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

precise medical supplies pty ltd - 62143 - gastroschisis silo bag - intended to contain and isolate the protruding intestine of a neonate with gastroschisis to minimise heat and exudate loss, stabilise the protruding gut, and assist retraction of the herniation.

Singapore - English - HSA (Health Sciences Authority)

cook south east asia pte ltd - cardiovascular - cook rosch-uchida transjugular liver access set is used for transjugular liver access in diagnostic and interventional procedures.

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

hf acquisition co llc, dba healthfirst - epinephrine (unii: ykh834o4bh) (epinephrine - unii:ykh834o4bh) - adrenalin® is available as a single-use 1 ml vial and a multiple-use 30 ml vial for intramuscular and subcutaneous use. emergency treatment of allergic reactions (type i), including anaphylaxis, which may result from allergic reactions to insect stings, biting insects, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. the signs and symptoms associated with anaphylaxis include flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with hypotension, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, airway swelling, laryngospasm, bronchospasm, pruritus, urticaria or angioedema, swelling of the eyelids, lips, and tongue. none. 8.1 pregnancy teratogenic effects: pregnancy category c. there are no adequate and well-controlled studies in pregnant women. epinephrine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus (fetal anoxia, spontaneous abortion, or both). epinephrine is teratogenic in rabbits, mice and hamsters dosed during organogenesis. epinephrine has been shown to have teratogenic effects (including gastroschisis and embryonic lethality) when administered subcutaneous in rabbits at approximately 15 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m2 basis at a maternal subcutaneous dose of 1.2 mg/kg/day for two to three days). in mice, teratogenic effects (including embryonic lethality) were observed at approximately 3 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m2 basis at maternal subcutaneous dose of 1 mg/kg/day for 10 days). these effects were not seen in mice at approximately 2 times the maximum recommended daily intramuscular or subcutaneous dose (on a mg/m2 basis at a subcutaneous maternal dose of 0.5 mg/kg/day for 10 days). in hamsters, teratogenic effects were observed at approximately 2 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day for 4 days). 8.2 labor and delivery use with caution during labor and delivery. although epinephrine improves maternal hypotension associated with anaphylaxis, it may result in uterine vasoconstriction, decreased uterine blood flow, and fetal anoxia. 8.3 nursing mothers it is not known whether epinephrine is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when epinephrine is administered to a nursing woman. 8.4 pediatric use clinical use data support weight-based dosing for treatment of anaphylaxis in pediatric patients, and other reported clinical experience with the use of epinephrine suggests that the adverse reactions seen in children are similar in nature and extent to those both expected and reported in adults. 8.5 geriatric use clinical studies for the treatment of anaphylaxis have not been performed in subjects aged 65 and over to determine whether they respond differently from younger subjects. however, other reported clinical experience with use of epinephrine for the treatment of anaphylaxis has identified that geriatric patients may be particularly sensitive to the effects of epinephrine. therefore, for the treatment of anaphylaxis, consider starting with a lower dose to take into account potential concomitant disease or other drug therapy.

Malta - English - Malta Medicines Authority

midas pharma gmbh rheinstrasse 49, 55218 ingelheim, germany - ketoprofen - granules for oral solution - ketoprofen 25 mg - antiinflammatory and antirheumatic products

Malta - English - Malta Medicines Authority

midas pharma gmbh rheinstrasse 49, 55218 ingelheim, germany - ketoprofen - granules for oral solution - ketoprofen 50 mg - antiinflammatory and antirheumatic products

Malta - English - Malta Medicines Authority

midas pharma gmbh rheinstrasse 49, 55218 ingelheim, germany - ketoprofen - granules for oral solution - ketoprofen 25 mg - antiinflammatory and antirheumatic products

Malta - English - Malta Medicines Authority

midas pharma gmbh rheinstrasse 49, 55218 ingelheim, germany - ketoprofen - granules for oral solution - ketoprofen 50 mg - antiinflammatory and antirheumatic products

