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

pluspak safety pty ltd - 11879 - glove, - non-sterile single use medical examination and chemical handling use glove

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

pluspak safety pty ltd -

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

pluspak safety pty ltd -

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

pluspak safety pty ltd -

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

pluspak safety pty ltd - 35492 - gown, isolation, single use - isolation gowns are designed to protect healthcare workers and patients from transfer of microorganisms and body fluids during medical procedures. they protect against contaminants.

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

ge healthcare inc. - gadodiamide (unii: 84f6u3j2r6) (gadodiamide - unii:84f6u3j2r6) - gadodiamide 287 mg in 1 ml - omniscan is a gadolinium-based contrast agent indicated for intravenous use in mri to visualize lesions with abnormal vascularity (or those thought to cause abnormalities in the blood-brain barrier) in the brain (intracranial lesions), spine, and associated tissues [see clinical studies (14.1)]. omniscan is a gadolinium-based contrast agent indicated for intravenous use in mri to facilitate the visualization of lesions with abnormal vascularity within the thoracic (noncardiac), abdominal, pelvic cavities, and the retroperitoneal space [see clinical studies (14.2)]. omniscan is contraindicated in patients with: - chronic, severe kidney disease (glomerular filtration rate, gfr < 30 ml/min/1.73m2 ) or acute kidney injury - prior hypersensitivity to omniscan risk summary gbcas cross the human placenta and result in fetal exposure and gadolinium retention. the human data on the association between gbcas and adverse fetal outcomes are limited and inconclusive (see data) . in animal reproduction studies, no adverse

