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use only if needed, under medical advice.","… ychotics at 1-866-961-2388 or online at http:\u002F\u002Fwomensmentalhealth.org\u002Fclinical-and-research-programs\u002Fpregnancyregistry\u002F Risk Summary Neonates exposed to antipsychotic drugs (including quetiapine tablet) during the third trimester are at risk for extrapyramidal and\u002For withdrawal symptoms following delivery (see …",[240],{"source":34,"section":241},"8.1",{"level":234,"text":243,"quote":246,"refs":247},{"fa":244,"en":245},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary Limited data from published literature report the presence of quetiapine in human breast milk at relative infant dose of \u003C1% of the maternal weight-adjusted dosage.",[248],{"source":34,"section":249},"8.2",{"level":251,"text":252,"quote":255,"refs":256},"avoid",{"fa":253,"en":254},"هشدار جعبه‌ای برچسب درباره کودکان.","Boxed warning in the label about children.","Quetiapine is not approved for use in pediatric patients under ten years of age [ see Use in Specific Populations (8.4) ].",[257],{"source":34,"section":258},"Boxed Warning",{"level":251,"text":260,"quote":263,"refs":264},{"fa":261,"en":262},"برچسب: در سالمندان هشدار جدی یا پرهیز.","Label: serious warning or avoid in older adults.","Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death [ see Warnings and Precautions (5.1) ].",[265],{"source":34,"section":258},{"level":234,"text":267,"quote":270,"refs":271},{"fa":268,"en":269},"برچسب نکته‌ای درباره بارداری، پیشگیری یا باروری زنان و مردان دارد.","Label has advice on pregnancy testing, contraception or fertility for females and males.","Infertility Females Based on the pharmacologic action of quetiapine (D2 antagonism), treatment with quetiapine tablets may result in an increase in serum prolactin levels, which may lead to a reversible reduction in fertility in females of reproductive potential [see Warnings and Precautions ( 5.15 )].",[272],{"source":34,"section":273},"8.3",{"kind":275,"refs":276,"id":219},"ANDA",[277],{"source":34,"section":278},"SPL approval \u002F marketing category",1792191879045]