosses the placenta. use during pregnancy may increase risk of respiratory abnormalities, hypospadias, and eye or ear malformations but causal relationship is unclear. the collaborative perinatal project found no relationship between first trimester use of atropine and birth defects in the offspring but found an increase in birth defects in general in the offspring of pregnancies where the mother had taken belladonna. there was no relationship to any particular syndrome of anomalies. a statistically significant (although weak) association was discovered between congenital anomalies and maternal use of belladonna. a study was conducted based on the infants of 554 women who took belladonna during the first four months of pregnancy. the study was conducted in the collaborative perinatal project and showed that belladonna is unlikely to cause minor congenital abnormalities. the estimated maximum risk is most likely less than 3% if maternal belladonna is used early in pregnancy.1 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. belladonna and opium suppositories is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. opioid analgesics, including belladonna and opium suppositories, 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. risk summary the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for belladonna and opium suppositories and any potential adverse effects on the breastfed infant from belladonna and opium suppositories or from the underlying maternal condition. clinical considerations infants exposed to belladonna and opium suppositories through breast milk should be monitored for excess sedation and respiratory depression. withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped. infertility chronic use of opioids 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 (6.1)]. the safety and effectiveness of belladonna and opium suppositories in pediatric patients have not been established. elderly patients (aged 65 years or older) may have increased sensitivity to belladonna and opium. 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 belladonna and opium suppositories slowly in geriatric patients [see warnings and precautions (5.2) ]. belladonna and opium suppositories contains opium, a schedule ii controlled substance. belladonna and opium suppositories contains opium, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol. belladonna and opium suppositories can be abused and is subject to misuse, addiction, and criminal diversion [see warnings and precautions (5.1) ]. all patients treated with opioids require careful monitoring for signs of abuse and addiction, since use of opioid analgesic products carries the risk of addiction even under appropriate medical use. prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal. “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 health care provider(s). “doctor shopping” (visiting multiple prescribers) to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction. preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control. abuse and addiction are separate and distinct from physical dependence and tolerance. health care providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. in addition, abuse of opioids can occur in the absence of true addiction. belladonna and opium suppositories, like other opioids, can be diverted for non-medical 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 re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. risks specific to abuse of belladonna and opium suppositories belladonna and opium suppositories are for rectal use only. abuse of belladonna and opium suppositories poses a risk of overdose and death. the risk is increased with concurrent abuse of belladonna and opium suppositories with alcohol and other central nervous system 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 chronic opioid therapy. tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects. physical dependence results in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug. withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene), mixed agonist/antagonist analgesics (pentazocine, butorphanol, nalbuphine), or partial agonists (buprenorphine). physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage. belladonna and opium suppositories should not be abruptly discontinued [see dosage and administration (2.4) ]. if belladonna and opium suppositories is abruptly discontinued in a physically-dependent patient, a withdrawal syndrome may occur. some or all of the following can characterize this syndrome: restlessness, lacrimation, rhinorrhea, yawning, 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) ].

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

lake erie medical & surgical supply dba quality care products llc - milnacipran hydrochloride (unii: rnz43o5ww5) (milnacipran - unii:g56vk1hf36) - milnacipran hydrochloride 50 mg - savella is indicated for the management of fibromyalgia. savella is not approved for use in pediatric patients [see use in specific populations (8.4)]. concomitant use of savella in patients taking monoamine oxidase inhibitors (maois) is contraindicated. in patients receiving a serotonin reuptake inhibitor in combination with a monoamine oxidase inhibitor (maoi), there have been reports of serious, sometimes fatal, reactions including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma. these reactions have also been reported in patients who have recently discontinued serotonin reuptake inhibitors and have been started on an maoi. some cases presented with features resembling neuroleptic malignant syndrome. the effects of combined use of savella and maois have not been evaluated in humans. therefore, it is recommended that savella should not be used in combination wit

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

stat rx usa llc - milnacipran hydrochloride (unii: rnz43o5ww5) (milnacipran - unii:g56vk1hf36) - milnacipran hydrochloride 25 mg - savella is indicated for the management of fibromyalgia. savella is not approved for use in pediatric patients [see use in specific populations (8.4) ]. concomitant use of savella in patients taking monoamine oxidase inhibitors (maois) is contraindicated. in patients receiving a serotonin reuptake inhibitor in combination with a monoamine oxidase inhibitor (maoi), there have been reports of serious, sometimes fatal, reactions including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma. these reactions have also been reported in patients who have recently discontinued serotonin reuptake inhibitors and have been started on an maoi. some cases presented with features resembling neuroleptic malignant syndrome. the effects of combined use of savella and maois have not been evaluated in humans. therefore, it is recommended that savella should not be used in combination wi

