NATAZIA- estradiol valerate and estradiol valerate/dienogest kit

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

ESTRADIOL VALERATE (UNII: OKG364O896) (ESTRADIOL - UNII:4TI98Z838E)

Commercializzato da:

Bayer HealthCare Pharmaceuticals Inc.

INN (Nome Internazionale):

ESTRADIOL VALERATE

Composizione:

ESTRADIOL VALERATE 3 mg

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Natazia® is indicated for use by women to prevent pregnancy. The efficacy of Natazia in women with a body mass index (BMI) of > 30 kg/m2 has not been evaluated. Natazia is also indicated for the treatment of heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive as their method of contraception [see Clinical Studies (14.2)]. Natazia is contraindicated in females who are known to have or develop the following conditions: There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy. The administration of COCs to induce withdrawal bleeding should not be used as a test for pregnancy. COCs should not be used during pregnancy to treat threatened or habitual abortion. Wo

Dettagli prodotto:

Natazia (estradiol valerate and estradiol valerate/dienogest) tablets are available in packages of three blister packs (NDC 50419-409-03). The active and inert film-coated tablets are rounded with biconvex faces, one side is embossed with a regular hexagon shape with the letters DD or DJ or DH or DN or DT. Each blister pack (28 film-coated tablets) contains in the following order: Store at 25º C (77º F); excursions permitted to 15–30o C (59–86o F) [see USP Controlled Room Temperature] .

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

NATAZIA- ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST
BAYER HEALTHCARE PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NATAZIA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NATAZIA.
NATAZIA (ESTRADIOL VALERATE AND
ESTRADIOL VALERATE/DIENOGEST) TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 2010
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Natazia consists of 28 film-coated, unscored tablets in the following
order (3):
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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WOMEN OVER 35 YEARS OLD WHO SMOKE SHOULD NOT USE NATAZIA. (4)
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM
COMBINATION ORAL CONTRACEPTIVE (COC) USE. (4)
Natazia is an estrogen/progestin COC indicated for use by women to
prevent pregnancy. (1)
Treatment of heavy menstrual bleeding in women without organic
pathology who choose to use an
oral contraceptive as their method of contraception. (1.2)
The efficacy of Natazia in women with a body mass index (BMI) of
>30 kg/m has not been evaluated. (1, 8.8)
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Take one tablet daily by mouth at the same time every day. (2.1)
Tablets must be taken in the order directed on the blister pack. (2.1)
Do not skip or delay intake by more than 12 hours. (2.1)
2 dark yellow tablets each containing 3 mg estradiol valerate
5 medium red tablets each containing 2 mg estradiol valerate and 2 mg
dienogest
17 light yellow tablets each containing 2 mg estradiol valerate and 3
mg dienogest
2 dark red tablets each containing 1 mg estradiol valerate
2 white tablets (inert)
A high risk of arterial or venous thrombotic diseases (4)
Undiagnosed abnormal uterine bleeding (4)
Breast cancer (4)
Liver tumors or liver disease (4)
Pregnancy (4)
Vascular risks: Stop Natazia