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Norgestimate And Ethinyl Estradiol (Previfem)

Trade Name : Previfem

Par Pharmaceutical, Inc.

KIT

Strength

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Norgestimate And Ethinyl Estradiol (Previfem) which is also known as Previfem and Manufactured by Par Pharmaceutical, Inc.. It is available in strength of per ml. Read more

Norgestimate And Ethinyl Estradiol (Previfem) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
  • See full prescribing information for complete boxed warning.
  • Norgestimate and ethinyl estradiol are contraindicated in women over 35 years old who smoke. (n- Array
  • Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. ()
  • Contraindications ()u00a0 08/2017 Warnings and Precautions ()u00a0 08/2017
  • Previfem (norgestimate and ethinyl estradiol tablets) are indicated for use by females of reproductive potential to prevent pregnancy [see .
  • Previfem (norgestimate and ethinyl estradiol tablets), are an estrogen/progestin COCs, indicated for use by women to prevent pregnancy. ()
  • No data
  • Take one tablet daily by mouth at the same time every day. ()
  • Take tablets in the order directed on the blister pack. ()
  • Do not skip or delay tablet intake. ()
  • Previfem is available in blister cards. Each blister pack contains 28 tablets in the following order:
  • Previfem (norgestimate and ethinyl estradiol tablets, USP) consists of 28 round tablets in the following order ():
  • 21 blue tablets each containing 0.25 mg norgestimate and 0.035 mg ethinyl estradiol
  • 7 green tablets (inert)
  • Do not prescribe norgestimate and ethinyl estradiol to women who are known to have the following conditions:
  • A high risk of arterial or venous thrombotic diseases ()
  • Liver tumors or liver disease ()
  • Undiagnosed abnormal uterine bleeding ()
  • Pregnancy ()
  • Breast cancer or other estrogen- or progestin-sensitive cancer ()
  • Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir ()
  • No data
  • Arrayn- Thromboembolic Disorders and Other Vascular Problems:
  • Arrayn- Liver disease:
  • Arrayn- High blood pressure:
  • Arrayn- Carbohydrate and lipid metabolic effects:
  • Arrayn- Headache:
  • Arrayn- Bleeding Irregularities and Amenorrhea
  • The following serious adverse reactions with the use of COCs are discussed elsewhere in labeling:
  • Adverse reactions commonly reported by COC users are:
  • The most common adverse reactions reported during clinical trials (u22652%) were:
  • Norgestimate and ethinyl estradiol: headache/migraine, abdominal/gastrointestinal pain, vaginal infection, genital discharge, breast issues (including breast pain, discharge, and enlargement), mood disorders (including depression and mood altered), flatulence, nervousness, rash. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Par Pharmaceutical at 1-800-828-9393u00a0or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Consult the labeling of concurrently used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.
  • No drug-drug interaction studies were conducted with norgestimate and ethinyl estradiol.
  • Drugs or herbal products that induce certain enzymes including CYP3A4, may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with COCs. ()
  • Nursing mothers
  • 8.3
  • There have been no reports of serious ill effects from overdosage of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.
  • Each of the following products is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17u03b1)-(+)-) and ethinyl estradiol is designated as (19-nor-17u03b1-pregna,1,3,5(10)-trien-20-yne-3,17-diol).
  • No data
  • [See n , n and n n n
  • In three US clinical trials with norgestimate and ethinyl estradiol, 1,651 women aged 18 to 38 years were studied for up to 24 cycles, proving a total of 24,272 cycles of exposure. The racial demographic was about 73 to 86% Caucasian, 8 to 13% African-American, 6 to 14% Hispanic with the remainder Asian or Other (u22641%). There were no exclusions on the basis of weight; the weight range for women treated was 82 to 303 lbs, with a mean weight of about 135 lbs. The pregnancy rate was approximately 1 pregnancy per 100 women-years.
  • No data
  • Arrayn- See FDA-approved patient labeling (Patient Information and Instructions for Use).
  • Counsel patients about the following information:
  • Manufactured by: Laboratorios Leon Farma S.A., Spain
  • Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977
  • Rev. 12/2018
  • Patient Informationn- Previfem (n- norgestimaten- and n- ethinyln- estradiol tablets, USP)
  • (n- nor-JES-n- tin- -maten- , ETH-n- in- -nil n- esn- -n- tran- -DYE-n- oln- )
  • What is the most important information I should know about n- Previfem?
  • Do not use n- Previfem if you smoke cigarettes and are over 35 years old.
  • What is n- Previfem?
  • Previfemn
  • How does n- Previfem work for contraception?
  • Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The better you follow the directions, the less chance you have of getting pregnant.
  • Based on the results of clinical studies, about 1 out of 100 women may get pregnant during the first year they use Previfem.
  • The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.
  • Who should not take n- Previfem?
  • Do not take n- Previfem if you:
  • If any of these conditions happen while you are taking n- Previfem, stop taking n- Previfem right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking n- Previfem.
  • What should I tell my healthcare provider before taking n- Previfem?
  • Tell your healthcare provider if you:
  • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
  • Previfem may affect the way other medicines work, and other medicines may affect how well Previfem works.
  • Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
  • How should I take n- Previfem?
  • Read the Instructions for Usen- .
  • What are the possible serious side effects of n- Previfem?
  • Serious blood clots can happen especially if you smoke, are obese, or are older than 35 years of age. Serious blood clots are more likely to happen when you:
  • Call your healthcare provider or go to a hospital emergency room right away if you have:
  • Other serious side effects include:
  • What are the most common side effects of n- Previfem?
  • These are not all the possible side effects of Previfem. For more information, ask your healthcare provider or pharmacist.
  • You may report side effects tou00a0Par Pharmaceutical at 1-800-828-9393 or FDA at 1-800-FDA-1088 or ..
  • What else should I know about taking n- Previfemn- Array
  • How should I store n- Previfemn- Array
  • General information about the safe and effective use of n- Previfemn- Array
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Previfem for a condition for which it was not prescribed. Do not give Previfem to other people, even if they have the same symptoms that you have.
  • This Patient Information summarizes the most important information about Previfem . You can ask your pharmacist or healthcare provider for information about Previfem that is written for health professionals. For more information, Par Pharmaceutical at 1-800-828-9393.
  • Do birth control pills cause cancer?
  • Birth control pills do not seem to cause breast cancer. However, if you have breast cancer now, or have had it in the past, do not use birth control pills because some breast cancers are sensitive to hormones.
  • Women who use birth control pills may have a slightly higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners.
  • What if I want to become pregnant?
  • You may stop taking the pill whenever you wish. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop taking the pill.
  • What should I know about my period when taking n- Previfemn- Array
  • Your periods may be lighter and shorter than usual. Some women may miss a period. Irregular vaginal bleeding or spotting may happen while you are taking Previfem, especially during the first few months of use. This usually is not a serious problem. It is important to continue taking your pills on a regular schedule to prevent a pregnancy.
  • What are the ingredients in n- Previfemn- Array
  • Active ingredients:
  • Inactive ingredients:
  • Arrayn- Blue pills:
  • Arrayn- Green pills:
  • Instructions For Usen- Previfemn- Arrayn- norgestimaten- and n- ethinyln- estradiol tablets, USP)
  • Important Information about taking n- Previfemn- Array
  • Before you start taking n- Previfemn- Array
  • When should I start taking n- Previfemn- Array
  • If you start taking n- Previfemn- Array
  • If you start taking n- Previfemn- Array
  • If you start taking n- Previfemn- Array
  • If you start taking n- Previfemn- Array
  • If you start taking n- Previfemn- Array
  • Keep a calendar to track your periodn- :n- If this is the first timen- When should I start taking n- Previfemn- Array
  • Follow these instructions for either a or a .
  • Sunday Startn- :
  • Day 1 Startn- :n- Day 1n- first day of your period.
  • Previfemn- Array
  • Arrayn- YOU START TAKING YOUR PILLS:
  • 1. BE SURE TO READ THESE DIRECTIONS:
  • Before you start taking your pills.
  • Anytime you are not sure what to do.
  • 2. THE RIGHT WAY TO TAKE THE PILL IS TO TAKE ONE PILL EVERY DAY AT THE SAME TIME.u00a0 If you miss pills you could get pregnant. This includes starting the pack late.
  • The more pills you miss, the more likely you are to get pregnant.
  • 3. MANY WOMEN HAVE SPOTTING OR LIGHT BLEEDING, OR MAY FEEL SICK TO THEIR STOMACH DURING THE FIRST 1 to 3 PACKS OF PILLS. If you feel sick to your stomach or have spotting or light bleeding, do not stop taking the pill. The problem will usually go away. If it doesn't go away, check with your healthcare professional.
  • 4. MISSING PILLS CAN ALSO CAUSE SPOTTING OR LIGHT BLEEDING, even when you make up these missedu00a0pills.
  • On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach.
  • 5. IF YOU HAVE VOMITING OR DIARRHEA, OR IF YOU TAKE SOME MEDICINES, your pills may not work as well.
  • Use a back-up method (such as a condom or spermicide) until you check with your healthcare professional.
  • 6. IF YOU HAVE TROUBLE REMEMBERING TO TAKE THE PILL, talk to your healthcare professional about how to make pill-taking easier or about using another method of birth control.
  • 7. IF YOU HAVE ANY QUESTIONS OR ARE UNSURE ABOUT THE INFORMATION IN THIS LEAFLET, call your healthcare professional.
  • Arrayn- YOU START TAKING YOUR PILLS
  • 1n- .DECIDE WHAT TIME OF DAY YOU WANT TO TAKE YOUR PILL.
  • It is important to take it at about the same time every day.
  • 2n- LOOK AT YOUR PILL PACK
  • The pill pack has 21 active pills (with hormones) to take for 3 weeks. This is followed by 1 week of reminder green pills (without hormones).
  • There are 21 blue active pills, and 7 green reminder pills.
  • 3. ALSO FIND:
  • 1) where on the pack to start takingu00a0pills,
  • 2) in what order to take the pills (follow theu00a0arrows)
  • 3) the week numbers as shown in the diagramu00a0below.
  • 4.BE SURE YOU HAVE READY AT ALL TIMES:
  • ANOTHER KIND OF BIRTH CONTROL (such as a condom or spermicide) to use as a back-up method in case you miss pills.
  • AN EXTRA, FULL PILL PACK.
  • What should I do if I miss any n- Previfemn- Array
  • If you miss 1 pill in Weeks 1, 2, or 3, follow these steps:
  • If you miss 2 pills in Week 1 or Week 2 of your pack, follow these steps:
  • If you miss 2 pills in a row in Week 3, or you miss 3 or more pills in a row during Weeks 1, 2, or 3 of the pack, follow these steps:
  • If you have any questions or are unsure about the information in this leaflet, call your healthcare provider.
  • This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.
  • Previfemu00ae is a trademark of Par Pharmaceutical LLC.
  • The brands listed are trademarks of their respective owners and are not trademarks of Par Pharmaceutical, LLC.
  • Manufactured by: Laboratorios Leu00f3n Farma S.A., Spain
  • Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977
  • Rev. 12/2018
  • No data

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