Presentation and Form
IV vial (sterile, white lyophilized powder) 600mg x 10’s
Product Description
Each vial contains glutathione sodium 646mg equivalent to glutathione 600mg
Pharmacodynamic Properties
Glutathione is a physiologic tripeptide – a chain of three amino acids – cystein, glycine and glutamic acid: and is irreversibly consume in the detoxification of electrophilic metabolites and xenobiotics. It is very efficient free radical scavenger and protects cell from noxious effect or reactive oxygen compound.
Enhanced oxidative stress has been implicated in the pathogenesis of several disorders; as made evident by the low glutathione levels found in immune compromised individuals , neuro-degenerative diseases such as multiple scelerosis, ALS, Alzheimer’s and Parkinson’s disease, artherosclerosos, male infertility, pregnancy complications, cataracts, cancer and HIV-infected patients
Published clinical and scientific research has demonstrated the protective effect of glutathione in several pathologic situation which cause cellular damage, as is the case of intoxications from substances such as ethyl alcohol, paracetamol, salicylates, Phenobarbital, tricyclic antidepressants, organophosphorous insecticides, etc.
source: FPR
The mechanism of neurotoxicity induced by chemotherapeutic agents has been proposed to involved the accumulation of platinum within he peripheral nervous system, especially in the dorsal root ganglia. A strategy optimal for reducing the neurotoxicity associated with platinum drugs may be the use of glutathione, which is able to prevent the initial accumulation of platinum adducts in the dorsal root ganglia.
Posology and mode of administration
Mild: 300-600mg slow IV or IM daily
Severe: 600-1200mg slow IV or IM daily
The dosage however is dependent on age, weight and clinical condition of the patient and should also be related to the dose and administration schedule of the chemotherapeutic agent. In case of simultaneous administration of glutathione and chemotherapeutic agent, the intravenous infusion of glutathione should be 15-30 minutes before the start of chemotheraphy.
Intravenous use: Dissolve 600mg lyophilized powder with 4ml water for injection (reconstituted solution contains 150mg/ml of glutathione)
Contradictions
Hypersensitivity.
Precautions
Products for parenteral use should be visually inspected before administration, when the container or the solution makes it possible, in order to possibly detect the presence of particles or of an abnormal color. Do not use in case of presence of turbidity or precipitates.
Use in pregnancy & lactation
The available data show that Glutathione, being a substance physiologically present in cells, does not cause unwanted effects in women during pregnancy or breast-feeding. Nevertheless, as with all drugs, Glutathione should only be administered to pregnant or lactating mothers on proper medical advice.
Interactions
Vitamin K3, Vitamin B12, Calcium Pantothenate, orotic acid, antihistamines, sulfanilamides and tetracycline can affect the bioavailability of glutathione. In the absence of compatibility studies, Glutathione should not be mixed with other products.
Undesirable effects
After intramascular administration, rare of skin rash have been reported which have disappeared after discontinuation of treatment.
Over dosage
No case of overdose has been reported. If needed, symptomatic treatments may be employed.
Storage
Store below 30ºC. Constituted solutions of Glutathione maintain satisfactory potency at room temperature (up to 25ºC) up to 8hrs.
Shelf life
（無菌，白色凍乾粉）為 600mg× 10的
產品描述
每管含有穀胱甘肽穀胱甘肽鈉646mg相當於600毫克
藥效學性質
穀胱甘肽是一種三肽的生理-三鏈氨基酸-半胱氨酸，甘氨酸和谷氨酸：和消費是不可逆的解毒代謝物和外來物質的電。這是非常有效的自由基清除劑，保護細胞的有害作用或活性氧化合物。
增強氧化應激有牽連的發病機制中的幾個障礙，正如作出明顯的低穀胱甘肽水平發現在免疫受損個體，神經退行性疾病，如多發性 scelerosis，ALS的，老年癡呆症和帕金森氏症，artherosclerosos，男性不孕，妊娠並發症，白內障，癌症和艾滋病病毒感染者
發表的臨床和科研已經證明穀胱甘肽的保護作用在一些病理情況，造成細胞損傷，因為是中毒案件從物質，如乙醇，撲熱息痛，水楊酸，苯巴比妥，三環類抗抑鬱藥，有機磷殺蟲劑，等等.
來源：
該機制的化療藥物引起的神經毒性，有人提出了涉及他積累鉑周圍神經系統內，尤其是在背根神經節。最佳的策略為減少毒性與鉑類藥物可能是使用的穀胱甘肽，這是能夠預防的初始積累的鉑金加合物在背根神經節。
劑量以及管理模式
輕度：300 -600毫克每日緩慢靜脈或IM
重度：6001200毫克每日緩慢靜脈或IM
然而劑量依賴於年齡，體重和病情的患者，也應與劑量和管理附表化療藥物。在行政案件的同時穀胱甘肽和化療藥物，靜脈輸液應穀胱甘肽15-30分鐘才開始的化療。
靜脈注射：溶於為 600mg凍乾粉注射液4ml水（復原解決方案包含150mg/ml穀胱甘肽）
注意事項
產品為注射用目視檢查應給藥前，當容器或解決方案，使之成為可能，以檢測可能存在的顆粒或異常的顏色。請勿在案件存在的渾濁或沉澱。
妊娠及哺乳期使用
現有數據表明，穀胱甘肽，是一種物質存在於細胞的生理，不會造成不必要的影響，婦女在懷孕期間或哺乳。然而，與所有藥物，只應穀胱甘肽管理，以懷孕或哺乳期的母親在適當的醫療意見。
維生素 K3，維生素 B12，泛酸鈣，乳清酸，抗組織胺，sulfanilamides和四環素可影響生物利用度的穀胱甘肽。在缺乏兼容性研究，穀胱甘肽不應混有其他產品。
不良反應.
肌肉注射後，罕見皮疹已報告有治療停藥後消失。
藥物過量
任何情況下，過量的報告。如果需要，可以採用對症治療。
存儲
商店低於 30攝氏度構成穀胱甘肽保持令人滿意的解決方案，效力於室溫（高達 25℃）至8小時。
保質期
No comments:
Post a Comment