Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme australia pty ltd - etonogestrel; ethinylestradiol -

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

benson medical services pty ltd - 33957 - antisnoring device - the device is a split tubular device which get inserted in nasal cavities at once whenever the user wishes for the purpose the product was designed for. specifically, this device is designed for anyone with nasal disorders such as: alar collapse, deviated septum, scarerd nostrils and narrow nostrils. this device aims to improve breathing through the nose instead through the mouth and also aims to prevent chronic snoring, sleep apnoea and also maintain or even improve conditions of asthma by breathing through the nose instead.

Ισραήλ - Αγγλικά - Ministry of Health

ferring pharmaceuticals ltd - progesterone - vaginal tablets - progesterone 100 mg - progesterone - progesterone - progesterone supplementation or replacement in cases such as treatment of infertile women and ivf.

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

william a cook australia pty ltd - 35281 - graft, vascular, synthetic - the zenith t-branch is a tubular endovascular graft with four branches and with a covered stent at the proximal end that contains barbs for additional fixation of the device. the graft is designed to be connected with the coeliac, superior mesenteric and two renal arteries. the zenith t-branch is shipped loaded onto the h&l-b one-shot introduction system. it has a sequential deployment method with built-in features to provide continuous control of the graft throughout the deployment process. the zenith t-branch thoracoabdominal endovascular graft is indicated for the endovascular treatment of high-risk patients with thoracoabdominal aneurysms who are not amenable to open surgical repair. the patients must have morphology suitable for endovascular repair, including: a) adequate iliac/femoral access compatible with a 22 fr / 8.5 mm od introduction system, b) non-aneurysmal thoracic aorta fixation segment proximal to the aneurysm: - with an angle less than 90 degrees relative to the long axis of the aneurysm - with a length of at least 25 mm, (50 mm of wall contact is preferred) - with a diameter measured outer wall to outer wall of no greater than 30 mm and no less than 24 mm - alternatively, the zenith t-branch graft may be attached to a pre-existing endovascular graft such as the zenith tx2 taa endovascular graft. c) visceral vessel anatomy compatible with zenith t-branch, specifically: - four indispensible arteries from the abdominal viscera - all target arteries to be accessible from an antegrade approach - coeliac and superior mesenteric artery (sma) to be 6 mm to 10 mm in diameter - renal arteries to be 4 mm to 8 mm in diameter - the distance between each cuff and the corresponding arterial orifice is less than 50 mm - the line between the cuff and the arterial orifice as projected onto the vessel wall deviates by no more than 45 degrees from the long axis of the aorta.

