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

major pharmaceuticals - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - tretinoin capsules are indicated for the induction of remission in patients with acute promyelocytic leukemia (apl), french-american-british (fab) classification m3 (including the m3 variant), characterized by the presence of the t(15;17) translocation and/or the presence of the pml/rarα gene who are refractory to, or who have relapsed from, anthracycline chemotherapy, or for whom anthracycline-based chemotherapy is contraindicated. tretinoin capsules are for the induction of remission only. the optimal consolidation or maintenance regimens have not been defined, but all patients should receive an accepted form of remission consolidation and/or maintenance therapy for apl after completion of induction therapy with tretinoin capsules. tretinoin capsules are contraindicated in patients with a known hypersensitivity to tretinoin capsules, any of its components, or other retinoids. tretinoin capsules should not be given to patients who are sensitive to parabens, which are used as preservatives in the gelatin caps

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

bryant ranch prepack - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - tretinoin capsules are indicated for the induction of remission in patients with acute promyelocytic leukemia (apl), french-american-british (fab) classification m3 (including the m3 variant), characterized by the presence of the t(15;17) translocation and/or the presence of the pml/rarα gene who are refractory to, or who have relapsed from, anthracycline chemotherapy, or for whom anthracycline-based chemotherapy is contraindicated. tretinoin capsules are for the induction of remission only. the optimal consolidation or maintenance regimens have not been defined, but all patients should receive an accepted form of remission consolidation and/or maintenance therapy for apl after completion of induction therapy with tretinoin capsules. tretinoin capsules are contraindicated in patients with a known hypersensitivity to tretinoin capsules, any of its components, or other retinoids. tretinoin capsules should not be given to patients who are sensitive to parabens, which are used as preservatives in the gelatin capsule.

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

avkare - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - tretinoin capsules are indicated for the induction of remission in patients with acute promyelocytic leukemia (apl), french-american-british (fab) classification m3 (including the m3 variant), characterized by the presence of the t(15;17) translocation and/or the presence of the pml/rarα gene who are refractory to, or who have relapsed from, anthracycline chemotherapy, or for whom anthracycline-based chemotherapy is contraindicated. tretinoin is for the induction of remission only. the optimal consolidation or maintenance regimens have not been defined, but all patients should receive an accepted form of remission consolidation and/or maintenance therapy for apl after completion of induction therapy with tretinoin. tretinoin is contraindicated in patients with a known hypersensitivity to tretinoin, any of its components, or other retinoids.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

alliance pharmaceuticals ltd - isotretinoin - oral capsule - 20mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

alliance healthcare (distribution) ltd - isotretinoin - oral capsule - 20mg

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

actavis pharma, inc. - isotretinoin (unii: eh28up18if) (isotretinoin - unii:eh28up18if) - isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. because of significant adverse reactions associated with its use, isotretinoin capsules are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. limitations of use : if a second course of isotretinoin capsules therapy is needed, it is not recommended before a two-month waiting period because the patient’s acne may continue to improve following a 15 to 20-week course of therapy [see dosage and administration (2.2)] . isotretinoin is contraindicated in pregnancy [see warnings and precautions (5.1) and use in specific populations (8.1)] . isotretinoin is contraindicated in patients with hypersensitivity to isotretinoin (or vitamin a, given the chemical similarity to isotretinoin) or to any of its components (anaphylaxis and other all

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

upsher-smith laboratories, llc - isotretinoin (unii: eh28up18if) (isotretinoin - unii:eh28up18if) - isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. because of significant adverse reactions associated with its use, isotretinoin capsules are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. limitations of use : if a second course of isotretinoin therapy is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15 to 20-week course of therapy [see dosage and administration (2.2)] . isotretinoin capsules are contraindicated in pregnancy [see warnings and precautions (5.1) and use in specific populations (8.1)] . isotretinoin capsules are contraindicated in patients with hypersensitivity to isotretinoin (or vitamin a, given the chemical similarity to isotretinoin) or to any of its components (anaphylaxis an

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

mayne pharma - isotretinoin (unii: eh28up18if) (isotretinoin - unii:eh28up18if) - isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. because of significant adverse reactions associated with its use, isotretinoin capsules are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. limitations of use : if a second course of isotretinoin therapy is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15 to 20-week course of therapy [see dosage and administration (2.2)] . isotretinoin capsules are contraindicated in pregnancy [see warnings and precautions (5.1) and use in specific populations (8.1)] . isotretinoin capsules are contraindicated in patients with hypersensitivity to isotretinoin (or vitamin a, given the chemical similarity to isotretinoin) or to any of its components (anaphylaxis an

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

mayne pharma - isotretinoin (unii: eh28up18if) (isotretinoin - unii:eh28up18if) - isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. because of significant adverse reactions associated with its use, isotretinoin capsules are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. limitations of use : if a second course of isotretinoin therapy is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15 to 20-week course of therapy [see dosage and administration (2.2)] . isotretinoin capsules are contraindicated in pregnancy [see warnings and precautions (5.1) and use in specific populations (8.1)] . isotretinoin capsules are contraindicated in patients with hypersensitivity to isotretinoin (or vitamin a, given the chemical similarity to isotretinoin) or to any of its components (anaphylaxis an

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

sun pharmaceutical industries, inc. - isotretinoin (unii: eh28up18if) (isotretinoin - unii:eh28up18if) - isotretinoin 10 mg - absorica and absorica ld are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. because of significant adverse reactions associated with its use, absorica and absorica ld are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. limitations of use : if a second course of absorica/absorica ld therapy is needed, it is not recommended before a two-month waiting period because the patient’s acne may continue to improve following a 15 to 20-week course of therapy [see dosage and administration (2.2)]. absorica/absorica ld is contraindicated in pregnancy [see warnings and precautions (5.1) and use in specific populations (8.1)]. absorica/absorica ld is contraindicated in patients with hypersensitivity to isotretinoin (or vitamin a, given the chemical similarity to isotretinoin) or to any of its components (anaphy