Ավստրալիա - անգլերեն - APVMA (Australian Pesticides and Veterinary Medicines Authority)

4 farmers australia pty ltd - glyphosate present as the isopropylamine salt - soluble concentrate - glyphosate present as the isopropylamine salt glycine active 510.0 g/l - herbicide

Ավստրալիա - անգլերեն - APVMA (Australian Pesticides and Veterinary Medicines Authority)

sinochem international australia pty. ltd. - glyphosate present as the potassium salt - soluble concentrate - glyphosate present as the potassium salt glycine active 540.0 g/l - herbicide

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

molnlycke health care pty ltd - 58316 - synthetic polymer semi-permeable film dressing, wound-nonadherent - intended to protect fragile and sensitive skin and minimize risk of skin breakdown. it can be used as secondary dressing, fixating e.g. gauze or nonwoven swabs or as a landing zone for aggressive tapes to secure devices to skin. it can be used as a protective dressing over iv sites when the iv device is secured through adhesive tape or sutures.

Ավստրալիա - անգլերեն - APVMA (Australian Pesticides and Veterinary Medicines Authority)

titan ag pty ltd - 2,4-d present as the dimethylamine and diethanolamine sa - soluble concentrate - 2,4-d present as the dimethylamine and diethanolamine sa phenoxy acids-2,4-d active 700.0 g/l - herbicide

