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

baxter healthcare pty ltd - sodium chloride, quantity: 6.43 g/l; potassium chloride, quantity: 1.19 g/l; magnesium chloride hexahydrate, quantity: 3.25 g/l; calcium chloride dihydrate, quantity: 0.176 g/l - solution - excipient ingredients: water for injections; hydrochloric acid - other conditions: the ph of the solution must be adjusted to 7.4 to 7. 8 with 10ml of sodium bicarbonate 8.4% w/v injection bp (not supplied) before use. indications: following ph adjustment with 10ml of sodium bicarbonate 8.4% w/v injection bp, cardioplegia "a" solution is used in combination with ischaemia and hypothermia to induce cardiac arrest during open heart surgery and to preserve the myocardium during asystole.

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

nostrum laboratories, inc. - morphine sulfate (unii: x3p646a2j0) (morphine - unii:76i7g6d29c) - morphine sulfate 10 mg in 5 ml - morphine sulfate oral solution (10 mg per 5 ml and 20 mg per 5 ml ) are formulations of morphine, an opioid agonist, indicated for the relief of moderate to severe acute and chronic pain where use of an opioid analgesic is appropriate. morphine sulfate is contraindicated in patients with known hypersensitivity to morphine, morphine salts, or any components of the product. morphine sulfate is contraindicated in patients with respiratory depression in the absence of resuscitative equipment. morphine sulfate is contraindicated in patients with acute or severe bronchial asthma or hypercarbia. morphine sulfate is contraindicated in any patient who has or is suspected of having paralytic ileus. no formal studies to assess the teratogenic effects of morphine in animals have been conducted.  it is also not known whether morphine can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.  morphine should be given to a pregnant woman only if clearly needed. in humans, the frequency

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

pharmaceutical solution industries (psi), saudi arabia - dextrose monohydrate, sodium chloride, potassium chloride, calcium chloride 2h2o, sodium lactate solution - solution for injection - 55 , 6 , 0.40 , 0.27 , 3.20 g/ml

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

baxter healthcare pty ltd - calcium chloride; potassium chloride; sodium lactate; sodium chloride - parenteral liquid/solution/suspension - calcium chloride mineral-calcium-salt active 0.27 g/l; potassium chloride mineral-potassium active 0.4 g/l; sodium lactate mineral-sodium active 3.22 g/l; sodium chloride mineral-sodium-salt active 6.0 g/l - nutrition & metabolism - all animals - dehydration | electrolyte replacement

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

phebra pty ltd - caffeine, quantity: 12.5 mg - oral liquid, solution - excipient ingredients: citric acid monohydrate; sodium citrate dihydrate; water for injections - cafnea oral solution is indicated for the short-term treatment of apnoea of prematurity in infants between 28 and 33 weeks gestational age.

Malta - English - Medicines Authority

pinewood laboratories limited ballymacarbry, clonmel, co. tipperary, ireland - heparin sodium - solution for injection concentrate for solution for infusion - heparin sodium 1000 iu/ml - antithrombotic agents

