Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

wockhardt bio pty ltd - voriconazole, quantity: 200 mg - injection, powder for - excipient ingredients: sodium chloride; hydroxypropylbetadex - voriwok is indicated for treatment of the following fungal infections:,invasive aspergillosis.,serious candida infections (including c. krusei), including systemic candida infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia).,serious fungal infections caused by scedosporium spp and fusarium spp.,other serious fungal infections, in patients intolerant of, or refractory to, other therapy.,prophylaxis in patients who are at high risk of developing invasive fungal infections. the indication is based on studies including patients undergoing haematopoietic stem cell transplantation.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - voriconazole, quantity: 200 mg - injection, powder for - excipient ingredients: sulfobutyl betadex sodium - vfend is indicated for treatment of the following fungal infections: invasive aspergillosis. serious candida infections (including c. krusei), including oesophageal and systemic candida infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia). serious fungal infections caused by scedosporium spp and fusarium spp. other serious fungal infections, in patients intolerant of, or refractory to, other therapy. *prophylaxis in patients who are at high risk of developing invasive fungal infections. the indication is based on studies including patients undergoing haematopoietic stem cell transplantation.

Stati Uniti - Ingliż - NLM (National Library of Medicine)

akorn - alfentanil hydrochloride (unii: 11s92g0tiw) (alfentanil - unii:1n74hm2bs7) - alfentanil 500 ug in 1 ml - alfentanil hcl injection is indicated: - as an analgesic adjunct given in incremental doses in the maintenance of anesthesia with barbiturate/nitrous oxide/oxygen. - as an analgesic administered by continuous infusion with nitrous oxide/oxygen in the maintenance of general anesthesia. - as a primary anesthetic agent for the induction of anesthesia in patients undergoing general surgery in which endotracheal intubation and mechanical ventilation are required. - as the analgesic component for monitored anesthesia care (mac). alfentanil hcl injection is contraindicated in patients with: - hypersensitivity to alfentanil (e.g., anaphylaxis) [see adverse reactions (6)] risk summary prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. available data with alfentanil hcl injection in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. in animal reproduction studies, alfentanil reduced pup birth weights and increased pup mortality when administered to pregnant rats during gestation and throughout lactation at 9 times the human dose of 335 mcg/kg per procedure. alfentanil was embryocidal when administered to pregnant rabbits during organogenesis at 72.6 times the human dose of 335 mcg/kg per procedure. no malformations were noted in rats or rabbits treated with alfentanil during organogenesis [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. clinical considerations fetal/neonatal adverse reactions prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. the onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see warnings and precautions (5.3)]. labor or delivery opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. an opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. alfentanil hcl injection is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. opioid analgesics, including alfentanil hcl injection, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. however, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. data animal data pregnant rats were treated with intravenous alfentanil doses of 0.08, 0.31, or 1.25 mg/kg/day (2.3, 9, or 36.6 times the human total dose of 335 mcg/kg based on body surface area, respectively). no malformations or embryotoxic effects were noted despite maternal toxicity (increased mortality in the mid- and high-dose group). pregnant rabbits were treated with intravenous alfentanil doses of 0.08, 0.31, or 1.25 mg/kg/day (4.6, 18, or 72.6 times the human total dose of 335 mcg/kg based on body surface area, respectively). decreased live fetuses per litter and decreased litter size in the high dose group were noted in the presence of maternal toxicity (decreased body weight gain and mortality in the high-dose group). no evidence of malformations or adverse effects on the fetus was reported in a published study in which pregnant rats were administered 8 mg/kg/day alfentanil (232 times the human dose of 335 mcg/kg/day based on body surface area) continuously from gestation day 5 through gestation day 20 via subcutaneously implanted osmotic minipumps. pregnant rats were treated intravenously with alfentanil 0.08, 0.31, or 1.25 mg/kg/day (2.3, 9, or 36.6 times the human total dose of 335 mcg/day based on body surface area, respectively) during gestation and throughout lactation. reduced birth weights and decreased pup survival were noted in the mid- and high-dose groups in the presence of maternal toxicity (increased mortality in the mid- and high-dose groups). risk summary the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for alfentanil hcl injection and any potential adverse effects on the breastfed infant from alfentanil hcl injection or from the underlying maternal condition. clinical considerations infants exposed to alfentanil hcl injection through breast milk should be monitored for excess sedation and respiratory depression. withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast- feeding is stopped. infertility chronic use of opioids may cause reduced fertility in females and males of reproductive potential. it is not known whether these effects on fertility are reversible [see adverse reactions (6.2)]. adequate data to support the use of alfentanil hcl injection in children under the age of 12 years of age are not presently available. in one clinical trial, the dose of alfentanil required to produce anesthesia, as determined by appearance of delta waves in eeg, was 40% lower in geriatric patients than that needed in healthy young patients. the initial dose of alfentanil hcl injection should be appropriately reduced in elderly. patients over the age of 65 have been found to have reduced plasma clearance and extended terminal elimination which may prolong postoperative recovery. elderly patients (aged 65 years or older) may have increased sensitivity to alfentanil. in general, use caution when selecting a dosage for an elderly patient, 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. respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. titrate the dosage of alfentanil hcl injection slowly in geriatric patients [see warnings and precautions (5.6)]. this drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. alfentanil hcl injection should be administered with caution patients with liver dysfunction because of the extensive hepatic metabolism. reduce the dosage as needed and monitor closely for signs of respiratory depression, sedation, and hypotension. alfentanil hcl injection should be administered with caution to patients with kidney dysfunction because of the renal excretion of alfentanil hcl and its metabolites. reduce the dosage as needed and monitor for signs of respiratory depression, sedation, and hypotension. alfentanil hcl injection should be used with caution in patients with pulmonary disease, decreased respiratory reserve, or potentially compromised respiration, in such patients opioids may additionally decrease respiratory drive and increase airway resistance. during anesthesia, this can be managed by assisted or controlled respiration. alfentanil hcl injection contains alfentanil, a schedule ii controlled substance. alfentanil hcl injection contains alfentanil, a substance with a high potential for abuse similar to other opioids including morphine, sufentanil etc. alfentanil hcl injection can be abused and is subject to misuse, addiction, and criminal diversion [see warnings and precautions (5.1)]. 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. alfentanil hcl injection, like other opioids, can be diverted for non-medical use into illicit channels of distribution. careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. risks specific to abuse of sufentanil citrate injection abuse of sufentanil citrate injection poses a risk of overdose and death. the risk is increased with concurrent use of sufentanil citrate injection with alcohol and other central nervous system depressants. parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and hiv. both tolerance and physical dependence can develop during chronic opioid therapy. tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects. physical dependence results in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug. withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene), mixed agonist/ antagonist analgesics (pentazocine, butorphanol, nalbuphine), or partial agonists (buprenorphine). physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage. alfentanil hcl injection should not be abruptly discontinued [see dosage and administration (2.13)] . if alfentanil hcl injection is abruptly discontinued in a physically-dependent patient, a withdrawal syndrome may occur. some or all of the following can characterize this syndrome: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. other signs and symptoms also may develop, including: irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see use in specific populations (8.1)].

