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FDA Drug Import News

Import Rules Regarding Personal Medicine Orders:

Current FDA policy is not a law or a regulation, but serves as guidance for FDA personnel.

The importation of certain unapproved prescription medications for personal use may be allowed in some circumstances where these factors apply:


    1). The Drug is for personal use and is a 3-month supply or less and not for resale or commercialization.

    2). If no drug commercialization or drug promotion to U.S. residents by pharmacy companies involved in the distribution of the necessary drug exists.

    3). If an individual seeking to import the drug affirms in writing, that it is for the patient's private use and provides the name and address of the licensed American physician responsible for treatment.

    4). Provides evidence that the drug is for continuation of a treatment begun in a foreign country.

    5). The intended use is for a serious condition for which effective treatment may not be available domestically.

    6). If the product is not considered to represent an unreasonable health issue.

    7). Overnite FedEx shipments require copy of your identification and the prescription.

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GEMZAR {gemcitabine} 200mg Injectable Vial

GEMZAR {gemcitabine} 200mg Injectable Vial
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Price: $155.00
Product ID : gemzar_200mg
Manufacturer: ELI-LILLY
Shipping Price: $25.00
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Description

GEMZAR 200mg Inj. Vial {gemcitabine}

Patient Education - English

  • Generic Name: gemcitabine
  • Pronounced: jem SYE ta been
  • Brand Name: Gemzar

What is the most important information I should know about gemcitabine?

 

Do not receive this medication without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Gemcitabine is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. Gemcitabine is usually given once a week for several weeks. The medicine must be given slowly through an IV infusion, and can take up to 30 minutes to complete.

Gemcitabine can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your kidney and liver function may also need to be checked. Do not miss any scheduled visits to your doctor.

Do not receive a "live" vaccine while you are being treated with gemcitabine, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you.

If any of this medicine accidentally gets on your skin, wash the area thoroughly with soap and warm water.

What is gemcitabine?

Gemcitabine is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Gemcitabine is used to treat cancers of the pancreas, lung and breast.

Gemcitabine may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving gemcitabine?

 

Do not use this medication if you are allergic to gemcitabine.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

  • kidney disease;
  • liver disease; or
  • if you are receiving radiation treatment.

FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not receive gemcitabine without telling your doctor if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

It is not known whether gemcitabine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is gemcitabine used?

 

Gemcitabine is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion, and can take up to 30 minutes to complete.

Gemcitabine is usually given once a week for up to 7 weeks.

Gemcitabine can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your kidney and liver function may also need to be checked. Do not miss any scheduled visits to your doctor.

If any of this medicine accidentally gets on your skin, wash the area thoroughly with soap and warm water.

What happens if I miss a dose?

Contact your doctor if you miss a miss an appointment to receive your gemcitabine infusion.

What happens if I overdose?

 

Seek emergency medical attention if you think you have received too much of this medicine.

Overdose symptoms may include numbness or tingly feeling, severe skin rash, fever, chills, flu symptoms, or any signs of infection.

What should I avoid while using gemcitabine?

Avoid contact with people who have colds, the flu, or other contagious illnesses. Contact your doctor immediately if you develop signs of infection.

Do not receive a "live" vaccine while you are being treated with gemcitabine, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you.

What are the possible side effects of gemcitabine?

 

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • pale skin, easy bruising or bleeding, unusual weakness;
  • urinating less than usual or not at all;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • fever, chills, body aches, flu symptoms;
  • white patches or sores inside your mouth or on your lips;
  • pain, swelling, or skin changes where the needle was placed;
  • hearing problems;
  • blood in your urine; or
  • breathing problems.

Less serious side effects may include:

  • mild nausea, vomiting, upset stomach;
  • diarrhea or constipation;
  • swelling in your hands, ankles, or feet;
  • skin rash;
  • numbness or tingly feeling;
  • drowsiness; or
  • hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect gemcitabine?

There may be other drugs that can interact with gemcitabine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about gemcitabine.

Pill Pictures

Gemzar (gemcitabine) 200 mg
Gemzar (gemcitabine) 200 mg
Gemzar (gemcitabine) 1 g
Gemzar (gemcitabine) 1 g

 


Gemzar® (gemcitabine HCl) is a nucleoside analogue that exhibits antitumor activity. Gemcitabine HCl is 2′-deoxy-2′,2′-difluorocytidine monohydrochloride (β–isomer).

Gemzar is a cancer medication that interferes with the growth and spread of cancer cells in the body. Gemzar is used to treat cancers of the pancreas, lung and breast. It is also used in combination with carboplatin to treat ovarian cancer.

Gemcitabine (jem-SITE-a-been) belongs to the group of medicines called antimetabolites. It is used to treat cancer of the breast,pancreas and lung. It may also be used to treat other kinds of cancer, as determined by your doctor.

Breast Cancer

Data from a multi–national, randomized Phase 3 study (529 patients) support the use of Gemzar in combination with paclitaxel for treatment of breast cancer patients who have received prior adjuvant/neoadjuvant anthracycline chemotherapy unless clinically contraindicated. Gemzar 1250 mg/m2 was administered on Days 1 and 8 of a 21–day cycle with paclitaxel 175 mg/m2 administered prior to Gemzar on Day 1 of each cycle. Single–agent paclitaxel 175 mg/m2 was administered on Day 1 of each 21–day cycle as the control arm.

The addition of Gemzar to paclitaxel resulted in statistically significant improvement in time to documented disease progression and overall response rate compared to monotherapy with paclitaxel as shown in Table 4 and Figure 2. Further, there was a strong trend toward improved survival for the group given Gemzar based on an interim survival analysis.

Gemcitabine interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by the medicine, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may occur after treatment with gemcitabine has been stopped.

This medicine is available only with your doctor's prescription, in the following dosage form:

  • Parenteral
  • Injection

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