68ga psma 11 074 185gbq radionuklidový generátor - 搜索结果

澳大利亚 - 英文 - APVMA (Australian Pesticides and Veterinary Medicines Authority)

iga signature insect spray fast knockdown

澳大利亚 - 英文 - APVMA (Australian Pesticides and Veterinary Medicines Authority)

iga signature surface spray high performance

澳大利亚 - 英文 - APVMA (Australian Pesticides and Veterinary Medicines Authority)

iga signature insect spray low irritant

澳大利亚 - 英文 - APVMA (Australian Pesticides and Veterinary Medicines Authority)

iga signature surface spray low irritant

英国 - 英文 - myHealthbox

valganciclovir 450mg film-coated tablets

milpharm limited - valganciclovir - film-coated tablets - 450mg - antivirals for systemic use, nucleosides and nucleotides excl. reverse transcriptase inhibitors - it is indicated for the induction and maintenance treatment of cytomegalovirus (cmv) retinitis in adult patients with acquired immunodeficiency syndrome (aids) and for the prevention of cmv disease in cmvnegative adults and children (aged from birth to 18 years) who have received a solid organ transplant from a cmv-positive donor.

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

valganciclovir sz valganciclovir (as hydrochloride) 450 mg tablet bottle

cipla australia pty ltd - valganciclovir hydrochloride -

美国 - 英文 - NLM (National Library of Medicine)