Kanada - Ingliż - Health Canada

sterimax inc - remifentanil (remifentanil hydrochloride) - powder for solution - 1mg - remifentanil (remifentanil hydrochloride) 1mg - opiate agonists

Kanada - Ingliż - Health Canada

sterimax inc - remifentanil (remifentanil hydrochloride) - powder for solution - 2mg - remifentanil (remifentanil hydrochloride) 2mg - opiate agonists

Kanada - Ingliż - Health Canada

sterimax inc - remifentanil (remifentanil hydrochloride) - powder for solution - 5mg - remifentanil (remifentanil hydrochloride) 5mg - opiate agonists

Stati Uniti - Ingliż - NLM (National Library of Medicine)

akorn - sufentanil citrate (unii: s9zfx8403r) (sufentanil - unii:afe2yw0iiz) - sufentanil 50 ug in 1 ml - sufentanil citrate injection is indicated for intravenous administration in adults and pediatric patients: - as an analgesic adjunct in the maintenance of balanced general anesthesia in patients who are intubated and ventilated. - as a primary anesthetic agent for the induction and maintenance of anesthesia with 100% oxygen in patients undergoing major surgical procedures, in patients who are intubated and ventilated, such as cardiovascular surgery or neurosurgical procedures in the sitting position, to provide favorable myocardial and cerebral oxygen balance or when extended postoperative ventilation is anticipated. sufentanil citrate injection is indicated for epidural administration: - as an analgesic combined with low dose (usually 12.5 mg per administration) bupivacaine usually during labor and vaginal delivery. sufentanil citrate injection is contraindicated in patients with: - hypersensitivity to sufentanil (e.g., anaphylaxis) [see adverse reactions (6.2)] risk summary prolonged use of opioid analgesic

Stati Uniti - Ingliż - NLM (National Library of Medicine)

west-ward pharmaceuticals corp. - sufentanil citrate (unii: s9zfx8403r) (sufentanil - unii:afe2yw0iiz) - sufentanil 0.05 mg in 1 ml - sufentanil citrate injection is indicated for intravenous administration in adults and pediatric patients: - as an analgesic adjunct in the maintenance of balanced general anesthesia in patients who are intubated and ventilated. - as a primary anesthetic agent for the induction and maintenance of anesthesia with 100% oxygen in patients undergoing major surgical procedures, in patients who are intubated and ventilated, such as cardiovascular surgery or neurosurgical procedures in the sitting position, to provide favorable myocardial and cerebral oxygen balance or when extended postoperative ventilation is anticipated. sufentanil citrate injection is indicated for epidural administration: - as an analgesic combined with low dose (usually 12.5 mg per administration) bupivacaine usually during labor and vaginal delivery. sufentanil citrate injection is contraindicated in patients with: - hypersensitivity to sufentanil (e.g., anaphylaxis) [see adverse reactions (6.2)] risk summary prolonged use of opioid analgesic

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - parecoxib sodium, quantity: 42.36 mg - injection, powder for - excipient ingredients: dibasic sodium phosphate; phosphoric acid; sodium hydroxide - for a single peri-operative dose for the management of post-operative pain.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

aft pharmaceuticals pty ltd - parecoxib sodium, quantity: 42.36 mg (equivalent: parecoxib, qty 40 mg) - injection, powder for - excipient ingredients: sodium hydroxide; dibasic sodium phosphate; phosphoric acid - for a single peri-operative dose for the management of post-operative pain