briellyn norethindrone and ethinyl estradiol kit
INDICATIONS AND USAGE Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE 1: LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD % of Women Experiencing an Accidental Pregnancy in the First Year of Continuous Use Method Lowest Expected* Typical** (No contraception) (85) (85) Oral contraceptives combined 0.1 3*** progestin only 0.5 3*** Diaphragm with spermicidal cream or jelly 6 18 Spermicides alone (foam, creams, jellies and vaginal suppositories) 3 21 Vaginal sponge nulliparous 6 18 multiparous 9 28 IUD 0.8-2.0 3# Condom without spermicides 2 12 Periodic abstinence (all methods) 1-9 20 Injectable progestogen 0.3-0.4 0.3-0.4 Implants 6 capsules 0.04 0.04 2 rods 0.03 0.03 Female sterilization 0.2 0.4 Male sterilization 0.1 0.15 Reproduced with permission of the Population Counsil from J. Trusell, et. al: Contraceptive failure in the United States: An update. Studies in Family Planning, 21(1), January-February 1990. * The authors’ best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any reason other than pregnancy. ** This term represents “typical” couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use for any reason other than pregnancy. *** Combined typical rate for both combined and progestin only. # Combined typical rate for both medicated and nonmedicated IUD.
glenmark pharmaceuticals inc., usa
ROUND PINK G 316
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briellyn norethindrone and ethinyl estradiol kit
glenmark pharmaceuticals inc., usa
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HOW SUPPLIED BRIELLYN 28-Day (
NORETHINDRONE AND ETHINYL ESTRADIOL Tablets, USP 0.4 mg/0.035 mg) are available in cartons of 3 blisters each containing 28 tablets. Each blister contains: 21 active tablets: Light peach, round, flat faced, beveled-edged, uncoated tablets with ‘316’ debossed on one side and ‘G’ on the other side. 7 Inert tablets: white to off-white, capsule-shaped, biconvex, uncoated tablet with ‘317’ debossed on one side and ‘ G ’ on the other side. (NDC 68462-316-29) Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. References are available upon request. Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 (888) 721-7115 www.glenmarkpharma-us.com May 2022 Glenmark logo1
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