USA - engelsk - NLM (National Library of Medicine)

piramal critical care inc - ampicillin sodium (unii: jfn36l5s8k) (ampicillin - unii:7c782967rd) - ampicillin for injection, usp is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions: respiratory tract infections caused by streptococcus pneumoniae , staphylococcus aureus (penicillinase and nonpenicillinase-producing), h. influenzae , and group a beta-hemolytic streptococci. bacterial meningitis caused by e . coli , group b streptococci, and other gram-negative bacteria ( listeria monocytogenes, n. meningitidis ). the addition of an aminoglycoside with ampicillin may increase its effectiveness against gram-negative bacteria. septicemia and endocarditis caused by susceptible gram-positive organisms including streptococcus spp., penicillin g-susceptible staphylococci, and enterococci. gram-negative sepsis caused by e. coli, proteus mirabilis and salmonella spp. responds to ampicillin. endocarditis due to enterococcal strains usually respond to intravenous therapy. the addition of an aminoglycoside may

USA - engelsk - NLM (National Library of Medicine)

piramal critical care inc - succinylcholine chloride (unii: i9l0ddd30i) (succinylcholine - unii:j2r869a8yf) - succinylcholine chloride injection is indicated in adults and pediatric patients: • as an adjunct to general anesthesia • to facilitate tracheal intubation • to provide skeletal muscle relaxation during surgery or mechanical ventilation. succinylcholine chloride injection is contraindicated: • in patients with skeletal muscle myopathies [see warnings and precautions ( 5.1)] • in patients with known hypersensitivity to succinylcholine. severe anaphylactic reactions to succinylcholine have been reported [see warnings and precautions ( 5.2)] • after the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury, which may result in severe hyperkalemia and cardiac arrest [see warnings and precautions ( 5.4)] • in patients with known or suspected genetic susceptibility to malignant hyperthermia [see warnings and precautions ( 5.5), clinical pharmacology ( 12.5)] risk summary available data from published literature from case reports and case series over decades of use with succinylcholine during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. succinylcholine is used commonly during delivery by caesarean section to provide muscle relaxation. if succinylcholine is used during labor and delivery, there is a risk for prolonged apnea in some pregnant women (see clinical considerations). animal reproduction studies have not been conducted with succinylcholine chloride. 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 maternal adverse reactions plasma cholinesterase levels are decreased by approximately 24% during pregnancy and for several days postpartum which can prolong the effect of succinylcholine. therefore, some pregnant patients may experience prolonged apnea. fetal/neonatal adverse reactions apnea and flaccidity may occur in the newborn after repeated high doses to, or in the presence of atypical plasma cholinesterase in, the mother. labor or delivery succinylcholine is commonly used to provide muscle relaxation during delivery by caesarean section. succinylcholine is known to cross the placental barrier in an amount that is dependent on the concentration gradient between the maternal and fetal circulation. risk summary there are no data on the presence of succinylcholine or its metabolite in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for succinylcholine chloride and any potential adverse effects on the breastfed infant from succinylcholine chloride or from the underlying maternal condition. safety and effectiveness of succinylcholine chloride have been established in pediatric patient age groups, neonate to adolescent. because of a risk of ventricular dysrhythmias, cardiac arrest, and death from hyperkalemic rhabdomyolysis in pediatric patients, reserve the use of succinylcholine chloride in pediatric patients for emergency intubation or instances where immediate securing of the airway is necessary, e.g., laryngospasm, difficult airway, full stomach, or for intramuscular use when a suitable vein is inaccessible [see warnings and precautions ( 5.1)] . intravenous bolus administration of succinylcholine chloride in pediatric patients (including infants) may result in profound bradycardia or, rarely, asystole. the incidence and severity of bradycardia is higher in pediatric patients than adults [see warnings and precautions ( 5.6)] . the effective dose of succinylcholine chloride in pediatric patients may be higher than that predicted by body weight dosing alone [see dosage and administration ( 2.3)] . clinical studies of succinylcholine chloride did not include sufficient numbers of subjects aged 65 years 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.

USA - engelsk - NLM (National Library of Medicine)

piramal critical care inc - glycopyrrolate (unii: v92so9wp2i) (glycopyrronium - unii:a14fb57v1d) - in anesthesia glycopyrrolate injection, usp is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. when indicated, glycopyrrolate injection, usp may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants. in peptic ulcer for use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated. known hypersensitivity to glycopyrrolate or any of its inactive ingredients. in addition, in the management of peptic ulcer   patients, because of the longer duration of therapy, glycopyrrolate injection may be contraindicated in patients with the following concurrent conditions: glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.