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

ge healthcare - gadoterate meglumine (unii: l0nd3981ag) (gadolinium cation (3+) - unii:azv954tz9n) - clariscan is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (mri) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (bbb) and/or abnormal vascularity. history of clinically important hypersensitivity reactions to clariscan [see warnings and precautions (5.2)]. risk summary gbcas cross the human placenta and result in fetal exposure and gadolinium retention. the human data on the association between gbcas and adverse fetal outcomes are limited and inconclusive (see data) . in animal reproduction studies, there were no adverse developmental effects observed in rats or rabbits with intravenous administration of gadoterate meglumine during organogenesis at doses of 16 and 10 times, respectively, the recommended human dose (see data) . because of the potential risks of gadolinium to the fetus, use clariscan only if imaging is essential during pregnancy and cannot be delayed. the estimated background risk of major birth defects and miscarriage for the indicated population(s) 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 2-4% and 15-20%, respectively. data human data contrast enhancement is visualized in the placenta and fetal tissues after maternal gbca administration. cohort studies and case reports on exposure to gbcas during pregnancy have not reported a clear association between gbcas and adverse effects in the exposed neonates. however, a retrospective cohort study, comparing pregnant women who had a gbca mri to pregnant women who did not have an mri, reported a higher occurrence of stillbirths and neonatal deaths in the group receiving gbca mri. limitations of this study include a lack of comparison with non-contrast mri and lack of information about the material indication for mri. overall, these data preclude a reliable evaluation of the potential risk of adverse fetal outcomes with the use of gbcas in pregnancy. animal data gadolinium retention gbcas administered to pregnant non-human primates (0.1 mmol/kg on gestational days 85 and 135) result in measurable gadolinium concentration in the offspring in bone, brain, skin, liver, kidney, and spleen for at least 7 months. gbcas administered to pregnant mice (2 mmol/kg daily on gestational days 16 through 19) result in measurable gadolinium concentrations in the pups in bone, brain, kidney, liver, blood, muscle, and spleen at one-month postnatal age. reproductive toxicology gadoterate meglumine was administered in intravenous doses of 0, 2, 4 and 10 mmol/kg/day [3, 7 and 16 times the recommended human dose (rhd) based on body surface area (bsa)] to female rats for 14 days before mating, throughout the mating period and until gestation day (gd) 17. pregnant rabbits were administered gadoterate meglumine in intravenous doses of 0, 1, 3 and 7 mmol/kg/day (3, 10 and 23 times the rhd based on bsa) from gd6 to gd19. no effects on embryo-fetal development were observed at doses up to 10 mmol/kg/day in rats and 3 mmol/kg/day in rabbits. maternal toxicity was observed in rats at 10 mmol/kg/day and in rabbits at 7 mmol/kg/day. this maternal toxicity was characterized in rats by a slightly lower litter size and gravid uterus weight compared to the control group, and in rabbits by a reduction in body weight and food consumption. risk summary there are no data on the presence of gadoterate in human milk, the effects on the breastfed infant, or the effects on milk production. however, published lactation data on other gbcas indicate that 0.01 to 0.04% of the maternal gadolinium dose is present in breast milk. additionally, there is limited gbca gastrointestinal absorption in the breastfed infant. gadoterate is present in goat milk (see data ). the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clariscan and any potential adverse effects on the breastfed infant from clariscan or from the underlying maternal condition. data nonclinical data demonstrate that gadoterate is detected in goat milk in amounts of < 0.1% of the dose intravenously administered. furthermore, in rats, absorption of gadoterate via the gastrointestinal tract is poor (1.2% of the administered dose was absorbed and eliminated in urine). the safety and efficacy of gadoterate meglumine at a single dose of 0.1 mmol/kg have been established in pediatric patients from birth (term neonates ≥ 37 weeks gestational age) to 17 years of age based on clinical data in 133 pediatric patients 2 years of age and older, and clinical data in 52 pediatric patients birth to less than 2 years of age that supported extrapolation from adult data [see clinical studies (14)] . adverse reactions in pediatric patients were similar to those reported in adults [see adverse reactions (6.1)] . no dose adjustment according to age is necessary in pediatric patients [see dosage and administration (2.1), pharmacokinetics (12.3)] . the safety of gadoterate meglumine has not been established in preterm neonates. no cases of nsf associated with gadoterate meglumine or any other gbca have been identified in pediatric patients age 6 years and younger [see warnings and precautions (5.1)] . normal estimated gfr (egfr) is approximately 30 ml/minute/1.73 m2 at birth and increases to adult values by 2 years of age. juvenile animal data single and repeat-dose toxicity studies in neonatal and juvenile rats did not reveal findings suggestive of a specific risk for use in pediatric patients including term neonates and infants. in clinical studies of gadoterate meglumine, 900 patients were 65 years of age and over, and 304 patients were 75 years of age and over. no overall differences in safety or efficacy were observed between these subjects and younger subjects. in general, use of clariscan in elderly patients should be cautious, reflecting the greater frequency of impaired renal function and concomitant disease or other drug therapy. no age-related dosage adjustment is necessary. no clariscan dosage adjustment is recommended for patients with renal impairment. gadoterate can be removed from the body by hemodialysis [see warnings and precautions (5.1) and clinical pharmacology (12.3)].

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

ge healthcare inc. - iohexol (unii: 4419t9mx03) (iohexol - unii:4419t9mx03) - iodine 140 mg in 1 ml - adults omnipaque 180, 240, and 300 - myelography (lumbar, thoracic, cervical, total columnar) - computerized tomography (ct) (myelography, cisternography, ventriculography) pediatrics omnipaque 180 - myelography (lumbar, thoracic, cervical, total columnar) - ct (myelography, cisternography) adults omnipaque 140 - intra-arterial digital subtraction angiography of the head, neck, abdominal, renal and peripheral vessels omnipaque 240 - ct head imaging - peripheral venography (phlebography) omnipaque 300 - aortography including studies of the aortic arch, abdominal aorta and its branches - ct head and body imaging - cerebral arteriography - peripheral venography (phlebography) - peripheral arteriography - excretory urography omnipaque 350 - angiocardiography (ventriculography, selective coronary arteriography) - aortography including studies of the aortic root, aortic arch, ascending aorta, abdominal aorta and its branches - ct head and body imaging - intravenous digital subtraction angiography of the head, neck,

