États-Unis - anglais - NLM (National Library of Medicine)

mylan institutional llc - sodium nitroprusside (unii: eao03pe1tc) (nitroprusside - unii:169d1260km) - sodium nitroprusside injection is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. concomitant longer-acting antihypertensive medication should be administered so that the duration of treatment with sodium nitroprusside can be minimized. sodium nitroprusside injection is also indicated for producing controlled hypotension in order to reduce bleeding during surgery. sodium nitroprusside injection is also indicated for the treatment of acute congestive heart failure. sodium nitroprusside should not be used in the treatment of compensatory hypertension, where the primary hemodynamic lesion is aortic coarctation or arteriovenous shunting. sodium nitroprusside should not be used to produce hypotension during surgery in patients with known inadequate cerebral circulation, or in moribund patients (a.s.a. class 5e) coming to emergency surgery. patients with congenital (leber’s) optic atrophy or with tobacco amblyopia have unusually high cyanide/thiocyanat

États-Unis - anglais - NLM (National Library of Medicine)

mylan institutional llc - dexamethasone sodium phosphate (unii: ai9376y64p) (dexamethasone - unii:7s5i7g3jql) - 1. endocrine disorders: primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used). preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected. congenital adrenal hyperplasia. nonsuppurative thyroiditis. hypercalcemia associated with cancer. 2. rheumatic disorders: as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: post-traumatic osteoarthritis. synovitis of osteoarthritis. rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). acute and subacute bursitis. epicondylitis. acute nonspecific tenosynovitis. acute gouty arthritis. psoriatic arthritis. ankylosing spondylitis. 3. collagen diseases: during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus. acute rheumatic carditis. 4. dermatologic diseases: pemphigus. severe erythema multiforme. (stevens-johnson syndrome) exfoliative dermatitis. bullous dermatitis herpetiformis. severe seborrheic dermatitis. severe psoriasis. mycosis fungoides. 5. allergic states: control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in: bronchial asthma. contact dermatitis. atopic dermatitis. serum sickness. seasonal or perennial allergic rhinitis. drug hypersensitivity reactions. urticarial transfusion reactions. acute noninfectious laryngeal edema (epinephrine is the drug of first choice). 6. ophthalmic diseases: severe acute and chronic allergic and inflammatory processes involving the eye, such as: herpes zoster ophthalmicus. iritis, iridocyclitis. chorioretinitis. diffuse posterior uveitis and choroiditis. optic neuritis. sympathetic ophthalmia. anterior segment inflammation. allergic conjunctivitis. keratitis. allergic corneal marginal ulcers. 7. gastrointestinal diseases: to tide the patient over a critical period of the disease in: ulcerative colitis (systemic therapy). regional enteritis (systemic therapy). 8. respiratory diseases: symptomatic sarcoidosis. berylliosis. fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. loeffler's syndrome not manageable by other means. aspiration pneumonitis. 9. hematologic disorders: acquired (autoimmune) hemolytic anemia. idiopathic thrombocytopenic purpura in adults (iv only; im administration is contraindicated). secondary thrombocytopenia in adults. erythroblastopenia (rbc anemia). congenital (erythroid) hypoplastic anemia. 10. neoplastic diseases: for palliative management of: leukemias and lymphomas in adults. acute leukemia of childhood. 11. edematous states: to induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 12. miscellaneous: tuberculosis meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. trichinosis with neurologic or myocardial involvement. 13. diagnostic testing of adrenocortical hyperfunction. 14. cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. use in cerebral edema is not a substitute for careful neurosurgical evaluation and definitive management such as neurosurgery or other specific therapy. as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: synovitis of osteoarthritis. rheumatoid arthritis. acute and subacute bursitis. acute gouty arthritis. epicondylitis. acute nonspecific tenosynovitis. post-traumatic osteoarthritis. keloids. localized hypertrophic, infiltrated, inflammatory lesions of: lichen planus, psoriatic plaques, granuloma annulare, and lichen simplex chronicus (neurodermatitis). discoid lupus erythematosus. necrobiosis lipoidica diabeticorum. alopecia areata. may also be useful in cystic tumors of an aponeurosis or tendon (ganglia). systemic fungal infections. (see warnings regarding amphotericin b)

