Marekani - Kiingereza - NLM (National Library of Medicine)

allergan, inc. - triptorelin pamoate (unii: 08an7wa2g0) (triptorelin - unii:9081y98w2v) - triptorelin 3.75 mg in 2 ml - trelstar is indicated for the palliative treatment of advanced prostate cancer [see  clinical studies (14) ]. trelstar is contraindicated in individuals with a known hypersensitivity to triptorelin or any other component of the product, or other gnrh agonists or gnrh [see warnings and precautions (5.1) ]. risk summary based on findings in animal studies and mechanism of action, trelstar can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1) ] . expected hormonal changes that occur with trelstar treatment increase the risk for pregnancy loss. in animal developmental and reproductive toxicology studies, daily administration of triptorelin to pregnant rats during the period of organogenesis caused maternal toxicity and embryo-fetal toxicities, including loss of pregnancy, at doses as low as 0.2, 0.8, and 8 times the estimated human daily dose based on body surface area. advise pregnant patients and females of reproductive potential of the potential risk to the fetus. dat

Marekani - Kiingereza - NLM (National Library of Medicine)

janssen pharmaceuticals, inc. - norethindrone (unii: t18f433x4s) (norethindrone - unii:t18f433x4s) - norethindrone 0.35 mg - progestin-only oral contraceptives are indicated for the prevention of pregnancy. if used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.3%. however, the typical failure rate is estimated to be closer to 9%, due to late or omitted pills. table 1 lists the pregnancy rates for users of all major methods of contraception. ortho micronor® tablets have not been studied for and are not indicated for use in emergency contraception. progestin-only oral contraceptives (pops) should not be used by women who currently have the following conditions: - known or suspected pregnancy - known or suspected carcinoma of the breast - undiagnosed abnormal genital bleeding - hypersensitivity to any component of this product - benign or malignant liver tumors - acute liver disease - it's best to take your first pop on the first day of your menstrual period (day 1 start). if you use a day 1 start, you are protected from becoming pregnant as soon as you take your first pill. - if you decide to tak

Marekani - Kiingereza - NLM (National Library of Medicine)

bluepoint laboratories - gemcitabine hydrochloride (unii: u347pv74il) (gemcitabine - unii:b76n6sbz8r) - gemcitabine 38 mg in 1 ml -       gemcitabine for injection in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.       gemcitabine for injection in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.       gemcitabine for injection is indicated in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (stage iiia or iiib), or metastatic (stage iv) non-small cell lung cancer.       gemcitabine for injection is indicated as first-line treatment for patients with locally advanced (nonresectable stage ii or stage iii) or metastatic (stage iv) adenocarcinoma of the pancreas. gemcitabine for injection is indicated for patients previously treated with 5-fu. gemcitabine for injection is

Marekani - Kiingereza - NLM (National Library of Medicine)

validus pharmaceuticals llc - calcitriol (unii: fxc9231jvh) (calcitriol - unii:fxc9231jvh) - calcitriol 0.25 ug - predialysis patients rocaltrol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (ccr 15 to 55 ml/min) not yet on dialysis. in children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. a serum ipth level of ≥ 100 pg/ml is strongly suggestive of secondary hyperparathyroidism. dialysis patients rocaltrol is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. in these patients, rocaltrol administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization. hypoparathyroidism patients rocaltrol is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism. rocaltrol should not be given to patients with hypercalcemia or evidence of vitamin d toxicity. use of rocaltrol in patients with known hypersensitivity to rocaltrol (or drugs of the same class) or any of the inactive ingredients is contraindicated.

Marekani - Kiingereza - NLM (National Library of Medicine)

roche pharmaceuticals - calcitriol (unii: fxc9231jvh) (calcitriol - unii:fxc9231jvh) - capsule, liquid filled - 0.25 ug - rocaltrol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (ccr 15 to 55 ml/min) not yet on dialysis. in children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. a serum ipth level of ≥ 100 pg/ml is strongly suggestive of secondary hyperparathyroidism. rocaltrol is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. in these patients, rocaltrol administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization. rocaltrol is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism. rocalt

Marekani - Kiingereza - NLM (National Library of Medicine)

the feinstein institute for medical research - fludeoxyglucose f-18 (unii: 0z5b2cjx4d) (fludeoxyglucose f-18 - unii:0z5b2cjx4d) - fludeoxyglucose f-18 300 mci in 1 ml - for the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures. none. pregnancy category c animal reproduction studies have not been conducted with fludeoxyglucose f 18 injection. it is also not known whether fludeoxyglucose f 18 injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.  consider alternative diagnostic tests in a pregnant woman; administer fludeoxyglucose f 18 injection only if clearly needed. it is not known whether fludeoxyglucose f 18 injection is excreted in human milk. consider alternative diagnostic tests in women who are breast-feeding.  use alternatives to breast feeding (e.g., stored breast milk or infant formula) for at least 10 half-lives of radioactive decay, if fludeoxyglucose f 18 injection is administered to a woman who is breast-feeding. the safety and effectiveness of fludeoxyglucose f 18 injection in pediatric patients with epilepsy is established on the basis of studies in adult and

Marekani - Kiingereza - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - haloperidol lactate (unii: 6387s86pk3) (haloperidol - unii:j6292f8l3d) - haloperidol 2 mg in 1 ml - haloperidol oral solution is indicated for use in the management of manifestations of psychotic disorders. haloperidol oral solution is indicated for the control of tics and vocal utterances of tourette’s disorder in children and adults. haloperidol oral solution is effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). haloperidol is also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance. haloperidol should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics. haloperidol oral solution is contraindicated in severe toxic central nervous system depression or comatose states from any ca

Marekani - Kiingereza - NLM (National Library of Medicine)

american health packaging - ranitidine hydrochloride (unii: bk76465ihm) (ranitidine - unii:884kt10yb7) - ranitidine 15 mg in 1 ml - ranitidine oral solution is indicated in: - short-term treatment of active duodenal ulcer. most patients heal within 4 weeks. studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks. - maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. no placebo-controlled comparative studies have been carried out for periods of longer than 1 year. - the treatment of pathological hypersecretory conditions (e.g., zollinger-ellison syndrome and systemic mastocytosis). - short-term treatment of active, benign gastric ulcer. most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks. - maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. placebo-controlled studies have been carried out

Marekani - Kiingereza - NLM (National Library of Medicine)

macleods pharmaceuticals limited - rizatriptan benzoate (unii: wr978s7qhh) (rizatriptan - unii:51086hbw8g) - rizatriptan 5 mg - rizatriptan benzoate orally disintegrating tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. limitations of use • rizatriptan benzoate orally disintegrating tablets should only be used where a clear diagnosis of migraine has been established. if a patient has no response for the first migraine attack treated with rizatriptan benzoate orally disintegrating tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks. • rizatriptan benzoate orally disintegrating tablets are not indicated for use in the management of hemiplegic or basilar migraine [see contraindications (4)]. • rizatriptan benzoate orally disintegrating tablets are not indicated for the prevention of migraine attacks. • safety and effectiveness of rizatriptan benzoate orally disintegrating tablets have not been established for cluster headache. rizatriptan benzoate o

Marekani - Kiingereza - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - azithromycin monohydrate (unii: jte4mnn1md) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin anhydrous 100 mg in 5 ml - azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications [see dosage and administration (2) ]. [see use in specific populations (8.4) and clinical studies (14.2) .] azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following: to reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacteria