MICROGESTIN FE 1/20- norethindrone acetate and ethinyl estradiol and ferrous fumarate kit MICROGESTIN 1/20- norethindrone aceta

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Osta kohe

Laadi alla Toote omadused (SPC)
09-05-2022

Toimeaine:

NORETHINDRONE ACETATE (UNII: 9S44LIC7OJ) (NORETHINDRONE - UNII:T18F433X4S), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

Saadav alates:

Mayne Pharma Inc.

INN (Rahvusvaheline Nimetus):

NORETHINDRONE ACETATE

Koostis:

NORETHINDRONE ACETATE 1 mg

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

MICROGESTIN and MICROGESTIN Fe are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I 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 I: LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD % Of Women Experiencing an Unintended Pregnancy in the First Year of Continuous Use Lowest Method Expected* Typical** (No contraception) ...................... (85) (85) Oral contraceptives .................... 3 combined ................................ 0.1 N/A*** progestin only ........................ 0.5 N/A*** Diaphragm with spermicidal cream or jelly .......................... 6 20 Spe

Toote kokkuvõte:

MICROGESTIN 1/20 is available in dispensers each containing 21 white tablets. Each tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol, with “P-D 915” embossed only on one side. Available in packages of 6 dispensers. NDC  51862-007-06 MICROGESTIN Fe 1/20 is available in dispensers each containing 21 white tablets and 7 brown tablets. Each white tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol, with “P-D 915” embossed only on one side. Each brown tablet contains 75 mg ferrous fumarate, with “624” embossed on one side and “WC” on the other side. Available in packages of 6 dispensers. NDC  51862-012-06 MICROGESTIN 1.5/30 is available in dispensers each containing 21 green tablets. Each tablet contains 1.5 mg of norethindrone acetate and 30 mcg of ethinyl estradiol, with “P-D 916” embossed only on one side. Available in packages of 6 dispensers. NDC  51862-279-06 MICROGESTIN Fe 1.5/30 is available in dispensers each containing 21 green tablets and 7 brown tablets. Each green tablet contains 1.5 mg of norethindrone acetate and 30 mcg of ethinyl estradiol, with “P-D 916” embossed only on one side. Each brown tablet contains 75 mg ferrous fumarate, with “624” embossed on one side and “WC” on the other side. Available in packages of 6 dispensers. NDC  51862-292-06 Store below 30˚ C (86˚ F).

Volitamisolek:

New Drug Application Authorized Generic

Toote omadused

                                MICROGESTIN FE 1/20- NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND
FERROUS FUMARATE
MICROGESTIN 1/20- NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET
MICROGESTIN 1.5/30- NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET
MICROGESTIN FE 1.5/30- NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND
FERROUS FUMARATE
MAYNE PHARMA INC.
----------
MICROGESTIN®
(NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, USP)
MICROGESTIN®
(NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, USP)
MICROGESTIN® 1/20
(Each white tablet contains 1 mg norethindrone acetate and 20 mcg
ethinyl estradiol.)
MICROGESTIN® 1.5/30
(Each green tablet contains 1.5 mg norethindrone acetate and 30 mcg
ethinyl estradiol.)
MICROGESTIN® FE
(NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, USP AND FERROUS
FUMARATE TABLETS*)
*FERROUS FUMARATE TABLETS ARE NOT USP FOR DISSOLUTION AND ASSAY.
MICROGESTIN® Fe 1/20
(Each white tablet contains 1 mg norethindrone acetate and 20 mcg
ethinyl estradiol.
Each brown tablet contains 75 mg ferrous fumarate.)
MICROGESTIN® Fe 1.5/30
(Each green tablet contains 1.5 mg norethindrone acetate and 30 mcg
ethinyl estradiol.
Each brown tablet contains 75 mg ferrous fumarate.)
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV
INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
MICROGESTIN and MICROGESTIN Fe are progestogen-estrogen combinations.
MICROGESTIN Fe 1/20 and 1.5/30: Each provides a continuous dosage
regimen
consisting of 21 oral contraceptive tablets and seven ferrous fumarate
tablets. The
ferrous fumarate tablets are present to facilitate ease of drug
administration via a 28-
day regimen, are non-hormonal, and do not serve any therapeutic
purpose.
Each white tablet contains norethindrone acetate (17
alpha-ethinyl-19-nortestosterone
acetate), 1 mg; ethinyl estradiol (17
alpha-ethinyl-1,3,5(10)-estratriene-3, 17 beta-diol),
20 mcg. Also contains acacia, NF; lactose, NF; magnesium stearate, NF;
starch, NF;
confectioner’s sugar, NF; talc, USP.
Each green table
                                
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