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

genus lifesciences inc. - cocaine hydrochloride (unii: xh8t8t6wzh) (cocaine - unii:i5y540lhvr) - cocaine hydrochloride nasal solution is indicated for the induction of local anesthesia of the mucous membranes when performing diagnostic procedures and surgeries on or through the nasal cavities in adults. cocaine hydrochloride nasal solution is contraindicated in patients with a known history of hypersensitivity to cocaine hydrochloride, other ester-based anesthetics, or any other component of the product. risk summary in animal studies conducted in accordance with good laboratory practices, malformations including vertebral and rib abnormalities were reported when pregnant rabbits were treated with 16 mg/kg cocaine hydrochloride during organogenesis (8 times the adult human exposure following administration of pledgets containing 160 mg of cocaine) and increased pup mortality was noted when pregnant rats were exposed to cocaine hydrochloride during pregnancy at 47 times the adult human auc exposures. published rodent studies testing high exposures to cocaine during organogenesis report various malformations at 17 to 34 times the adult human auc exposures following administration of pledgets containing 160 mg of cocaine. data human data there are no available data on the use of intranasal cocaine hydrochloride solution in pregnant women to inform a drug-associated risk adverse developmental outcomes. there are published data describing adverse developmental outcomes in women with chronic cocaine abuse during pregnancy. the published case-control and observational studies examining the effect of in utero cocaine exposure on fetal growth parameters, after controlling for confounding variables, found exposure was associated with reduced fetal growth compared with non-drug-abuse populations. published data from a large number of studies of women with chronic cocaine abuse during pregnancy are inconsistent in their findings with regard to other developmental outcomes. prospective studies controlling for polydrug use (marijuana, alcohol, tobacco) and lifestyle factors, have not demonstrated any association between cocaine abuse and specific major or minor fetal anomalies or other forms of fetal harm (premature birth, stillbirth, miscarriage, low birth weight, reduced head circumference, or placental abruption). the applicability of the findings from these studies of chronic abuse in pregnancy to a single topical exposure is limited. animal data no clear evidence of fetal malformations was noted in a study where pregnant rats were treated subcutaneously with up to 30 mg/kg cocaine hydrochloride (48 times the human adult exposure based on auc following administration of pledgets containing 160 mg of cocaine) from gestation day 7 through 17 in the absence of overt maternal rat toxicity. however, a single high-dose fetus was reported with both meningoencephalocele and anophthalmia (unilateral). malformations, including vertebral and rib anomalies, were observed when pregnant rabbits were treated subcutaneously with 16 mg/kg cocaine hydrochloride (8 times the human adult exposure based on auc exposures following administration of pledgets containing 160 mg of cocaine) from gestation day 7 through 20. this dose level was associated with evidence of maternal toxicity (convulsions, decreased body weight gain). no adverse effects were noted in animals treated with 8 mg/kg (1.5 times the adult human auc following administration of pledgets containing 160 mg of cocaine). an increased incidence of pup mortality between postnatal day (pnd) 0 to pnd 4 and decreased pup body weights from pnd 1 to pnd 21 were noted when pregnant rats were treated from gd 6 through lactation day 20 with 20 mg/kg cocaine hydrochloride (47 times the adult human auc following administration of pledgets containing 160 mg of cocaine) in the absence of overt maternal toxicity. there was no adverse effect on pre- or postnatal development at 6 mg/kg (7 times the human adult auc exposure following administration of pledgets containing 160 mg cocaine). published studies in pregnant mice suggest that high exposure to cocaine (approximately 17-32 times the adult human auc following administration of pledgets containing 160 mg of cocaine) produced adverse fetal effects including: exencephaly, cerebral hemorrhage, hydrocephalus, immaturely developed cerebral ventricles, limb anomalies, incomplete bone ossification, hydronephrosis, cryptorchidism, dilated or cystic ureters, and cleft lip/palate. in a published nonhuman primate study, no adverse effects on physical development or cognitive function were noted after 1 mg/kg cocaine was administered via intramuscular injection three times a day (tid) (approximately 5 times the adult human auc following administration of pledgets containing 160 mg of cocaine). however, higher exposures to cocaine decreased body weights, overall body length and crown circumference of offspring from pregnant rhesus monkeys treated with escalating doses up to 7.5 mg/kg cocaine tid intramuscularity per day for 5 days per week from prior to conception to term (39 times the adult human auc following administration of pledgets containing 160 mg of cocaine). risk summary based on limited case reports in published literature, cocaine is present in human milk at widely varying concentrations. based on its pharmacochemical characteristics, high concentrations of cocaine are expected in breast milk with systemic exposure. the applicability of these findings to a single topical exposure with limited systemic absorption is unclear. no studies have evaluated cocaine concentrations in milk after topical administration of cocaine hydrochloride nasal solution. cocaine is detected in human breastmilk in chronic abuse situations and is expected to be at higher concentrations in milk than in maternal blood based on its physicochemical characteristics. breastfeeding immediately after administration of cocaine hydrochloride nasal solution could result in infant plasma concentrations that are approximately half the anticipated maximum maternal plasma concentrations at the clinical dose of 160 mg. the effects of this cocaine plasma concentration in an infant are unknown, but no level of cocaine exposure is considered safe