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

benuvia operations, llc - dronabinol (unii: 7j8897w37s) (dronabinol - unii:7j8897w37s) - syndros is indicated in adults for the treatment of: - anorexia associated with weight loss in patients with acquired immune deficiency syndrome (aids). - nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. syndros is contraindicated in patients: - with a history of a hypersensitivity reaction to dronabinol. reported hypersensitivity reactions to dronabinol include lip swelling, hives, disseminated rash, oral lesions, skin burning, flushing, throat tightness [see adverse reactions (6.2)] . - with a history of a hypersensitivity reaction to alcohol. - who are receiving, or have recently received, disulfiram- or metronidazole-containing products within 14 days [see warning and precautions (5.3)] . syndros contains 50% (w/w) dehydrated alcohol and 5.5% (w/w) propylene glycol. risk summary syndros, a synthetic cannabinoid containing alcohol, may cause fetal harm. avoid use of syndros in pregnant women. although there is little published data on the use of synthetic cannabinoids during pregnancy, use of cannabis (e.g., marijuana) and use of alcohol during pregnancy have been associated with adverse fetal/neonatal outcomes (see clinical considerations) . cannabinoids have been found in the umbilical cord blood from pregnant women who smoke cannabis. in animal reproduction studies, no teratogenicity was reported in mice administered dronabinol (delta-9-thc) at up to 30 times the mrhd (maximum recommended human doses) and up to 5 times the mrhd for patients with aids and cancer, respectively. similar findings were reported in pregnant rats administered dronabinol at up to 5 to 20 times the mrhd and 3 times the mrhd for patients with aids and cancer, respectively. decreased maternal weight gain and number of viable pups and increased fetal mortality and early resorptions were observed in both species at doses which induced maternal toxicity. in rats, maternal administration of dronabinol from pregnancy (implantation) through weaning was associated with maternal toxicity, including mortality of pups, and adverse developmental and neurodevelopmental effects on the pups at 2 to 20 times the mrhd for patients with aids and less than and up to 3.3 times the mrhd for patients with cancer. (see data) . the estimated background risk of major birth defects and miscarriage for the indicated populations are 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 to 4% and 15 to 20%, respectively. clinical considerations fetal/neonatal adverse reactions published studies suggest that during pregnancy, the use of cannabis, which includes thc, whether for recreational or medicinal purposes, may increase the risk of adverse fetal/neonatal outcomes including fetal growth restriction, low birth weight, preterm birth, small-for-gestational age, admission to the neonatal intensive care unit, and stillbirth. therefore, use of cannabis during pregnancy should be avoided. syndros contains alcohol. published studies have demonstrated that alcohol is associated with fetal harm including central nervous system abnormalities, behavioral disorders, and impaired intellectual development. avoid use of syndros in pregnant women. data human data delta-9-thc has been measured in the cord blood of some infants whose mothers reported prenatal use of cannabis, suggesting that dronabinol may cross the placenta to the fetus during pregnancy. the effects of delta-9-thc on the fetus are not known. animal data the recommended dose ranges for syndros in patients with aids and patients with cancer are designed to achieve the same systemic exposure ranges to delta-9-thc as with the recommended dose ranges for dronabinol capsules. therefore, animal to human dose multiples, as shown below, are based on the mrhds (maximum recommended human doses) for dronabinol capsules, instead of the mrhds for syndros, which are 15% lower. this approach for dose comparison between animals and humans is supported by the demonstrated difference in dronabinol bioavailability between syndros and dronabinol capsules. reproduction studies with dronabinol have been performed in mice at 15 to 450 mg/m2 , equivalent to 1 to 30 times the mrhd of 15 mg/m2 /day (dronabinol capsules) in patients with aids or 0.2 to 5 times the mrhd of 90 mg/m2 /day (dronabinol capsules) in patients with cancer, and in rats at 74 to 295 mg/m2 (equivalent to 5 to 20 times the mrhd of 15 mg/m2 /day in patients with aids or 0.8 to 3 times the mrhd of 90 mg/m2 /day in patients with cancer). these studies have revealed no evidence of teratogenicity due to delta-9-thc. at these dronabinol dosages in mice and rats, delta-9-thc decreased maternal weight gain and number of viable pups and increased fetal mortality and early resorptions. such effects were dose dependent and less apparent at lower doses that produced less maternal toxicity. review of published literature indicates that the endocannabinoid system plays a role in neurodevelopmental processes such as neurogenesis, migration, and synaptogenesis. exposure of pregnant rats to delta-9-thc (during and after organogenesis) may modulate these processes to result in abnormal patterns of neuronal connectivity and subsequent cognitive impairments in the offspring. nonclinical toxicity studies in pregnant rats and newborn pups have shown prenatal exposure to delta-9-thc that resulted in impairment of motor function, alteration in synaptic activity, and interference in cortical projection of neuron development in the offspring. prenatal exposure has shown effects on cognitive function such as learning, short- and long-term memory, attention, decreased ability to remember task, and ability to discriminate between novel and same objects. overall, prenatal exposure to delta-9-thc has resulted in significant and long-term changes in brain development, cognition, and behavior in rat offspring. in a pre- and post-natal developmental study, female rats administered dronabinol by oral gavage in a vehicle of medium chain triglycerides at doses of 5, 25 and 50 mg/kg/day (equivalent to 1.7, 10, and 20 times the mrhd for patients with aids and 0.33, 1.7, and 3.3 times the mrhd for patients with cancer, respectively, based on body surface area) from gestation day 6 (implantation) through lactation day 20 (weaning). maternal toxicity caused mortality of pups at and above 10 times the mrhd for patients with aids and 1.7 times the mrhd for patients with cancer. at 20 times the mrhd for patients with aids and 3.3 times the mrhd for patients with cancer, treatment with dronabinol was associated with an increase in the number of dams with 100% pup