New Zealand - English - Ministry for Primary Industries

arxada nz limited - metribuzin - metribuzin 500 g/litre - herbicide

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

jazz pharmaceuticals, inc. - cannabidiol (unii: 19gbj60sn5) (cannabidiol - unii:19gbj60sn5) - epidiolex is indicated for the treatment of seizures associated with lennox-gastaut syndrome (lgs), dravet syndrome (ds), or tuberous sclerosis complex (tsc) in patients 1 year of age and older. epidiolex is contraindicated in patients with a history of hypersensitivity to cannabidiol or any of the ingredients in the product [see description (11) and warnings and precautions (5.4)].   pregnancy surveillance program and pregnancy exposure registry there are two programs, an epidiolex pregnancy surveillance program and an antiepileptic drug (aed) pregnancy exposure registry, that monitor pregnancy outcomes.  encourage women who are taking epidiolex during pregnancy to enroll in both, by calling the toll free numbers or visiting the websites below: risk summary there are no adequate data on the developmental risks associated with the use of epidiolex in pregnant women.  administration of cannabidiol to pregnant animals produced evidence of developmental toxicity (increased embryofetal mortality in rats and decreased fetal body weights in rabbits; decreased growth, delayed sexual maturation, long-term neurobehavioral changes, and adverse effects on the reproductive system in rat offspring) at maternal plasma exposures similar to (rabbit) or greater than (rat) that in humans at therapeutic doses (see animal data).   in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. the background risks of major birth defects and miscarriage for the indicated populations are unknown. data animal data oral administration of cannabidiol (0, 75, 150, or 250 mg/kg/day) to pregnant rats throughout the period of organogenesis resulted in embryofetal mortality at the highest dose tested.  there were no other drug-related maternal or developmental effects.  the highest no-effect dose for embryofetal toxicity in rats was associated with maternal plasma cannabidiol exposures (auc) approximately 16 and 9 times that in humans at the recommended human doses (rhd) of 20 and 25 mg/kg/day, respectively. oral administration of cannabidiol (0, 50, 80, or 125 mg/kg/day) to pregnant rabbits throughout organogenesis resulted in decreased fetal body weights and increased fetal structural variations at the highest dose tested, which was also associated with maternal toxicity.  maternal plasma cannabidiol exposures at the no-effect level for embryofetal developmental toxicity in rabbits were less than that in humans at the rhds. when cannabidiol (75, 150, or 250 mg/kg/day) was orally administered to rats throughout pregnancy and lactation, decreased growth, delayed sexual maturation, neurobehavioral changes (decreased activity), and adverse effects on male reproductive organ development (small testes in adult offspring) and fertility were observed in the offspring at the mid and high dose.  these effects occurred in the absence of maternal toxicity.  the no-effect dose for pre- and post-natal developmental toxicity in rats was associated with maternal plasma cannabidiol exposures approximately 9 and 5 times that in humans at the rhds of 20 and 25 mg/kg/day, respectively. risk summary there are no data on the presence of cannabidiol or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.  the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for epidiolex and any potential adverse effects on the breastfed infant from epidiolex or from the underlying maternal condition. safety and effectiveness of epidiolex for the treatment of seizures associated with lgs, ds, or tsc have been established in patients 1 year of age and older.  the use of epidiolex in these indications is supported by adequate and well-controlled studies in patients 2 years of age and older with lgs and ds and in patients 1 year of age and older with tsc [see clinical studies (14.1, 14.2, 14.3)]. safety and effectiveness of epidiolex in pediatric patients below 1 year of age have not been established. juvenile animal data administration of cannabidiol (subcutaneous doses of 0 or 15 mg/kg on postnatal days (pnds) 4-6 followed by oral administration of 0, 100, 150, or 250 mg/kg on pnds 7-77) to juvenile rats for 10 weeks resulted in increased body weight, delayed male sexual maturation, neurobehavioral effects (decreased locomotor activity and auditory startle habituation), increased bone mineral density, and liver hepatocyte vacuolation.  a no-effect dose was not established.  the lowest dose causing developmental toxicity in juvenile rats (15 sc/100 po mg/kg) was associated with cannabidiol exposures (auc) approximately 15 and 8 times that in humans at the rhds of 20 and 25 mg/kg/day, respectively. clinical trials of epidiolex in the treatment of lgs, ds, and tsc did not include a sufficient number of patients aged above 55 years to determine whether or not they respond differently from younger patients.  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 [see dosage and administration (2.6), warnings and precautions (5.1), and clinical pharmacology (12.3)] . because of an increase in exposure to epidiolex, dosage adjustments are necessary in patients with moderate or severe hepatic impairment [see dosage and administration (2.6), warnings and precautions (5.1), and clinical pharmacology (12.3)] .  