for a breastfed infant. adverse reactions have occurred in infants ingesting cocaine through breastmilk, including vomiting, diarrhea, convulsions, hypertension, tachycardia, agitation and irritability. the long-term effects on infants exposed to cocaine through breast milk are unknown. there are no data on the effects of cocaine hydrochloride nasal solution on milk production. because of the potential for serious adverse reactions in breastfed infants, advise nursing women that breastfeeding is not recommended during treatment with cocaine hydrochloride nasal solution and to pump and discard breastmilk for 48 hours after use of cocaine hydrochloride nasal solution. the safety and effectiveness of cocaine hydrochloride nasal solution in pediatric patients (17 years of age and younger) has not been evaluated. animal data adverse cns-related clinical signs within the first several days of dosing and decreased body weights were observed when juvenile rat pups were dosed subcutaneously with 25 mg/kg cocaine hydrochloride (15 and 32 times the adult human auc exposure following administration of pledgets containing 160 mg of cocaine for males and females, respectively) from pnd 7 to pnd 28. no adverse effects were noted in pups dosed with 12.5 mg/kg (7 times the adult human auc exposure following administration of pledgets containing 160 mg of cocaine). a single mortality (male) and transient cns signs were observed in male and female juvenile rat pups that were dosed subcutaneously up to 25 mg/kg cocaine hydrochloride (113 times the adult human auc exposure) from pnd 28 to pnd 56. no adverse effects were noted in male pups dosed with 12.5 mg/kg or female pups dosed with 25 mg/kg (84 and 117 times the adult human auc exposure following administration of pledgets containing 160 mg of cocaine, respectively). of the total number of subjects in the phase 3 study, 12.1% of those who received cocaine hydrochloride nasal solution were 65 and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience and pharmacokinetic data [see clinical pharmacology (12.3)] has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. no dosage adjustment of cocaine hydrochloride nasal solution is needed in patients with mild, moderate, or severe renal impairment [see clinical pharmacology (12.3)] . no dosage adjustment of cocaine hydrochloride nasal solution is needed in patients with hepatic impairment. monitor patients with hepatic impairment for adverse reactions such as headache, epistaxis, and clinically-relevant increases in heart rate or blood pressure and do not administer a second dose of cocaine hydrochloride nasal solution to these patients within 24 hours of the first dose [see clinical pharmacology (12.3)] . cocaine has been described in literature to be primarily metabolized and inactivated by non-enzymatic ester hydrolysis and hepatic carboxylesterase, and also by plasma cholinesterase, hepatic carboxylesterase and cyp3a4 [see clinical pharmacology (12.3)] . pharmacokinetics of cocaine hydrochloride nasal solution in patients with reduced plasma cholinesterase activity has not been studied. genetic abnormalities of plasma cholinesterase (e.g., patients who are heterozygous or homozygous for atypical plasma cholinesterase gene), disease conditions such as malignant tumors, severe liver or kidney disease, decompensated heart disease, infections, burns, anemia, peptic ulcer, or myxedema or other physiological states such as pregnancy may lead to reduced plasma cholinesterase activity. patients with reduced plasma cholinesterase (pseudocholinesterase) activity may have reduced clearance and increased exposure of plasma cocaine after administration of cocaine hydrochloride nasal solution. since cocaine is metabolized by multiple enzymes, the effect of reduced plasma cholinesterase activity on cocaine exposure may be limited. no dosage adjustment of cocaine hydrochloride nasal solution is needed in patients with reduced plasma cholinesterase. monitor patients with reduced plasma cholinesterase activity for adverse reactions such as headache, epistaxis, and clinically-relevant increases in heart rate or blood pressure. cocaine hydrochloride nasal solution contains cocaine, a schedule ii controlled substance. goprelto contains cocaine, a substance with a high potential for abuse. cocaine hydrochloride nasal solution can be misused and abused, which can lead to addiction. cocaine hydrochloride nasal solution may also be diverted for abuse purposes [see warnings and precautions (5.1)] . drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal. drug abuse of a substance may occur without progression to drug addiction. "drug-seeking" behavior is very common in persons with substance use disorders. drug abuse and addiction are conditions that are separate and distinct from physical dependence and tolerance [ see dependence (9.3)]. health care providers should be aware that abuse and addiction may occur in the absence of symptoms indicative of physical dependence and tolerance. individuals who abuse stimulants may use cocaine hydrochloride nasal solution for abuse purposes. adverse events associated with abuse of cocaine include euphoria, excitation, irritability, restlessness, anxiety, paranoia, confusion, headache, psychosis, hypertension, stroke, seizures, dilated pupils, nausea, vomiting, and abdominal pain. intranasal abuse can produce damage to the nostrils (e.g., ulceration and deviated septum). abuse of cocaine can result in overdose, convulsions, unconsciousness, coma, and death [see overdosage (10)] . parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and hiv. cocaine hydrochloride nasal solution, like all prescription drugs with abuse potential, can be diverted for non-medical use into illicit channels of distribution. in order to minimize these risks, effective accounting procedures should be implemented, in addition to routine procedures for handling controlled substances. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. cocaine hydrochloride nasal solution is approved for topical single use during diagnostic procedures and surgeries, so physical dependence and withdrawal symptoms are unlikely to develop. although goprelto is not indicated for chronic therapy, repeated misuse or abuse of this product may lead to physical dependence.