mortality on lactation days 1 to 4. at 2 and 10 times the mrhd for patients with aids and 0.33 and 1.7 times the mrhd for patients with cancer, dronabinol produced adverse effects on the offspring including delays in developmental landmark parameters (e.g., surface righting reflex, negative geotaxis, and air righting reflex), decreased fertility and pregnancy index, reduced ovary and uterus weights, decreased implantations and viable embryos, and increased post-implantation loss. neurological adverse effects such as piloerection, landing foot splay and an increase in the number of rears in open field were observed in offspring at 10 and 20 times the mrhd for patients with aids and 0.33 and 1.7 times the mrhd for patients with cancer. administration of dronabinol in 50% ethanol (used in the vehicle for syndos), was poorly tolerated in maternal animals. serious adverse signs of toxicity were observed in the control group (vehicle only) and in dronabinol-containing dose groups at 10 and 20 times the mrhd for patients with aids and 1.7 and 3.3 times the mrhd for patients with cancer, resulting in termination of all animals at the 50 mg/kg dose level prior to delivery of litters. these animal findings are difficult to interpret due to effects of alcohol in the vehicle. risk summary for mothers infected with the human immunodeficiency virus (hiv), the centers for disease control and prevention recommend that hiv-infected mothers not breastfeed their infants to avoid risking postnatal transmission of hiv. because of the potential for hiv transmission (in hiv-negative infants) and serious adverse reactions in a breastfed infant, instruct mothers not to breastfeed if they are receiving syndros. for mothers with nausea and vomiting associated with cancer chemotherapy, there are limited data on the presence of dronabinol in human milk, the effects on the breastfed infant, or the effects on milk production. the reported effects of inhaled cannabis transferred to the breastfeeding infant have been inconsistent and insufficient to establish causality. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for syndros and any potential adverse effects on the breastfed infant from syndros or from the underlying maternal condition. the safety and effectiveness of syndros have not been established in pediatric patients. pediatric patients may be more sensitive to neurological and psychoactive effects of syndros [see warnings and precautions ( 5.1)] . syndros contains the excipients 50% (w/w) dehydrated alcohol and 5.5% (w/w) propylene glycol. ethanol competitively inhibits the metabolism of propylene glycol, which may lead to elevated concentrations of propylene glycol. preterm neonates may be at increased risk of propylene glycol-associated adverse events due to diminished ability to metabolize propylene glycol, thereby, leading to accumulation [see warnings and precautions (5.7)] . clinical studies of dronabinol capsules in aids and cancer patients did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. elderly patients may be more sensitive to the neuropsychiatric and postural hypotensive effects of syndros [see warnings and precautions (5.1, 5.2)] . elderly patients with dementia are at increased risk for falls as a result of their underlying disease state, which may be exacerbated by the cns effects of somnolence and dizziness associated with syndros [see warnings and precautions (5.1)] . these patients should be monitored closely and placed on fall precautions prior to initiating syndros therapy. in antiemetic studies, no difference in efficacy was apparent in patients greater than 55 years of age compared to 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 falls, decreased hepatic, renal, or cardiac function, increased sensitivity to psychoactive effects, and of concomitant disease or other drug therapy [see dosage and administration (2.2, 2.3)] . published data suggest that systemic clearance of dronabinol may be reduced and concentrations may be increased in presence of cyp2c9 genetic polymorphism. monitoring for increased adverse reactions is recommended in patients known to carry genetic variants associated with diminished cyp2c9 function [see clinical pharmacology (12.5)] . syndros contains dronabinol oral solution, a schedule ii controlled substance. syndros contains dronabinol, the main psychoactive component in marijuana. ingestion of high doses of dronabinol increases the risk of psychiatric adverse reactions if abused or misused, while continued administration can lead to addiction. psychiatric adverse reactions may include psychosis, hallucinations, depersonalization, mood alteration, and paranoia. in vitro studies demonstrate that syndros can be easily and effectively abused without manipulation. syndros contains 50% (w/w) dehydrated alcohol [see warning and precautions ( 5.5)] . in a randomized, single-dose, double-blind, placebo- and active-controlled crossover pharmacodynamic study of 43 experienced marijuana smokers, “drug liking” responses and safety of syndros were compared with placebo and dronabinol in sesame oil oral capsules. treatment arms were 10 mg and 30 mg dronabinol capsules, 10 mg and 30 mg dronabinol from syndros, and placebo oral solution and capsules. greater “drug liking” scores were reported with the 30 mg dose, compared with the 10 mg dose, for both syndros and dronabinol-containing capsules. overall, the pharmacodynamic results from this study demonstrated no statistically significant differences in various measures of drug liking for the doses taken, though the syndros results were consistently greater than those of dronabinol capsules. similarly, observed adverse reactions were greater for syndros. the pharmacodynamic and safety effects of syndros following multiple doses have not been evaluated. patients should be instructed to keep syndros in a secure place out of reach of others for whom the medication has not been prescribed. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use. physical dependence manifests by drug class-specific withdrawal symptoms after abrupt discontinuation or a significant dose reduction of a drug. the appearance of a withdrawal syndrome when administration of the drug is terminated is the only actual evidence of physical dependence. physical dependence can develop during chronic therapy with syndros and develops after chronic abuse of marijuana. a withdrawal syndrome was reported after the abrupt discontinuation of dronabinol capsules in subjects receiving dosages of 210 mg per day for 12 to 16 consecutive days. within 12 hours after discontinuation, subjects manifested symptoms such as irritability, insomnia, and restlessness. by approximately 24 hours post-dronabinol discontinuation, withdrawal symptoms intensified to include “hot flashes”, sweating, rhinorrhea, loose stools, hiccoughs, and anorexia. these withdrawal symptoms gradually dissipated over the next 48 hours. electroencephalographic changes consistent with the effects of drug withdrawal (hyperexcitation) were recorded in patients after abrupt dechallenge. patients also complained of disturbed sleep for several weeks after discontinuing therapy with high dosages of dronabinol. instructions for use syndros (sin dros) (dronabinol) oral solution, cii read this instructions for use before you start taking syndros oral solution and each time you get a refill. there may be new information. this information does not take the place of talking to your doctor about your medical condition or your treatment. important information about measuring syndros oral solution: - always use the oral syringe that comes with your syndros oral solution to measure your prescribed dose. ask your doctor or pharmacist to show you how to measure your prescribed dose. important information about giving syndros oral solution through a feeding tube: - give syndros oral solution through feeding tubes that are made with silicone and that are size 14 french or larger. do not give syndros oral solution through feeding tubes that are not made with silicone or that are smaller than size 14 french. - do not use feeding tubes made with polyurethane. - syndros oral solution can be given through a naso-gastric tube (ng tube), gatrostomy tube (g-tube), percutaneous endoscopic gastrostomy tube (peg-tube), and gastro-jejunostomy tube (gj-tube). - each syndros carton contains (see figure a): 1 bottle of syndros oral solution 1 oral syringe 1 adapter (you will need to insert the adapter into the bottle before using the bottle for the first time.) the contents in the syndros carton are wrapped in plastic. do not use the contents if they are not wrapped in plastic when you receive them. - 1 bottle of syndros oral solution - 1 oral syringe - 1 adapter (you will need to insert the adapter into the bottle before using the bottle for the first time.) the contents in the syndros carton are wrapped in plastic. do not use the contents if they are not wrapped in plastic when you receive them. - you do not receive an oral syringe or adapter with your syndros - you lose the oral syringe that comes with syndros - the contents in the syndros carton are not wrapped in plastic when you receive them. step 8: check that the correct dose of syndros oral solution was drawn up into the oral syringe. if you are taking your dose of syndros by mouth, follow the instructions in “how to take a dose of syndros oral solution by mouth.” if you are taking your dose of syndros through a feeding tube, follow the instructions in “how to take a dose of syndros oral solution through a feeding tube.” how to take a dose of syndros oral solution by mouth: step 1: open your mouth. place the oral syringe tip in the back of your mouth on top of your tongue. tilt your head back slightly and close your lips around the barrel of the oral syringe. slowly push down the plunger until the oral syringe is empty (see figure k). swallow the oral solution. if your prescribed dose is more than 1 ml, repeat steps 4-8 in “how to prepare a dose of syndros oral solution after the adapter is inserted” to draw up the remaining dose until the prescribed dose is given. for example, if your prescribed dose is 1.6 ml, take a 1 ml dose first, then an additional dose of 0.6 ml. take your syndros oral solution right away after it is drawn up into the oral syringe. see “important information about giving syndros oral solution through a feeding tube.” step 1: place the oral syringe into the feeding tube. slowly push down the plunger until the oral syringe is empty (see figure n). if your prescribed dose is more than 1 ml, repeat steps 4-8 in “how to prepare a dose of syndros oral solution after the adapter is inserted” to draw up the remaining dose until the prescribed dose is given. for example, if your prescribed dose is 1.6 ml, take a 1 ml dose first, then an additional dose of 0.6 ml. step 4 : remove the plunger from the oral syringe barrel. rinse the oral syringe barrel and plunger with warm water after each use and let them air dry. when the oral syringe barrel and plunger are dry, put the plunger back into the oral syringe barrel for the next use. keep syndros oral solution and the oral syringe in the carton that it comes in. do not throw away the oral syringe. how should i store syndros? - store syndros in the refrigerator between 36°f and 46°f (2°c and 8°c). - after the bottle is opened, syndros can be stored at room temperature, between 68°f and 77°f (20°c and 25°c), for up to 42 days. - do not use syndros that has been stored in the refrigerator or at room temperature 42 days after opening the bottle. write the date that you open the bottle of syndros on the bottle and carton it comes in. see “how should i dispose of unused syndros?” keep syndros and all medicines out of the reach of children. how should i dispose of unused syndros? - dispose of unused syndros as soon as you no longer need it or 42 days after opening the bottle. talk to your doctor or pharmacist if you have questions about how to use syndros oral solution. for more information, go to www.syndros.com or call 1-844-558-8289. this patient information and instructions for use have been approved by the u.s. food and drug administration. manufactured for: benuvia therapeutics inc. by: benuvia manufacturing round rock, tx 78665 revised: september 2022

Ավստրալիա - անգլերեն - APVMA (Australian Pesticides and Veterinary Medicines Authority)

nufarm australia limited - 2,4-d p/a the dimethylamine and monomethylamine salts - soluble concentrate - 2,4-d p/a the dimethylamine and monomethylamine salts phenoxy acids-2,4d active 500.0 g/l - herbicide

Իռլանդիա - անգլերեն - HPRA (Health Products Regulatory Authority)

organon pharma (ireland) limited - mometasone furoate - inhalation powder - 200 microgram(s) - glucocorticoids; mometasone

Իռլանդիա - անգլերեն - HPRA (Health Products Regulatory Authority)

organon pharma (ireland) limited - mometasone furoate - inhalation powder - 400 microgram(s) - glucocorticoids; mometasone

Իռլանդիա - անգլերեն - HPRA (Health Products Regulatory Authority)

organon pharma (ireland) limited - desogestrel - film-coated tablet - 75 microgram(s) - progestogens; desogestrel

Իռլանդիա - անգլերեն - HPRA (Health Products Regulatory Authority)

organon pharma (ireland) limited - betamethasone dipropionate; salicylic acid - cutaneous solution - 0.05 %w/w+2 percent weight/weight - corticosteroids, potent, other combinations; betamethasone