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

ge healthcare inc. - iodixanol (unii: hw8w27htxx) (iodixanol - unii:hw8w27htxx) - iodine 320 mg in 1 ml - visipaque is indicated in for: adult and pediatric patients 12 years of age and older - (270 and 320 mg iodine/ml) intra-arterial digital subtraction angiography (ia-dsa). - (320 mg iodine/ml) angiocardiography (left ventriculography and selective coronary arteriography), peripheral arteriography, visceral arteriography, and cerebral arteriography. pediatric patients less than 12 years of age - (320 mg iodine/ml) angiocardiography, cerebral arteriography, and visceral arteriography. adult and pediatric patients 12 years of age and older - (270 and 320 mg iodine/ml) ct imaging of the head and body. - (270 and 320 mg iodine/ml) excretory urography. - (270 mg iodine/ml) peripheral venography. - (320 mg iodine/ml) coronary computed tomography angiography (ccta) to assist in the diagnostic evaluation of patients with suspected coronary artery disease. pediatric patients less than 12 years of age - (270 mg iodine/ml) ct imaging of the head and body. - (270 mg iodine/ml) excretory urography. visipaque is contraindic

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

ge healthcare inc. - iohexol (unii: 4419t9mx03) (iohexol - unii:4419t9mx03) - adults omnipaque 180, 240, and 300 - myelography (lumbar, thoracic, cervical, total columnar) - computerized tomography (ct) (myelography, cisternography, ventriculography) pediatrics omnipaque 180 - myelography (lumbar, thoracic, cervical, total columnar) - ct (myelography, cisternography) adults omnipaque 140 - intra-arterial digital subtraction angiography of the head, neck, abdominal, renal and peripheral vessels omnipaque 240 - ct head imaging - peripheral venography (phlebography) omnipaque 300 - aortography including studies of the aortic arch, abdominal aorta and its branches - ct head and body imaging - cerebral arteriography - peripheral venography (phlebography) - peripheral arteriography - excretory urography omnipaque 350 - angiocardiography (ventriculography, selective coronary arteriography) - aortography including studies of the aortic root, aortic arch, ascending aorta, abdominal aorta and its branches - ct head and body imaging - intravenous digital subtraction angiography of the head, neck, abdominal, renal and peripheral vessels - peripheral arteriography - excretory urography pediatrics omnipaque 240 - ct head and body imaging omnipaque 300 - angiocardiography (ventriculography) - excretory urography - ct head and body imaging omnipaque 350 - angiocardiography (ventriculography, pulmonary arteriography, venography, and studies of the collateral arteries) - aortography including the aortic root, aortic arch, ascending and descending aorta adults omnipaque 350 - oral radiographic examination of the gastrointestinal tract pediatrics omnipaque 180, 240 and 300 - oral and rectal radiographic examination of the gastrointestinal tract diluted omnipaque injection adults omnipaque 240, 300 and 350 diluted and administered orally in conjunction with omnipaque 300 administered intravenously - ct of the abdomen pediatrics omnipaque 240, 300 and 350 diluted and administered orally in conjunction with omnipaque 240 or omnipaque 300 administered intravenously - ct of the abdomen omnipaque oral solution adults omnipaque oral solution 9 and 12 administered orally in conjunction with omnipaque 300 administered intravenously - ct of the abdomen pediatrics omnipaque oral solution 9 and 12 administered orally in conjunction with omnipaque 240 or omnipaque 300 administered intravenously - ct of the abdomen adults omnipaque 240, 300, and 350 - arthrography adults omnipaque 240 - endoscopic retrograde pancreatography (erp) and cholangiopancreatography (ercp) - herniography - hysterosalpingography omnipaque 300 - hysterosalpingography pediatrics omnipaque 240, 300 and 350 diluted - voiding cystourethrography (vcu) - omnipaque 140 and omnipaque 350 are contraindicated for intrathecal use [see warnings and precautions (5.1)] : - omnipaque oral solution 9 and 12 are contraindicated for parenteral administration [see warnings and precautions (5.2)] : - omnipaque body cavity 240 and 300 for hysterosalpingography is contraindicated during pregnancy or suspected pregnancy, menstruation or when menstruation is imminent, within 6 months after termination of pregnancy, within 30 days after conization or curettage, when signs of infection are present in any portion of the genital tract including the external genitalia, and when reproductive tract neoplasia