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

hf acquisition co llc, dba healthfirst - epinephrine (unii: ykh834o4bh) (epinephrine - unii:ykh834o4bh) - auvi-q® is indicated in the emergency treatment of allergic reactions (type i) including anaphylaxis to stinging insects (e.g., order hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. auvi-q is intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema. auvi-q is intended for immediate self-administration as emergency supportive therapy only and is not a substitute for immediate medical care. none. 8.1 pregnancy risk summary there are no adequate and well controlled studies of the acute effect of epinephrine in pregnant women. in animal reproductive studies, epinephrine administered by the subcutaneous route to rabbits, mice, and hamsters during the period of organogenesis was teratogenic at doses 7 times and higher than the maximum recommended human intramuscular and subcutaneous dose on a mg/m2 basis. epinephrine is the first-line medication of choice for the treatment of anaphylaxis during pregnancy in humans. epinephrine should be used for treatment of anaphylaxis during pregnancy in the same manner as it is used in non-pregnant patients. 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 disease-associated maternal and embryo/fetal risk: during pregnancy, anaphylaxis can be catastrophic and can lead to hypoxic-ischemic encephalopathy and permanent central nervous system damage or death in the mother and, more commonly, in the fetus or neonate. the prevalence of anaphylaxis occurring during pregnancy is reported to be approximately 3 cases per 100,000 deliveries. management of anaphylaxis during pregnancy is similar to management in the general population. epinephrine is the first line-medication of choice for treatment of anaphylaxis; it should be used in the same manner in pregnant and non-pregnant patients. in conjunction with the administration of epinephrine, the patient should seek immediate medical or hospital care. data animal data: in an embryofetal development study with rabbits dosed during the period of organogenesis, epinephrine was shown to be teratogenic (including gastroschisis and embryonic lethality) at doses approximately 40 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m2 basis at a maternal subcutaneous dose of 1.2 mg/kg/day for two to three days). in an embryofetal development study with mice dosed during the period of organogenesis, epinephrine was shown to be teratogenic (including embryonic lethality) at doses approximately 8 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m2 basis at a maternal subcutaneous dose of 1 mg/kg/day for 10 days). these effects were not seen in mice at approximately 4 times the maximum recommended daily intramuscular or subcutaneous dose (on a mg/m2 basis at a subcutaneous maternal dose of 0.5 mg/kg/day for 10 days). in an embryofetal development study with hamsters dosed during the period of organogenesis from gestation days 7 to 10, epinephrine was shown to be teratogenic at doses approximately 7 times the maximum recommended daily intramuscular or subcutaneous dose (on a mg/m2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day for 4 days). 8.2 lactation risk summary there is no information on the presence of epinephrine in human milk, the effects on breastfed infants, or the effects on milk production. epinephrine is the first line-medication of choice for treatment of anaphylaxis; it should be used in the same manner in breastfeeding and non-breastfeeding patients. 8.4 pediatric use auvi-q may be administered to pediatric patients at a dosage appropriate to body weight [see dosage and administration ( 2)]. clinical experience with the use of epinephrine suggests that the adverse reactions seen in children are similar in nature and extent to those both expected and reported in adults. since the doses of epinephrine delivered from auvi-q are fixed, consider using other forms of injectable epinephrine if doses lower than 0.1 mg are deemed necessary. 8.5 geriatric use clinical studies of auvi-q did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. epinephrine should be administered with caution in elderly individuals, who may be at greater risk for developing adverse reactions after epinephrine administration [see warnings and precautions ( 5-5.5), overdosage ( 10)]. important: the trainer for auvi-q does not contain a needle or medicine. in case of an allergic emergency, use the real auvi-q and not the gray trainer. always carry your real auvi-q with you in case of an allergic emergency. important information about the trainer for auvi-q: inside your trainer for auvi-q are: batteries a speaker that will make a beeping sound and that produces electronic voice instructions red and green blinking lights the trainer for auvi-q batteries are made to last long enough for you to practice 1 time each day for 2 years. if your trainer for auvi-q does not work properly call your healthcare provider for a new trainer. storage: store the trainer for auvi-q at room temperature; the trainer for auvi-q should not be used at temperatures less than 50°f (10°c) or greater than 104°f (40°c). store the trainer for auvi-q in its outer case. keep the trainer for auvi-q away from dirt, chemicals, and water. disposal: the trainer for auvi-q contains electronics and lithium coin cell batteries, and should be disposed of in the correct manner. follow your state and local environmental regulations for disposal. for california only: this product uses batteries containing perchlorate material - special handling may apply. see www.dtsc.ca.gov/hazardouswaste/perchlorate manufactured for: kaleo, inc. richmond, va 23219 usa this product may be covered by one or more u.s. patents or pending patent applications. see www.kaleopharma.com/pat for details. rev nov 2017

