Bandaríkin - enska - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - iptacopan hydrochloride (unii: xw5ck7c6yh) (iptacopan - unii:8e05t07z6w) - fabhalta is indicated for the treatment of adults with paroxysmal nocturnal hemoglobinuria (pnh). fabhalta is contraindicated: - in patients with serious hypersensitivity to iptacopan or any of the excipients. - for initiation in patients with unresolved serious infection caused by encapsulated bacteria, including streptococcus pneumoniae, neisseria meningitidis, or haemophilus influenzae type b. risk summary available data from clinical trials with fabhalta use 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 untreated pnh in pregnancy (see clinical considerations) . the use of fabhalta in pregnant women or women planning to become pregnant may be considered following an assessment of the risks and benefits. in animal reproduction studies, oral administration of iptacopan to pregnant rats and rabbits during organogenesis at exposures 4 to 6-times the human exposure (based on auc) at the maximum recommended human dose (mrhd) of 200 mg twice daily did not induce embryo or fetal toxicity (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 major birth defects, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk pnh in pregnancy is associated with adverse maternal outcomes, including worsening cytopenias, thrombosis, infections, bleeding, miscarriages, increased maternal mortality, and adverse fetal outcomes, including fetal death and premature delivery. data animal data in an embryo-fetal development study in rats, oral administration of iptacopan during organogenesis did not cause embryo-fetal toxicity when given up to the highest dose of 1,000 mg/kg/day, which corresponds to 4-times the mrhd based on auc. in an embryo-fetal development study in rabbits, oral administration of iptacopan during organogenesis did not cause embryo-fetal toxicity when given up to the highest dose of 450 mg/kg/day, which corresponds to 6-times the mrhd based on auc. in a pre- and postnatal development study in rats, oral administration of iptacopan during gestation, parturition, and lactation did not cause adverse effects in offspring when given up to the highest dose of 1,000 mg/kg/day, which corresponds to 4-times the mrhd based on auc. risk summary there are no data on the presence of iptacopan or its metabolite in either human or animal milk, the effects on the breastfed child or on milk production. since many medicinal products are secreted into human milk, and because of the potential for serious adverse reactions in a breastfed child, breastfeeding should be discontinued during treatment and for 5 days after the final dose. safety and effectiveness in pediatric patients with pnh have not been established. there were 29 pnh patients 65 years of age and older in apply-pnh and appoint-pnh [see clinical studies (14)] . of the total number of fabhalta-treated patients during the 24-week treatment period in these studies, 21 (20.6%) were 65 years of age and older, while 7 (6.9%) were 75 years of age and older. clinical studies of fabhalta did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. the use of fabhalta is not recommended in patients with severe renal impairment (estimated glomerular filtration rate (egfr) < 30 ml/min/1.73 m2 ) with or without hemodialysis. no dose adjustment is required in patients with mild (egfr 60 to < 90 ml/min/1.73 m2 ) or moderate (egfr 30 to < 60 ml/min/1.73 m2 ) renal impairment [see clinical pharmacology (12.3)] . the use of fabhalta is not recommended in patients with severe hepatic impairment (child-pugh class c). no dose adjustment is required for patients with mild (child-pugh class a) or moderate (child-pugh class b) hepatic impairment [see clinical pharmacology (12.3)] .

Filippseyjar - enska - FDA (Food And Drug Administration)

euro-med laboratories phil., inc. - 20% mannitol - solution for iv injection - each 100 ml contains 20 q.s.

Sádi-Arabía - enska - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

pharmaceutical solution industries (psi), saudi arabia - dextrose - solution for injection - 20 %

Nýja-Sjáland - enska - Medsafe (Medicines Safety Authority)

max health limited - acetylcysteine 20%{relative} - concentrate for infusion - 20% w/v - active: acetylcysteine 20%{relative} excipient: disodium edetate sodium hydroxide - n-acetylcysteine is indicated for the treatment of paracetamol overdose in patients: · who present within 15 hours after an acute overdose with a plasma paracetamol level on or above a line joining points of 150mg/l at 4h and 20mg/l at 15h (see nomogram below) or · who have taken more than 200mg/kg or 10g (whichever is less) of sustained release paracetamol or have one of two serum paracetamol levels taken four hours apart on or above a line joining points of 150mg/l at 4h and 20mg/l at 15h (see nomogram below) or · who have taken an acute overdose of paracetamol with opiates or medicines with anticholinergic effects and have one of two serum paracetamol levels taken four hours apart on or above a line joining points of 150mg/l at 4h and 20mg/l at 15h (see nomogram below) or · where there is any doubt over the time of an acute overdose, irrespective of plasma paracetamol level or · who present more than 15 hours after an overdose with abnormal liver biochemistry (inr >1.3 and/or alt>150) or fulminant hepatic failure or · who have taken a staggered overdose irrespective of plasma paracetamol level. staggered is defined as an overdose of 200mg/kg or 10g (whichever is less) over a single 24 hour period or 150mg/kg of 6g (whichever is less) per 24 hour period for at least 48 hours.

Nýja-Sjáland - enska - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - albumin 200 g/l (albumin ex nz) - solution for infusion - 20% w/v - active: albumin 200 g/l (albumin ex nz) excipient: octanoate ions sodium water for injection - hypoproteinaemia in the acutely ill patient; albumex® 20 is administered when there are existing or anticipated clinical problems or complications from reduced oncotic pressure, and/or as an adjunct to diuretic therapy.

Nýja-Sjáland - enska - Medsafe (Medicines Safety Authority)

baxter healthcare ltd - mannitol 20% - solution for infusion - 20 % - active: mannitol 20% excipient: water for injection - osmitrol intravenous infusion can be used in - the promotion of diuresis, in the prevention and/or treatment of the oliguric phase of acute renal failure before irreversible renal failure becomes established;

Nýja-Sjáland - enska - Medsafe (Medicines Safety Authority)

link pharmaceuticals ltd - argipressin 20 pressor units/ml (7.5% overage added) - solution for injection - 20 pressor units/ml - active: argipressin 20 pressor units/ml (7.5% overage added) excipient: glacial acetic acid water for injection - pitressin is indicated for prevention and treatment of post-operative abdominal distention in abdominal radiography to dispel interfering gas shadows and in diabetes insipidus.

Nýja-Sjáland - enska - Medsafe (Medicines Safety Authority)

carsl consulting - podophyllum resin 20%{relative}; salicylic acid 25%{relative} - topical ointment - 20%/25% - active: podophyllum resin 20%{relative} salicylic acid 25%{relative} excipient: liquid paraffin yellow soft paraffin

Nýja-Sjáland - enska - Medsafe (Medicines Safety Authority)

fresenius kabi new zealand limited - structured triglycerides 200 g/l (64:36 ratio of long chain:medium chain triglycerides);  ;   - emulsion for infusion - 20% w/v - active: structured triglycerides 200 g/l (64:36 ratio of long chain:medium chain triglycerides)     excipient: egg lecithin glycerol nitrogen sodium hydroxide water for injection

Írland - enska - HPRA (Health Products Regulatory Authority)

imbat limited - buprenorphine - transdermal patch - 20 microgram per hour - oripavine derivatives; buprenorphine