GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Amino Acids Solution for Intravenous Infusion (5%)
B. Amino Acids Solution for Intravenous Infusion (10%)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Amino Acids Solution for Intravenous Infusion (5%)
Composition:
Each 100ml contains:
Isoleucine Ph. Eur. ……………………0.25g
Leucine Ph. Eur. ………………………0.37g
Lysine acetate USP…………………0.4655g
Lysine……………………………………0.33g
Methionine Ph. Eur. ………………0.215g
Phenylalanine Ph. Eur. ………………0.255g
Threonine Ph. Eur. ……………………0.22g
Tryptophan Ph. Eur. ………………0.1g
Valine Ph. Eur. …………………………0.31g
Arginine Ph. Eur. ………………………0.6g
Histidine Ph. Eur. ………………………0.15g
Alanine Ph. Eur. …………………………0.7g
Glycine Ph. Eur. …………………………0.55g
Proline Ph. Eur. ……………………………0.56g
Serine Ph. Eur. ………………………………0.325g
Tyrosine Ph. Eur. ……………………………0.02g
Taurine …………………………………………0.05g
Water for Injection Ph. Eur. ……………q.s.
Total amino acids: 50.0 g/l
pH: 5.5-6.3
Total nitrogen: 8.1 g/l
Titration acidity: 12mmol NaOH/l
Total energy: 840kJ/l
(=200kcal/l)
Theoretical osmolarity: 495 mosm/l

B. Amino Acids Solution for Intravenous Infusion (10%)
Composition:
Each 100ml contains:
Isoleucine Ph. Eur. ……………………0.5g
Leucine Ph. Eur. ………………………0.74g
Lysine acetate USP…………………0.931g
Lysine……………………………………0.66g
Methionine Ph. Eur. ………………0.43g
Phenylalanine Ph. Eur. ………………0.51g
Threonine Ph. Eur. ……………………0.44g
Tryptophan Ph. Eur. ………………0.2g
Valine Ph. Eur. …………………………0.62g
Arginine Ph. Eur. ………………………1.2g
Histidine Ph. Eur. ………………………0.3g
Alanine Ph. Eur. …………………………1.4g
Glycine Ph. Eur. …………………………1.1g
Proline Ph. Eur. ……………………………1.12g
Serine Ph. Eur. ………………………………0.65g
Tyrosine Ph. Eur. ……………………………0.04g
Taurine …………………………………………0.1g
Water for Injection Ph. Eur. ……………q.s.
Total amino acids: 100.0 g/l
pH: 5.5-6.3
Total nitrogen: 16.2 g/l
Titration acidity: 22mmol NaOH/l
Total energy: 1680 kJ/l
(=400kcal/l)
Theoretical osmolarity: 990 mosm/l


THERAPEUTIC INDICATIONS:

Amino Acids Solution for Intravenous Infusion are organic compounds that are chained together to form proteins. It is used to treat nutritional deficiencies. It promotes nitrogen-balancing in the body, also replenishes the protein reserve of the body in extensive burns or protein-calorie malnutrition.

PACKING:

Strength PACK SIZE
5%---- 250ml, 500ml
10%---- 100ml, 250ml, 500ml

DIRECTION OF USE:

To be used with Non-pyrogenic I.V. administration set with aseptic technique.
For I.V. infusion.

CAUTION & WARNING:

CAUTION: Use only clear, particle-free solutions & undamaged containers.
Keep container in outer carton.
WARNING: TO BE SOLD BY THE RETAILERS ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Store at a temperature not exceeding 25°C. Protect from light. Do not freeze.
STERILE, APYROGENIC, SINGLE DOSE CONTAINER.
Keep medicine out of reach of children.
FOR HUMAN USE ONLY
Dosage: As directed by the Physician.

Amino Acids Solution for Intravenous Infusion 10% Technical Specification:

Product Name:Amino Acids Solution for Intravenous Infusion (10%)
Brand Name:Generics
Strength:5%, 10%
Dosage Form:I.V. Infusion Bottle (LVP)
Packing:100mL, 250mL, 500mL 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:Nutrients & minerals
Indication: Amino Acids Solution for Intravenous Infusion are organic compounds that are chained together to form proteins. It is used to treat nutritional deficiencies. It promotes nitrogen-balancing in the body, also replenishes the protein reserve of the body in extensive burns or protein-calorie malnutrition.
Storage:Store at a temperature not exceeding 25°C. Protect from light. Do not freeze.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Amino Acids Solution for Intravenous Infusion (10%)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Amino Acids Solution for Intravenous Infusion (10%)
    Composition:
    Each 100ml contains:
    Isoleucine Ph. Eur. ……………………0.5g
    Leucine Ph. Eur. ………………………0.74g
    Lysine acetate USP…………………0.931g
    Lysine……………………………………0.66g
    Methionine Ph. Eur. ………………0.43g
    Phenylalanine Ph. Eur. ………………0.51g
    Threonine Ph. Eur. ……………………0.44g
    Tryptophan Ph. Eur. ………………0.2g
    Valine Ph. Eur. …………………………0.62g
    Arginine Ph. Eur. ………………………1.2g
    Histidine Ph. Eur. ………………………0.3g
    Alanine Ph. Eur. …………………………1.4g
    Glycine Ph. Eur. …………………………1.1g
    Proline Ph. Eur. ……………………………1.12g
    Serine Ph. Eur. ………………………………0.65g
    Tyrosine Ph. Eur. ……………………………0.04g
    Taurine …………………………………………0.1g
    Water for Injection Ph. Eur. ……………q.s.
    Total amino acids:   100.0 g/l       pH:                                       5.5-6.3
    Total nitrogen:         16.2 g/l          Titration acidity:               22mmol NaOH/l
    Total energy:           1680kJ/l          Theoretical osmolarity:  990 mosm/l
    (=400kcal/l)

THERAPEUTIC INDICATIONS:

Amino Acids Solution for Intravenous Infusion are organic compounds that are chained together to form proteins. It is used to treat nutritional deficiencies. It promotes nitrogen-balancing in the body, also replenishes the protein reserve of the body in extensive burns or protein-calorie malnutrition.

PACKING:

StrengthPACK SIZE
5%250ml, 500ml
10%100ml, 250ml, 500ml

DIRECTION OF USE:

To be used with Non-pyrogenic I.V. administration set with aseptic technique.

For I.V. infusion.

CAUTION & WARNING:

CAUTION: Use only clear, particle-free solutions & undamaged containers.

Keep container in outer carton.

WARNING: TO BE SOLD BY THE RETAILERS ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Store at a temperature not exceeding 25°C. Protect from light. Do not freeze.

STERILE, APYROGENIC, SINGLE DOSE CONTAINER.

Keep medicine out of reach of children.
FOR HUMAN USE ONLY

Dosage: As directed by the Physician.