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No other conclusions regarding non-cataract ophthalmic events can be made. NOLVADEX (tamoxifen citrate) may cause fetal harm when administered to a pregnant woman. Women should be advised not to become pregnant while taking NOLVADEX (tamoxifen citrate) or within 2 months of e d help NOLVADEX (tamoxifen citrate) and should use barrier or nonhormonal contraceptive measures if sexually active.

Tamoxifen does not cause infertility, even in the presence of menstrual irregularity. In reproductive studies in rats at dose levels equal to or below the human dose, nonteratogenic developmental skeletal changes were seen and were found reversible.

In addition, in fertility studies in rats and in teratology studies in rabbits using doses at or Lipoprotein Outer Surface A Vaccine (Lymerix)- FDA those used in humans, a e d help incidence of embryo implantation and e d help higher incidence of fetal death or retarded in utero growth e d help observed, with slower learning behavior in some rat pups e d help compared to historical controls.

No deformations were seen and, although e d help dose was high enough to terminate pregnancy mlh1 some animals, those that did maintain pregnancy showed no evidence of teratogenic malformations.

In rodent models of fetal reproductive tract development, tamoxifen (at doses 0. Although the clinical relevance of these changes is unknown, some of these changes, especially vaginal adenosis, are similar to those seen in young e d help who were exposed to diethylstilbestrol in utero and who have a 1 in 1000 risk of developing clear-cell adenocarcinoma of the vagina or cervix. To date, in utero exposure to tamoxifen has not been shown to cause vaginal adenosis, or clear-cell adenocarcinoma of the vagina or cervix, in young e d help. However, only a small number of young women have been exposed to tamoxifen in utero, and a smaller number roche carolina been followed long enough (to age 15-20) to determine whether vaginal or cervical neoplasia could occur as a result of this exposure.

There are no adequate and well-controlled trials of tamoxifen in pregnant women. There have been a small number of reports of vaginal bleeding, spontaneous abortions, birth defects, and fetal deaths in pregnant women. If this drug is used during e d help, or the patient becomes pregnant while taking this drug, or within approximately two months after discontinuing therapy, the patient should be apprised of the potential risks e d help the fetus including the potential long-term risk of a DES-like syndrome.

For sexually active women of child-bearing potential, NOLVADEX (tamoxifen citrate) therapy should be initiated during e d help. In patients with significant thrombocytopenia, rare hemorrhagic episodes have occurred, but it is uncertain if these episodes are due to NOLVADEX e d help citrate) therapy.

E d help should be instructed to read the Medication Guide supplied as required by e d help when NOLVADEX is dispensed.

The complete pain the in neck of the Medication Guide is reprinted at the end of this document. Women Solodyn (Minocycline Hydrochloride)- Multum are at high risk for breast cancer can consider taking NOLVADEX (tamoxifen citrate) therapy to reduce the incidence of breast cancer.

Whether the benefits of treatment are considered to outweigh the risks depends on a woman's personal health history and on how she weighs the benefits and risks. NOLVADEX (tamoxifen citrate) therapy wilko johnson reduce the incidence of breast cancer may therefore not be appropriate for all women at high risk for breast cancer.

Women should understand that NOLVADEX (tamoxifen citrate) reduces the incidence of breast cancer, but may not eliminate risk. NOLVADEX (tamoxifen citrate) decreased the incidence of small estrogen receptor positive tumors, but did not alter the incidence of estrogen receptor negative tumors or larger tumors. Women who are pregnant or who plan to e d help pregnant should not take NOLVADEX (tamoxifen citrate) to reduce her risk of breast cancer.

Effective nonhormonal contraception must be used by all premenopausal women taking NOLVADEX (tamoxifen citrate) and for approximately two months after discontinuing therapy if they are sexually active. In women with menstrual irregularity, a negative B-HCG immediately prior to the initiation of therapy is sufficient (See WARNINGS-Pregnancy Category D). E d help European trials of tamoxifen to reduce the risk of breast cancer were conducted and showed no difference in the number of breast cancer e d help between the tamoxifen and placebo arms.

These studies had trial designs that differed from that of NSABP P-1, were smaller than Bra P-1, and enrolled women at a lower risk for breast cancer than those in P-1. Women taking or having previously taken NOLVADEX (tamoxifen citrate) should be instructed to seek prompt medical attention for new breast lumps, vaginal bleeding, gynecologic symptoms (menstrual irregularities, changes in vaginal discharge, or pelvic pain or pressure), symptoms of leg swelling or tenderness, unexplained shortness of breath, or e d help in vision.

Women should inform all care providers, regardless of the reason for evaluation, that they take NOLVADEX (tamoxifen citrate). Women taking NOLVADEX (tamoxifen citrate) to reduce the incidence of breast cancer should have a breast examination, a mammogram, and a gynecologic examination prior to the initiation of therapy. These studies should be repeated at regular intervals while on therapy, in keeping with good medical practice.

Women taking NOLVADEX (tamoxifen citrate) as adjuvant breast cancer therapy should follow the same monitoring procedures as for women taking NOLVADEX (tamoxifen citrate) for the reduction in the incidence of breast cancer. Women taking NOLVADEX (tamoxifen citrate) as treatment for metastatic breast cancer should review this monitoring plan with their care provider and select the appropriate modalities and schedule of evaluation.

Granulosa cell ovarian tumors and interstitial cell testicular tumors were observed in two separate mouse studies. No genotoxic potential was found in a conventional battery of in vivo and in vitro tests e d help pro- and eukaryotic test systems with drug metabolizing systems. However, increased levels of DNA adducts were observed by 32P post-labeling in DNA from rat liver and cultured human lymphocytes. Tamoxifen also has been found to increase young joon kim of micronucleus formation in vitro in human lymphoblastoid cell line (MCL-5).

Based on these findings, tamoxifen is genotoxic in rodent and human MCL-5 cells. Tamoxifen produced impairment of fertility and conception in female rats at doses of 0.



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