


NAVELBINE 酒石酸长春瑞滨软胶囊

通用中文 | 酒石酸长春瑞滨软胶囊 | 通用外文 | VINORELBINE TARTRATE |
品牌中文 | 诺维本 | 品牌外文 | NAVELBINE |
其他名称 | |||
公司 | 皮尔·法伯(PIERRE FABRE) | 产地 | 法国(France) |
含量 | 20mg | 包装 | 1粒/盒 |
剂型给药 | 储存 | 2度-8度(冰箱冷藏,禁止冷冻) | |
适用范围 | 非小细胞肺癌、转移性乳腺癌以及难治性淋巴瘤、卵巢癌、头颈部肿瘤 |
通用中文 | 酒石酸长春瑞滨软胶囊 |
通用外文 | VINORELBINE TARTRATE |
品牌中文 | 诺维本 |
品牌外文 | NAVELBINE |
其他名称 | |
公司 | 皮尔·法伯(PIERRE FABRE) |
产地 | 法国(France) |
含量 | 20mg |
包装 | 1粒/盒 |
剂型给药 | |
储存 | 2度-8度(冰箱冷藏,禁止冷冻) |
适用范围 | 非小细胞肺癌、转移性乳腺癌以及难治性淋巴瘤、卵巢癌、头颈部肿瘤 |
通用名称:酒石酸长春瑞滨软胶囊
英文名称:Vinorelbine Tartrate Soft Capsule
【成份】 |
本品主要成份是酒石酸长春瑞滨。 |
【性状】 |
本品为浅棕色(规格为20mg)或粉红色(规格为30mg)软胶囊。内容物为粘性、澄清的浅黄至橘黄色溶液,基本无可见颗粒。 |
【功能主治】 |
本品适用于不可手术切除的局部晚期或转移性非小细胞肺癌,和转移性乳腺癌的单药或联合化疗。 |
【规格】 |
(1)20mg(按C45H54N4O3计);(2)30mg(按C45H54N4O3计) |
【用法用量】 |
单药治疗
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【不良反应】 |
本药的副作用的统计来自138位病人的(其中76位患非小细胞支气管癌症,62位患乳腺癌)临床研究(前三个疗程使用60mg/m2每周的剂量,接下来的疗程使用80mg/m2每周的剂量)而得出的结论。
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【禁忌】 |
绝对禁忌:
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【注意事项】 |
酒石酸长春瑞滨软胶囊须在对化疗有丰富经验的合格医师的指导下使用。
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【孕妇及哺乳期妇女用药】 |
妊娠及哺乳期的患者禁止服用酒石酸长春瑞滨软胶囊(参看禁忌症一栏)。 |
【儿童用药】 |
儿童对本品的适应能力及疗效尚未有研究结果。 |
【老年用药】 |
临床使用中还没有发现老年患者和中青年患者的治疗反应有何不同,但不排除某一些老年患者显得更为敏感,对药物反应更大。 |
【药物相互作用】 |
将酒石酸长春瑞滨软胶囊与有骨髓毒性的药物共同使用会产生骨髓抑制。
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【药物过量】 |
人体试验:酒石酸长春瑞滨软胶囊过量使用的情况没有记载。然而,酒石酸长春瑞滨软胶囊的大剂量使用可能会诱发骨髓再生障碍,并可能伴有感染性综合症或麻痹性肠梗阻。 |
【药理毒理】 |
药理作用:
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【药代动力学】 |
口服酒石酸长春瑞滨软胶囊80毫克每平方米之后,药品被迅速吸收,血清峰浓度于1.5至3小时(Tmax)后到达,峰值(Cmax)大约为130ng/ml。绝对生物利用度为40%,同时进食不会影响到长春瑞滨的药效。口服长春瑞滨60毫克每平方米或80毫克每平方米可以和静脉注射25毫克每平方米或30毫克每平方米的长春瑞滨达到相同的血浓度。口服后个体间血浓度差异的程度与静脉给药相同。剂量提高后血浓度相应提高。血清蛋白的结合率较低,为13.5%;但是,长春瑞滨和血细胞的结合率很高,特别是和血小板,达到了78%。
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【贮藏】 |
在2℃至8℃条件下保存(冷藏)。本品应保存于原包装内。 |
【包装】 |
可推式PVC/PVDC/铝塑包装。 |
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【生产企业】 |
公司名称:PIERRE FABRE MEDICAMENT |
Navelbine
Generic Name: Vinorelbine
Other Names: Vinorelbine Tartrate
Drug Type:
Navelbine is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. Navelbine is classified as a "plant alkaloid."
