Spojené státy - angličtina - NLM (National Library of Medicine)

general injectables & vaccines - lidocaine hydrochloride (unii: v13007z41a) (lidocaine - unii:98pi200987), epinephrine (unii: ykh834o4bh) (epinephrine - unii:ykh834o4bh) - lidocaine hydrochloride anhydrous 20 mg in 1 ml - lidocaine hydrochloride and epinephrine injection, usp is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection, by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed. lidocaine hcl is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

Spojené státy - angličtina - NLM (National Library of Medicine)

sciegen pharmaceuticals inc - pramipexole dihydrochloride (unii: 3d867np06j) (pramipexole - unii:83619peu5t) - pramipexole dihydrochloride 0.125 mg - pramipexole dihydrochloride tablets are indicated for the treatment of parkinson’s disease. pramipexole dihydrochloride tablets are indicated for the treatment of moderate-to-severe primary restless legs syndrome (rls). none. risk summary there are no adequate data on the developmental risk associated with the use of pramipexole in pregnant women. no adverse developmental effects were observed in animal studies in which pramipexole was administered to rabbits during pregnancy. effects on embryofetal development could not be adequately assessed in pregnant rats; however, postnatal growth was inhibited at clinically relevant exposures [see data]. in the u.s. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data oral administration of pramipexo

Spojené státy - angličtina - NLM (National Library of Medicine)

golden state medical supply, inc. - pramipexole dihydrochloride (unii: 3d867np06j) (pramipexole - unii:83619peu5t) - pramipexole dihydrochloride 0.125 mg - pramipexole dihydrochloride tablets are indicated for the treatment of parkinson’s disease. pramipexole dihydrochloride tablets are indicated for the treatment of moderate-to-severe primary restless legs syndrome (rls). none. risk summary there are no adequate data on the developmental risk associated with the use of pramipexole in pregnant women. no adverse developmental effects were observed in animal studies in which pramipexole was administered to rabbits during pregnancy. effects on embryofetal development could not be adequately assessed in pregnant rats; however, postnatal growth was inhibited at clinically relevant exposures [see data]. in the u.s. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data oral administration of pramipexole (0.1, 0.5, or 1.5 mg/kg/day) to pregnant rats during the period of organogenesis resulted in a high incidence of total resorption of embryos at the highest dose tested. this increase in embryolethality is thought to result from the prolactin-lowering effect of pramipexole; prolactin is necessary for implantation and maintenance of early pregnancy in rats but not in rabbits or humans. because of pregnancy disruption and early embryonic loss in this study, the teratogenic potential of pramipexole could not be adequately assessed in rats. the highest no-effect dose for embryolethality in rats was associated with maternal plasma drug exposures (auc) approximately equal to those in humans receiving the maximum recommended human dose (mrhd) of 4.5 mg/day. there were no adverse effects on embryo-fetal development following oral administration of pramipexole (0.1, 1, or 10 mg/kg/day) to pregnant rabbits during organogenesis (plasma auc up to approximately 70 times that in humans at the mrhd). postnatal growth was inhibited in the offspring of rats treated with pramipexole (0.1, 0.5, or 1.5 mg/kg/day) during the latter part of pregnancy and throughout lactation. the no-effect dose for adverse effects on offspring growth (0.1 mg/kg/day) was associated with maternal plasma drug exposures lower than that in humans at the mrhd. risk summary there are no data on the presence of pramipexole in human milk, the effects of pramipexole on the breastfed infant, or the effects of pramipexole on milk production. however, inhibition of lactation is expected because pramipexole inhibits secretion of prolactin in humans. pramipexole or metabolites, or both, are present in rat milk [see data]. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for pramipexole and any potential adverse effects on the breastfed infant from pramipexole or from the underlying maternal condition. data in a study of radio-labeled pramipexole, pramipexole or metabolites, or both, were present in rat milk at concentrations three to six times higher than those in maternal plasma. safety and effectiveness of pramipexole dihydrochloride tablets in pediatric patients has not been established. pramipexole total oral clearance is approximately 30% lower in subjects older than 65 years compared with younger subjects, because of a decline in pramipexole renal clearance due to an age-related reduction in renal function. this resulted in an increase in elimination half-life from approximately 8.5 hours to 12 hours. in clinical studies with parkinson’s disease patients, 38.7% of patients were older than 65 years. there were no apparent differences in efficacy or safety between older and younger patients, except that the relative risk of hallucination associated with the use of pramipexole dihydrochloride tablets was increased in the elderly. in clinical studies with rls patients, 22% of patients were at least 65 years old. there were no apparent differences in efficacy or safety between older and younger patients. the elimination of pramipexole is dependent on renal function. pramipexole clearance is extremely low in dialysis patients, as a negligible amount of pramipexole is removed by dialysis. caution should be exercised when administering pramipexole dihydrochloride tablets to patients with renal disease [see dosage and administration ( 2.2), warnings and precautions ( 5.7) , and clinical pharmacology ( 12.3) ].