États-Unis - anglais - NLM (National Library of Medicine)

mylan institutional llc - baclofen (unii: h789n3fke8) (baclofen - unii:h789n3fke8) - baclofen injection (intrathecal) is indicated for use in the management of severe spasticity. patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump. for spasticity of spinal cord origin, chronic infusion of baclofen injection (intrathecal) via an implantable pump should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable cns side effects at effective doses. patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal baclofen therapy. baclofen injection (intrathecal) is intended for use by the intrathecal route in single bolus test doses (via spinal catheter or lumbar puncture) and, for chronic use, only in implantable pumps approved by the fda specifically for the administration of baclofen injection (intrathecal) into the intrathecal space. spasticity of spinal cord origin: evidence su

États-Unis - anglais - NLM (National Library of Medicine)

mylan institutional llc - prochlorperazine edisylate (unii: pg20w5vqzs) (prochlorperazine - unii:yhp6ylt61t) - to control severe nausea and vomiting. for the treatment of schizophrenia. prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation. do not use in patients with known hypersensitivity to phenothiazines. do not use in comatose states or in the presence of large amounts of central nervous system depressants (alcohol, barbiturates, narcotics, etc.). do not use in pediatric surgery. do not use in pediatric patients under 2 years of age or under 20 lbs. do not use in children for conditions for which dosage has not been established.

États-Unis - anglais - NLM (National Library of Medicine)

mylan institutional llc - sodium nitroprusside (unii: eao03pe1tc) (nitroprusside - unii:169d1260km) - sodium nitroprusside injection is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. concomitant longer-acting antihypertensive medication should be administered so that the duration of treatment with sodium nitroprusside can be minimized. sodium nitroprusside injection is also indicated for producing controlled hypotension in order to reduce bleeding during surgery. sodium nitroprusside injection is also indicated for the treatment of acute congestive heart failure. sodium nitroprusside should not be used in the treatment of compensatory hypertension, where the primary hemodynamic lesion is aortic coarctation or arteriovenous shunting. sodium nitroprusside should not be used to produce hypotension during surgery in patients with known inadequate cerebral circulation, or in moribund patients (a.s.a. class 5e) coming to emergency surgery. patients with congenital (leber’s) optic atrophy or with tobacco amblyopia have unusually high cyanide/thiocyanat

États-Unis - anglais - NLM (National Library of Medicine)

mylan institutional llc - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole injection, usp is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. indicated surgical procedures should be performed in conjunction with metronidazole therapy. in a mixed aerobic and anaerobic infection, antibiotics appropriate for the treatment of the aerobic infection should be used in addition to metronidazole. metronidazole is effective in bacteroides fragilis infections resistant to clindamycin, chloramphenicol and penicillin. intra-abdominal infections , including peritonitis, intra-abdominal abscess and liver abscess, caused by bacteroides species including the b. fragilis group (b. fragilis, b. distasonis, b. ovatus, b. thetaiotaomicron, b. vulgatus ). clostridium species, eubacterium species, peptococcus species, and peptostreptococcus species. skin and skin structure infections caused by bacteroides species including b. fragilis group, clostridium species, peptococcus species, peptostreptococcus species and fusobacterium species.