For more detail, see "How Navelbine Works" section below.
What Navelbine Is Used For:
Non-small cell lung cancer
Some healthcare providers may also give Navelbine for breast cancer, ovarian cancer, or Hodgkin's disease.
Note: If a drug has been approved for one use, physicians sometimes elect to use this same drug for other problems if they believe it might be helpful.
How Navelbine Is Given:
Navelbine is given through a vein by intravenous injection (IV push) or infusion (IV). There is no pill form.
Navelbine is a vesicant. A vesicant is a chemical that causes extensive tissue damage and blistering if it escapes from the vein.
The nurse or doctor who gives Navelbine must be carefully trained.
If you notice pain, redness or swelling at the IV site while you are receiving Navelbine, alert your health care professional immediately.
The amount of Navelbine you will receive depends on many factors, including your height and weight, your general health or other health problems, and the type of cancer being treated. Your doctor will determine your dose and schedule.
Navelbine Side Effects:
Along with its needed effects, Navelbine may cause some unwanted side effects. Important things to remember about the side effects of Navelbine include:
Most people do not experience all of the side effects listed Side effects are often predictable in terms of their onset and duration
Side effects are almost always reversible and will go away after treatment is complete
There are many options to help minimize or prevent side effects
There is no relationship between the presence or severity of side effects and the effectiveness of Navelbine.
The following side effects are common (occurring in greater than 30%) for patients taking Navelbine:
Low blood counts. Your white and red blood cells may temporarily decrease. This can put you at increased risk for infection or anemia.
Nadir: Meaning low point, nadir is the point in time between chemotherapy cycles in which you experience low blood counts.
Onset: 4-7 days
Nadir: 7-10 days
Recovery: 14-21 days
Nausea or vomiting
Muscle weakness
Constipation
The following are less common side effects (occurring in 10-29%) for patients receiving Navelbine:
Pain along the site where Navelbine was given
Peripheral neuropathy (numbness in your fingers and toes) may occur with repeated doses.
This should be reported to your healthcare provider.
Diarrhea
Hair loss
Low platelet (these help to clot the blood) counts. This can put you at increased risk for bleeding.
Not all side effects are listed above, some that are rare (occurring in less than 10% of patients) are not listed here.
However, you should always inform your health care provider if you experience any unusual symptoms.
When To Contact Your Doctor or Health Care Provider:Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:
Fever of 100.5º F (38º C) or higher, chills (possible signs of infection)
The following symptoms require medical attention, but are not emergency situations. Contact your health care provider within 24 hours of noticing any of the following.
Nausea (interferes with ability to eat and unrelieved with prescribed medications)
Vomiting (vomiting more than 4-5 times in a 24-hour period)
Unusual bleeding or bruising
Black or tarry stools, or blood in your stools or urine
Constipation
Diarrhea (4-6 episodes in a 24-hour period)
Lip or mouth sores
Always inform your health care provider if you experience any unusual symptoms.
Navelbine Precautions:
Before starting Navelbine treatment, make sure you tell your doctor, as well as all healthcare providers, about any other medications you are taking (including over-the-counter, vitamins, or herbal remedies). Do not take aspirin or products containing aspirin unless your healthcare provider permits this.
Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Pregnancy category D(Navelbine may be hazardous to the fetus.
Women who are pregnant or become pregnant must be advised of the potential hazard to the fetus).
For both men and women: Do not conceive a child (get pregnant) while taking Navelbine.
