Pregnancy and Lactation. The University shall provide reasonable accommodations for pregnancy or pregnancy-related conditions (examples include but are not limited to, morning sickness and lactation) unless to do so would impose an undue hardship on the University. Examples of such accommodations include, but are not limited to, a modified work schedule; more frequent restroom, food, or water breaks; providing equipment for seating; limits on lifting; more frequent or longer paid or unpaid breaks; time off, with or without pay, to attend to a pregnancy-related complication; private non-bathroom space for expressing breast milk; and assistance with manual labor. No such accommodations can result in decreased pay or benefits for the SW. The University provides many lactation rooms across the University. Any nursing SW or their spouses/partners who are breastfeeding can register to use a Harvard lactation room. Locations of such lactation rooms can be found on the XXXXxx website.
Pregnancy and Lactation. [*] [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. Xxxxxx® (vapreotide acetate) Version 1.0
Pregnancy and Lactation. Very little data available on safety. Avoid unless the risk of drinking without it is so high that the benefit of naltrexone outweighs the risks. Avoid during breastfeeding.
Pregnancy and Lactation. Do not prescribe to pregnant or breastfeeding women.
Pregnancy and Lactation. There is no relevant clinical experience with KTE-X19 in pregnant or lactating women, and animal reproductive studies have not been performed. Women of child bearing potential must have a negative pregnancy test prior to enrollment because of the potentially dangerous effects of the preparative chemotherapy on the fetus. Women of childbearing potential should be monitored according to local and country-specific regulations. This experimental therapy should not be administered to pregnant women or women who are breastfeeding. Female subjects and female partners of male subjects are recommended to use highly effective contraception (method must achieve an annual failure rate of < 1%) for at least 6 months after conditioning chemotherapy dosing. Male subjects are recommended to not father a child for 6 months after the conditioning chemotherapy dosing. If a pregnancy occurs in a female subject enrolled into the study, or a female partner of a male subject within 6 months of completing the KTE-X19 infusion, the pregnancy must be reported to the key sponsor contact. Information regarding the pregnancy and/or the outcome may be requested by the key sponsor. In addition to reporting any pregnancies occurring during the study, investigators should monitor for pregnancies that occur after the last dose of conditioning chemotherapy through 6 months for female subjects and for 6 months for the female partner of the male subjects. The pregnancy should be reported to the key sponsor contact within 24 hours of the investigators knowledge of the pregnancy event. If a lactation case occurs while the female subject is taking protocol required therapies report the lactation case to the key sponsor contact. In addition to reporting a lactation case during the study, investigators should monitor for lactation cases that occur after the last dose of protocol required therapies through 6 months. Any lactation case should be reported to the key sponsor contact within 24 hours of the investigator’s knowledge of the event.
Pregnancy and Lactation. Caution – see SmPC for details.
Pregnancy and Lactation. No animal reproductive studies have been conducted. It is not known whether Diacol™ Tablets can cause harm to the unborn foetus if administered to a pregnant woman, or interfere with reproductive capacity. Diacol™ Tablets should not be used during pregnancy or by lactating mothers.
Pregnancy and Lactation. Administration during pregnancy should be avoided unless there are compelling reasons for Budenofalk® 2mg rectal foam therapy. In pregnant animals, budesonide, like other glucocorticosteroids, has been shown to cause abnormalities of foetal development. The relevance of this to man has not been established. Since it is not known if budesonide passes into breast milk, the infant should not be breast-fed during treatment with Budenofalk® 2mg rectal foam.
Pregnancy and Lactation. Carboplatin may cause fetal harm; therefore, women of childbearing potential should be advised to avoid becoming pregnant.
Pregnancy and Lactation. Acamprosate should be avoided in pregnancy unless the potential benefit outweighs the risk and avoided in breastfeeding patients.