États-Unis - anglais - NLM (National Library of Medicine)

mylan institutional llc - rifampin (unii: vjt6j7r4tr) (rifampin - unii:vjt6j7r4tr) - rifampin 600 mg in 10 ml - in the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. if test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified. rifampin is indicated in the treatment of all forms of tuberculosis. a three-drug regimen consisting of rifampin, isoniazid, and pyrazinamide is recommended in the initial phase of short-course therapy which is usually continued for 2 months. the advisory council for the elimination of tuberculosis, the american thoracic society, and centers for disease control and prevention recommend that either streptomycin or ethambutol be added as a fourth drug in a regimen containing isoniazid (inh), rifampin, and pyrazinamide for initial treatment of tuberculosis unless the likelihood of inh resistance is very low. the need for a fourth drug should be reassessed when the results of susceptibility testing are known. if community rates of inh resistance are currently less than 4%, an initial treatment regimen with less than four drugs may be considered. following the initial phase, treatment should be continued with rifampin and isoniazid for at least 4 months. treatment should be continued for longer if the patient is still sputum or culture positive, if resistant organisms are present, or if the patient is hiv positive. rifampin for injection, usp is indicated for the initial treatment and retreatment of tuberculosis when the drug cannot be taken by mouth. rifampin is indicated for the treatment of asymptomatic carriers of neisseria meningitidis to eliminate meningococci from the nasopharynx. rifampin is not indicated for the treatment of meningococcal infection because of the possibility of the rapid emergence of resistant organisms. (see warnings .) rifampin should not be used indiscriminately, and, therefore, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed for establishment of the carrier state and the correct treatment. so that the usefulness of rifampin in the treatment of asymptomatic meningococcal carriers is preserved, the drug should be used only when the risk of meningococcal disease is high. to reduce the development of drug-resistant bacteria and maintain the effectiveness of rifampin and other antibacterial drugs, rifampin should be used only to treat or prevent 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 antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. rifampin is contraindicated in patients with a history of hypersensitivity to rifampin or any of the components, or to any of the rifamycins. (see warnings .) rifampin is contraindicated in patients who are also receiving ritonavir-boosted saquinavir due to an increased risk of severe hepatocellular toxicity. (see precautions, drug interactions .) rifampin is contraindicated in patients who are also receiving atazanavir, darunavir, fosamprenavir, saquinavir, or tipranavir due to the potential of rifampin to substantially decrease plasma concentrations of these antiviral drugs, which may result in loss of antiviral efficacy and/or development of viral resistance. rifampin is contraindicated in patients receiving praziquantel since therapeutically effective blood levels of praziquantel may not be achieved. in patients receiving rifampin who need immediate treatment with praziquantel alternative agents should be considered. however, if treatment with praziquantel is necessary, rifampin should be discontinued 4 weeks before administration of praziquantel. treatment with rifampin can then be restarted one day after completion of praziquantel treatment. rifampin is contraindicated in patients receiving lurasidone. concomitant use of lurasidone with strong cyp3a4 inducers (e.g., rifampin) decreased the exposure of lurasidone compared to the use of lurasidone alone. (see precautions, drug interactions ).

États-Unis - anglais - NLM (National Library of Medicine)