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

amneal pharmaceuticals llc - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e), norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - activella is indicated for: limitation of use   when prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal        atrophy due to menopause, first consider the use of topical vaginal products. limitation of use   when prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. consider estrogen therapy only for women at significant risk of osteoporosis. activella is contraindicated in women with any of the following conditions:   - undiagnosed abnormal genital bleeding [see warnings and precautions (5.2)] - breast cancer or history of breast cancer [see warnings and precautions (5.2)] - estrogen-dependent neoplasia [see warnings and precautions (5.2)] - active dvt, pe, or history of these conditions [see warnings and precautions (5.1)] - active arterial thromboembolic disease (for example, stroke and mi), or a history of these conditions [see warnings and precautions (5.1)] - known anaphylactic reaction, angioedema, or hypersensitivity to activella - hepatic impairment or disease - protein c, protein s, or antithrombin deficiency, or other known thrombophilic disorders risk summary activella is not indicated for use in pregnancy. there are no data with the use of activella in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalities and limb-reduction defects) following exposure to combined hormonal contraceptives (estrogen and progestins) before conception or during early pregnancy. 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. risk summary estrogens plus progestogens are present in human milk and can reduce milk production in breast-feeding women. this reduction can occur at any time but is less likely to occur once breast-feeding is well established. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for activella and any potential adverse effects on the breastfed child from activella or from the underlying maternal condition. activella is not indicated for use in pediatric patients. clinical studies have not been conducted in the pediatric population. there have not been sufficient numbers of geriatric women involved in clinical studies utilizing activella to determine whether those over 65 years of age differ from younger subjects in their response to activella. the women’s health initiative studies in the whi estrogen plus progestin substudy (daily ce [0.625 mg] plus mpa [2.5 mg] versus placebo), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age [see clinical studies (14.5)] . in the whi estrogen-alone substudy (daily ce [0.625 mg]-alone versus placebo), there was a higher relative risk of stroke in women greater than 65 years of age [see clinical studies (14.5)] . the women’s health initiative memory study in the whims ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen plus progestin or estrogen-alone when compared to placebo. it is unknown whether this finding applies to younger postmenopausal women [see warnings and precautions (5.3), and clinical studies (14.6)] . since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women8 [see warnings and precautions (5.3), and clinical studies (14.6)] .

Australija - engleski - APVMA (Australian Pesticides and Veterinary Medicines Authority)

intervet australia pty limited - inactivated salmonella dublin & typhimurium antigens; thiomersal - misc. vaccines or anti sera - inactivated salmonella dublin & typhimurium antigens vaccine-microbial active 0.0 undefined; thiomersal mercury other 0.1 mg/ml - immunotherapy - cattle | beef | bos indicus | bos taurus | bovine | buffalo | bull | bullock | calf | cow | dairy cow | heifer | steer - salmonella | including b-lactamase producin | salmonellosis

