USA - engelsk - NLM (National Library of Medicine)

merck sharp & dohme llc - interferon alfa-2b (unii: 43k1w2t1m6) (interferon alfa-2b - unii:43k1w2t1m6) - interferon alfa-2b 38 ug in 1 ml - intron® a is indicated for the treatment of patients 18 years of age or older with hairy cell leukemia. intron a is indicated as adjuvant to surgical treatment in patients 18 years of age or older with malignant melanoma who are free of disease but at high risk for systemic recurrence, within 56 days of surgery. intron a is indicated for the initial treatment of clinically aggressive (see clinical pharmacology ) follicular non-hodgkin's lymphoma in conjunction with anthracycline-containing combination chemotherapy in patients 18 years of age or older. efficacy of intron a therapy in patients with low-grade, low-tumor burden follicular non-hodgkin's lymphoma has not been demonstrated. intron a is indicated for intralesional treatment of selected patients 18 years of age or older with condylomata acuminata involving external surfaces of the genital and perianal areas (see dosage and administration ). the use of this product in adolescents has not been studied. intron a is indicated for the treatment of select

USA - engelsk - NLM (National Library of Medicine)

merck sharp & dohme corp. - peginterferon alfa-2b (unii: g8rgg88b68) (interferon alfa-2b - unii:43k1w2t1m6) - peginterferon alfa-2b 50 ug in 0.5 ml - pegintron® , as part of a combination regimen, is indicated for the treatment of chronic hepatitis c (chc) in patients with compensated liver disease. - pegintron in combination with ribavirin and an approved hepatitis c virus (hcv) ns3/4a protease inhibitor is indicated in adult patients with hcv genotype 1 infection (see labeling of the specific hcv ns3/4a protease inhibitor for further information). - pegintron in combination with ribavirin is indicated in patients with genotypes other than 1, pediatric patients (3-17 years of age), or in patients with genotype 1 infection where use of an hcv ns3/4a protease inhibitor is not warranted based on tolerability, contraindications or other clinical factors. pegintron monotherapy should only be used in the treatment of chc in patients with compensated liver disease if there are contraindications to or significant intolerance of ribavirin and is indicated for use only in previously untreated adult patients. combination therapy provides substantially better respons

USA - engelsk - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - 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 is contraindicated in the following conditions: there are no adequate and well-controlled studies of dalfampridine in pregnant women. administration of dalfampridine to animals during pregnancy and lactation resulted in decreased offspring viability and growth at doses similar to the maximum recommended human dose (mrhd) of 20 mg/day. dalfampridine extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in developmental toxicity studies in rats and rabbits, dalfampridine was administered orally at doses up to 10 and 5 mg/kg/day, respectively, during the period of organogenesis. these doses are approximately 5 times the mrhd on a body surface area (mg/m2 ) basis. no evidence

USA - engelsk - NLM (National Library of Medicine)

actavis pharma, inc. - 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 is 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 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 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 birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% an

USA - engelsk - 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

USA - engelsk - NLM (National Library of Medicine)

bryant ranch prepack - 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 birt

Brasil - portugisisk - ANVISA (Agência Nacional de Vigilância Sanitária)

chron epigen indÚstria e comÉrcio ltda - interferon alfa 2a - antineoplasico

Slovenia - slovensk - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

interferon alfa-2b - kapljice za oko, raztopina - interferon alfa-2b 0,3 ml / 4,5 ml - interferon

USA - engelsk - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - interferon beta-1b (unii: ttd90r31wz) (interferon beta-1b - unii:ttd90r31wz) - interferon beta-1b 0.25 mg in 1.0 ml - extavia is indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. extavia is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, albumin (human), or any other component of the formulation. risk summary although there have been no well-controlled studies in pregnant women, available data, which include prospective observational studies, have not generally indicated a drug-associated risk of major birth defects with interferon beta-1b during pregnancy. administration of interferon beta-1b to monkeys during gestation resulted in increased embryo-fetal death at or above exposures greater than 3 times the human therapeutic dose (see animal data ). in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respective

USA - engelsk - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - interferon beta-1b (unii: ttd90r31wz) (interferon beta-1b - unii:ttd90r31wz) - interferon beta-1b 0.25 mg in 1 ml - betaseron is indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. betaseron is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, albumin (human), or any other component of the formulation. although there have been no well-controlled studies in pregnant women, available data, which includes prospective observational studies, have not generally indicated a drug-associated risk of major birth defects with interferon beta-1b during pregnancy. administration of betaseron to monkeys during gestation resulted in increased embryo-fetal death at or above exposures greater than 3 times the human therapeutic dose (see animal data ). in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. the background risk o