epidiolex does not require dosage adjustments in patients with mild hepatic impairment. epidiolex is not a controlled substance. animal abuse-related studies show that cannabidiol does not produce cannabinoid-like behavioral responses, including generalization to delta-9-tetrahydrocannabinol (thc) in a drug discrimination study. cannabidiol also does not produce animal self-administration, suggesting it does not produce rewarding effects.  in a human abuse potential study, acute administration of cannabidiol to non-dependent adult recreational drug users at therapeutic and supratherapeutic doses of 750, 1500, and 4500 mg in the fasted state (equivalent respectively to 10, 20, and 60 mg/kg in a 75 kg adult) produced responses on positive subjective measures such as drug liking and take drug again that were within the acceptable placebo range.  in contrast, 10 and 30 mg of dronabinol (synthetic thc) and 2 mg alprazolam produced large increases on positive subjective measures compared to placebo that were statistically significantly greater than those produced by cannabidiol.  in other phase 1 clinical studies conducted with cannabidiol, there were no reports of abuse-related adverse events. in a human physical dependence study, administration of cannabidiol 1500 mg/day (750 mg twice daily) to adults for 28 days did not produce signs or symptoms of withdrawal over a 6-week assessment period  beginning three days after drug discontinuation.  this suggests that cannabidiol likely does not produce physical dependence. instructions for use epidiolex® (eh-peh-dye-oh-lex) (cannabidiol) oral solution 100 mg/ml be sure that you read, understand and follow these instructions carefully to ensure proper dosing of the oral solution. important: each package contains: child-resistant cap 2 bottle adapters 1 bottle of epidiolex oral solution (100 mg/ml) 2  reusable 1 ml oral syringes and 2 reusable 5 ml oral syringes: if your dose of epidiolex is 1 ml or less , use the 1 ml syringes to take your medicine. for each syringe size:                            note: if you lose or damage an oral syringe, or cannot read the markings, use the spare syringe. prepare the bottle- to use epidiolex for the first time              note: do not remove the bottle adapter from the bottle after it is inserted. prepare the dose your healthcare provider will tell you how much epidiolex to take or give.               dose                                                                     how to measure                1 ml or less                                                           use the 1 ml oral syringe 1 time                more than 1 ml and less than 5 ml                        use the 5 ml oral syringe 1 time                more than 5 ml                                                     use the 5 ml oral syringe more than 1 time              line up the end of the plunger with the marking for your dose of epidiolex.                if there are air bubbles in the oral syringe, keep the bottle upside down and push the plunger so that all of the                liquid flows back into the bottle. repeat step 5 until the air bubbles are gone. give epidiolex              do not forcefully push on the plunger.              do not direct the medicine to the back of the mouth or throat. this may cause choking.              if the dose of epidiolex prescribed by the healthcare provider is more than 5 ml, repeat steps 4 through 8  to complete the dose.                 for example:                 if your dose of epidiolex is 8 ml, withdraw 5 ml of medicine into the syringe and give the medicine.                 insert the tip of the oral syringe back into the bottle adapter and withdraw 3 ml of medicine. give the                 medicine to receive a total dose of 8 ml. clean up                do not remove the bottle adapter. the cap will fit over it.                do not wash the oral syringe in the dishwasher.           do not throw away the oral syringe. how should i store epidiolex? helpline details for additional assistance, call the toll-free helpline at 1-833-426-4243. hours: monday-friday                                       08:00am – 08:00pm est frequently asked questions q:  what if there are air bubbles in the oral syringe? a:   push the liquid back into the bottle and repeat step 5 until the air bubbles are gone. q:  what should i do if the liquid in the bottle has turned cloudy? a:  the liquid in the bottle may turn cloudy if water gets in the bottle. this does not change the safety or how well the medicine works. continue to use the cloudy liquid as prescribed by your healthcare provider. always make sure the oral syringes are completely dry before each use. q:  what should i do if the oral syringe is not completely dry before use? a:  if the oral syringe is not completely dry, use the spare syringe provided in the pack.  distributed by: jazz pharmaceuticals, inc. palo alto, ca 94304 epidiolex® is a registered trademark of jazz pharmaceuticals plc or its subsidiaries. © 2023 jazz pharmaceuticals, inc. this instructions for use has been approved by the u.s. food and drug administration. revised: 01/2023

