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

actavis pharma, inc. - zoledronic acid (unii: 6xc1pad3kf) (zoledronic acid anhydrous - unii:70hz18ph24) - zoledronic acid anhydrous 4 mg in 5 ml - zoledronic acid injection is indicated for the treatment of hypercalcemia of malignancy defined as an albumin-corrected calcium (cca) of greater than or equal to 12 mg/dl [3.0 mmol/l] using the formula: cca in mg/dl=ca in mg/dl + 0.8 (4.0 g/dl - patient albumin [g/dl]). zoledronic acid injection is indicated for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. prostate cancer should have progressed after treatment with at least one hormonal therapy. limitations of use the safety and efficacy of zoledronic acid injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions have not been established. hypersensitivity to zoledronic acid or any components of zoledronic acid injection hypersensitivity reactions including rare cases of urticaria and angioedema, and very rare cases of anaphylactic reaction/shock have been reported [see ad

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

alcon laboratories, inc. - sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152), sodium phosphate, dibasic, unspecified form (unii: gr686lba74) (sodium cation - unii:lyr4m0nh37), sodium bicarbonate (unii: 8mdf5v39qo) (sodium cation - unii:lyr4m0nh37) - sodium chloride 7.44 mg in 1 ml - indications and usage:  bss plus is indicated for use as an intraocular irrigating solution during intraocular surgical procedures involving perfusion of the eye. contraindications:  there are no specific contraindications to the use of bss plus; however, contraindications for the surgical procedure during which bss plus is to be used should be strictly adhered to. geriatric use:  no overall differences in safety or effectiveness have been observed between elderly and younger patients. reconstitution instructions directions: use aseptic technique - remove the blue flip-off seal from the bss plus® part i (480 ml) bottle. remove the blue flip-off seal from the bss plus part ii (20 ml) vial. prepare the stoppers on both parts by using sterile alcohol wipes. - peel open a bss plus vacuum transfer device package (supplied) and remove the sterile transfer spike. note: this device is vented permitting air to enter vial during solution transfer, thereby preventing the creation of a vacuum inside the vial. an air-inlet filter is provided to protect the system. do not remove the air-inlet filter. - remove protector from the white plastic piercing pin. - firmly grasp device from behind the flange and insert the white plastic piercing pin into the upright rubber stopper of the bss plus part ii (20 ml) vial. - remove guard from filter needle. firmly grasp vial in the palm of one hand and with thumb and index finger, hold plastic flange against top of vial. - invert vial and immediately insert filter needle into the outer target of the rubber stopper of the bss plus part i (480 ml) bottle. (see illustration.) - fluid will automatically transfer from the vial into the large vacuum bottle unless filter becomes occluded or loss of vacuum occurs. note: an excess amount of bss plus part ii is provided in each vial. a non-transferred solution residual of approximately 0.3 ml can be expected to remain in the vial. - immediately remove needle from the bss plus part i container and discard it after solution transfer has been completed. - place a sterile safety cap over the rubber stopper of part i if the solution is not going to be used immediately. mix the solution gently until uniform. peel off the right-hand side of part i bottle label (fully reconstituted bss plus solution). record the patient’s name and the date and time of reconstitution. bss plus solution is now ready for use. caution: reconstituted bss plus solution must be used within six hours of mixing. discard any solution which has aged beyond that time. never use the same bottle of bss plus solution on more than one patient. alternative transfer method if preferred, the contents of the bss plus part ii component may be aspirated with an 18-gauge cannula attached to a 20 ml syringe and then transferred into the part i bottle. alcon distributed by: alcon laboratories, inc. fort worth, texas 76134 usa revised: april 2023

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

aphena pharma solutions - tennessee, llc - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 100 mg - quetiapine fumarate tablets are indicated for the treatment of schizophrenia. the efficacy of quetiapine fumarate tablets in schizophrenia was established in three 6 week trials in adults and one 6 week trial in adolescents (13 to 17 years). the effectiveness of quetiapine fumarate tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see clinical studies ( 14.1   )] . quetiapine fumarate tablets are indicated for the acute treatment of manic episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. efficacy was established in two 12 week monotherapy trials in adults, in one 3 week adjunctive trial in adults, and in one 3 week monotherapy trial in pediatric patients (10 to 17 years) [see clinical studies ( 14.2   )] . quetiapine fumarate tablets are indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. efficacy was established in two 8 wee

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

hospira, inc. - midazolam hydrochloride (unii: w7ttw573jj) (midazolam - unii:r60l0sm5bc) - midazolam 1 mg in 1 ml - 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 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 c

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

ge healthcare australia pty ltd - gadoteric acid, quantity: 279.32 mg/ml - solution - excipient ingredients: meglumine; water for injections; tetraxetan - clariscan is indicated, in adults and children, for use with magnetic resonance imaging to provide contrast enhancement for intracranial and spinal lesions with abnormal blood brain barrier or abnormal vascularity, and for whole body imaging (see clinical studies).

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

ge healthcare australia pty ltd - gadoteric acid, quantity: 279.32 mg/ml - solution - excipient ingredients: meglumine; water for injections; tetraxetan - clariscan is indicated, in adults and children, for use with magnetic resonance imaging to provide contrast enhancement for intracranial and spinal lesions with abnormal blood brain barrier or abnormal vascularity, and for whole body imaging (see clinical studies).

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

ge healthcare australia pty ltd - gadoteric acid, quantity: 279.32 mg/ml - solution - excipient ingredients: meglumine; water for injections; tetraxetan - clariscan is indicated, in adults and children, for use with magnetic resonance imaging to provide contrast enhancement for intracranial and spinal lesions with abnormal blood brain barrier or abnormal vascularity, and for whole body imaging (see clinical studies).

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

ge healthcare australia pty ltd - gadoteric acid, quantity: 279.32 mg/ml - solution - excipient ingredients: meglumine; water for injections; tetraxetan - clariscan is indicated, in adults and children, for use with magnetic resonance imaging to provide contrast enhancement for intracranial and spinal lesions with abnormal blood brain barrier or abnormal vascularity, and for whole body imaging (see clinical studies).

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

ge healthcare australia pty ltd - gadoteric acid, quantity: 279.32 mg/ml - solution - excipient ingredients: meglumine; water for injections; tetraxetan - clariscan is indicated, in adults and children, for use with magnetic resonance imaging to provide contrast enhancement for intracranial and spinal lesions with abnormal blood brain barrier or abnormal vascularity, and for whole body imaging (see clinical studies).

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

hospira, inc. - midazolam hydrochloride (unii: w7ttw573jj) (midazolam - unii:r60l0sm5bc) - midazolam injection is indicated: injectable midazolam is contraindicated in patients with a known hypersensitivity to the drug. benzodiazepines are contraindicated in patients with acute narrow-angle glaucoma. benzodiazepines may be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. measurements of intraocular pressure in patients without eye disease show a moderate lowering following induction with midazolam; patients with glaucoma have not been studied. midazolam injection contains midazolam a schedule iv control substance. midazolam was actively self-administered in primate models used to assess the positive reinforcing effects of psychoactive drugs. midazolam produced physical dependence of a mild to moderate intensity in cynomolgus monkeys after 5 to 10 weeks of administration. available data concerning the drug abuse and dependence potential of midazolam suggest that its abuse potential is at least equivalent to that of diazepam. withdrawal symptoms, similar in ch