Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

evive biotechnology singapore pte. ltd. - efbemalenograstim alfa (unii: 5upw5hjw3o) (efbemalenograstim alfa - unii:5upw5hjw3o) - ryzneuta is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. limitations of use ryzneuta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. ryzneuta is contraindicated in patients with a history of serious allergic reactions to granulocyte stimulating factors such as efbemalenograstim alfa-vuxw, pegfilgrastim, or filgrastim products [see warnings and precautions ( 5.3)] . risk summary although available data with ryzneuta use in pregnant women are insufficient to establish whether there is a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, there are available data from published studies in pregnant women exposed to other human g csf products. these studies have not established an association of g-csf product use during pregnancy with major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal studies, no evidence of reproductive/developmental toxicity occurred in the offspring of pregnant rats and rabbits that received cumulative doses of efbemalenograstim alfa-vuxw approximately 2.6 and 0.7 times, respectively, the recommended human dose (based on body surface area). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data three studies were conducted in pregnant rats dosed with efbemalenograstim alfa-vuxw at cumulative doses up to approximately 2.6 times the recommended human dose at the following stages of gestation: during the period of organogenesis, from mating through the first half of pregnancy, and from the first trimester through delivery and lactation. no evidence of fetal loss or structural malformations was observed in any study. growth and learning were also unaffected. pregnant rabbits were dosed with efbemalenograstim alfa-vuxw every other day during organogenesis at cumulative doses up to 0.7 times the recommended human dose showed no signs of fetal loss or structural malformations. maternal toxicity (decreased weight gain or weight loss and/or death) was observed when higher cumulative doses of efbemalenograstim alfa-vuxw were used in an early dose-ranging study in rabbits. risk summary there are no data on the presence of efbemalenograstim alfa-vuxw or its metabolite in either human or animal milk, the effects on the breastfed child, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for efbemalenograstim alfa-vuxw and any potential adverse effects on the breastfed child from efbemalenograstim alfa-vuxw or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. clinical studies of ryzneuta did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience with ryzneuta has not identified differences in responses between the elderly and younger patients.

Australia - Inggeris - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - lenograstim -

Australia - Inggeris - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - lenograstim -

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

guna spa - angelica sinensis root (unii: b66f4574ug) (angelica sinensis root - unii:b66f4574ug), sus scrofa blood (unii: 994r458eck) (sus scrofa blood - unii:994r458eck), lenograstim (unii: 6ws4c399gb) (lenograstim - unii:6ws4c399gb), interleukin-11 (unii: o14q7a13pt) (interleukin-11 - unii:o14q7a13pt), interleukin-3 (unii: a802907mi4) (interleukin-3 - unii:a802907mi4), binetrakin (unii: 751635z921) (binetrakin - unii:751635z921), shiitake mushroom (unii: 1a64qn2d2f) (shiitake mushroom - unii:1a64qn2d2f), reish - angelica sinensis root 3 [hp_x] in 4 g - angelica sinensis, radix    3x    detoxification blood                                    4c, 7c    promotes recovery gcsf                                        4c    strengthens immune response interleukin 11                    5c    anti-inflammatory interleukin 3                        5c    strengthens immune response interleukin 4                        4c    immune support japanese forest mushroom    8x    strengthens immune response ling chi mushroom        8x    antioxidant lymphatic gland            4c    strengthens resistance to infection melatonin            4c, 7c    antioxidant spleen                4c    strengthens resistance to infection temporary relief of symptoms due to tonsillitis such as: - sore throat - loss of voice - swollen lymph nodes turn tube upside down and rotate cap to release pellets into cap. unscrew cap and without touching pell

Ireland - Inggeris - HPRA (Health Products Regulatory Authority)

chugai pharma uk ltd - lenograstim - powder and solvent for solution for injection/infusion - 105mcg microgram(s) - colony stimulating factors; lenograstim

Ireland - Inggeris - HPRA (Health Products Regulatory Authority)

chugai pharma uk ltd - lenograstim - powder and solvent for solution for injection/infusion - 263mcg microgram(s) - colony stimulating factors; lenograstim

Ireland - Inggeris - HPRA (Health Products Regulatory Authority)

chugai pharma france - lenograstim - powder and solvent for solution for injection/infusion - 13 international unit(s)/millilitre - colony stimulating factors; lenograstim

Ireland - Inggeris - HPRA (Health Products Regulatory Authority)

chugai pharma france - lenograstim - powder and solvent for solution for injection/infusion - 34 million international unit(s)/millilitre - colony stimulating factors; lenograstim

Belgium - Inggeris - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

chugai pharma france - lenograstim 105 - powder and solvent for solution for infusion - 1 miu/ml - lenograstim (rhug-csf) 105 µg - lenograstim

Belgium - Inggeris - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

chugai pharma france - lenograstim 263 - powder and solvent for solution for infusion - 1 miu/ml - lenograstim (rhug-csf) 263 µg - lenograstim