Canada - English - Health Canada

astrazeneca canada inc - sodium zirconium cyclosilicate - powder for suspension - 5g - sodium zirconium cyclosilicate 5g - potassium-removing agents

Canada - English - Health Canada

astrazeneca canada inc - sodium zirconium cyclosilicate - powder for suspension - 10g - sodium zirconium cyclosilicate 10g - potassium-removing agents

Malta - English - Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - pantoprazole - gastro-resistant tablet - pantoprazole 20 mg - drugs for acid related disorders

Malta - English - Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - pantoprazole - gastro-resistant tablet - pantoprazole 20 mg - drugs for acid related disorders

Malta - English - Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - pantoprazole - gastro-resistant tablet - pantoprazole 40 mg - drugs for acid related disorders

Canada - English - Health Canada

curium canada inc - sodium pertechnetate tc-99m - solution - 19ci - sodium pertechnetate tc-99m 19ci - roentgenography

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

pharmacosmos therapeutics inc. - ferric derisomaltose (unii: ahu547pi9h) (ferric derisomaltose - unii:ahu547pi9h) - monoferric is indicated for the treatment of iron deficiency anemia (ida) in adult patients: - who have intolerance to oral iron or have had unsatisfactory response to oral iron - who have non-hemodialysis dependent chronic kidney disease (ndd-ckd) monoferric is contraindicated in patients with a history of serious hypersensitivity to monoferric or any of its components (see warnings and precautions (5.1), description (11)) . reactions have included shock, clinically significant hypotension, loss of consciousness, and/or collapse. risk summary there are no available data on monoferric use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. published studies on the use of intravenous iron products in pregnant women have not reported an association with adverse developmental outcomes. however, these studies cannot establish or exclude the absence of any drug-related risk during pregnancy because the studies were not designed to assess for the risk of major birth defects ( see data) . there are risks to the mother and fetus associated with untreated iron deficiency anemia (ida) in pregnancy as well as risks to the fetus associated with maternal severe hypersensitivity reactions ( see clinical considerations) . iron complexes have been reported to be teratogenic and embryocidal in non-iron depleted pregnant animals. the findings in animals may be due to iron overload and may not be applicable to patients with iron deficiency. animal reproduction studies of ferric derisomaltose administered to rats and rabbits during the period of organogenesis caused adverse developmental outcomes including structural abnormalities and embryo-fetal mortality at doses approximately 0.09 and 0.4 times the maximum recommended human dose (mrhd) of 1000 mg, respectively, based on body surface area ( see data) . the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. 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. clinical considerations disease-associated maternal and/or embryo/fetal risk untreated iron deficiency anemia (ida) in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. adverse pregnancy outcomes associated with ida includes increased risk for preterm delivery and low birth weight. fetal/neonatal adverse reactions severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with parenteral iron products (such as monoferric) which may cause fetal bradycardia, especially during the second and third trimester. data animal data iron complexes have been reported to be teratogenic and embryocidal in non-anemic pregnant animals at single doses above 125 mg iron/kg body weight. the highest recommended dose in human clinical use is 20 mg iron/kg body weight. in a combined fertility and embryo-fetal development study in rats, ferric derisomaltose was administered intravenously to female rats 14 days prior to cohabitation and through gestation day (gd) 17 at doses of 3, 11, and 32 mg fe/kg/day. the doses of 11 and 32 mg fe/kg/day (approximately 0.1 and 0.3 times the mrhd of 1000 mg, based on body surface area (bsa)) resulted in an increase in the incidence of skeletal developmental delays. ferric derisomaltose was administered intravenously to pregnant rabbits during organogenesis, from gd7 to gd20, at doses of 11, 25 and 43 mg fe/kg/day. the dose of 43 mg fe/kg/day (approximately 0.8 times the mrhd of 1000 mg, based on bsa) resulted in increased maternal mortality, abortion, and premature delivery, and increased postimplantation loss. adverse developmental findings at this dose included fetal mortality, reduced fetal weights, and fetal developmental variations and malformations (including domed head, cleft palate, microglossia, hydrocephaly, small brain). fetal malformations and reduced fetal weights were also noted in the 25 mg fe/kg/day group (approximately 0.5 times the mrhd based on bsa). risk summary the available data on the use of monoferric in lactating women demonstrate that iron is present in breast milk. however, the data do not inform the potential exposure of iron for the breastfed child or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for monoferric in addition to any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition. clinical considerations monitor breastfed children for gastrointestinal toxicity (constipation, diarrhea). safety and effectiveness have not been established in pediatric patients. of the 3934 patients in clinical studies of monoferric, 29% were 65 years and over, while 13% were 75 years and over. no overall differences in safety or effectiveness were observed between these patients and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Canada - English - Health Canada

novartis pharmaceuticals canada inc - indacaterol (indacaterol acetate); glycopyrronium (glycopyrronium bromide); mometasone furoate - capsule - 150mcg; 50mcg; 160mcg - indacaterol (indacaterol acetate) 150mcg; glycopyrronium (glycopyrronium bromide) 50mcg; mometasone furoate 160mcg - antimuscarinics antispasmodics

