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卟吩姆钠注射剂PHOTOFRIN(PORFIMER SODIUM)

2012-12-06 02:22:04  作者:新特药房  来源:互联网  浏览次数:278  文字大小:【】【】【
简介: 英文药名:PHOTOFRIN(PORFIMER SODIUM) 中文药名:卟吩姆钠注射剂 药品介绍PHOTOFRIN是国际上已获FDA批准可应用于恶性肿瘤治疗的唯一的PDT药物。它是一种从牛血中提取并进行化学改性的卟啉低聚体 ...

英文药名:PHOTOFRIN(PORFIMER SODIUM INJECTION)

中文药名:卟吩姆钠注射剂

生产厂家:Pinnacle和辉瑞公司
药品介绍
商品名  PHOTOFRIN®
通用名  Porfimer Sodium
药品成分:
Porfimer Sodium是一种以醚键或酯键连接的卟啉低聚体混合物,注射针剂是一种瓶装无菌的,红褐色冻干粉剂。
储 存:
PHOTOFRIN®应在摄氏15~25度状态下避光储存,有效期四年。
注意事项 
PHOTOFRIN®应用5%葡萄糖注射液稀释,最后浓度为每毫升2.5mg porfimer sodium。配置后的稀释液应于摄氏2~8度下避光贮存,并于24小时后废弃。常规用药剂量为2mg/kg。患者在注射PHOTOFRIN®后6周内,应注意避免强光照射,以防皮肤或者眼睛发生光过敏反应
PHOTOFRIN(PORFIMER SODIUM)INJECTABLE INJECTION-光动力 PDT 光敏剂
PHOTOFRIN是国际上已获FDA批准可应用于恶性肿瘤治疗的唯一的PDT药物
。它是一种从牛血中提取并进行化学改性的卟啉低聚体混合物,PHOTOFRIN是其商品名,专用名为porfimer sodium。
该药于1984年在美国Roswell Park癌症研究所开发成功(曾用名Photofrin II,DHE),后由加拿大QLT Phototherapeutics Inc购买专利组织生产,1996年在美国通过FDA,这前后在加拿大(1993)、法国(1997)、荷兰(1997)、德国(1997)、日本(1997)等国也获政府药管部门认可。
PHOTOFRIN经世界各地肿瘤医疗单位多年使用,其有效性和安全性均得到专业人士的充分肯定。但由于激活该药的630nm红光,并非处于该药的最佳吸收光波长范围,也不处于组织的最佳透过光波长范围,而是兼顾二者的折中选择。这就决定了该药杀伤深度较浅这一主要缺点。同时,另一明显的缺点是这种光敏剂在皮肤中的存留时间长达数周,容易引起皮肤光敏副反应。
完整使用资料附件:
1):http://www.info.pmda.go.jp/go/pack/4299403D1031_2_03/
2):https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5c4841b4-fbc0-4163-8ee1-cb28629cbfbf
PHOTOFRIN(porfimer sodium)INJECTION
Generic Name and Formulations:
Porfimer (as sodium) 75mg/vial; pwd for IV inj after reconstitution; preservative-free.
Company:
Pinnacle Biologics
Select therapeutic use: Colorectal and other GI cancers
Respiratory and thoracic cancers
Indications for PHOTOFRIN:
Palliation of patients with completely obstructing esophageal cancer or partially obstructing esophageal cancer who cannot be satisfactorily treated with Nd:YAG laser therapy. Ablation of high-grade dysplasia in Barrett's esophagus patients who do not undergo esophagectomy.
Adult:
See literature. Give by slow IV inj over 3–5 minutes. 2mg/kg then illumination with laser light 40–50 hours following injection. Esophageal cancer: 2nd course may be given at a minimum of 30 days after initial therapy; max 3 courses (separated by ≥30 days). Ablation of high-grade dysplasia in Barrett's esophagus: 2nd course may be given at a minimum of 90 days after initial therapy; max 3 courses (separated by ≥90 days).
Children:
Not recommended.
Contraindications:
Porphyria. Existing tracheoesophageal or bronchoesophageal fistula. Tumors eroding into a major blood vessel. Emergency treatment of patients with severe acute respiratory distress caused by an obstructing endobronchial lesion. Esophageal or gastric varices. Esophageal ulcers >1cm in diameter.
Warnings/Precautions:
Avoid direct sunlight or bright indoor light; wear dark sunglasses when outdoors. Increased risk of fatal massive hemoptysis with large, centrally located tumors, cavitating tumors, extensive tumor extrinsic to the bronchus. Caution with endobronchial tumors in locations where treatment-induced inflammation could obstruct airway. Avoid extravasation. Pregnancy (Cat.C; use adequate contraception), nursing mothers: not recommended.
Interactions:
Increased risk of photosensitivity reactions with other photosensitizing agents (eg, tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics, griseofulvin, fluoroquinolones). May be antagonized by dimethyl sulfoxide, β-carotene, ethanol, formate, mannitol, allopurinol, calcium channel blockers, prostaglandin synthesis inhibitors, drugs that decreased clotting, vasoconstriction or platelet aggregation (eg, thromboxane A2 inhibitors), glucocorticoid hormones. Separate radiotherapy by 2–4 weeks.
Pharmacological Class:
Photosensitizing agent.
Adverse Reactions:
Photosensitivity reactions (eg, erythema, swelling, itching, burning sensation, feeling hot, blisters), fluid imbalance, chest pain, fever, pain, abdominal pain, GI upset, constipation, mucositis, ocular sensitivity, dyspnea, pleural effusion, anemia, fistula formation, fatal massive hemoptysis, others.
How Supplied:
Vial—1
Indications for PHOTOFRIN:
Reduction of obstruction and palliation in patients with completely or partially obstructing endobronchial non-small-cell lung cancer (NSCLC). Treatment of microinvasive endobronchial NSCLC in patients for whom surgery and radiotherapy is not indicated.
Adult:
See literature. Give by slow IV inj over 3–5 minutes. 2mg/kg then illumination with laser light 40–50 hours following injection. 2nd course may be given at a minimum of 30 days after initial therapy; max 3 courses (separated by ≥30 days).
Children:
Not recommended.
Contraindications:
Porphyria. Existing tracheoesophageal or bronchoesophageal fistula. Tumors eroding into a major blood vessel. Emergency treatment of patients with severe acute respiratory distress caused by an obstructing endobronchial lesion. Esophageal or gastric varices. Esophageal ulcers >1cm in diameter.
Warnings/Precautions:
Avoid direct sunlight or bright indoor light; wear dark sunglasses when outdoors. Increased risk of fatal massive hemoptysis with large, centrally located tumors, cavitating tumors, extensive tumor extrinsic to the bronchus. Caution with endobronchial tumors in locations where treatment-induced inflammation could obstruct airway. Avoid extravasation. Pregnancy (Cat.C; use adequate contraception), nursing mothers: not recommended.
Interactions:
Increased risk of photosensitivity reactions with other photosensitizing agents (eg, tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics, griseofulvin, fluoroquinolones). May be antagonized by dimethyl sulfoxide, β-carotene, ethanol, formate, mannitol, allopurinol, calcium channel blockers, prostaglandin synthesis inhibitors, drugs that decreased clotting, vasoconstriction or platelet aggregation (eg, thromboxane A2 inhibitors), glucocorticoid hormones. Separate radiotherapy by 2–4 weeks.
Pharmacological Class:
Photosensitizing agent.
Adverse Reactions:
Photosensitivity reactions (eg, erythema, swelling, itching, burning sensation, feeling hot, blisters), fluid imbalance, chest pain, fever, pain, abdominal pain, GI upset, constipation, mucositis, ocular sensitivity, dyspnea, pleural effusion, anemia, fistula formation, fatal massive hemoptysis, others.
How Supplied:
Vial—1
----------------------------------------------
产地国家: 美国
原产地英文商品名:
PHOTOFRIN 75mg/vial
原产地英文药品名:
PORFIMER SODIUM
中文参考商品译名:
PHOTOFRIN 75毫克/瓶
中文参考药品译名:
卟吩姆钠
生产厂家英文名:
Pinnacle Biologics, Inc


----------------------------------------------
产地国家: 日本 
原产地英文商品名:
PHOTOFRIN INJECTION(フォトフリン静注用)75mg/vial
原产地英文药品名:
Porfimer sodium 
中文参考商品译名:
PHOTOFRIN(フォトフリン静注用)75毫克/瓶
中文参考药品译名:
卟吩姆钠
生产厂家中文参考译名:
辉瑞公司
生产厂家英文名:
Pfizer

责任编辑:admin


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