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SALUTA Reduced
Glutathione for Injection
Manufactured by: Shandong Luye Pharmaceutical Co., Ltd. -SINGAPORE
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.
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)
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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
Two years from date of manufacture.
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