Великобритания - английски - MHRA (Medicines & Healthcare Products Regulatory Agency)

sandoz ltd - cyclophosphamide monohydrate - powder for solution for injection - 2gram

Великобритания - английски - MHRA (Medicines & Healthcare Products Regulatory Agency)

sandoz ltd - cyclophosphamide monohydrate - powder for solution for injection - 1gram

Великобритания - английски - MHRA (Medicines & Healthcare Products Regulatory Agency)

sandoz ltd - cyclophosphamide monohydrate - powder for solution for injection - 500mg

Великобритания - английски - MHRA (Medicines & Healthcare Products Regulatory Agency)

baxter healthcare ltd - cyclophosphamide monohydrate - powder for solution for injection - 500mg

Великобритания - английски - MHRA (Medicines & Healthcare Products Regulatory Agency)

baxter healthcare ltd - cyclophosphamide monohydrate - powder for solution for injection - 1gram

САЩ - английски - NLM (National Library of Medicine)

sandoz inc - cyclophosphamide (unii: 8n3dw7272p) (4-hydroxycyclophosphamide - unii:1xbf4e50hs) - malignant diseases cyclophosphamide injection is indicated for the treatment of adult patients with: cyclophosphamide, although effective alone in susceptible malignancies, is more frequently used concurrently or sequentially with other antineoplastic drugs. limitations of use this cyclophosphamide product is not indicated for use in pediatric patients due to the to the alcohol and propylene glycol content in this product. if treatment with cyclophosphamide is indicated in a pediatric patient, use a different cyclophosphamide product [see warnings and precautions (5.7), use in specific populations (8.4), and description (11)] . risk summary based on its mechanism of action and published reports of effects in pregnant patients or animals, cyclophosphamide injection can cause fetal harm when administered to a pregnant woman based on its mechanism of action and published reports of effects in pregnant patients or animals [see clinical pharmacology (12.1) and nonclinical toxicology (13.1)] . exposure to cyclophosphamide during pregnancy may cause fetal malformations, miscarriage, fetal growth retardation, and toxic effects in the newborn [see data] . cyclophosphamide is teratogenic and embryo-fetal toxic in mice, rats, rabbits and monkeys [see data] . advise pregnant women and females of reproductive potential of the potential risk to the fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects is 2%-4% and of miscarriage is 15%-20% of clinically recognized pregnancies. data human data malformations of the skeleton, palate, limbs and eyes as well as miscarriage have been reported after exposure to cyclophosphamide in the first trimester. fetal growth retardation and toxic effects manifesting in the newborn, including leukopenia, anemia, pancytopenia, severe bone marrow hypoplasia, and gastroenteritis have been reported after exposure to cyclophosphamide. animal data administration of cyclophosphamide to pregnant mice, rats, rabbits, and monkeys during the period of organogenesis at doses at or below the dose in patients based on body surface area resulted in various malformations, which included neural tube defects, limb and digit defects and other skeletal anomalies, cleft lip and palate, and reduced skeletal ossification. risk summary cyclophosphamide is present in breast milk. neutropenia, thrombocytopenia, low hemoglobin, and diarrhea have been reported in infants breast fed by women treated with cyclophosphamide. because of the potential for serious adverse reactions in a breastfed infant from cyclophosphamide injection, lactating women should be advised not to breastfeed during the treatment and for 1 week after the last dose. cyclophosphamide injection can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing verify the pregnancy status of females of reproductive potential prior to the initiation of cyclophosphamide injection [see use in specific populations (8.1)] . contraception females advise female patients of reproductive potential to use effective contraception during treatment with cyclophosphamide injection and for up to 1 year after therapy [see use in specific populations (8.1) and nonclinical toxicology (13.1)] . males based on findings in genetic toxicity and animal reproduction studies, advise male patients with female partners of reproductive potential to use effective contraception during treatment with cyclophosphamide injection for 4 months after therapy [see use in specific populations (8.1) and nonclinical toxicology (13.1)] . infertility females amenorrhea, transient or permanent, associated with decreased estrogen and increased gonadotropin secretion develops in a proportion of women treated with cyclophosphamide. affected patients generally resume regular menses within a few months after cessation of therapy. the risk of premature menopause with cyclophosphamide increases with age. oligomenorrhea has also been reported in association with cyclophosphamide treatment. animal data suggest an increased risk of failed pregnancy and malformations may persist after discontinuation of cyclophosphamide as long as oocytes/follicles exist that were exposed to cyclophosphamide during any of their maturation phases. the exact duration of follicular development in humans is not known but may be longer than 12 months [see nonclinical toxicology (13.1)] . males men treated with cyclophosphamide may develop oligospermia or azoospermia which are normally associated with increased gonadotropin but normal testosterone secretion. this cyclophosphamide product is not indicated for use in pediatric patients due to the alcohol and propylene glycol content in this product. if treatment with cyclophosphamide is indicated in a pediatric patient, use a different cyclophosphamide product. since propylene glycol and alcohol are both metabolized by the same enzymes, co-administration of these excipients may raise systemic exposure to alcohol, particularly in pediatric patients. [see indications and usage (1), warnings and precautions (5.7), and description (11)] . other cyclophosphamide products may have a different amount of alcohol or no alcohol. pre-pubescent girls treated with cyclophosphamide generally develop secondary sexual characteristics normally and have regular menses. ovarian fibrosis with apparent complete loss of germ cells after prolonged cyclophosphamide treatment in late pre-pubescence has been reported. girls treated with cyclophosphamide who have retained ovarian function after completing treatment are at increased risk of developing premature menopause. pre-pubescent boys treated with cyclophosphamide develop secondary sexual characteristics normally but may have oligospermia or azoospermia and increased gonadotropin secretion. some degree of testicular atrophy may occur. cyclophosphamide induced azoospermia is reversible in some patients, though the reversibility may not occur for several years after cessation of therapy. there is insufficient data from clinical studies of cyclophosphamide available for patients 65 years of age and older to determine whether they respond differently than younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac functioning, and of concomitant disease or other drug therapy. in patients with severe renal impairment, decreased renal excretion may result in increased plasma levels of cyclophosphamide and its metabolites. this may result in increased toxicity [see clinical pharmacology (12.3)] . monitor patients with severe renal impairment (clcr =10 ml/min to 24 ml/min) for signs and symptoms of toxicity. cyclophosphamide and its metabolites are dialyzable [see clinical pharmacology (12.3)] although there are probably quantitative differences depending upon the dialysis system being used. use of a consistent interval between cyclophosphamide administration and dialysis should be considered in patients requiring dialysis. patients with severe hepatic impairment have reduced conversion of cyclophosphamide to the active 4-hydroxyl metabolite, potentially reducing efficacy [see clinical pharmacology (12.3)] . the alcohol content of cyclophosphamide injection should be taken into account when given to patients with hepatic impairment [see warnings and precautions (5.7)].

САЩ - английски - NLM (National Library of Medicine)

ax pharmaceutical corp - cyclophosphamide (unii: 8n3dw7272p) (cyclophosphamide anhydrous - unii:6uxw23996m) - cyclophosphamide anhydrous 495 g in 500 g

Малта - английски - Malta Medicines Authority

baxter holding b.v. kobaltweg 49, 3542ce utrecht, netherlands - cyclophosphamide monohydrate - powder for solution for injection - cyclophosphamide monohydrate 1000 mg - antineoplastic agents

Ирландия - английски - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - cyclophosphamide monohydrate - coated tablets - 50 milligram - cyclophosphamide

Малта - английски - Malta Medicines Authority

baxter holding b.v. kobaltweg 49, 3542ce utrecht, netherlands - cyclophosphamide - coated tablet - cyclophosphamide 50 mg - antineoplastic agents