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

genentech, inc. - mycophenolate mofetil (unii: 9242ecw6r0) (mycophenolic acid - unii:hu9dx48n0t) - mycophenolate mofetil 500 mg - cellcept [mycophenolate mofetil (mmf)] is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see clinical studies (14.1)], heart [see clinical studies (14.2)] or liver transplants [see clinical studies (14.3)] , in combination with other immunosuppressants. allergic reactions to cellcept have been observed; therefore, cellcept is contraindicated in patients with a hypersensitivity to mycophenolate mofetil (mmf), mycophenolic acid (mpa) or any component of the drug product. cellcept intravenous is contraindicated in patients who are allergic to polysorbate 80 (tween). pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to mycophenolate during pregnancy and those becoming pregnant within 6 weeks of discontinuing cellcept treatment. to report a pregnancy or obtain information about the registry, visit www.mycophenolaterems.com or call 1-800-617-8191. risk summary use of mycophenolate mofetil (mmf) during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of multiple congenital malformations in multiple organ systems [see human data] . oral administration of mycophenolate to rats and rabbits during the period of organogenesis produced congenital malformations and pregnancy loss at doses less than the recommended clinical dose (0.01 to 0.05 times the recommended clinical doses in kidney and heart transplant patients) [see animal data]. consider alternative immunosuppressants with less potential for embryofetal toxicity. risks and benefits of cellcept should be discussed with the pregnant woman. the estimated background risk of pregnancy loss and congenital malformations in organ transplant populations is not clear. 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 human data a spectrum of congenital malformations (including multiple malformations in individual newborns) has been reported in 23 to 27% of live births in mmf exposed pregnancies, based on published data from pregnancy registries. malformations that have been documented include external ear, eye, and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, kidney, and nervous system. based on published data from pregnancy registries, the risk of first trimester pregnancy loss has been reported at 45 to 49% following mmf exposure. animal data in animal reproductive toxicology studies, there were increased rates of fetal resorptions and malformations in the absence of maternal toxicity. oral administration of mmf to pregnant rats from gestational day 7 to day 16 produced increased embryofetal lethality and fetal malformations including anophthalmia, agnathia, and hydrocephaly at doses equivalent to 0.015 and 0.01 times the recommended human doses for renal and cardiac transplant patients, respectively, when corrected for bsa. oral administration of mmf to pregnant rabbits from gestational day 7 to day 19 produced increased embryofetal lethality and fetal malformations included ectopia cordis, ectopic kidneys, diaphragmatic hernia, and umbilical hernia at dose equivalents as low as 0.05 and 0.03 times the recommended human doses for renal and cardiac transplant patients, respectively, when corrected for bsa. risk summary there are no data on the presence of mycophenolate in human milk, or the effects on milk production. there are limited data in the national transplantation pregnancy registry on the effects of mycophenolate on a breastfed child [see data] . studies in rats treated with mmf have shown mycophenolic acid (mpa) to be present in milk. because available data are limited, it is not possible to exclude potential risks to a breastfeeding infant. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for cellcept and any potential adverse effects on the breastfed infant from cellcept or from the underlying maternal condition. data limited information is available from the national transplantation pregnancy registry. of seven infants reported by the national transplantation pregnancy registry to have been breastfed while the mother was taking mycophenolate, all were born at 34-40 weeks gestation, and breastfed for up to 14 months. no adverse events were reported. females of reproductive potential must be made aware of the increased risk of first trimester pregnancy loss and congenital malformations and must be counseled regarding pregnancy prevention and planning. pregnancy planning for patients who are considering pregnancy, consider alternative immunosuppressants with less potential for embryofetal toxicity whenever possible. risks and benefits of cellcept should be discussed with the patient. pregnancy testing to prevent unplanned exposure during pregnancy, all females of reproductive potential should have a serum or urine pregnancy test with a sensitivity of at least 25 miu/ml immediately before starting cellcept. another pregnancy test with the same sensitivity should be done 8 to 10 days later. repeat pregnancy tests should be performed during routine follow-up visits. results of all pregnancy tests should be discussed with the patient. in the event of a positive pregnancy test, consider alternative immunosuppressants with less potential for embryofetal toxicity whenever possible. contraception female patients females of reproductive potential taking cellcept must receive contraceptive counseling and use acceptable contraception (see table 9 for acceptable contraception methods). patients must use acceptable birth control during the entire cellcept therapy, and for 6 weeks after stopping cellcept, unless the patient chooses abstinence. patients should be aware that cellcept reduces blood levels of the hormones from the oral contraceptive pill and could theoretically reduce its effectiveness [see drug interactions (7.2)]. - intrauterine devices (iuds) - tubal sterilization - patient's partner vasectomy - oral contraceptive pill - transdermal patch - vaginal ring - injection - implant - diaphragm with spermicide - cervical cap with spermicide - contraceptive sponge - male condom - female condom - diaphragm with spermicide - cervical cap with spermicide - contraceptive sponge - male condom - female condom male patients genotoxic effects have been observed in animal studies at exposures exceeding the human therapeutic exposures by approximately 1.25 times. thus, the risk of genotoxic effects on sperm cells cannot be excluded. based on this potential risk, sexually active male patients and/or their female partners are recommended to use effective contraception during treatment of the male patient and for at least 90 days after cessation of treatment. also, based on the potential risk of genotoxic effects, male patients should not donate sperm during