GENERIC NAME OF THE MEDICINAL PRODUCT:
Multiple Electrolyte & Dextrose Injection Type III (Arolyte "M" with 5% Dextrose)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Multiple Electrolyte & Dextrose Injection Type III (Arolyte "M" with 5% Dextrose)
Composition:
Each 100ml contains:
Dextrose Anhydrous……………………………5g
Sodium Chloride………………………………0.1g
Potassium Chloride…………………………… 0.15g
Sodium Acetate……………………………… 0.28g
Sodium metabisulphite……………………… 21mg
Dipotassium Hydrogen Phosphate……… 0.13mg
Water for Injection………………………………q.s.
Composition:
Each 100ml contains:
Dextrose Anhydrous……………………………5g
Sodium Chloride………………………………0.1g
Potassium Chloride…………………………… 0.15g
Sodium Acetate……………………………… 0.28g
Sodium metabisulphite……………………… 21mg
Dipotassium Hydrogen Phosphate……… 0.13mg
Water for Injection………………………………q.s.
THERAPEUTIC INDICATIONS:
Arolyte "M" with 5% Dextrose used for the diagnosis or treatment of metabolic alkalosis, gastric juice replacement.
DIRECTION OF USE:
To be used with Non-pyrogenic I.V. administration set with aseptic technique.
For I.V. use only.
For I.V. use only.
CAUTION & WARNING:
CAUTION: Use only if solution is clear & container & seals are intact.
Do not use in series connection.
Do not remove overwrap until ready for use.
After removing the overwrap, check for minute leaks by squeezing container firmly.
If leaks are found, discard solution as sterility may be impaired.
Not made with natural rubber latex, PVC or DEHP.
WARNING: Some additives may be incompatible. Consult with pharmacist; when introducing additives, use aseptic techniques. Mix thoroughly. Do not store.
Do not use in series connection.
Do not remove overwrap until ready for use.
After removing the overwrap, check for minute leaks by squeezing container firmly.
If leaks are found, discard solution as sterility may be impaired.
Not made with natural rubber latex, PVC or DEHP.
WARNING: Some additives may be incompatible. Consult with pharmacist; when introducing additives, use aseptic techniques. Mix thoroughly. Do not store.
STORAGE & DOSAGE:
Storage: Store at room temperature 25°C. Avoid excessive heat. Protect from freezing.
STERILE, NON-PYROGENIC, SINGLE DOSE CONTAINER.
Keep medicine out of reach of children.
FOR HUMAN USE ONLY
Dosage: As directed by the Physician.
STERILE, NON-PYROGENIC, SINGLE DOSE CONTAINER.
Keep medicine out of reach of children.
FOR HUMAN USE ONLY
Dosage: As directed by the Physician.
Multiple Electrolyte & Dextrose Injection Type III (Arolyte ‘M’ with 5% dextrose) Technical Specifications:
| Product Name: | Multiple Electrolyte & Dextrose Injection Type III (Arolyte ‘M’ with 5% dextrose) |
| Brand Name: | Generics |
| Strength: | See Detailed Composition |
| Dosage Form: | I.V. Infusion Bottle (LVP) |
| Packing: | 100mL, 250mL, 500mL, 1000mL 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: | Nutritive |
| Indication: | Arolyte “M” with 5% Dextrose used for the diagnosis or treatment of metabolic alkalosis, gastric juice replacement. |
| Storage: | Store at room temperature 25°C. Avoid excessive heat. Protect from freezing. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Multiple Electrolyte & Dextrose Injection Type III (Arolyte “M” with 5% Dextrose)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Multiple Electrolyte & Dextrose Injection Type III (Arolyte “M” with 5% Dextrose)
Composition:
Each 100ml contains:
Dextrose Anhydrous……………………………5g
Sodium Chloride………………………………0.1g
Potassium Chloride…………………………… 0.15g
Sodium Acetate……………………………… 0.28g
Sodium metabisulphite……………………… 21mg
Dipotassium Hydrogen Phosphate……… 0.13mg
Water for Injection………………………………q.s.
THERAPEUTIC INDICATIONS:
Arolyte “M” with 5% Dextrose used for the diagnosis or treatment of metabolic alkalosis, gastric juice replacement.
DIRECTION OF USE:
To be used with Non-pyrogenic I.V. administration set with aseptic technique.
For I.V. use only.
CAUTION & WARNING:
CAUTION: Use only if solution is clear & container & seals are intact.
Do not use in series connection.
Do not remove overwrap until ready for use.
After removing the overwrap, check for minute leaks by squeezing container firmly.
If leaks are found, discard solution as sterility may be impaired.
Not made with natural rubber latex, PVC or DEHP.
WARNING: Some additives may be incompatible. Consult with pharmacist; when introducing additives, use aseptic techniques. Mix thoroughly. Do not store.
STORAGE & DOSAGE:
Storage: Store at room temperature 25°C. Avoid excessive heat. Protect from freezing.
STERILE, NON-PYROGENIC, SINGLE DOSE CONTAINER.
Keep medicine out of reach of children.
FOR HUMAN USE ONLY
Dosage: As directed by the Physician.
