Glutathione 600mg/4ml powder and solvent for solution for injection/infusion
Certifications
Marketed as a finished pharmaceutical formulation classified under medicament HS code 3004 for therapeutic or prophylactic use.
Manufactured under pharmaceutical Good Manufacturing Practice (GMP) and an appropriate quality management system (e.g. ISO 13485/ICH Q10), as required for parenteral medicinal products.
Product composition and handling consistent with official product literature for TAD 600 mg/4 ml powder and solvent for solution for injection.
Marketed as a finished pharmaceutical formulation classified under medicament HS code 3004 for therapeutic or prophylactic use.
Manufactured under pharmaceutical Good Manufacturing Practice (GMP) and an appropriate quality management system (e.g. ISO 13485/ICH Q10), as required for parenteral medicinal products.
Product composition and handling consistent with official product literature for TAD 600 mg/4 ml powder and solvent for solution for injection.
Glutathione 600mg/4ml powder and solvent for solution for injection/infusion
Description
Glutathione 600mg/4ml (Powder + Solvent) is a prescription-only injectable preparation containing lyophilised reduced glutathione with a matching solvent ampoule for reconstitution. Each vial of powder contains 646 mg of glutathione sodium salt, corresponding to 600 mg of glutathione. After reconstitution with the 4 ml water-for-injection ampoule, the solution contains 150 mg/ml glutathione and is intended for intravenous (IV) or intramuscular (IM) administration under medical supervision. Glutathione is a powerful endogenous antioxidant that protects cells from oxidative damage, supports detoxification processes (particularly in the liver) and contributes to immune and cellular health. The 600 mg/4 ml format provides a high-strength dose suitable for clinical use in settings where enhanced antioxidant support is required.
Bnefits
Delivers a high-dose, systemic source of glutathione, the body’s key endogenous antioxidant.
Helps neutralise reactive oxygen species and reduce oxidative stress at a cellular level.
Supports hepatic detoxification pathways and assists in the removal or neutralisation of toxins and metabolic by-products.
Provides rapid systemic availability when administered intravenously or intramuscularly after reconstitution.
Standardised 600 mg dose per vial allows accurate dosing and predictable pharmacological effect under medical supervision.
Supplied as powder plus solvent, ensuring correct concentration (150 mg/ml) when reconstituted as per instructions.
Indications
Use as an antioxidant and detoxification-support therapy in conditions associated with increased oxidative stress, as determined by a prescribing clinician.
Adjunctive treatment in clinical situations where enhancing glutathione levels is considered beneficial to support liver function and cellular protection.
Use in hospital, clinic or specialist wellness settings where parenteral antioxidant therapy is prescribed and monitored by healthcare professionals.
Active ingredient (per powder vial): 646 mg glutathione sodium salt, corresponding to 600 mg glutathione.
Solvent ampoule: 4 ml water for injections.
Reconstituted solution: 150 mg/ml glutathione in water for injections.
Other excipients: inactive formulation components used to stabilise the lyophilised powder (full list as per official product information).
Formulation
Pharmaceutical lyophilised powder and solvent for solution for injection/infusion.
Each treatment unit consists of one type III glass vial containing white lyophilised glutathione powder and one type I glass ampoule containing 4 ml water for injections.
After reconstitution in the powder vial using the full 4 ml solvent, the solution is intended for IV or IM use by a healthcare professional.
Classified as a prescription-only medicinal product; not a cosmetic or food supplement.
Packaging
Commercial presentation commonly supplied as a box containing 10 powder vials plus 10 solvent ampoules of 4 ml each (10 treatments).
Each powder vial is sealed with a rubber closure and aluminium cap; each solvent ampoule is a sealed glass ampoule containing sterile water for injections.
Outer carton is labelled with product name, strength (600 mg/4 ml), batch number, expiry date, route of administration and storage information.
Usage
For parenteral use only and only under medical supervision by appropriately trained healthcare professionals.
Reconstitute the product immediately before use: aseptically draw the complete 4 ml of water for injections from the solvent ampoule into a sterile syringe with an appropriate needle.
Inject the solvent into the powder vial and gently swirl until the lyophilised powder is completely dissolved; avoid vigorous shaking to minimise foaming.
Visually inspect the reconstituted solution; use only if it is clear and free from visible particles or discoloration.
Administer the reconstituted solution by slow intravenous injection, infusion, or intramuscular injection according to the prescribing clinician’s protocol and the official product information.
Use the solution within the period specified in the product literature (commonly within 8 hours at temperatures not exceeding 25°C); any unused solution should be discarded.
Dosage, route, and frequency of administration must be determined by the prescribing physician based on the patient’s clinical status and therapeutic goals.
Do not mix with other medicinal products in the same syringe or infusion solution unless compatibility has been established.
Discard vials, ampoules, needles, and syringes safely in line with local regulations for medical sharps and pharmaceutical waste.
Contraindications
Known hypersensitivity to glutathione, glutathione sodium salt or any excipient contained in the formulation.
Use in patients for whom parenteral fluid administration is contraindicated, unless the benefit clearly outweighs the risk and is supervised by a physician.
Should not be used if the powder vial, solvent ampoule or reconstituted solution shows evidence of damage, contamination or particulate matter.
Caution, or avoidance, is advised in pregnancy and breastfeeding due to limited data for this specific parenteral preparation unless clearly indicated by a physician.
Adverse Effects
Local injection-site reactions such as pain, redness or swelling at the IM or IV injection site.
Possible systemic reactions including nausea, headache, dizziness or mild gastrointestinal upset in some patients.
Allergic or hypersensitivity reactions (e.g. rash, pruritus, urticaria, bronchospasm or anaphylactoid reactions) in susceptible individuals.
Potential changes in laboratory parameters related to oxidative status or hepatic function, depending on baseline condition and concurrent therapies.
As with any parenteral medicinal product, there is a risk of infection or thrombophlebitis if aseptic technique or venous access is inadequate.
Storage Conditions
Store the unopened powder vials and solvent ampoules in their original packaging to protect from light and moisture.
This medicinal product typically does not require any special storage conditions beyond normal room temperature, as stated in the official product information, provided extremes of heat and cold are avoided.
Do not freeze. Keep away from excessive heat and direct sunlight.
Keep out of the sight and reach of children.
Use by the expiry date printed on the packaging and vial labels.
After reconstitution, use the solution within the timeframe and conditions specified in the product literature (commonly within 8 hours at or below 25°C); any unused solution should be discarded.
Duration
Treatment duration and course (single dose versus repeated injections/infusions over days or weeks) are determined individually by the prescribing clinician according to indication, patient response and clinical guidelines.
Onset
Systemic antioxidant activity begins shortly after intravenous or intramuscular administration of the reconstituted solution; the clinical onset and duration of benefit depend on the underlying condition, dose, and frequency of administration.