is known or suspected because of the risk of peritoneal spread of neoplasm. risk summary hysterosalpingography is contraindicated in pregnant women due to the potential risk to the fetus from an intrauterine procedure [see contraindications (4)]. there are no data with iohexol use in pregnant women to inform any drug-associated risks. iohexol crosses the placenta and reaches fetal tissues in small amounts (see data ). in animal reproduction studies, no developmental toxicity occurred with intravenous iohexol administration to rats and rabbits at doses up to 0.4 (rat) and 0.5 (rabbit) times the maximum recommended human intravenous dose ( 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 risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data human data literature reports show that intravenously administered iohexol crosses the placenta and is visualized in the digestive tract of exposed infants after birth. animal data iohexol was neither embryotoxic nor teratogenic in either rats or rabbits at the following dose levels tested: 1.0, 2.0, 4.0 g iodine/kg in rats, administered intravenously to 3 groups of 25 dams once daily during days 6 through 15 of pregnancy; 0.3, 1.0, 2.5 g iodine/kg in rabbits, administered intravenously to 3 groups of 18 rabbits dosed once a day during days 6 through 18 of pregnancy. risk summary published literature reports that breast feeding after intravenous iohexol administration to the mother would result in the infant receiving an oral dose of approximately 0.7% of the maternal intravenous dose; however, lactation studies have not been conducted with oral, intrathecal, or intracavity administration of iohexol. there is no information on the effects of the drug on the breastfed infant or on milk production. iodinated contrast agents are excreted unchanged in human milk in very low amounts with poor absorption from the gastrointestinal tract of a breastfed infant. exposure to iohexol to a breastfed infant can be minimized by temporary discontinuation of breastfeeding (see clinical considerations). the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for omnipaque and any potential adverse effects on the breastfed infant from omnipaque or from the underlying maternal condition. clinical considerations interruption of breastfeeding after exposure to iodinated contrast agents is not necessary because the potential exposure of the breastfed infant to iodine is small. however, a lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk for 10 hours (approximately 5 elimination half-lives) after omnipaque administration to minimize drug exposure to a breastfed infant. intrathecal use the safety and effectiveness of omnipaque 180 have been established in pediatric patients 2 weeks to 17 years of age for myelography (lumbar, thoracic, cervical, total columnar) and for ct (myelography, cisternography). use of omnipaque 180 is supported by controlled clinical studies in adults for myelography, in addition to clinical studies in pediatric patients undergoing myelography. the safety and effectiveness of omnipaque 180 have not been established for intrathecal use in patient pediatric patients less than 2 weeks of age. the safety and effectiveness of omnipaque 240 and 300 have not been established in pediatric patients for myelography (lumbar, thoracic, cervical, total columnar) and for ct (myelography, cisternography, or ventriculography). intravascular use angiocardiography ( ventriculography, pulmonary arteriography, venography, and studies of the collateral arteries) and aortography the safety and effectiveness of omnipaque 300 have been established in pediatric patients from birth to 17 years of age for angiocardiography (ventriculography) and of omnipaque 350 in pediatric patients from birth to 17 years of age for angiocardiography (ventriculography, pulmonary arteriography, venography, and studies of the collateral arteries) and aortography. use of omnipaque 300 and 350 is supported by controlled clinical studies in adults for angiocardiography and aortography, in addition to controlled clinical studies in pediatric patients undergoing angiocardiography, including aortography. the safety and effectiveness of omnipaque 300 have not been established in pediatric patients for aortography. intra-arterial digital subtraction angiography, intravenous digital subtraction angiography, cerebral arteriography, or peripheral arteriography and venography the safety and effectiveness of omnipaque have not been established in pediatric patients for intra-arterial digital subtraction angiography, intravenous digital