藥品名稱
drug name
自費 Measles,Mumps,Rubella Virus Vaccine (Priorix, 麻疹、腮腺炎、德國麻疹疫苗(派立克)) 0.5 mL/1 dose/vial
藥檔狀態使用中 (需冷藏)
成  份
Ingredient
Measles, Mumps, Rubella Virus Vaccine, Live Attenuated
單位含量0.5 mL/1 dose/vial
Dosage FormsInjection, powder for reconstitution [preservative free]: 0.5 mL/1 dose/vial
外觀描述 針劑/皮下注射
Appearanceinjection/SC
標  示
outward
廠商名稱
Manufacturer
荷商葛蘭素史克藥廠股份有限公司臺灣分公司
製 造 商
Manufacturer
FIDIA FARMACEUTICI S.P.A., ITALY
字  號
Product ID
衛署菌疫輸字第000510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 Prophylaxis of measles, mumps, and rubella
衛福部核准適用症狀
MOHW approved indications
麻疹、腮腺炎及德國麻疹之主動免疫。
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 Hypersensitivity to measles, mumps, and/or rubella vaccine or any component of the formulation (including neomycin); current febrile respiratory illness or other febrile infection; patients receiving immunosuppressive therapy (does not include corticosteroids as replacement therapy); primary and acquired immunodeficiency states; individuals with blood dyscrasias, leukemia, lymphomas, or other malignant neoplasms affecting the bone marrow or lymphatic systems; family history of congenital or hereditary immunodeficiency (until immune competence in the vaccine recipient is demonstrated); pregnancy
常見副作用注射部位紅腫、疼痛;關節痛、肌肉痛。
Common adverse drug reactionsInjection site inflamed, pain;joint pain, muscle pain.
Adverse Reactions Frequency not defined:
Cardiovascular: Syncope, vasculitis
Central nervous system: Acute disseminated encephalomyelitis, ataxia, dizziness, Guillain-Barre syndrome, headache, irritability, malaise, paresthesia, polyneuropathy, retrobulbar neuritis, seizure, sensorineural hearing loss, subacute sclerosing panencephalitis, transverse myelitis
Dermatologic: Erythema multiforme, IgA vasculitis (Henoch-Schnolein purpura/acute hemorrhagic edema of infancy), morbilliform rash, pruritus, rash, Stevens-Johnson syndrome, urticaria
Endocrine & metabolic: Diabetes mellitus
Gastrointestinal: Diarrhea, nausea, pancreatitis, parotitis, sore throat, vomiting
Genitourinary: Epididymitis, orchitis
Hematologic & oncologic: Leukocytosis, lymphadenopathy (regional), purpura, thrombocytopenia
Hypersensitivity: Anaphylactoid reaction, anaphylaxis, angioedema
Infection: Atypical measles
Local: Injection site reaction (including burning, induration, redness, stinging, swelling, tenderness, vesiculation, wheal and flare)
Neuromuscular & skeletal: Arthropathy (arthralgia/arthritis: Women 12% to 26%; children ≦3%), myalgia, panniculitis
Ophthalmic: Conjunctivitis, oculomotor nerve paralysis, optic neuritis, optic papillitis, retinitis
Otic: Otitis media
Respiratory: Bronchospasm, cough, pneumonia, rhinitis
Miscellaneous: Febrile seizures, fever

<1%, postmarketing, and/or case reports: Aseptic meningitis (associated with Urabe strain of mumps vaccine), brain disease, encephalitis
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 & precautionsAdminister SubQ in outer aspect of the upper arm.
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。(1080702仿單資訊)
針劑稀釋條件 不需稀釋
針劑不相容性 不可與其他的疫苗在同一支注射針筒中混合。 (1080702仿單資訊)
針劑施打條件 供皮下注射。(1080702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。(1080702仿單資訊)
最近修改日期時間
Updated
9/4/2019 3:36:21 PM
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