Spojené státy - angličtina - NLM (National Library of Medicine)

vensun pharmaceuticals, inc. - pramipexole dihydrochloride (unii: 3d867np06j) (pramipexole - unii:83619peu5t) - pramipexole dihydrochloride 0.125 mg - pramipexole dihydrochloride tablets are indicated for the treatment of parkinson’s disease. pramipexole dihydrochloride tablets are indicated for the treatment of moderate-to-severe primary restless legs syndrome (rls). none. risk summary there are no adequate data on the developmental risk associated with the use of pramipexole in pregnant women. no adverse developmental effects were observed in animal studies in which pramipexole was administered to rabbits during pregnancy. effects on embryofetal development could not be adequately assessed in pregnant rats; however, postnatal growth was inhibited at clinically relevant exposures [see data]. in the u.s. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data oral administration of pramipexole (0.1, 0.5, or 1.5 mg/kg/day)

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - remifentanil hydrochloride, quantity: 5.485 mg (equivalent: remifentanil, qty 5 mg) - injection, powder for - excipient ingredients: glycine; hydrochloric acid - remifentanil viatris for injection is indicated * as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical procedures including cardiac surgery in adults.. * as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical but not cardiac procedures in children aged 1 to 12 years.. * for continuation as an analgesic into the immediate post-operative period under the close supervision of medically qualified persons trained in the use of anaesthetic drugs, during transition to longer acting analgesia following adult cardiac surgery - when endotracheal intubation and controlled ventilation are anticipated.. * for provision of analgesia and sedation in mechanically ventilated intensive care patients.

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - remifentanil hydrochloride, quantity: 2.194 mg (equivalent: remifentanil, qty 2 mg) - injection, powder for - excipient ingredients: glycine; hydrochloric acid - remifentanil viatris for injection is indicated * as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical procedures including cardiac surgery in adults.. * as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical but not cardiac procedures in children aged 1 to 12 years.. * for continuation as an analgesic into the immediate post-operative period under the close supervision of medically qualified persons trained in the use of anaesthetic drugs, during transition to longer acting analgesia following adult cardiac surgery - when endotracheal intubation and controlled ventilation are anticipated.. * for provision of analgesia and sedation in mechanically ventilated intensive care patients.

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - remifentanil hydrochloride, quantity: 1.097 mg (equivalent: remifentanil, qty 1 mg) - injection, powder for - excipient ingredients: hydrochloric acid; glycine - remifentanil viatris for injection is indicated * as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical procedures including cardiac surgery in adults.. * as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical but not cardiac procedures in children aged 1 to 12 years.. * for continuation as an analgesic into the immediate post-operative period under the close supervision of medically qualified persons trained in the use of anaesthetic drugs, during transition to longer acting analgesia following adult cardiac surgery - when endotracheal intubation and controlled ventilation are anticipated.. * for provision of analgesia and sedation in mechanically ventilated intensive care patients.

Spojené státy - angličtina - NLM (National Library of Medicine)

mckesson packaging services business unit of mckesson corporation - lidocaine hydrochloride anhydrous (unii: ec2cnf7xfp) (lidocaine - unii:98pi200987), epinephrine (unii: ykh834o4bh) (epinephrine - unii:ykh834o4bh) - lidocaine hydrochloride anhydrous 10 mg in 1 ml - lidocaine hydrochloride and epinephrine injection, usp is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection, by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed. lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

Spojené státy - angličtina - NLM (National Library of Medicine)

us medsource, llc - lidocaine hydrochloride anhydrous (unii: ec2cnf7xfp) (lidocaine - unii:98pi200987), epinephrine (unii: ykh834o4bh) (epinephrine - unii:ykh834o4bh) - lidocaine hydrochloride anhydrous 10 mg in 1 ml - lidocaine hydrochloride and epinephrine injection, usp is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection, by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed. lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

Spojené státy - angličtina - NLM (National Library of Medicine)

actavis pharma, inc. - trientine hydrochloride (unii: hc3nx54582) (trientine - unii:sj76y07h5f) - trientine hydrochloride 250 mg - trientine hydrochloride is indicated in the treatment of patients with wilson's disease who are intolerant of penicillamine. clinical experience with trientine hydrochloride is limited and alternate dosing regimens have not been well-characterized; all endpoints in determining an individual patient's dose have not been well defined. trientine hydrochloride and penicillamine cannot be considered interchangeable. trientine hydrochloride should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects. unlike penicillamine, trientine hydrochloride is not recommended in cystinuria or rheumatoid arthritis. the absence of a sulfhydryl moiety renders it incapable of binding cystine and, therefore, it is of no use in cystinuria. in 15 patients with rheumatoid arthritis, trientine hydrochloride was reported not to be effective in improving any clinical or biochemical parameter after 12 weeks of treatment. trientine hydrochloride is not indicated f