subtraction angiography, cerebral arteriography, or peripheral arteriography and venography. ct of the head and body the safety and effectiveness of omnipaque 240 and 300 have been established in pediatric patients from birth to 17 years of age for ct imaging of the head and body. use of omnipaque 240 and 300 is supported by controlled clinical studies in adults for head and body ct, in addition to clinical studies in pediatric patients undergoing head ct and in 69 pediatric patients undergoing ct of the abdomen after oral administration of diluted omnipaque plus intravenous administration of omnipaque. the safety and effectiveness of omnipaque 350 have not been established in pediatric patients for ct imaging of the head and body. urography the safety and effectiveness of omnipque 300 have been established in pediatric patients from birth to 17 years of age for urography. use of omnipaque 300 is supported by controlled clinical studies in adults for urography, in addition to controlled clinical studies in pediatric patients undergoing urography and clinical safety data in pediatric patients down to birth. oral or rectal use undiluted omnipaque injection the safety and effectiveness of omnipaque 180, 240, and 300 administered orally and rectally have been established in pediatric patients, from birth to 17 years of age for examination of the gi tract. use of omnipaque 180, 240, and 300 administered orally and rectally is supported by controlled studies in adults for examination of the gi tract, in addition to clinical studies in pediatric patients undergoing examination of the gi tract. oral use in conjunction with intravenous use diluted omnipaque injection the safety and effectiveness of omnipaque injection diluted to concentrations from 9 to 21 mg iodine/ml administered orally in conjunction with omnipaque injection administered intravenously for ct of the abdomen have been established in pediatric patients from birth to 17 years of age. use is supported by clinical trials in adults, in addition to clinical studies in 69 pediatric patients undergoing ct of the abdomen after oral administration of diluted omnipaque plus intravenous administration of omnipaque. omnipaque oral solution the safety and effectiveness of omnipaque oral solution 9 and 12 administered orally in conjunction with omnipaque injection administered intravenously for ct of the abdomen in pediatric patients have been established in pediatric patients from birth to 17 years of age. use is supported by the data establishing safety and effectiveness for omnipaque injection diluted and administered orally in conjunction with omnipaque injection administered intravenously for ct of the abdomen in pediatric patients. intraarticular use the safety and effectiveness of omnipaque have not been established in pediatric patients for arthrography. body cavity use omnipaque 240, 300, 350 diluted to concentrations from 50 mg iodine/ml to 100 mg iodine/ml is indicated for use in pediatric patients from birth to 17 years of age for voiding cystourethrography (vcu). the use for voiding cystourethrography is supported by clinical studies in 51 pediatric patients undergoing vcu. the safety and effectiveness of omnipaque have not been established in pediatric patients for ercp, herniography, or hysterosalpingography. in general, the frequency of adverse reactions in pediatric patients was similar to that seen in adults [ see adverse reactions (6.1) ]. pediatric patients at higher risk of experiencing adverse events during contrast-medium administration may include those having asthma, a sensitivity to medication and/or allergens, congestive heart failure, a serum creatinine greater than 1.5 mg/dl or those less than 12 months of age. thyroid function tests indicative of thyroid dysfunction, characterized by hypothyroidism or transient thyroid suppression have been reported following iodinated contrast media administration in pediatric patients, including term and preterm neonates. some patients were treated for hypothyroidism. after exposure to iodinated contrast media, individualize thyroid function monitoring in pediatric patients 0 to 3 years of age based on underlying risk factors, especially in term and preterm neonates [see warnings and precautions (5.9)and adverse reactions (6.2)]. in clinical studies of omnipaque for ct, 52/299 (17%) of patients were 70 and over. no overall differences in safety were observed between these patients and younger patients. other reported clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. 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.