Australia - English - Department of Health (Therapeutic Goods Administration)

jazz pharmaceuticals anz pty ltd - defibrotide, quantity: 200 mg - injection, concentrated - excipient ingredients: hydrochloric acid; sodium citrate dihydrate; sodium hydroxide; water for injections - defitelio is indicated for the treatment of severe hepatic veno-occlusive disease (vod) also known as sinusoidal obstruction syndrome (sos) in haematopoietic stem-cell transplantation (hsct) therapy.,it is indicated in adults and in adolescents, children and infants of 1 month of age and above.

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

jazz pharmaceuticals, inc. - solriamfetol (unii: 939u7c91ai) (solriamfetol - unii:939u7c91ai) - sunosi is indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (osa) [see clinical studies (14)]. limitations of use sunosi is not indicated to treat the underlying airway obstruction in osa. ensure that the underlying airway obstruction is treated (e.g., with continuous positive airway pressure (cpap)) for at least one month prior to initiating sunosi for excessive daytime sleepiness. modalities to treat the underlying airway obstruction should be continued during treatment with sunosi. sunosi is not a substitute for these modalities. sunosi is contraindicated in patients receiving concomitant treatment with monoamine oxidase (mao) inhibitors, or within 14 days following discontinuation of monoamine oxidase inhibitor, because of the risk of hypertensive reaction [see drug interactions (7.1)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to sunosi during pregnancy. healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-877-283-6220 or contacting the company at www.sunosipregnancyregistry.com. risk summary available data from case reports are not sufficient to determine drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproductive studies, oral administration of solriamfetol during organogenesis caused maternal and fetal toxicities in rats and rabbits at doses ≥ 4 and 5 times and was teratogenic at doses 19 and ≥ 5 times, respectively, the maximum recommended human dose (mrhd) of 150 mg based on mg/m2 body surface area. oral administration of solriamfetol to pregnant rats during pregnancy and lactation at doses ≥ 7 times the mrhd based on mg/m2 body surface area resulted in maternal toxicity and adverse effects on fertility, growth, and development in offspring (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 risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. data animal data solriamfetol was administered orally to pregnant rats during the period of organogenesis at 15, 67, and 295 mg/kg/day, which are approximately 1, 4, and 19 times the mrhd based on mg/m2 body surface area. solriamfetol at ≥ 4 times the mrhd caused maternal toxicity that included hyperactivity, significant decreases in body weight, weight gain, and food consumption. fetal toxicity at these maternally toxic doses included increased incidence of early resorption and post-implantation loss, and decreased fetal weight. solriamfetol was teratogenic at 19 times the mrhd; it increased the incidence of fetal malformations that included severe sternebrae mal-alignment, hindlimb rotation, bent limb bones, and situs inversus. this dose was also maternally toxic. the no-adverse-effect level for malformation is 4 times and for maternal and embryofetal toxicity is approximately 1 times the mrhd based on mg/m2 body surface area. solriamfetol was administered orally to pregnant rabbits during the period of organogenesis at 17, 38, and 76 mg/kg/day, which are approximately 2, 5, and 10 times the mrhd based on mg/m2 body surface area. solriamfetol at 10 times the mrhd caused maternal toxicity of body weight loss and decreased food consumption. solriamfetol was teratogenic at ≥ 5 times the mrhd, it caused fetal skeletal malformation (slight-to-moderate sternebrae mal-alignment) and decreased fetal weight. the no-adverse-effect level for malformation and fetal toxicity is approximately 2 times and for maternal toxicity is approximately 5 times the mrhd based on mg/m2 body surface area. solriamfetol was administered orally to pregnant rats during the period of organogenesis from gestation day 7 through lactation day 20 post-partum, at 