Barrier methods of contraception, such as condoms, are recommended. Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.
Do not breast feed while taking Navelbine.
Navelbine Self Care Tips:
Apply warm compress if you have any pain, redness or swelling at the IV site, and notify your doctor.
Keep your bowels moving. Your health care provider may prescribe a stool softener to help prevent constipation that may be caused by Navelbine.
If you experience diarrhea of greater than 3-5 stools per day, contact your healthcare provider and increase your fluid intake.
Drink 2 to 3 quarts of fluid every 24 hours, unless you were told to restrict your fluid intake, and maintain good nutrition. This will decrease your chances of being constipated, and prevent dehydration.
You may be at risk of infection so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your healthcare provider.
Wash your hands often.
Use an electric razor and soft toothbrush to minimize bleeding.
Avoid contact sports or activities that could cause injury.
Avoid sun exposure. Wear SPF 15 (or higher) sun block and protective clothing.
To reduce nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals.
Keep your mouth clean with baking soda and salt rinses. You can mix 1/4 tsp. of baking soda and 1/4 tsp. salt in 8 ounces of water, and use as a mouthwash, to avoid or decrease the severity of mouth sores.
In general, drinking alcoholic beverages should be minimized or avoided. You should discuss this with your doctor.
If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.
Monitoring and Testing While Taking Navelbine:
Periodic blood work will be obtained to monitor your complete blood count (CBC). Your doctor will order blood tests and other tests as needed to monitor side effects and check your response to therapy.
How Navelbine Works:
Cancerous tumors are characterized by cell division, which is no longer controlled as it is in normal tissue. "Normal" cells stop dividing when they come into contact with like cells, a mechanism known as contact inhibition.
Cancerous cells lose this ability.
Cancer cells no longer have the normal checks and balances in place that control and limit cell division. The process of cell division, whether normal or cancerous cells, is through the cell cycle.
The cell cycle goes from the resting phase, through active growing phases, and then to mitosis (division).
The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division.
Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division.
If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink.
They also induce cell suicide (self-death or apoptosis).
Chemotherapy drugs that affect cells only when they are dividing are called cell-cycle specific. Chemotherapy drugs that affect cells when they are at rest are called cell-cycle non-specific.
The scheduling of chemotherapy is set based on the type of cells, rate at which they divide, and the time at which a given drug is likely to be effective. This is why chemotherapy is typically given in cycles.
Chemotherapy is most effective at killing cells that are rapidly dividing. Unfortunately, chemotherapy does not know the difference between the cancerous cells and the normal cells. The "normal" cells will grow back and be healthy but in the meantime, side effects occur. The "normal" cells most commonly affected by chemotherapy are the blood cells, the cells in the mouth, stomach and bowel, and
the hair follicles; resulting in low blood counts, mouth sores, nausea, diarrhea, and/or hair loss. Different drugs may affect different parts of the body.
Navelbine belongs to a class of chemotherapy drugs called plant alkaloids. Plant alkaloids are made from plants. The vinca alkaloids are made from the periwinkle plant (catharanthus rosea).
The taxanes are made from the bark of the Pacific Yew tree (taxus).
The vinca alkaloids and taxanes are also known as antimicrotubule agents.
The podophyllotoxins are derived from the May apple plant.
Camptothecan analogs are derived from the Asian "Happy Tree" (Camptotheca acuminata).
Podophyllotoxins and camptothecan analogs are also known as topoisomerase inhibitors. The plant alkaloids are cell-cycle specific. This means they attack the cells during various phases of division.
Vinca alkaloids: Vincristine, Vinblastine and Navelbine
Taxanes: Paclitaxel and Docetaxel
Podophyllotoxins: Etoposide and Tenisopide
Camptothecan analogs: Irinotecan and Topotecan
Antimicrotubule agents (such as Navelbine), inhibit the microtubule structures within the cell.
Microtubules are part of the cell's apparatus for dividing and replicating itself. Inhibition of these structures ultimately results in cell death.
Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments.
The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.