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

hf acquisition co llc, dba healthfirst - epinephrine (unii: ykh834o4bh) (epinephrine - unii:ykh834o4bh) - adrenalin® is available as a single-use 1 ml vial and a multiple-use 30 ml vial for intramuscular and subcutaneous use. emergency treatment of allergic reactions (type i), including anaphylaxis, which may result from allergic reactions to insect stings, biting insects, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. the signs and symptoms associated with anaphylaxis include flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with hypotension, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, airway swelling, laryngospasm, bronchospasm, pruritus, urticaria or angioedema, swelling of the eyelids, lips, and tongue. none. 8.1 pregnancy teratogenic effects: pregnancy category c. there are no adequate and well-controlled studies in pregnant women. epinephrine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus (fetal

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

hf acquisition co llc, dba healthfirst - epinephrine (unii: ykh834o4bh) (epinephrine - unii:ykh834o4bh) - 1.1 hypotension associated with septic shock epinephrine injection usp, 1 mg/10 ml (0.1 mg/ml) is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. none. 8.1 pregnancy risk summary limited published data on epinephrine use in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. however, there are risks to the mother and fetus associated with epinephrine use during labor or delivery, and risks due to untreated hypotension associated with septic shock (see clinical considerations below). in animal reproduction studies, epinephrine demonstrated adverse developmental effects when administered to pregnant rabbits (gastroschisis), mice (teratogenic effects, embryonic lethality, and delayed skeletal ossification), and hamsters (embryonic lethality and delayed skeletal ossification) during organogenesis at doses approximately 15 times, 3 times and 2 times, respectively, the maximum recommended daily intramuscular or subcutaneous dose (see data below). all pregnancies have a background risk of birth defects, loss, or other adverse outcomes. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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 disease-associated maternal and/or embryo/fetal risk hypotension associated with septic shock is a medical emergency in pregnancy which can be fatal if left untreated. delaying treatment in pregnant women with hypotension associated with septic shock may increase the risk of maternal and fetal morbidity and mortality. do not withhold life-sustaining therapy for a pregnant woman. labor or delivery epinephrine usually inhibits spontaneous or oxytocin induced contractions of the pregnant human uterus and may delay the second stage of labor. avoid epinephrine during the second stage of labor. in dosage sufficient to reduce uterine contractions, the drug may cause a prolonged period of uterine atony with hemorrhage. avoid epinephrine in obstetrics when maternal blood pressure exceeds 130/80 mmhg. although epinephrine improves maternal hypotension associated with anaphylaxis, it may result in uterine vasoconstriction, decreased uterine blood flow, and fetal anoxia. data animal data in a study in pregnant rabbits administered 1.2 mg/kg/day epinephrine (approximately 15 times the maximum recommended intramuscular or subcutaneous dose on a mg/m2 basis) subcutaneously during organogenesis (on days 3 to 5, 6 to 7 or 7 to 9 of gestation), epinephrine caused teratogenic effects (including gastroschisis). animals treated on days 6 to 7 had decreased number of implantations. in a teratology study, pregnant mice were subcutaneously administered epinephrine (0.1 to 10 mg/kg/day) on gestation days 6 to 15. teratogenic effects, embryonic lethality, and delays in skeletal ossification were observed at approximately 3 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m2 basis at maternal subcutaneous dose of 1 mg/kg/day for 10 days). these effects were not seen in mice at approximately 2 times the maximum recommended daily intramuscular or subcutaneous dose (on a mg/m2 basis at a subcutaneous maternal dose of 0.5 mg/kg/day for 10 days). subcutaneous administration of epinephrine to pregnant hamsters at a dose of 0.5 mg/kg/day (approximately 2 times the maximum recommended intramuscular or subcutaneous dose on a mg/m2 basis) on gestation days 7 to 10 resulted in delayed skeletal ossification and a reduction in litter size. 8.2 lactation risk summary there is no information regarding the presence of epinephrine in human milk, or the effects of epinephrine on the breastfed infant or on milk production. however, due to its poor oral bioavailability and short half-life, epinephrine exposure is expected to be very low in the breastfed infant. the lack of clinical data during lactation precludes a clear determination of the risk of epinephrine to a breastfed infant. 8.4 pediatric use safety and effectiveness in pediatric patients have not been established. 8.5 geriatric use clinical studies of epinephrine for the treatment of hypotension associated with septic shock did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and 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. close