pradaxa- dabigatran etexilate mesylate capsule

boehringer ingelheim pharmaceuticals inc. - dabigatran etexilate mesylate (unii: sc7nuw5iit) (dabigatran - unii:i0vm4m70gc) - dabigatran etexilate 75 mg - pradaxa capsules is indicated to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation. pradaxa capsules is indicated for the treatment of deep venous thrombosis and pulmonary embolism in adult patients who have been treated with a parenteral anticoagulant for 5-10 days. pradaxa capsules is indicated to reduce the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patients who have been previously treated. pradaxa capsules is indicated for the prophylaxis of deep vein thrombosis and pulmonary embolism in adult patients who have undergone hip replacement surgery. pradaxa capsules is indicated for the treatment of venous thromboembolic events (vte) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days [see dosage and administration (2.3)] . pradaxa capsules is indicated to reduce the risk of recurrence of vte in pediatric patients 8 to less than 18 years of age who have been previously treated [see dosage and administration (2.3)] . pradaxa is contraindicated in patients with: - active pathological bleeding [see warnings and precautions (5.2) and adverse reactions (6.1)] - history of a serious hypersensitivity reaction to dabigatran, dabigatran etexilate, or to one of the excipients of the product (e.g., anaphylactic reaction or anaphylactic shock) [see adverse reactions (6.1)] - mechanical prosthetic heart valve [see warnings and precautions (5.4)] risk summary the limited available data on pradaxa use in pregnant women are insufficient to determine drug-associated risks for adverse developmental outcomes. there are risks to the mother associated with untreated venous thromboembolism in pregnancy and a risk of hemorrhage in the mother and fetus associated with the use of anticoagulants (see clinical considerations) . in pregnant rats treated from implantation until weaning, dabigatran increased the number of dead offspring and caused excess vaginal/uterine bleeding close to parturition at an exposure 2.6 times the human exposure. at a similar exposure, dabigatran decreased the number of implantations when rats were treated prior to mating and up to implantation (gestation day 6). dabigatran administered to pregnant rats and rabbits during organogenesis up to exposures 8 and 13 times the human exposure, respectively, did not induce major malformations. however, the incidence of delayed or irregular ossification of fetal skull bones and vertebrae was increased in the rat (see data) . 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%-4% and 15%-20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk pregnancy confers an increased risk for thromboembolism that is higher for women with underlying thromboembolic disease and certain high-risk pregnancy conditions. published data describe that women with a previous history of venous thrombosis are at high risk for recurrence during pregnancy. fetal/neonatal adverse reaction use of anticoagulants, including pradaxa, may increase the risk of bleeding in the fetus and neonate. monitor neonates for bleeding [see warnings and precautions (5.2)]. labor or delivery all patients receiving anticoagulants, including pregnant women, are at risk for bleeding. pradaxa use during labor or delivery in women who are receiving neuraxial anesthesia may result in epidural or spinal hematomas. consider discontinuation or use of shorter acting anticoagulant as delivery approaches [see warnings and precautions (5.2, 5.3)] . data animal data dabigatran has been shown to decrease the number of implantations when male and female rats were treated at a dosage of 70 mg/kg (about 2.6 to 3.0 times the human exposure at mrhd of 300 mg/day based on area under the curve [auc] comparisons) prior to mating and up to implantation (gestation day 6). treatment of pregnant rats after implantation with dabigatran at the same dose increased the number of dead offspring and caused excess vaginal/uterine bleeding close to parturition. dabigatran administered to pregnant rats and rabbits during organogenesis up to maternally toxic doses of 200 mg/kg (8 and 13 times the human exposure, respectively, at a mrhd of 300 mg/day based on auc comparisons) did not induce major malformations, but increased the incidence of delayed or irregular ossification of fetal skull bones and vertebrae in the rat. death of offspring and mother rats during labor in association with uterine bleeding occurred during treatment of pregnant rats from implantation (gestation day 7) to weaning (lactation day 21) with dabigatran at a dose of 70 mg/kg (about 2.6 times the human exposure at mrhd of 300 mg/day based on auc comparisons). risk summary there are no data on the presence of dabigatran in human milk, the effects on the breastfed child, or on milk production. dabigatran and/or its metabolites were present in rat milk. breastfeeding is not recommended during treatment with pradaxa. females of reproductive potential requiring anticoagulation should discuss pregnancy planning with their physician. the risk of clinically significant uterine bleeding, potentially requiring gynecological surgical interventions, identified with oral anticoagulants including pradaxa should be assessed in females of reproductive potential and those with abnormal uterine bleeding. the safety and effectiveness of pradaxa capsules for the treatment and the reduction in risk of recurrence of venous thromboembolism have been established in pediatric patients 8 to less than 18 years of age. use of pradaxa for this indication is supported by evidence from adequate and well-controlled studies in pediatric patients. these studies included an open-label, randomized, parallel-group study and an open-label, single-arm safety study [see adverse reactions (6.1) and clinical studies (14.4, 14.5)] . other age-appropriate pediatric dosage forms of dabigatran etexilate are available for pediatric patients less than 8 years of age for these indications. safety and effectiveness of pradaxa capsules have not been established in pediatric patients with non-valvular atrial fibrillation or those who have undergone hip replacement surgery. of the total number of patients in the re-ly study, 82% were 65 and over, while 40% were 75 and over. the risk of stroke and bleeding increases with age, but the risk-benefit profile is favorable in all age groups [see warnings and precautions (5), adverse reactions (6.1), and clinical studies (14.1)] . reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients no dose adjustment of pradaxa is recommended in patients with mild or moderate renal impairment [see clinical pharmacology (12.3)] . reduce the dose of pradaxa in patients with severe renal impairment (crcl 15-30 ml/min) [see dosage and administration (2.2, 2.4) and clinical pharmacology (12.3)] . dosing recommendations for patients with crcl < 15 ml/min or on dialysis cannot be provided. adjust dose appropriately in patients with renal impairment receiving concomitant p-gp inhibitors [see warnings and precautions (5.5), drug interactions (7.1), and clinical pharmacology (12.3)]. treatment and reduction in the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patients patients with severe renal impairment (crcl ≤ 30 ml/min) were excluded from re-cover. dosing recommendations for patients with crcl ≤ 30 ml/min or on dialysis cannot be provided. avoid use of pradaxa with concomitant p-gp inhibitors in patients with crcl < 50 ml/min [see warnings and precautions (5.5), drug interactions (7.2), and clinical pharmacology (12.3)]. prophylaxis of deep vein thrombosis and pulmonary embolism in adult patients following hip replacement surgery patients with severe renal impairment (crcl < 30 ml/min) were excluded from re-novate and re-novate ii. dosing recommendations for patients with crcl < 30 ml/min or on dialysis cannot be provided. avoid use of pradaxa with concomitant p-gp inhibitors in patients with crcl < 50 ml/min [see warnings and precautions (5.5), drug interactions (7.3), and clinical pharmacology (12.2, 12.3)]. treatment and reduction in the risk of recurrence of vte in pediatric patients pradaxa has not been studied in pediatric patients with egfr < 50 ml/min/1.73 m2 . reduced renal function could increase exposure. dosing recommendations cannot be provided for treatment of these patients. avoid use of pradaxa capsules in these patients [see dosage and administration (2.4)].

