藥品名稱
drug name | 自費 Measles, Mumps and Rubella Virus Vaccine, Live (M-M-R II, 麻疹、腮腺炎、德國麻疹疫苗) 0.5 mL/vial |
| 藥檔狀態 | 使用中 （需冷藏） |
成 份
Ingredient | Measles Mumps & Rubella Virus Vaccine (自費) |
| 單位含量 | 0.5 mL/vial |
| Dosage Forms | Powder for injection, lyophilized: 0.5 mL/vial [Each dose contains: Not less than the equivalent 1000 TCID50 (tissue culture infectious doses) of the U.S. Reference Measles Virus, 20,000 TCID50 of the U.S. Reference Mumps Virus, 1000 TCID50 of the U.S. Reference Rubella Virus, and approximately 25 mcg of neomycin] |
| 外觀描述 | 針劑/小瓶 |
| Appearance | injection/vial |
標 示
outward | |
廠商名稱
Manufacturer | 美商默沙東藥廠股份有限公司 |
製 造 商
Manufacturer | MERCK SHARP & DOHME LLC.,USA |
字 號
Product ID | 衛署菌疫輸字第000364號 |
藥理分類
Pharmacologic Category | Biologic and Immunologic Agents/ Immunizations/ Vaccines-Virus (Live) |
作用機轉
Mechanism of action | As a live, attenuated vaccine, MMR vaccine offers active immunity to disease caused by the measles, mumps, and rubella viruses. |
| 用途/適應症 | 麻疹、腮腺炎、德國麻疹疫苗 |
| Use |
Measles, mumps, and rubella prophylaxis
|
衛福部核准適用症狀
MOHW approved indications |
預防麻疹、腮腺炎、德國麻疹。
|
| Dose |
Administration Route: SC
Adults:
Immunization: 0.5 mL per dose; 1 or 2 doses administered at least 28 days apart based upon the following criteria (CDC/ACIP): Healthcare personnel: Persons born in or after 1957 should have 2 doses of vaccine unless they have acceptable evidence of immunity. HIV infection (without severe immunosuppression): Two doses of MMR unless there is acceptable evidence of immunity. Women of childbearing potential: One dose of MMR unless they have acceptable evidence of immunity. Vaccination should not be given during pregnancy and pregnancy should be avoided for 28 days after vaccine administration.
Pediatrics:
Note: The minimum interval between 2 doses of MMR vaccine is 28 days (CDC/ACIP)
Infants <12 months: If there is risk of exposure to measles, single-antigen measles vaccine should be administered at 6-11 months of age with a second dose (of MMR) at >12 months of age
Children ?12 months: 0.5 mL at 12 months and then repeated at 4-6 years of age. If the second dose was not received, the schedule should be completed by the 11- to 12-years old visit. Administer in outer aspect of the upper arm. Recommended age of primary immuniztion is 12-15 months; revaccination is recommended prior to elementary school
|
懷孕分級
Pregnancy Risk Factor |
C
Lactation:
Measles/mumps: Excretion in breast milk unknown/use caution
Rubella: Enters breast milk/use caution
|
| 禁忌症 |
1.對此疫苗之任何成份包括動物膠有過敏者。
2.孕婦勿接種M-M-R II；此疫苗對胎兒發展的可能影響在此階段尚未知曉。青春期後女性接種此疫苗之後三個月內必須避免懷孕。
3.對neomycin會產生過敏或類過敏反應者(稀釋後每劑量疫苗內約25微克之neomycin)。
4.任何發燒的呼吸道疾病或其他活動性發燒感染。
5.活動性未治療的肺結核。
6.接受免疫抑制療法患者不可接種，但使用皮質類固醇作為置換療法如愛迪生氏病(Addison,s disease)之患者，不在此限。
7.惡血質病、白血病、任何類型的淋巴瘤，其他影響骨髓或淋巴系統的惡性腫瘤患者。
8.原發性及後天性免疫缺乏情況，包括因AIDS或其他人類免疫缺乏病毒感染之免疫抑制患者細胞性免疫缺乏；及低丙種球蛋白血症(hypopammaglobulinemic)與血中兩種球蛋白功能不良症(dysgammaglobulinemic)。有報告指出，當含麻疹病毒的疫苗不慎被使用於嚴重的免疫力妥協病人時，此疫苗中散佈的麻疹病毒直接造成麻疹包含性腦炎(measles inclusion body encephalitis, MIBE)，肺炎及死亡。
9.有先天性或遺傳性免疫缺乏家族史的個人，在其免疫能力被確定前。
|
| Contraindications |
Blood dyscrasias, leukemia, lymphomas, malignant neoplasms affecting the bone marrow or lymphatics systems, active untreated tuberculosis, history of anaphylaxis to neomycin, patients receiving immunosuppressive therapy, primary, acquired, or familial immunodeficiency, pregnancy.
|
| 常見副作用 | 注射部位紅腫、疼痛、發燒、發疹。 |
| Common adverse drug reactions | Injection site erythem, pain, fever and rash. |
| Adverse Reactions |
Arthritis, arthralgia, myalgia, cold symptoms, fever, injection site pain/erythema, lymphadenopathy, rash, anaphylaxis, encephalitis, polyneuritis, polyneuropathy, optic neuritis, Guillain-Barre syndrome, Stevens-Johnson syndrome, thrombocytopenia
|
監測
Monitoring |
Monitor for syncope for 15 minutes following administration. If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion
|
| 警語與注意事項 | 皮下注射。 |
| Warnings & precautions | |
| 針劑溶解條件 |
稀釋時，只使用與疫苗提供的稀釋液。
因其不含防腐劑及其他會使疫苗失去活性的物質。(1020111仿單資訊)
|
| 針劑稀釋條件 |
|
| 針劑不相容性 |
|
| 針劑施打條件 |
供皮下注射。(1020111仿單資訊)
|
| 針劑保存安定性 |
2-8℃, 冷藏及避光儲存 。
稀釋液可與疫苗一起貯存於冰箱中或將其單獨置於室溫中，切勿冷凍。
稀釋後請儘快使用。若需貯存，則將此稀釋後的疫苗置於其原來小瓶中貯存於2-8℃黑暗處。若於8小時內未使用完即需丟棄。(1020111仿單資訊)
|
最近修改日期時間
Updated | 6/14/2024 2:19:09 PM |