35, 110, and 350 mg/kg/day, which are approximately 2, 7, and 22 times the mrhd based on mg/m2 body surface area. at ≥ 7 times the mrhd, solriamfetol caused maternal toxicity that included decreased body weight gain, decreased food consumption, and hyperpnea. at these maternally toxic doses, fetal toxicity included increased incidence of stillbirth, postnatal pup mortality, and decreased pup weight. developmental toxicity in offspring after lactation day 20 included decreased body weight, decreased weight gain, and delayed sexual maturation. mating and fertility of offspring were decreased at maternal doses 22 times the mrhd without affecting learning and memory. the no-adverse-effect level for maternal and developmental toxicity is approximately 2 times the mrhd based on mg/m2 body surface area. risk summary there are no data available on the presence of solriamfetol or its metabolites in human milk, the effects on the breastfed infant, or the effect of this drug on milk production. solriamfetol is present in rat milk. when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for sunosi and any potential adverse effects on the breastfed child from sunosi or from the underlying maternal condition. clinical considerations monitor breastfed infants for adverse reactions, such as agitation, insomnia, anorexia and reduced weight gain. safety and effectiveness in pediatric patients have not been established. clinical studies of sunosi in pediatric patients have not been conducted. of the total number of patients in the narcolepsy and osa clinical studies treated with sunosi, 13% (123/930) were 65 years of age or over. no clinically meaningful differences in safety or effectiveness were observed between elderly and younger patients. solriamfetol is predominantly eliminated by the kidney. because elderly patients are more likely to have decreased renal function, dosing may need to be adjusted based on egfr in these patients. consideration should be given to the use of lower doses and close monitoring in this population [see dosage and administration (2.5)] . dosage adjustment is not required for patients with mild renal impairment (egfr 60‑89 ml/min/1.73 m2 ). dosage adjustment is recommended for patients with moderate to severe renal impairment (egfr 15‑59 ml/min/1.73 m2 ). sunosi is not recommended for patients with end stage renal disease (egfr <15 ml/min/1.73 m2 ) [see dosage and administration (2.5), warnings and precautions (5.1, 5.2), clinical pharmacology (12.3)] . sunosi contains solriamfetol, a schedule iv controlled substance. sunosi has potential for abuse. abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. the abuse potential of sunosi 300 mg, 600 mg, and 1200 mg (two, four, and eight times the maximum recommended dose, respectively) was assessed relative to phentermine, 45 mg and 90 mg, (a schedule iv controlled substance) in a human abuse potential study in individuals experienced with the recreational use of stimulants. results from this clinical study demonstrated that sunosi produced drug liking scores similar to or lower than phentermine. in this crossover study, elevated mood was reported by 2.4% of placebo‑treated subjects, 8 to 24% of sunosi‑treated subjects, and 10 to 18% of phentermine‑treated subjects. a ‘feeling of relaxation’ was reported in 5% of placebo-treated subjects, 5 to 19% of sunosi‑treated subjects and 15 to 20% of phentermine-treated subjects. physicians should carefully evaluate patients for a recent history of drug abuse, especially those with a history of stimulant (e.g., methylphenidate, amphetamine, or cocaine) or alcohol abuse, and follow such patients closely, observing them for signs of misuse or abuse of sunosi (e.g., incrementation of doses, drug-seeking behavior). in a long-term safety and maintenance of efficacy study, the effects of abrupt discontinuation of sunosi were evaluated following at least 6 months of sunosi use in patients with narcolepsy or osa. the effects of abrupt discontinuation of sunosi were also evaluated during the two-week safety follow‑up periods in the phase 3 studies. there was no evidence that abrupt discontinuation of sunosi resulted in a consistent pattern of adverse events in individual subjects that was suggestive of physical dependence or withdrawal.