mylan institutional llc - methadone hydrochloride (unii: 229809935b) (methadone - unii:uc6vbe7v1z) - methadone hydrochloride 10 mg in 1 ml - code of federal regulations, title 42, sec 8. methadone products when used for the treatment of opioid addiction in detoxification or maintenance programs, shall be dispensed only by opioid treatment programs (and agencies, practitioners or institutions by formal agreement with the program sponsor) certified by the substance abuse and mental health services administration and approved by the designated state authority. certified treatment programs shall dispense and use methadone in oral form only and according to the treatment requirements stipulated in the federal opioid treatment standards (42 cfr 8.12). see below for important regulatory exceptions to the general requirement for certification to provide opioid agonist treatment. failure to abide by the requirements in these regulations may result in criminal prosecution, seizure of the drug supply, revocation of the program approval, and injunction precluding operation of the program. regulatory exceptions to the general requirement for certification to provide opioid agonist treatment: during inpatient care, when the patient was admitted for any condition other than concurrent opioid addiction (pursuant to 21cfr 1306.07(c)), to facilitate the treatment of the primary admitting diagnosis. during an emergency period of no longer than 3 days while definitive care for the addiction is being sought in an appropriately licensed facility (pursuant to 21cfr 1306.07(b)). methadone hydrochloride injection is contraindicated in patients with: methadone hydrochloride injection contains methadone, a schedule ii controlled substance. methadone hydrochloride injection contains methadone, a substance with high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction (see warnings). misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. misuse and abuse of methadone hydrochloride injection increases risk of overdose, which may lead to central nervous system and respiratory depression, hypotension, seizures, and death. the risk is increased with concurrent abuse of methadone hydrochloride injection with alcohol and/or other central nervous system depressants. abuse of and addiction to opioids in some individuals may not be accompanied by concurrent tolerance and symptoms of physical dependence. in addition, abuse of opioids can occur in the absence of addiction. all patients treated with opioids require careful and frequent reevaluation for signs of misuse, abuse, and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. patients at high risk of methadone hydrochloride injection abuse include those with a history of prolonged use of any opioid, including products containing methadone, those with a history of drug or alcohol abuse, or those who use methadone hydrochloride injection in combination with other abused drugs. “drug-seeking” behavior is very common in persons with substance use disorders. drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating healthcare provider(s). “doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among people who abuse drugs and people with substance use disorder. preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with inadequate pain control. methadone hydrochloride injection, like other opioids, can be diverted for nonmedical use into illicit channels of distribution. careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. risks specific to abuse of methadone hydrochloride injection abuse of methadone hydrochloride injection poses a risk of overdose and death. the risk is increased with concurrent use of methadone hydrochloride injection with alcohol and/or other cns depressants. parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and hiv. both tolerance and physical dependence can develop during use of opioid therapy. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). physical dependence is a state that develops as a result of a 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. withdrawal may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). physical dependence may not occur to a clinically significant degree until after several days to weeks of continued use. do not abruptly discontinue methadone hydrochloride injection in a patient physically dependent on opioids. rapid tapering of methadone hydrochloride injection in a patient physically dependent on opioids may lead to serious withdrawal symptoms, uncontrolled pain, and suicide. rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse. when discontinuing methadone hydrochloride injection, gradually taper the dosage using a patient-specific plan that considers the following: the dose of methadone hydrochloride injection the patient has been taking, the duration of treatment, and the physical and psychological attributes of the patient. to improve the likelihood of a successful taper and minimize withdrawal symptoms, it is important that the opioid tapering schedule is agreed upon by the patient. in patients taking opioids for an extended period of time at high doses, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper (see dosage and administration, and warnings). infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs (see precautions: pregnancy).

États-Unis - anglais - NLM (National Library of Medicine)

mylan institutional llc - pamidronate disodium (unii: 8742t8zqza) (pamidronic acid - unii:oyy3447omc) - pamidronate disodium 3 mg in 1 ml - pamidronate disodium, in conjunction with adequate hydration, is indicated for the treatment of moderate or severe hypercalcemia associated with malignancy, with or without bone metastases. patients who have either epidermoid or non-epidermoid tumors respond to treatment with pamidronate disodium. vigorous saline hydration, an integral part of hypercalcemia therapy, should be initiated promptly and an attempt should be made to restore the urine output to about 2 l/day throughout treatment. mild or asymptomatic hypercalcemia may be treated with conservative measures (i.e., saline hydration, with or without loop diuretics). patients should be hydrated adequately throughout the treatment, but overhydration, especially in those patients who have cardiac failure, must be avoided. diuretic therapy should not be employed prior to correction of hypovolemia. the safety and efficacy of pamidronate disodium in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions h

Espagne - espagnol - AEMPS (Agencia Española de Medicamentos y Productos Sanitarios)

mylan pharmaceuticals, s.l. - escitalopram oxalato - comprimido recubierto con pelÍcula - 10 mg - escitalopram oxalato 10 mg - escitalopram