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

general injectables and vaccines, inc. - calcium gluconate monohydrate (unii: czn0mi5r31) (calcium cation - unii:2m83c4r6zb) - calcium gluconate monohydrate 98 mg in 1 ml - these highlights do not include all the information needed to use calcium gluconate injection safely and effectively. see full prescribing information for calcium gluconate injection.calcium gluconate injection, for intravenous use initial u.s. approval: 1941 calcium gluconate injection is indicationd for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. limitations of use the safety of calcium gluconate injection for long term use has not been established. calcium gluconate injection is contraindicated in: - hypercalcemia - neonates (28 days of age or younger) receiving ceftriaxone [see warnings and precautions (5.2 )] 8.1 pregnancy risk summary limited available data with calcium gluconate injection use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. there are risks to the mother and the fetus associated with hypocalcemia in pregnancy [see clinical considerations] . the estimated background risk of major birth defects an

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

general injectables and vaccines, inc. - water (unii: 059qf0ko0r) (water - unii:059qf0ko0r) - this parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered. sterile water for injection, usp must be made approximately isotonic prior to use.

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

general injectables and vaccines, inc. - ondansetron hydrochloride (unii: nmh84ozk2b) (ondansetron - unii:4af302esos) - 1.1 prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy ondansetron injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin. ondansetron injection is approved for patients aged 6 months and older. 1.2 prevention of postoperative nausea and/or vomiting ondansetron injection is indicated for the prevention of postoperative nausea and/or vomiting. as with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. in patients in whom nausea and/or vomiting must be avoided postoperatively, ondansetron injection is recommended even when the incidence of postoperative nausea and/or vomiting is low. for patients who do not receive prophylactic ondansetron injection and experience nausea and/or vomiting postoperatively, ondansetron injection m

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

general injectables and vaccines, inc - flumazenil (unii: 40p7xk9392) (flumazenil - unii:40p7xk9392) - adult patients flumazenil injection, usp is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained with benzodiazepines, where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures, and for the management of benzodiazepine overdose. pediatric patients (aged 1 to 17) flumazenil injection, usp is indicated for the reversal of conscious sedation induced with benzodiazepines (see precautions; pediatric use ). flumazenil is contraindicated: - in patients with a known hypersensitivity to flumazenil or benzodiazepines. - in patients who have been given a benzodiazepine for control of a potentially life-threatening condition (e.g., control of intracranial pressure or status epilepticus). - in patients who are showing signs of serious cyctic antidepressant overdose (see warnings ). flumazenil acts as a benzodiazepine antagonist, blocks the effects of benzodiazepines in animals and

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

general injectables and vaccines, inc. - verapamil hydrochloride (unii: v3888oey5r) (verapamil - unii:cj0o37ku29) - verapamil hydrochloride injection, usp is indicated for the following: - rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (wolff-parkinson-white [w-p-w] and lown-ganong-levine [l-g-l] syndromes). when clinically advisable, appropriate vagal maneuvers (e.g., valsalva maneuver) should be attempted prior to verapamil hydrochloride administration. - temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation except when the atrial flutter and/or atrial fibrillation are associated with accessory bypass tracts (wolff-parkinson-white (w-p-w) and lown-ganong-levine (l-g-l) syndromes). in controlled studies in the united states, about 60% of patients with supraventricular tachycardia converted to normal sinus rhythm within 10 minutes after intravenous verapamil hydrochloride. uncontrolled studies reported in the world literature describe a conversion rate of about 80%. about 70% of patients with atrial flutter

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

general injectables and vaccines, inc. - midazolam hydrochloride (unii: w7ttw573jj) (midazolam - unii:r60l0sm5bc) - midazolam injection, usp is indicated: intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia; intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other cns depressants; intravenously for induction of general anesthesia, before administration of other anesthetic agents. with the use of narcotic premedication, induction of anesthesia can be attained within a relatively narrow dose range and in a short period of time. intravenous midazolam can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia); continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a crit

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

general injectables and vaccines, inc. - cefazolin sodium (unii: p380m0454z) (cefazolin - unii:ihs69l0y4t) - cefazolin for injection, usp is indicated in the treatment of the following serious infections due to susceptible organisms: respiratory tract infections: due to s. pneumoniae , klebsiella species, h. influenzae, s. aureus (penicillin-sensitive and penicillin-resistant), and group a beta-hemolytic streptococci. injectable benzathine penicillin is considered to be the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. cefazolin for injection is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of cefazolin for injection in the subsequent prevention of rheumatic fever are not available at present. urinary tract infections: due to e. coli, p. mirabilis, klebsiella species, and some strains of enterobacter and enterococci. skin and skin structure infections: due to s. aureus (penicillin-sensitive and penicillin-resistant), group a beta-hemolytic streptococci, and other strains of stre

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

general injectables and vaccines, inc. - midazolam hydrochloride (unii: w7ttw573jj) (midazolam - unii:r60l0sm5bc) - midazolam injection is indicated: - intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia; - intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other cns depressants; - intravenously for induction of general anesthesia, before administration of other anesthetic agents. with the sue of narcotic premedications, induction of anesthesia can be attained within a relatively narrow dose range and in a short period of time. intravenous midazolam can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia): - continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a

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

general injectables and vaccines, inc. - flumazenil (unii: 40p7xk9392) (flumazenil - unii:40p7xk9392) - adult patients: flumazenil injection is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained with benzodiazepines, where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures, and for the management of benzodiazepine overdose. pediatric patients (aged 1 to 17): flumazenil injection is indicated for the reversal of conscious sedation induced with benzodiazepines (see precautions: pediatric use). close contraindications flumazenil injection is contraindicated: •in patients with a known hypersensitivity to flumazenil or benzodiazepines. •in patients who have been given a benzodiazepine for control of a potentially life-threatening condition (e.g., control of intracranial pressure or status epilepticus). •in patients who are showing signs of serious cyclic antidepressant overdose (see warnings). flumazenil acts as a benzodiazepine antagonist, blocks the effects of benzo

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

general injectables and vaccines, inc. - flumazenil (unii: 40p7xk9392) (flumazenil - unii:40p7xk9392) - adult patients: flumazenil injection is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained with benzodiazepines, where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures, and for the management of benzodiazepine overdose. pediatric patients (aged 1 to 17): flumazenil injection is indicated for the reversal of conscious sedation induced with benzodiazepines (see precautions: pediatric use). flumazenil injection is contraindicated: •in patients with a known hypersensitivity to flumazenil or benzodiazepines. •in patients who have been given a benzodiazepine for control of a potentially life-threatening condition (e.g., control of intracranial pressure or status epilepticus). •in patients who are showing signs of serious cyclic antidepressant overdose (see warnings). flumazenil acts as a benzodiazepine antagonist, blocks the effects of benzodiazepines in animals and