JUNEL 1.5/30- norethindrone acetate and ethinyl estradiol tablet JUNEL FE 1/20- norethindrone acetate and ethinyl estradiol, an

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Physicians Total Care, Inc.

INN (Rahvusvaheline Nimetus):

NORETHINDRONE ACETATE

Koostis:

NORETHINDRONE ACETATE 1.5 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

June l ® 21 and Junel ® Fe 28 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. Oral contraceptives should not be used in women who currently have the following conditions: - Thrombophlebitis or thromboembolic disorders - A past history of deep vein thrombophlebitis or thromboembolic disorders - Cerebral vascular or coronary artery disease - Known or suspected carcinoma of the breast - Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia - Undiagnosed abnormal genital bleeding - Cholestatic jaundice of pregnancy or jaundice with prior p

Toote kokkuvõte:

Junel ® Fe 1/20 (28 Tablets) (norethindrone acetate 1 mg and ethinyl estradiol 20 mcg tablets, USP, and ferrous fumarate tablets) are packaged in cartons of blister cards. Each card contains 21 light yellow, round, flat-faced, beveled-edge, unscored tablets debossed with stylized b on one side and 977 on the other side and 7 brown, round, flat-faced, beveled-edge, unscored tablets debossed with stylized b on one side and 247 on the other side. Each brown tablet contains 75 mg ferrous fumarate. 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. (NDC 54868-5326-0) . Junel ® 1.5/30 (21 Tablets) (norethindrone acetate 1.5 mg and ethinyl estradiol 30 mcg tablets, USP) are packaged in cartons of blister cards. Each card contains 21 pink, round, flat-faced, beveled-edge, unscored tablets debossed with stylized b on one side and 978 on the other side. (NDC 54868-6272-0) . Junel ® Fe 1.5/30 (28 Tablets) (norethindrone acetate 1.5 mg and ethinyl estradiol 30 mcg tablets, USP, and ferrous fumarate tablets) are packaged in cartons of blister cards. Each card contains 21 pink, round, flat-faced, beveled-edge, unscored tablets debossed with stylized b on one side and 978 on the other side and 7 brown, round, flat-faced, beveled-edge, unscored tablets debossed with stylized b on one side and 247 on the other side. Each brown tablet contains 75 mg ferrous fumarate. 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. (NDC 54868-5935-0) . Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

JUNEL 1.5/30 - NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET
JUNEL FE 1/20 - NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND
FERROUS FUMARATE
JUNEL FE 1.5/30 - NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND
FERROUS FUMARATE
PHYSICIANS TOTAL CARE, INC.
----------
JUNEL 21 DAY
(NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, USP)
JUNEL FE 28 DAY
(NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, USP AND FERROUS
FUMARATE TABLETS*)
*FERROUS FUMARATE TABLETS ARE NOT USP FOR DISSOLUTION AND ASSAY.
_JUNEL _ 1/20
(Each light yellow tablet contains 1 mg norethindrone acetate and 20
mcg ethinyl estradiol.)
_JUNE_L 1.5/30
(Each pink tablet contains 1.5 mg norethindrone acetate and 30 mcg
ethinyl estradiol.)
_JUNEL_
_ FE_ 1/20
(Each light yellow tablet contains 1 mg norethindrone acetate and 20
mcg ethinyl estradiol. Each brown
tablet contains 75 mg ferrous fumarate.)
_JUNEL _
_ FE_ 1.5/30
(Each pink tablet contains 1.5 mg norethindrone acetate and 30 mcg
ethinyl estradiol. Each brown tablet
contains 75 mg ferrous fumarate.)
Rx only
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTIONS (AIDS)
AND OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION:
_JUNEL_
_ 21 _AND _JUNEL _
_ FE 28 _are progestogen-estrogen combinations.
_JUNEL _
_ 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 light yellow tablet contains norethindrone acetate
(17α-ethinyl-19-nortestosterone acetate), 1 mg;
ethinyl estradiol (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol),
20 mcg. Each light yellow tablet
contains the following inactive ingredients: acacia, compressible
sugar, D&C yellow no. 10 aluminum
lake, lactose monohydrate, magnesium stearate and pregelatinized
starch.
Each pink tablet contains norethindrone acetate
(17α-ethinyl-19-nortesto