美国 - 英文 - NLM (National Library of Medicine)

valcyte- valganciclovir tablet, film coated valcyte- valganciclovir hydrochloride powder, for solution

genentech, inc. - valganciclovir hydrochloride (unii: 4p3t9qf9nz) (ganciclovir - unii:p9g3ckz4p5) - valganciclovir 450 mg - treatment of cytomegalovirus (cmv) retinitis: valcyte is indicated for the treatment of cmv retinitis in patients with acquired immunodeficiency syndrome (aids) [see clinical studies (14.1)] . prevention of cmv disease: valcyte is indicated for the prevention of cmv disease in kidney, heart, and kidney-pancreas transplant patients at high risk (donor cmv seropositive/recipient cmv seronegative [d+/r-]) [see clinical studies (14.1)] . prevention of cmv disease: valcyte is indicated for the prevention of cmv disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk [see clinical studies (14.2)] . valcyte is contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valganciclovir, ganciclovir, or any component of the formulation [see adverse reactions (6.1)]. risk summary after oral administration, valganciclovir (prodrug) is converted to ganciclovir (active drug) and, therefore, valcyte is expected to have reproductive toxicity effects similar to ganciclovir. in animal studies, ganciclovir caused maternal and fetal toxicity and embryo-fetal mortality in pregnant mice and rabbits as well as teratogenicity in rabbits at exposures two-times the human exposure. there are no available human data on use of valcyte or ganciclovir in pregnant women to establish the presence or absence of drug-associated risk. the background risk of major birth defects and miscarriage for the indicated populations is unknown. however, the background risk in the u.s. general population of major birth defects is 2–4% and the risk of miscarriage is 15–20% of clinically recognized pregnancies. advise pregnant women of the potential risk to the fetus [see warnings and precautions (5.3), use in specific populations (8.3)]. clinical considerations disease-associated maternal and/or embryo/fetal risk most maternal cmv infections are asymptomatic or they may be associated with a self-limited mononucleosis-like syndrome. however, in immunocompromised patients (i.e., transplant patients or patients with aids) cmv infections may be symptomatic and may result in significant maternal morbidity and mortality. the transmission of cmv to the fetus is a result of maternal viremia and transplacental infection. perinatal infection can also occur from exposure of the neonate to cmv shedding in the genital tract. approximately 10% of children with congenital cmv infection are symptomatic at birth. mortality in these infants is about 10% and approximately 50–90% of symptomatic surviving newborns experience significant morbidity, including mental retardation, sensorineural hearing loss, microcephaly, seizures, and other medical problems. the risk of congenital cmv infection resulting from primary maternal cmv infection may be higher and of greater severity than that resulting from maternal reactivation of cmv infection. data animal data doses resulting in two-times the human exposure of ganciclovir (based on the human auc following a single intravenous infusion of 5 mg per kg of ganciclovir) resulted in maternal and embryo-fetal toxicity in pregnant mice and rabbits as well as teratogenicity in the rabbits. fetal resorptions were present in at least 85% of rabbits and mice. rabbits showed increased embryo-fetal mortality, growth retardation of the fetuses and structural abnormalities of multiple organs of the fetuses including the palate (cleft palate), eyes (anophthalmia/microphthalmia), brain (hydrocephalus), jaw (brachygnathia), kidneys and pancreas (aplastic organs). increased embryo-fetal mortality was also seen in mice. daily intravenous doses of approximately 1.7 times the human exposure (based on auc) administered to female mice prior to mating, during gestation, and during lactation caused hypoplasia of the testes and seminal vesicles in the male offspring, as well as pathologic changes in the nonglandular region of the stomach. data from an ex-vivo human placental model showed that ganciclovir crosses the human placenta. the transfer occurred by passive diffusion and was not saturable over a concentration range of 1 to 10 mg/ml. risk summary no data are available regarding the presence of valganciclovir (prodrug) or ganciclovir (active drug) in human milk, the effects on the breastfed infant, or the effects on milk production. animal data indicate that ganciclovir is excreted in the milk of lactating rats. the centers for disease control and prevention recommend that hiv-infected mothers not breastfeed their infants to avoid risking postnatal transmission of hiv. advise nursing mothers that breastfeeding is not recommended during treatment with valcyte because of the potential for serious adverse events in nursing infants and because of the potential for transmission of hiv [see boxed warning, warnings and precautions (5.1, 5.3, 5.4, 5.5), nonclinical toxicology (13.1)] . pregnancy testing females of reproductive potential should undergo pregnancy testing before initiation of valcyte [see use in specific populations (8.1)] . contraception females because of the mutagenic and teratogenic potential of valcyte, females of reproductive potential should be advised to use effective contraception during treatment and for at least 30 days following treatment with valcyte [see dosage and administration (2.6), warnings and precautions (5.4, 5.5), nonclinical toxicology (13.1)] . males because of its mutagenic potential, males should be advised to use condoms during and for at least 90 days following, treatment with valcyte [see dosage and administration (2.6), warnings and precautions (5.3, 5.5), nonclinical toxicology (13.1)]. infertility valcyte at the recommended doses may cause temporary or permanent female and male infertility [see warnings and precautions (5.3), nonclinical toxicology (13.1)]. data human data in a small, open-label, non-randomized clinical study, adult male renal transplant patients receiving valcyte for cmv prophylaxis for up to 200 days post-transplantation were compared to an untreated control group. patients were followed-up for six months after valcyte discontinuation. among 24 evaluable patients in the valcyte group, the mean sperm density at the end of treatment visit decreased by 11 million/ml from baseline; whereas, among 14 evaluable patients in the control group the mean sperm density increased by 33 million/ml. however, at the follow-up visit among 20 evaluable patients in the valcyte group the mean sperm density was comparable to that observed among 10 evaluable patients in the untreated control group (the mean sperm density at the end of follow-up visit increased by 41 million/ml from baseline in the valcyte group and by 43 million/ml in the untreated group). valcyte for oral solution and tablets are indicated for the