treatment with cellcept and for at least 90 days after cessation of treatment [see use in special populations (8.1), nonclinical toxicology (13.1), patient counseling information (17.9)] . safety and effectiveness have been established in pediatric patients 3 months and older for the prophylaxis of organ rejection of allogenic kidney, heart or liver transplants. kidney transplant use of cellcept in this population is supported by evidence from adequate and well-controlled studies of cellcept in adults with additional data from one open-label, pharmacokinetic and safety study of cellcept in pediatric patients after receiving allogeneic kidney transplant (100 patients, 3 months to 18 years of age) [see dosage and administration (2.2), adverse reactions (6.1), clinical pharmacology (12.3), clinical studies (14.1)] . heart transplant and liver transplant use of cellcept in pediatric heart transplant and liver transplant patients is supported by adequate and well-controlled studies and pharmacokinetic data in adult heart transplant and liver transplant patients. additional supportive data include pharmacokinetic data in pediatric kidney transplant and pediatric liver transplant patients (8 liver transplant patients, 9 months to 5 years of age, in an open-label, pharmacokinetic and safety study) and published evidence of clinical efficacy and safety in pediatric heart transplant and pediatric liver transplant patients [see dosage and administration (2.3, 2.4), adverse reactions (6.1), clinical pharmacology (12.3), clinical studies (14.1)] . clinical studies of cellcept did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between geriatric and younger patients. in general, dose selection for a geriatric patient should take into consideration the presence of decreased hepatic, renal or cardiac function and of concomitant drug therapies [see adverse reactions (6.1), drug interactions (7)]. patients with kidney transplant no dosage adjustments are needed in kidney transplant patients experiencing delayed graft function postoperatively but patients should be carefully monitored [see clinical pharmacology (12.3)]. in kidney transplant patients with severe chronic impairment of the graft (gfr <25 ml/min/1.73 m2 ), no dose adjustments are necessary; however, doses greater than 1 g administered twice a day should be avoided. patients with heart and liver transplant no data are available for heart or liver transplant patients with severe chronic renal impairment. cellcept may be used for heart or liver transplant patients with severe chronic renal impairment if the potential benefits outweigh the potential risks. patients with kidney transplant no dosage adjustments are recommended for kidney transplant patients with severe hepatic parenchymal disease. however, it is not known whether dosage adjustments are needed for hepatic disease with other etiologies [see clinical pharmacology (12.3)]. patients with heart transplant no data are available for heart transplant patients with severe hepatic parenchymal disease. read this instructions for use before you take or give cellcept for the first time and each time you get a refill. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or treatment. important: - always use the oral dispenser provided with cellcept oral suspension to make sure you measure the right amount of medicine. if your cellcept oral suspension does not come with the oral dispenser, contact your pharmacist. - call your pharmacist if your oral dispenser is lost or damaged. - your pharmacist will write the expiration date on your cellcept oral suspension bottle label. do not use cellcept after the expiration date. - ask your doctor or pharmacist if you have any questions or are unsure about how to take or give the right amount of medicine. - the cellcept oral suspension should not be mixed with any type of liquids before taking or giving the dose. - do not let the cellcept oral suspension come in contact with the skin. if this happens, wash the skin well with soap and water. if the cellcept oral suspension gets in the eyes, rinse the eyes with plain water. - if you spill any cellcept oral suspension, wipe it up using paper towels wet with water. put the child-resistant bottle cap back on the bottle and wipe the outside of the bottle with wet paper towels. supplies needed to take or give a dose of cellcept oral suspension : to take or give a dose of cellcept oral suspension, you will need the bottle of medicine and the oral dispenser provided with the medicine (see figure 1 ). your pharmacist will insert the bottle adapter in the cellcept oral suspension bottle. do not remove the bottle adapter from the bottle. taking or giving a dose of cellcept oral suspension: - remove the plunger from the oral dispenser. - rinse the oral dispenser and plunger with water only and let them air dry on a paper towel. - when the oral dispenser and plunger are dry, put the plunger back in the oral dispenser for the next use. do not throw away the oral dispenser. store the oral dispenser in a clean, dry place. - do not boil the oral dispenser. do not use solvent-containing wipes to clean the oral dispenser. do not use cloths or wipes to dry the oral dispenser. how should i store cellcept oral suspension? - store the cellcept oral suspension at room temperature between 59°f to 86°f (15°c to 30°c), for up to 60 days. you can also store the cellcept oral suspension in the refrigerator between 36°f to 46°f (2°c to 8°c). ) - do not freeze. keep cellcept oral suspension and all medicines out of the reach of children. distributed by: genentech usa, inc. a member of the roche group 1 dna way south san francisco, ca 94080-4990 © 2022 genentech, inc. all rights reserved. this instructions for use has been approved by the u.s. food and drug administration. revised: august 2022

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

rebel distributors corp - mycophenolate mofetil (unii: 9242ecw6r0) (mycophenolic acid - unii:hu9dx48n0t) - mycophenolate mofetil 250 mg - cellcept is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. cellcept should be used concomitantly with cyclosporine and corticosteroids. cellcept intravenous is an alternative dosage form to cellcept capsules, tablets and oral suspension. cellcept intravenous should be administered within 24 hours following transplantation. cellcept intravenous can be administered for up to 14 days; patients should be switched to oral cellcept as soon as they can tolerate oral medication. allergic reactions to cellcept have been observed; therefore, cellcept is contraindicated in patients with a hypersensitivity to mycophenolate mofetil, mycophenolic acid or any component of the drug product. cellcept intravenous is contraindicated in patients who are allergic to polysorbate 80 (tween).