PROCHIEVE 8％凝胶（90毫克孕酮）/18根/盒
      
Generic Name for PROCHIEVE
Progesterone (micronized) 4% (45mg/applicatorful), 8% (90mg/applicatorful); vaginal gel; contains mineral oil.
Legal Classification:
Rx

Manufacturer of PROCHIEVE
Columbia Laboratories
      
Indications for PROCHIEVE
Secondary amenorrhea.
      
Adult dose for PROCHIEVE
Initially one applicatorful of 4% (45mg) intravaginally every other day up to a total of 6 doses. If inadequate response may give 1 applicatorful of 8% (90mg) intravaginally every other day for a total of 6 doses.
Children's dosing for PROCHIEVE
Not applicable.
      
Contraindications for PROCHIEVE
Undiagnosed vaginal bleeding. Breast or genital carcinoma. Liver
dysfunction or disease. Missed abortion. Thrombophlebitis or
thromboembolic disorders.
Warnings/Precautions for PROCHIEVE
Conditions aggravated by fluid retention. Depression. Include Pap smear
with pretreatment exam. Discontinue if signs of thrombotic disorders (eg, thrombophlebitis, cerebrovascular disorders, pulmonary embolism, retinal thrombosis) occur. Pregnancy: see literature. Nursing mothers.
Interactions for PROCHIEVE
Allow at least 6 hours between administration of this and other
vaginally-administered products.
Adverse Reactions for PROCHIEVE
Cramps, emotional lability, fatigue, sleep disorders, depression,
headache, bloating, vaginal discharge, nausea, changes in appetite, back or abdominal pain, myalgia, pruritus genital, others.
      
How is PROCHIEVE supplied?
Prefilled applicators 4%—6
Prefilled applicators 8%—6, 18
Related Disease:
Amenorrhea~menopausal disorders
Menopausal disorders

通用名称PROCHIEVE
孕酮（微粉）4％（45mg/applicatorful），8％（90mg/applicatorful）;阴道凝胶，含有矿物油。

法律分类：
接收

制造商PROCHIEVE
哥伦比亚实验室
       
适应症PROCHIEVE
继发性闭经。

成人剂量PROCHIEVE
最初一4％（45mg）intravaginally每隔一天applicatorful最多为6次总计。如果不充分的反应可能会剂量为6共计1
8％（90毫克）intravaginally每隔一天applicatorful。

儿童剂量为PROCHIEVE
不适用。

禁忌的PROCHIEVE
未经诊断的阴道出血。乳房或生殖器癌。肝功能障碍或疾病。过期流产。血栓性静脉炎或血栓栓塞性疾病。

警告/注意事项的PROCHIEVE
由水肿加重条件。抑郁症。包括子宫颈抹片检查与治疗前考试。停止的迹象，如果血栓性疾病（如血栓性静脉炎，脑血管疾病，肺栓塞，视网膜血栓形成）发生。妊娠：见文献。哺乳的母亲。

互作PROCHIEVE
允许至少6间这个问题和其他阴道管理的产品管理小时。

不良反应为PROCHIEVE
痉挛，情绪不稳，疲劳，睡眠障碍，抑郁，头痛，腹胀，阴道分泌物，恶心，食欲改变，背部或腹部疼痛，肌肉痛，皮肤瘙痒外阴，等等。

Generic Name for PROCHIEVE
Progesterone (micronized) 4% (45mg/applicatorful), 8% (90mg/applicatorful); vaginal gel; contains mineral oil.
Legal Classification:
Rx

Manufacturer of PROCHIEVE
Columbia Laboratories
      
Indications for PROCHIEVE
8% strength: Progesterone supplementation or replacement as part of an
Assisted Reproductive Technology (ART) treatment for infertile women with progesterone deficiency.
      
Adult dose for PROCHIEVE
Supplementation: 1 applicatorful of 8% (90mg) intravaginally once daily.
Replacement: 1 applicatorful of 8% (90mg) intravaginally twice daily. If pregnancy occurs, may continue treatment until placental autonomy is
achieved (10–12 weeks).
Children's dosing for PROCHIEVE
Not applicable.
      
ontraindications for PROCHIEVE
Undiagnosed vaginal bleeding. Breast or genital carcinoma. Liver
dysfunction or disease. Missed abortion. Thrombophlebitis or thromboembolic disorders.
Warnings/Precautions for PROCHIEVE
Conditions aggravated by fluid retention. Depression. Include Pap smear
with pretreatment exam. Discontinue if signs of thrombotic disorders (eg, thrombophlebitis, cerebrovascular disorders, pulmonary embolism, retinal thrombosis) occur. Pregnancy: see literature. Nursing mothers.
Interactions for PROCHIEVE
Allow at least 6 hours between administration of this and other vaginally-administered products.
Adverse Reactions for PROCHIEVE
Mastodynia, constipation, somnolence, GI upset, headache, abdominal/perineal pain, nervousness, cramps, nocturia, depression,
decreased libido, arthralgia, bloating, pain, vaginal candidiasis/discharge, dizziness, dyspareunia, pruritus genital, allergy, fatigue, urinary tract infection, others.
      