prevention of cmv disease in pediatric kidney transplant patients 4 months to 16 years of age and in pediatric heart transplant patients 1 month to 16 years of age at risk for developing cmv disease [see indications and usage (1.2), dosage and administration (2.3)]. the use of valcyte for oral solution and tablets for the prevention of cmv disease in pediatric kidney transplant patients 4 months to 16 years of age is based on two single-arm, open-label, non-comparative studies in patients 4 months to 16 years of age. study 1 was a safety and pharmacokinetic study in pediatric solid organ transplant patients (kidney, liver, heart, and kidney/pancreas). valcyte was administered once daily within 10 days of transplantation for a maximum of 100 days post-transplantation. study 2 was a safety and tolerability study where valcyte was administered once daily within 10 days of transplantation for a maximum of 200 days post-transplantation in pediatric kidney transplant patients. the results of these studies were supported by previous demonstration of efficacy in adult patients [see adverse reactions (6.1), clinical pharmacology (12.3), clinical studies (14.2)]. the use of valcyte for oral solution and tablets for the prevention of cmv disease in pediatric heart transplant patients 1 month to 16 years of age is based on two studies (study 1 described above and study 3) and was supported by previous demonstration of efficacy in adult patients [see clinical pharmacology (12.3), clinical studies (14.2)] . study 3 was a pharmacokinetic and safety study of valcyte in pediatric heart transplant patients less than 4 months of age who received a single dose of valcyte oral solution on each of two consecutive days. a physiologically based pharmacokinetic (pbpk) model was developed based on the available pharmacokinetic data from pediatric and adult patients to support dosing in heart transplant patients less than 1 month of age. however, due to uncertainty in model predictions for neonates, valcyte is not indicated for prophylaxis in this age group. the safety and efficacy of valcyte for oral solution and tablets have not been established in children for prevention of cmv disease in pediatric liver transplant patients, in kidney transplant patients less than 4 months of age, in heart transplant patients less than 1 month of age, in pediatric aids patients with cmv retinitis, and in infants with congenital cmv infection. a pharmacokinetic and pharmacodynamic evaluation of valcyte for oral solution was performed in 24 neonates with congenital cmv infection involving the central nervous system. all patients were treated for 6 weeks with a combination of intravenous ganciclovir 6 mg per kg twice daily or valcyte for oral solution at doses ranging from 14 mg per kg to 20 mg per kg twice daily. the pharmacokinetic results showed that in infants greater than 7 days to 3 months of age, a dose of 16 mg per kg twice daily of valcyte for oral solution provided ganciclovir systemic exposures (median auc0-12h =23.6 [range 16.8–35.5] mcg∙ h/ml; n=6) comparable to those obtained in infants up to 3 months of age from a 6 mg per kg dose of intravenous ganciclovir twice daily (auc0-12h =25.3 [range 2.4–89.7] mcg∙ h/ml; n=18) or to the ganciclovir systemic exposures obtained in adults from a 900 mg dose of valcyte tablets twice daily. however, the efficacy and safety of intravenous ganciclovir and of valcyte have not been established for the treatment of congenital cmv infection in infants and no similar disease occurs in adults; therefore, efficacy cannot be extrapolated from intravenous ganciclovir use in adults. studies of valcyte for oral solution or tablets have not been conducted in adults older than 65 years of age. clinical studies of valcyte did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 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. valcyte is known to be substantially excreted by the kidneys, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because renal clearance decreases with age, valcyte should be administered with consideration of their renal status. renal function should be monitored and dosage adjustments should be made accordingly [see dosage and administration (2.5), warnings and precautions (5.2), use in specific populations (8.6), clinical pharmacology (12.3)]. dose reduction is recommended when administering valcyte to patients with renal impairment [see dosage and administration (2.5), warnings and precautions (5.2), clinical pharmacology (12.3)] . for adult patients on hemodialysis (crcl less than 10 ml/min), valcyte tablets should not be used. adult hemodialysis patients should use ganciclovir in accordance with the dose-reduction algorithm cited in the cytovene® -iv complete product information section on dosage and administration: renal impairment [see dosage and administration (2.5) and clinical pharmacology (12.3)]. the safety and efficacy of valcyte have not been studied in patients with hepatic impairment. be sure that you read, and that you understand and follow these instructions carefully to ensure proper dosing of the oral solution. important: - avoid contact with your skin or eyes. if you come in contact with the contents of the oral solution, wash your skin well with soap and water or rinse your eyes well with plain water. - do not use valcyte for oral solution after the discard date on the bottle. - always use the oral dispenser provided to give or take a dose of valcyte for oral solution. - call your pharmacist if your oral dispenser is lost or damaged, and they will tell you how to continue to give or take a dose of valcyte for oral solution. - ask your healthcare provider or pharmacist to show you how to measure your prescribed dose. to take a dose of valcyte for oral solution, you will need the bottle of medicine and an oral dispenser provided with the medicine (see figure 1) . your pharmacist inserts the bottle adapter in the valcyte for oral solution bottle. - place the tip of the oral dispenser in the mouth. - slowly push down the oral dispenser plunger until the oral dispenser is empty. - remove the plunger from the oral dispenser barrel by pulling the plunger all the way out of the barrel. - rinse the oral dispenser barrel and plunger with water and let them air dry. - when the oral dispenser barrel and plunger are dry, put the plunger back into the oral dispenser barrel for the next use. how should i store valcyte for oral solution? - store solution in the refrigerator at 36°f to 46°f (2°c to 8°c) for no longer than 49 days. - do not freeze. this patient information and instructions for use have been approved by the u.s. food and drug administration. valcyte is a registered trademark of hoffmann-la roche inc. distributed by: genentech usa, inc. a member of the roche group 1 dna way south san francisco, ca 94080-4990 revised: 10/2020 for more information, go to www.valcyte.com or call 1-888-835-2555. © 2020 genentech, inc. all rights reserved.