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

masimo australia pty ltd - 62911 - physiologic monitoring system alarm - a single use sensor that is indicated for monitoring the orientation and activity of patients including those susceptible to pressure ulcers. the sensor is also indicated for the measurement of respiration rate of adults. the sensor is designed to be connected to a physiologic monitoring system to provide alerts when patient orientation or activity deviates from parameters set by healthcare providers. the sensor is intended for use in healthcare environments.

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

rti surgical australia pty ltd - 44795 - bender, orthopaedic - the bender is a heavy duty surgical instrument used to deviate medical devices into different desired angles , typically those for implantation to the appropriate anatomical fit.

Αυστραλία - Αγγλικά - APVMA (Australian Pesticides and Veterinary Medicines Authority)

imtrade australia pty ltd - bifenthrin; n-methyl-2-pyrrolidone; liquid hydrocarbon - emulsifiable concentrate - bifenthrin pyrethroid active 400.0 g/l; n-methyl-2-pyrrolidone solvent other 100.0 g/l; liquid hydrocarbon solvent other 426.0 g/l - insecticide - commercial building/structure - external | domestic building/structure - external a | foundation or vertical barrier | framing t - ant | cockroach | european house borer | flea | fly | furniture beetle | mosquito | paper nest wasp | powderpost beetle | spider | subterranean termite | termite | termite - excluding m. darwiniensis | tick - except paralysis tick | timber beetle | adult mosquitoes | argentine ant | ctenocephalides spp. | drywood termite | ground fleas | large cockroach | papernest wasps | pharaoh ant | small cockroach | subterranean termite

Αυστραλία - Αγγλικά - APVMA (Australian Pesticides and Veterinary Medicines Authority)

sherwood corporation (thailand) public company limited - bifenthrin - suspension concentrate - bifenthrin pyrethroid active 100.0 g/l - insecticide - building construction | buildings - around | commercial building/structure - external | commercial building/structure-internal | - ants (except red imported fire ant) | cockroach | flea | fly | mosquito | paper nest wasp | spider | subterranean termite | tick - except paralysis tick | adult mosquitoes | ctenocephalides spp. | ground fleas | large cockroach | papernest wasps | small cockroach

Αυστραλία - Αγγλικά - APVMA (Australian Pesticides and Veterinary Medicines Authority)

sherwood corporation (thailand) public company limited - bifenthrin; n-methyl-2-pyrrolidone; liquid hydrocarbon - emulsifiable concentrate - bifenthrin pyrethroid active 100.0 g/l; n-methyl-2-pyrrolidone solvent other 50.0 g/l; liquid hydrocarbon solvent other 649.0 g/l - insecticide - commercial area - general | commercial building/structure - external | domestic and/or public area | domestic building/structure - ant | cockroach | flea | fly | mosquito | paper nest wasp | spider | subterranean termite | tick - except paralysis tick | adult mosquitoes | argentine ant | ctenocephalides spp. | ground fleas | large cockroach | papernest wasps | pharaoh ant | small cockroach