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

jazz pharmaceuticals, inc. - lurbinectedin (unii: 2cn60tn6zs) (lurbinectedin - unii:2cn60tn6zs) - zepzelca is indicated for the treatment of adult patients with metastatic small cell lung cancer (sclc) with disease progression on or after platinum-based chemotherapy. this indication is approved under accelerated approval based on overall response rate and duration of response [see clinical studies (14) ] . continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). none. risk summary based on animal data and its mechanism of action [see clinical pharmacology (12.1)] , zepzelca can cause fetal harm when administered to a pregnant woman. there are no available data to inform the risk of zepzelca use in pregnant women. intravenous administration of a single lurbinectedin dose (approximately 0.2 times the 3.2 mg/m2 clinical dose) to pregnant rats during the period of organogenesis caused embryolethality (see data) . advise pregnant women of the potential risk to a fetus. the estimated background risk of major birth defects and mi

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

jazz pharmaceuticals, inc. - sodium oxybate (unii: 7g33012534) (oxybate - unii:30iw36w5b2), calcium oxybate (unii: 8w24syd6zi) (oxybate - unii:30iw36w5b2), potassium oxybate (unii: s8nkf3h3kt) (oxybate - unii:30iw36w5b2), magnesium oxybate (unii: g983hlv265) (oxybate - unii:30iw36w5b2) - xywav is indicated for the treatment of cataplexy or excessive daytime sleepiness (eds) in patients 7 years of age and older with narcolepsy. xywav is indicated for the treatment of idiopathic hypersomnia (ih) in adults. xywav is contraindicated for use in: risk summary there are no adequate data on the developmental risk associated with the use of xywav or sodium oxybate in pregnant women. oral administration of sodium oxybate to pregnant rats (0, 150, 350, or 1,000 mg/kg/day) or rabbits (0, 300, 600, or 1,200 mg/kg/day) throughout organogenesis produced no clear evidence of developmental toxicity; however, oral administration to rats throughout pregnancy and lactation resulted in increased stillbirths and decreased offspring postnatal viability and growth, at a clinically relevant dose [see data] . 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. the background risk of major birth defec

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

jazz pharmaceuticals, inc. - betaine, anhydrous (unii: 3scv180c9w) (betaine, anhydrous - unii:3scv180c9w) - powder, for solution - 180 g in 1 g - cystadane (betaine anhydrous for oral solution) is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood levels. included within the category of homocystinuria are deficiencies or defects in: - cystathionine beta-synthase (cbs), - 5,10-methylenetetrahydrofolate reductase (mthfr), - cobalamin cofactor metabolism (cbl ). patient response to cystadane can be monitored by homocysteine plasma levels (see dosage and administration). response usually occurs within a week and steady state within a month. cystadane has been administered concomitantly with vitamin b6 (pyridoxine), vitamin b12 (cobalamin), and folate.

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

jazz pharmaceuticals, inc. - sodium oxybate (unii: 7g33012534) (4-hydroxybutanoic acid - unii:30iw36w5b2) - sodium oxybate 0.5 g in 1 ml - xyrem is indicated for the treatment of cataplexy or excessive daytime sleepiness (eds) in patients 7 years of age and older with narcolepsy. xyrem is contraindicated for use in: risk summary there are no adequate data on the developmental risk associated with the use of sodium oxybate in pregnant women. oral administration of sodium oxybate to pregnant rats (150, 350, or 1,000 mg/kg/day) or rabbits (300, 600, or 1,200 mg/kg/day) throughout organogenesis produced no clear evidence of developmental toxicity; however, oral administration to rats throughout pregnancy and lactation resulted in increased stillbirths and decreased offspring postnatal viability and growth, at a clinically relevant dose [see data] . 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. the background risk of major birth defects and miscarriage for the indicated population is unknown. clinical considerations labor or d

Ireland - English - HPRA (Health Products Regulatory Authority)

jazz pharmaceuticals france sas - cristanspase - powder for solution for injection - 10000  international unit(s) - other antineoplastic agents; asparaginase

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

jazz pharmaceuticals uk - defibrotide - solution for infusion - 80mg/1ml