How is PROCHIEVE supplied?
Prefilled applicators 4%—6
Prefilled applicators 8%—6, 18
      
Related Disease:

通用名称PROCHIEVE
孕酮（微粉）4％（45mg/applicatorful），8％（90mg/applicatorful）;阴道凝胶，含有矿物油。
法律分类：
接收

制造商PROCHIEVE
哥伦比亚实验室
       
适应症PROCHIEVE
8％的力量：孕激素补充或替代，作为一种辅助生殖技术（ART）的不孕妇女与孕激素缺乏症治疗的一部分。
      
成人剂量PROCHIEVE
补充：1 8％（90毫克），每日一次applicatorful intravaginally。更换：1
8％（90毫克），每日两次applicatorful intravaginally。如果怀孕时，胎盘可继续治疗，直到实现自治（10-12周）。
儿童剂量为PROCHIEVE
不适用。
        
禁忌的PROCHIEVE
未经诊断的阴道出血。乳房或生殖器癌。肝功能障碍或疾病。过期流产。血栓性静脉炎或血栓栓塞性疾病。
警告/注意事项的PROCHIEVE
由水肿加重条件。抑郁症。包括子宫颈抹片检查与治疗前考试。停止的迹象，如果血栓性疾病（如血栓性静脉炎，脑血管疾病，肺栓塞，视网膜血栓形成）发生。妊娠：见文献。哺乳的母亲。

互作PROCHIEVE
允许至少6间这个问题和其他阴道管理的产品管理小时。
不良反应为PROCHIEVE Mastodynia，便秘，嗜睡，胃肠不适，头痛，腹痛/会阴疼痛，紧张，痉挛，夜尿，抑郁，性欲减退，关节痛，腹胀，疼痛，阴道念珠菌/放电，头晕，性交疼痛，外阴瘙痒，过敏，疲劳，泌尿呼吸道感染，等等。

如何PROCHIEVE提供？
4％-6预灌封喷头
8％-6，18预灌封喷头

What Prochieve is

Prochieve is a specially formulated gel that you insert in your vagina. It contains the natural female hormone called progesterone. Prochieve 8% is used as part of a program for women who are undergoing fertility treatment.

Understanding the role of Prochieve in your infertility treatment

Progesterone is one of the hormones essential for maintaining a pregnancy. If you are undergoing ART treatment and your doctor has determined your body does not produce enough progesterone on its own, Prochieve may be prescribed to provide the progesterone you need.

The progesterone in Prochieve will help prepare the lining of your uterus so that it is ready to receive and nourish a fertilized egg. If pregnancy occurs, Prochieve may be supplemented for 10-12 weeks until production of progesterone by the placenta is adequate.

When you should not use Prochieve

If you are allergic to progesterone, progesterone-like drugs, or any of the inactive ingredients in the gel (ask a pharmacist if you are not sure about the inactive ingredients in Prochieve).  
If you have unusual vaginal bleeding which has not been eva luated by a doctor.  
If you have a liver disease.
If you have known or suspected cancer of the breast or genital organs.
If you have a miscarriage and your physician suspects some tissue is still in the uterus.
If you have or have had blood clots in the legs, lungs, eyes, or elsewhere.
Risks of Prochieve

Risk to the fetus. Birth defects have been reported in the offspring of women who were using Prochieve during early pregnancy. These included an abdominal wall defect and a cleft palate. A causal association has been neither confirmed nor refuted. You should check with your doctor about the risks to your unborn child of any medication used during pregnancy. 
Blood clots and related health problems. Blood clots have been reported with the use of estrogens and progestational drugs (alone or in combination). If blood clots do form in your bloodstream, they can cut off the blood supply to vital organs, causing serious problems. These problems may include a stroke (by cutting off blood to part of the brain), a heart attack (by cutting off blood to part of the heart), a pulmonary embolus (by cutting off blood to part of the lungs), or other problems. Any of these conditions may cause death or serious long-term disability. Call your doctor immediately if you suspect you have any of these conditions. He or she may advise you to stop using this drug. 
PRECAUTIONS

Be alert for unusual signs and symptoms. If any of these warning signals (or any other unusual symptoms) happen while you are using Prochieve, call your doctor immediately:

Abnormal bleeding from the vagina.
Pains in the calves or chest, a sudden shortness of breath or coughing blood indicating possible clots in the legs, heart, or lungs.
Severe headache or vomiting, dizziness, faintness, or changes in vision or speech, weakness or numbness of an arm or leg indicating possible clots in the brain or eye.  
Breast lumps, which could be associated with fibrocystic disorders, fibroadenoma, or breast cancer. (Ask your doctor or health-care provider to show you how to examine your breasts monthly.)  
Yellowing of the skin and/or white of the eyes indicating possible liver problems.
You should also notify your doctor if you experience depression, worsening of your diabetic condition, or fluid retention.