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

ascend laboratories, llc - lacosamide (unii: 563ks2pqy5) (lacosamide - unii:563ks2pqy5) - lacosamide oral solution is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. additional pediatric use information is approved for ucb, inc.’s vimpat® (lacosamide) oral solution. however, due to ucb, inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.  none. pregnancy exposure registry   there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as lacosamide oral solution, during pregnancy. encourage women who are taking lacomsamide oral solution during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. risk summary available data from the north american antiepileptic drug (naaed) pregnancy registry, a prospective cohort study, case reports, and a case series with lacosamide use in pregnant women are insufficient to identify a drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. lacosamide produced developmental toxicity (increased embryofetal and perinatal mortality, growth deficit) in rats following administration during pregnancy. developmental neurotoxicity was observed in rats following administration during a period of postnatal development corresponding to the third trimester of human pregnancy. these effects were observed at doses associated with clinically relevant plasma exposures (see data).  the 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 animal data oral administration of lacosamide to pregnant rats (20, 75, or 200 mg/kg/day) and rabbits (6.25, 12.5, or 25 mg/kg/day) during the period of organogenesis did not produce any effects on the incidences of fetal structural abnormalities. however, the maximum doses evaluated were limited by maternal toxicity in both species and embryofetal death in rats. these doses were associated with maternal plasma lacosamide exposures (auc) approximately 2 and 1 times (rat and rabbit, respectively) that in humans at the maximum recommended human dose (mrhd) of 400 mg/day. in two studies in which lacosamide (25, 70, or 200 mg/kg/day and 50, 100, or 200 mg/kg/day) was orally administered to rats throughout pregnancy and lactation, increased perinatal mortality and decreased body weights in the offspring were observed at the highest dose tested. the no-effect dose for pre- and postnatal developmental toxicity in rats (70 mg/kg/day) was associated with a maternal plasma lacosamide auc similar to that in humans at the mrhd. oral administration of lacosamide (30, 90, or 180 mg/kg/day) to rats during the neonatal and juvenile periods of development resulted in decreased brain weights and long-term neurobehavioral changes (altered open field performance, deficits in learning and memory). the early postnatal period in rats is generally thought to correspond to late pregnancy in humans in terms of brain development. the no-effect dose for developmental neurotoxicity in rats was associated with a plasma lacosamide auc less than that in humans at the mrhd. in vitro data lacosamide has been shown in vitro to interfere with the activity of collapsin response mediator protein-2 (crmp-2), a protein involved in neuronal differentiation and control of axonal outgrowth. potential adverse effects on cns development related to this activity cannot be ruled out. risk summary data from published literature indicate that lacosamide is present in human milk. there are reports of increased sleepiness in breastfed infants exposed to lacosamide (see clinical considerations). there is no information on the effects of lacosamide on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for lacosamide oral solution and any potential adverse effects on the breastfed infant from lacosamide oral solution or from the underlying maternal condition. clinical considerations monitor infants exposed to lacosamide through breastmilk for excess sedation. partial-onset seizures safety and effectiveness of lacosamide oral solution for the treatment of partial-onset seizures have been established in pediatric patients 4 years to less than 17 years of age. use of lacosamide oral solution in this age group is supported by evidence from adequate and well- controlled studies of lacosamide oral solution in adults with partial-onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data in 328 pediatric patients 4 years to less than 17 years of age [see adverse reactions (6.1), clinical pharmacology (12.3) , and clinical studies (14.1, 14.2) ]. safety and effectiveness in pediatric patients below 1 month of age  have not been established.  animal data lacosamide has been shown in vitro to interfere with the activity of collapsin response mediator protein-2 (crmp-2), a protein involved in neuronal differentiation and control of axonal outgrowth. potential related adverse effects on cns development cannot be ruled out. administration of lacosamide to rats during the neonatal and juvenile periods of postnatal development (approximately equivalent to neonatal through adolescent development in humans) resulted in decreased brain weights and long-term neurobehavioral changes (altered open field performance, deficits in learning and memory). the no-effect dose for developmental neurotoxicity in rats was associated with a plasma lacosamide exposure (auc) less than that in humans at the maximum recommended human dose of 400 mg/day. additional pediatric use information is approved for ucb, inc.’s vimpat® (lacosamide) oral solution. however, due to ucb, inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. there were insufficient numbers of elderly patients enrolled in partial-onset seizure trials (n=18) to adequately determine whether they respond differently from younger patients. no lacosamide oral solution dose adjustment based on age is necessary. in elderly patients, dose titration should be performed with caution, usually starting at the lower end of the dosing range, reflecting the greater frequency of decreased hepatic function, decreased renal function, increased cardiac conduction abnormalities, and polypharmacy [see dosage and administration (2.1, 2.4, 2.5) and clinical pharmacology (12.3) ]. no dose adjustment is necessary in patients with mild to moderate renal impairment (clcr ≥30 ml/min). in patients with severe renal impairment (clcr <30 ml/min as estimated by the cockcroft-gault equation for adults; clcr <30 ml/min/1.73m2 as estimated by the schwartz equation for pediatric patients) and in those with end-stage renal disease, a reduction of 25% of the maximum dosage is recommended [see dosage and administration (2.4) and clinical pharmacology (12.3)]. in all patients with renal impairment, dose initiation and titration should be based on clinical response and tolerability. lacosamide oral solution is effectively removed from plasma by hemodialysis. dosage supplementation of up to 50% following hemodialysis should be considered. for adult and pediatric patients with mild to moderate hepatic impairment, a reduction of 25% of the maximum dosage is recommended.  patients with mild to moderate hepatic impairment should be observed closely for adverse reactions, and dose initiation and titration should be based on clinical response and tolerability [see dosage and administration (2.5), clinical pharmacology (12.3)]. the pharmacokinetics of lacosamide has not been evaluated in severe hepatic impairment. lacosamide oral solution use is not recommended in patients with severe hepatic impairment. lacosamide oral solution contains lacosamide, a schedule v controlled substance. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. in a human abuse potential study, single doses of 200 mg (equal to the maximum single dosage) and 800 mg lacosamide (equal to twice the recommended daily maintenance dosage) produced euphoria-type subjective responses that differentiated statistically from placebo; at 800 mg, these euphoria-type responses were statistically indistinguishable from those produced by alprazolam, a schedule iv drug. the duration of the euphoria-type responses following lacosamide was less than that following alprazolam. a high rate of euphoria was also reported as an adverse event in the human abuse potential study following single doses of 800 mg lacosamide (15% [5/34]) compared to placebo (0%) and in two pharmacokinetic studies following single and multiple doses of 300 to 800 mg lacosamide (ranging from 6% [2/33] to 25% [3/12]) compared to placebo (0%). however, the rate of euphoria reported as an adverse event in the lacosamide oral solution development program at therapeutic doses was less than 1%. 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. abrupt termination of lacosamide in clinical trials with diabetic neuropathic pain patients produced no signs or symptoms that are associated with a withdrawal syndrome indicative of physical dependence.  however, psychological dependence cannot be excluded due to the ability of lacosamide to produce euphoria-type adverse events in humans. 

Singapore - English - HSA (Health Sciences Authority)

fresenius medical care singapore pte. ltd. - (solution a) anhydrous glucose 20 g/l eqv glucose monohydrate; (solution a) calcium chloride dihydrate; (solution a) magnesium chloride hexahydrate; (solution b) sodium chloride; (solution b) sodium hydrogen carbonate - solution, sterile - 0.2205 g/1000 ml - (solution a) anhydrous glucose 20 g/l eqv glucose monohydrate 22.00g/l; (solution a) calcium chloride dihydrate 4.410g/l; (solution a) magnesium chloride hexahydrate 2.033g/l; (solution b) sodium chloride 6.453g/l; (solution b) sodium hydrogen carbonate 3.104g/l

Ireland - English - HPRA (Health Products Regulatory Authority)

carelide - sodium chloride; calcium chloride dihydrate; potassium chloride; sodium lactate solution 60% - solution for infusion - solutions affecting the electrolyte balance; electrolytes

Ireland - English - HPRA (Health Products Regulatory Authority)

laboratoire aguettant - sodium chloride; calcium chloride dihydrate; potassium chloride; sodium lactate solution 60% - solution for infusion - solutions affecting the electrolyte balance; electrolytes