- L-Alanyl-L-Glutamine Solution for Infusion 20%w/v (Glukoxtaj)
- L-Alanyl-L-Glutamine Solution for Infusion 20%w/v
- L-Alanyl-L-Glutamine Solution for Infusion 20%w/v
- L-Alanyl-L-Glutamine Solution for Infusion 20%w/v
- L-Alanyl-L-Glutamine Solution for Infusion 20%w/v
- L-Alanyl-L-Glutamine Solution for Infusion 20%w/v
- L-Alanyl-L-Glutamine Solution for Infusion 20%w/v
- L-Alanyl-L-Glutamine Solution for Infusion 20%w/v
- L-Alanyl-L-Glutamine Solution for Infusion 20%w/v
GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Composition:
Each 100ml of concentrated solution for infusion contains:
N (2)-L-alanyl L-glutamine……………………………20.00g
(=L-alanine 8.20g, L-glutamine 13.46g)
Water for Injection USP………………………………… q.s. to 100ml
Osmolarity (calc.) ………………………………………921mOsmol/L
Titration acidity…………………………………………90-105 mmol NaOH/L
pH value…………………………………………………5.0-7.0
THERAPEUTIC INDICATIONS:
DIRECTION OF USE:
For I.V. use only.
CAUTION & WARNING:
WARNING: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.
Not infuse directly: Dilute the preparation with compatible intravenous solution prior to administration.
STORAGE & DOSAGE:
Do not refrigerate.
STERILE, NON-PYROGENIC, SINGLE DOSE CONTAINER.
Keep medicine out of reach of children.
FOR HUMAN USE ONLY
Dosage: As directed by the physician.
For full prescribing information please refer package insert.
L-Alanyl-L-Glutamine Solution for Infusion 20%w/v Technical Specification:
| Product Name: | L-Alanyl-L-Glutamine Solution for Infusion 20%w/v |
| Brand Name: | Glukoxtaj |
| Strength: | 20%w/v |
| Dosage Form: | I.V. Infusion Bottle (LVP) |
| Packing: | 100mL, 250mL IV Bottle |
| Route of Administration: | For I.V. use only |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Anti-bacterial & Antibiotics |
| Indication: | L-Alanyl L-Glutamine is a synthetic glutamine dipeptide administered alone or along with total parenteral nutrition (TPN) in ICU patients, gastrointestinal surgery patients, pancreatitis patients, severe burn patients, cancer chemotherapy patients, etc., to help in the recovery. |
| Storage: | Store at a room temperature not exceeding 25°C, protected from light. Do not refrigerate. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- L-Alanyl-L-Glutamine Solution for Infusion (20%w/v)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- L-Alanyl-L-Glutamine Solution for Infusion (20%w/v)
Composition:
Each 100ml of concentrated solution for infusion contains:
N (2)-L-alanyl L-glutamine……………………………20.00g
(=L-alanine 8.20g, L-glutamine 13.46g)
Water for Injection USP………………………………… q.s. to 100ml
Osmolarity (calc.) ………………………………………921mOsmol/L
Titration acidity…………………………………………90-105 mmol NaOH/L
pH value…………………………………………………5.0-7.0
THERAPEUTIC INDICATIONS:
L-Alanyl L-Glutamine is a synthetic glutamine dipeptide administered alone or along with total parenteral nutrition (TPN) in ICU patients, gastrointestinal surgery patients, pancreatitis patients, severe burn patients, cancer chemotherapy patients, etc., to help in the recovery.
DIRECTION OF USE:
To be used with Non-pyrogenic I.V. administration set with aseptic technique.
For I.V. use only.
CAUTION & WARNING:
CAUTION: Not to be used if container is found leaking or if the solution is cloudy or not clear. Solution containing visible solid particles must not be used.
WARNING: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.
Not infuse directly: Dilute the preparation with compatible intravenous solution prior to administration.
STORAGE & DOSAGE:
Storage: Store at a room temperature not exceeding 25°C, protected from light.
Do not refrigerate.
STERILE, NON-PYROGENIC, SINGLE DOSE CONTAINER.
Keep medicine out of reach of children.
FOR HUMAN USE ONLY
Dosage: As directed by the physician.
For full prescribing information please refer package insert.
