Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

ascend laboratories, llc - olanzapine (unii: n7u69t4szr) (olanzapine - unii:n7u69t4szr) - olanzapine 2.5 mg - oral olanzapine is indicated for the treatment of schizophrenia. efficacy was established in three clinical trials in adult patients with schizophrenia: two 6-week trials and one maintenance trial. in adolescent patients with schizophrenia (ages 13 to 17), efficacy was established in one 6-week trial [see clinical studies (14.1)].       when deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and dyslipidemia. clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents [see warnings and precautions (5.5)]. monotherapy — oral olanzapine is indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder and maintenance treatment of bipolar i disorder. efficacy was established in three clinical trials in adult patients with manic or mi

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

ascend laboratories, llc - clobazam (unii: 2mro291b4u) (clobazam - unii:2mro291b4u) - clobazam tablet is indicated for the adjunctive treatment of seizures associated with lennox-gastaut syndrome (lgs) in patients 2 years of age or older. clobazam is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients. hypersensitivity reactions have included serious dermatological reactions [see warnings and precautions (5.6)]. pregnancy registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, such as clobazam, during pregnancy. healthcare providers are encouraged to recommend that pregnant women taking clobazam enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or online at http://www.aedpregnancyregistry.org/ . risk summary neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal [see warnings and precautions (5.8) and clinical considerations] . available data from published obser

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

ascend laboratories, llc - dabigatran etexilate mesylate (unii: sc7nuw5iit) (dabigatran - unii:i0vm4m70gc) - dabigatran etexilate capsules is indicated to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation. dabigatran etexilate capsules is indicated for the treatment of deep venous thrombosis and pulmonary embolism in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days.  dabigatran etexilate capsules is indicated to reduce the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patients who have been previously treated. dabigatran etexilate capsules is indicated for the prophylaxis of deep vein thrombosis and pulmonary embolism, in adult patients who have undergone hip replacement surgery.  pediatric use information is approved for boehringer ingelheim pharmaceuticals, inc.’s pradaxa (dabigatran etexilate) capsules. however, due to boehringer ingelheim pharmaceuticals, inc.’s marketing exclusivity rights, this drug product is not labeled with that information. dabigatran etexilate capsules is contraindic

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

ascend laboratories, llc - deferasirox (unii: v8g4mof2v9) (deferasirox - unii:v8g4mof2v9) - deferasirox oral granules are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. deferasirox oral granules is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (ntdt) syndromes and with a liver iron concentration (lic) of at least 5 milligrams of iron per gram of liver dry weight (mg fe/g dw) and a serum ferritin greater than 300 mcg/l. this indication is approved under accelerated approval based on a reduction of liver iron concentrations (to less than 5 mg fe/g dw) and serum ferritin levels [see clinical studies (14)]. continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. the safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established. deferasirox is contraindicated in patients with: - estimated gf

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

ascend laboratories, llc - clobazam (unii: 2mro291b4u) (clobazam - unii:2mro291b4u) - clobazam oral suspension is indicated for the adjunctive treatment of seizures associated with lennox-gastaut syndrome (lgs) in patients 2 years of age or older. clobazam oral suspension is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients. hypersensitivity reactions have included serious dermatological reactions [see warnings and precautions (5.6)]. pregnancy registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, such as clobazam, during pregnancy. healthcare providers are encouraged to recommend that pregnant women taking clobazam enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or online at http://www.aedpregnancyregistry.org/. risk summary neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal [see warnings and precautions (5.8) and clinical considerations]. available da

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

ascend laboratories, llc - dalfampridine (unii: bh3b64okl9) (dalfampridine - unii:bh3b64okl9) -  dalfampridine extended-release tablets are indicated as a treatment to improve walking in adult patients with multiple sclerosis (ms). this was demonstrated by an increase in walking speed [see clinical studies (14)].   the use of dalfampridine extended-release tablets are contraindicated in the following conditions: - history of seizure [see warnings and precautions (5.1)] - moderate or severe renal impairment (crcl≤50 ml/min) [see warnings and precautions (5.2)] - history of hypersensitivity to dalfampridine extended-release tablets or 4-aminopyridine; reactions have included anaphylaxis [see warnings and precautions (5.4)] risk summary there are no adequate data on the developmental risk associated with use of dalfampridine extended-release tablets in pregnant women. administration of dalfampridine to animals during pregnancy and lactation resulted in decreased offspring viability and growth at clinically relevant doses [see data]. in the u.s. general population, the estimated background risk of major bi

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

ascend laboratories, llc - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride extended-release tablets is indicated for the treatment of: • attention deficit hyperactivity disorders (adhd) in pediatric patients 6 years and older and adults • narcolepsy • hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride extended-release tablets. hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see adverse reactions (6.1)]. • concomitant treatment with monoamine oxidase inhibitors (maois), or within 14 days following discontinuation of treatment with an maoi, because of the risk of hypertensive crises [see drug interactions (7.1)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including methylphenidate hydrochloride extended-release tablets, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy r

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

ascend laboratories, llc - morphine sulfate (unii: x3p646a2j0) (morphine - unii:76i7g6d29c) - morphine sulfate tablets are indicated for the management of: - adults with acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. - adults with chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see warnings and precautions (5.1)], reserve morphine sulfate tablets for use in patients for whom alternative treatment options [e.g., non- opioid analgesics or opioid combination products]: - have not been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia. morphine sulfate tablets are contraindicated in patients with: - significant respiratory depression [see warnings and precautions (5.3) ]. - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

ascend laboratories, llc - sirolimus (unii: w36zg6ft64) (sirolimus - unii:w36zg6ft64) - sirolimus is indicated for the prophylaxis of organ rejection in patients aged 13 years or older receiving renal transplants. in patients at low-to moderate-immunologic risk , it is recommended that sirolimus tablets be used initially in a regimen with cyclosporine and corticosteroids; cyclosporine should be withdrawn 2 to 4 months after transplantation [see dosage and administration (2.2)]. in patients at high-immunologic risk (defined as black recipients and/or repeat renal transplant recipients who lost a previous allograft for immunologic reason and/or patients with high panel-reactive antibodies [pra; peak pra level > 80%]), it is recommended that sirolimus tablets be used in combination with cyclosporine and corticosteroids for the first year following transplantation [see dosage and administration (2.3), clinical studies (14.3)]. cyclosporine withdrawal has not been studied in patients with banff grade 3 acute rejection or vascular rejection prior to cyclosporine withdrawal, those who are dial

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

ascend laboratories, llc - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older. levetiracetam tablets are indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. levetiracetam tablets are indicated as adjunctive therapy for the treatment of primary generalized tonic- clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy. levetiracetam tablets are contraindicated in patients with a hypersensitivity to levetiracetam. reactions have included anaphylaxis and angioedema [see warnings and precautions (5.4)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), including levetiracetam tablets, during pregnancy. encourage women who are taking levetiracetam tablets during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by