Canada - English - Health Canada

fresenius kabi canada ltd - glycine; proline; histidine; serine; taurine; tyrosine; sodium acetate; potassium chloride; sodium glycerophosphate; magnesium sulfate; calcium chloride; zinc sulfate heptahydrate; dextrose; soybean oil; medium chain triglycerides (mct); olive oil; fish oil; lysine (lysine acetate); phenylalanine; leucine; valine; threonine; methionine; isoleucine; tryptophan; alanine; arginine - emulsion - 0.72g; 0.73g; 0.2g; 0.43g; 0.065g; 0.026g; 0.16g; 0.23g; 0.23g; 0.061g; 0.028g; 0.00066g; 8.5g; 0.87g; 0.87g; 0.72g; 0.43g; 0.43g; 0.33g; 0.48g; 0.41g; 0.29g; 0.28g; 0.33g; 0.13g; 0.92g; 0.79g - glycine 0.72g; proline 0.73g; histidine 0.2g; serine 0.43g; taurine 0.065g; tyrosine 0.026g; sodium acetate 0.16g; potassium chloride 0.23g; sodium glycerophosphate 0.23g; magnesium sulfate 0.061g; calcium chloride 0.028g; zinc sulfate heptahydrate 0.00066g; dextrose 8.5g; soybean oil 0.87g; medium chain triglycerides (mct) 0.87g; olive oil 0.72g; fish oil 0.43g; lysine (lysine acetate) 0.43g; phenylalanine 0.33g; leucine 0.48g; valine 0.41g; threonine 0.29g; methionine 0.28g; isoleucine 0.33g; tryptophan 0.13g; alanine 0.92g; arginine 0.79g - replacement preparations

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

bryant ranch prepack - levorphanol tartrate (unii: 04wqu6t9qi) (levorphanol - unii:27618j1n2x) - levorphanol tartrate tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings ], reserve levorphanol tartrate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: - have not been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia levorphanol tartrate tablets are contraindicated in patients with: - significant respiratory depression [see warnings ] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings ] - known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings ]  - hypersensitivity to levorphanol or any of the formulation excipients (e.g., anaphylaxis) [see warnings ] levorphanol tartrate tablets contains levorphanol, a schedule ii controlled substance. levorphanol tartrate tablets contains levorphanol, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone and tapentadol. levorphanol can be abused and is subject to misuse, addiction, and criminal diversion [see warnings ]. all patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. prescription drug abuse is the intentional nontherapeutic 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-seeking” behavior is very common in persons with substance use disorders. drug- seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating health care provider(s). “doctor shopping” (visiting multiple prescribers to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction. preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control. abuse and addiction are separate and distinct from physical dependence and tolerance. health care providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. in addition, abuse of opioids can occur in the absence of true addiction. levorphanol tartrate tablets, 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 reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. risks specific to abuse of levorphanol tartrate tablets levorphanol tartrate tablets are for oral use only. abuse of levorphanol tartrate tablets poses a risk of overdose and death. the risk is increased with concurrent abuse of levorphanol tartrate tablets 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 is a physiological state in which the body adapts to the drug after a period of regular exposure, resulting 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 (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage. do not abruptly discontinue levorphanol tartrate tablets in a patient physically dependent on opioids. rapid tapering of levorphanol tartrate tablets in a patient physically dependent on opioids may lead to serious withdrawal symptoms, uncontrolled pain, and suicide. rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse. when discontinuing levorphanol tartrate tablets, gradually taper the dosage using a patient- specific plan that considers the following: the dose of levorphanol tartrate tablets the patient has been taking, the duration of treatment, and the physical and psychological attributes of the patient. to improve the likelihood of a successful taper and minimize withdrawal symptoms, it is important that the opioid tapering schedule is agreed upon by the patient. in patients taking opioids for a long duration at high doses, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper [see dosage and administration, warnings ]. infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see precautions; pregnancy ].