Possible side effects of Prochieve

In addition to the risks listed above, the following side effects have been reported with Prochieve used either for progesterone supplementation or for replacement as part of an ART treatment for infertile women with progesterone deficiency. Consult your doctor if you experience any of the side effects mentioned below, or other side effects.

SIDE EFFECTS REPORTED AT A FREQUENCY OF 5% OR GREATER

abdominal pain; perineal pain (the perineum is the area between the vagina and the rectum)  
headache  
constipation; diarrhea; nausea  
joint pain
depression; decreased libido; nervousness; sleepiness*
breast enlargement
excessive urination at night
SIDE EFFECTS REPORTED AT A FREQUENCY RANGING FROM 1% TO 5%

allergy; bloating; cramps; fatigue; pain  
dizziness*  
vomiting
mood swings  
breast pain  
difficult or painful intercourse; genital itching; genital yeast infection; vaginal discharge  
urinary tract infection
SIDE EFFECTS REPORTED AT A FREQUENCY OF LESS THAN 1% 

fever; flu-like symptoms  
water retention†
gastrointestinal discomfort; gas; abdominal swelling
back pain; leg pain  
insomnia
sinusitis; upper respiratory tract infection
asthma  
acne; itching
painful or difficult urination; frequent urination
*If you experience dizziness or sleepiness, do not drive or operate machinery.

†This may worsen some conditions such as asthma, epilepsy, migraine, heart disease, or kidney disease.

How Prochieve works

Prochieve has been formulated to be administered through the vagina. The moisturizing gel in Prochieve forms a coating on the walls of the vagina which allows for absorption of progesterone through the vaginal tissue. Small, white globules may appear as a vaginal discharge possibly due to gel accumulation, even several days after usage. Prochieve contains no irritating perfumes or dyes.

Other information

1.Your doctor has prescribed this drug for you and you alone. Do not give this drug to anyone else.

This medication was prescribed for your particular medical condition. Do not use it for another condition.  
Keep this and all drugs out of the reach of children.
How to use Prochieve

The dosage is one application of the 8% gel (90 mg of progesterone) vaginally, daily or twice daily as directed by your doctor. If you become pregnant, your doctor may decide to continue treatment for up to 10 to 12 weeks.

Prochieve is to be applied directly from the specially designed sealed applicator into the vagina. The applicator is designed to deliver a premeasured dose of Prochieve. A small amount of gel will be left in the tube after usage. Do not be concerned because you will still be receiving the appropriate, measured dosage.

1. Remove the applicator from the sealed wrapper. DO NOT remove the twist-off tab at this time. For use at altitudes above 2500 feet, see special instructions below.

2. Hold the applicator between thumb and forefinger along the seam on the side of the bulb. Shake down vigorously 3 to 4 times (like a thermometer) to ensure that the contents are at the thin end of the applicator.

3. Hold the applicator by the flat section of the bulb. Twist off the tab at the thin end and throw away. DO NOT squeeze the bulb while twisting the tab. This could force some gel to be released before it is inserted.

Twist off completely - Do not pull off.

4. The applicator may be inserted into the vagina while you are in a sitting position or when lying on your back with your knees bent. Gently insert the thin end well into the vagina.

5. Squeeze the bulb of the applicator to deposit the gel into the vagina. Remove the applicator and throw it away in a waste container. Do not be concerned if a small amount of gel is left in the applicator. You will still be receiving the appropriate, measured dosage.

 SPECIAL INSTRUCTIONS FOR USE AT ALTITUDES ABOVE 2500 FEET

1. Remove the applicator from the sealed wrapper. DO NOT remove the twist-off tab at this time. Hold the applicator on both sides of the bulb, as shown. Using a lancet or a stick pin, make a single puncture in the flat part of the bulb. This will relieve the difference in air pressure between the inside and outside of the applicator caused by high altitudes. It will not affect the amount of gel administered. You will still be receiving the appropriate, measured dosage.

2. See Step 2 above.

3. See Step 3 above.

4. See Step 4 above.

5. Place your thumb or finger over the puncture that you made in the bulb of the applicator. Squeeze the bulb of the applicator to deposit the gel into the vagina. Remove the applicator and throw it away in a waste container. Do not be concerned if a small amount of gel is left in the applicator. You will still be receiving the appropriate, measured dosage.

Prochieve coats the vaginal lining to provide long-lasting release of progesterone. Small, white globules may appear as a vaginal discharge possibly due to gel accumulation, even several days after usage. It is not unusual, but if you are concerned, discuss this with your doctor.

If you forget a dose of Prochieve, use it as soon as you remember, but do not use more than the recommended daily dose. Prochieve should not be used at the same time that you are using other vaginal therapy.

This leaflet provides the most important information about Prochieve. If you want to read more, ask your doctor or pharmacist about the professional leaflet. You may need their help to understand some of the information.

How Supplied

Prochieve is available as 8% gel (90 mg of progesterone).

Each box of the 8% gel contains either six or eighteen single use, disposable vaginal applicators with a twist-off tab. Each applicator is wrapped and sealed in a foil overwrap.
Prochieve should be stored at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).
Do not use Prochieve after the expiration date which is printed on the box.