USA - engelsk - NLM (National Library of Medicine)

piramal critical care inc - sulbactam sodium (unii: dkq4t82ye6) (sulbactam - unii:s4tf6i2330), ampicillin sodium (unii: jfn36l5s8k) (ampicillin - unii:7c782967rd) - ampicillin and sulbactam for injection, usp is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. skin and skin structure infections caused by beta-lactamase producing strains of staphylococcus aureus , escherichia coli ,* klebsiella spp.* (including k. pneumoniae* ), proteus mirabilis ,* bacteroides fragilis ,* enterobacter spp.,* and acinetobacter calcoaceticus.* note: for information on use in pediatric patients (see precautions-pediatric use and clinical studies sections). intra-abdominal infections caused by beta-lactamase producing strains of escherichia coli , klebsiella spp. (including k. pneumoniae* ), bacteroides spp. (including b. fragilis ), and enterobacter spp.* gynecological infections caused by beta-lactamase producing strains of escherichia coli,* and bacteroides spp.* (including b. fragilis* ). * efficacy for this organism in this organ syste

USA - engelsk - NLM (National Library of Medicine)

piramal critical care inc - sulbactam sodium (unii: dkq4t82ye6) (sulbactam - unii:s4tf6i2330), ampicillin sodium (unii: jfn36l5s8k) (ampicillin - unii:7c782967rd) - ampicillin and sulbactam for injection, usp is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. skin and skin structure infections caused by beta-lactamase producing strains of staphylococcus aureus , escherichia coli ,* klebsiella spp.* (including k. pneumoniae* ), proteus mirabilis ,* bacteroides fragilis ,* enterobacter spp.,* and acinetobacter calcoaceticus.* note: for information on use in pediatric patients (see precautions–pediatric use and clinical studies sections). intra-abdominal infections caused by beta-lactamase producing strains of escherichia coli , klebsiella spp. (including k. pneumoniae* ), bacteroides spp. (including b. fragilis ), and enterobacter spp.* gynecological infections caused by beta-lactamase producing strains of escherichia coli,* and bacteroides spp.* (including b. fragilis* ). * efficacy for this organism in this organ syste

USA - engelsk - NLM (National Library of Medicine)

piramal critical care inc - oxacillin sodium (unii: g0v6c994q5) (oxacillin - unii:uh95vd7v76) - oxacillin is indicated in the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug. cultures and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see clinical pharmacology: susceptibility testing ). oxacillin may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of susceptibility test results. oxacillin should not be used in infections caused by organisms susceptible to penicillin g. if the susceptibility tests indicate that the infection is due to an organism other than a resistant staphylococcus, therapy should not be continued with oxacillin. to reduce the development of drug-resistant bacteria and maintain the effectiveness of oxacillin for injection, usp and other antibacterial drugs, oxacillin for injection, usp should be used only to treat or prevent infections that are proven or strongly suspecte

USA - engelsk - NLM (National Library of Medicine)

piramal critical care inc - oxacillin sodium (unii: g0v6c994q5) (oxacillin - unii:uh95vd7v76) - oxacillin is indicated in the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug. cultures and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug. (see clinical pharmacology: susceptibility testing). oxacillin may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of susceptibility test results. oxacillin should not be used in infections caused by organisms susceptible to penicillin g. if the susceptibility tests indicate that the infection is due to an organism other than a resistant staphylococcus, therapy should not be continued with oxacillin. to reduce the development of drug-resistant bacteria and maintain the effectiveness of oxacillin for injection, usp and other antibacterial drugs, oxacillin for injection, usp should be used only to treat or prevent infections that are proven or strongly suspecte

USA - engelsk - NLM (National Library of Medicine)

piramal critical care inc - sulbactam sodium (unii: dkq4t82ye6) (sulbactam - unii:s4tf6i2330), ampicillin sodium (unii: jfn36l5s8k) (ampicillin - unii:7c782967rd) - ampicillin and sulbactam for injection, usp is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. skin and skin structure infections caused by beta-lactamase producing strains of staphylococcus aureus , escherichia coli ,* klebsiella spp.* (including k. pneumoniae* ), proteus mirabilis ,* bacteroides fragilis ,* enterobacter spp.,* and acinetobacter calcoaceticus.* note: for information on use in pediatric patients (see precautions-pediatric use and clinical studies sections). intra-abdominal infections caused by beta-lactamase producing strains of escherichia coli , klebsiella spp. (including k. pneumoniae* ), bacteroides spp. (including b. fragilis ), and enterobacte

USA - engelsk - NLM (National Library of Medicine)

piramal critical care inc - sulbactam sodium (unii: dkq4t82ye6) (sulbactam - unii:s4tf6i2330), ampicillin sodium (unii: jfn36l5s8k) (ampicillin - unii:7c782967rd) - ampicillin and sulbactam for injection, usp is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. skin and skin structure infections caused by beta-lactamase producing strains of staphylococcus aureus , escherichia coli *, klebsiella spp.* (including k. pneumoniae* ), proteus mirabilis *, bacteroides fragilis *, enterobacter spp.*, and acinetobacter calcoaceticus*. note: for information on use in pediatric patients see precautions–pediatric use and clinical studies sections. intra-abdominal infections caused by beta-lactamase producing strains of escherichia coli , klebsiella spp. (including k. pneumoniae* ), bacteroides spp. (including b. fragilis ), and enterobacter

Irland - engelsk - HPRA (Health Products Regulatory Authority)

piramal critical care limited - fentanyl citrate - solution for injection - 50 microgram(s)/millilitre - opioid anesthetics; fentanyl