美国 - 英文 - NLM (National Library of Medicine)

pradaxa- dabigatran etexilate mesylate capsule

rebel distributors corp - dabigatran etexilate mesylate (unii: sc7nuw5iit) (dabigatran etexilate - unii:2e18wx195x) - dabigatran etexilate 150 mg - pradaxa is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. pradaxa is contraindicated in patients with: - active pathological bleeding [see warnings and precautions (5.1) and adverse reactions (6.1)] . - history of a serious hypersensitivity reaction to pradaxa (e.g., anaphylactic reaction or anaphylactic shock) [see adverse reactions (6.1)] . there are no adequate and well-controlled studies in pregnant women. dabigatran has been shown to decrease the number of implantations when male and female rats were treated at a dosage of 70 mg/kg (about 2.6 to 3.0 times the human exposure at maximum recommended human dose [mrhd] of 300 mg/day based on area under the curve [auc] comparisons) prior to mating and up to implantation (gestation day 6). treatment of pregnant rats after implantation with dabigatran at the same dose increased the number of dead offspring and caused excess vaginal/uterine bleeding close to parturition. although dabigatran incr

美国 - 英文 - NLM (National Library of Medicine)

ga-68-dotatoc- edotreotide gallium ga-68 injection, solution

uihc – p e t imaging center - edotreotide gallium ga-68 (unii: y68179sy2l) (edotreotide gallium ga-68 - unii:y68179sy2l) - ga 68 dotatoc injection is indicated for use with positron emission tomography (pet) for the localization of somatostatin receptor positive neuroendocrine tumors (nets) in adult and pediatric patients. none risk summary there are no available data on the use of ga 68 dotatoc injection in pregnant women to identify a risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with ga 68 dotatoc. however, all radiopharmaceuticals, including ga 68 dotatoc injection have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. if considering ga 68 dotatoc injection administration to a pregnant woman, inform the patient of the potential for adverse pregnancy outcomes based on the radiation dose from ga 68 dotatoc injection and the gestational timing of exposure. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregn