Compound Sodium Lactate (Hartmann's Solution) and 5% Glucose

Țară: Noua Zeelandă

Limbă: engleză

Sursă: Medsafe (Medicines Safety Authority)

Ingredient activ:

Calcium chloride dihydrate 0.27 mg/mL; Glucose 50 mg/mL; Potassium chloride 0.4 mg/mL; Sodium chloride 6 mg/mL; Sodium lactate 3.22 mg/mL (lactic acid 0.0024mL/mL with sodium hydroxide 1.15mg/mL)

Disponibil de la:

Baxter Healthcare Ltd

INN (nume internaţional):

Calcium chloride dihydrate 0.27 mg/mL

Dozare:

5 %

Forma farmaceutică:

Solution for infusion

Compoziție:

Active: Calcium chloride dihydrate 0.27 mg/mL Glucose 50 mg/mL Potassium chloride 0.4 mg/mL Sodium chloride 6 mg/mL Sodium lactate 3.22 mg/mL (lactic acid 0.0024mL/mL with sodium hydroxide 1.15mg/mL)

Unități în pachet:

Bag, plastic, 1000 mL

Clasă:

General sale

Tip de prescriptie medicala:

General sale

Produs de:

Baxter Healthcare Pty Ltd

Indicații terapeutice:

Compound Sodium Lactate (Hartmann's Solution) and 5% Dextrose IV infusion solution is indicated as a source of water and electrolytes. It is also used in patients as a source of bicarbonate in the treatment of mild to moderate metabolic acidosis associated with dehydration or associated with potassium deficiency. These solutions are indicated as methods of intravenous drug delivery, if the drugs are compatible with the solutions.

Rezumat produs:

Package - Contents - Shelf Life: Bag, plastic, - 1000 mL - 24 months from date of manufacture stored at or below 30°C

Data de autorizare:

1974-08-22

Caracteristicilor produsului

NEW ZEALAND DATA SHEET
COMPOUND SODIUM LACTATE (HARTMANNS) & 5% GLUCOSE 23 September 2019
Page 1 of 12
Baxter Healthcare Ltd
1 COMPOUND SODIUM LACTATE (HARTMANN’S SOLUTION) & 5% GLUCOSE
(solution for infusion)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Compound Sodium Lactate (Hartmann’s Solution) and 5% Glucose
infusion solution
preparation in Water for Injection
Name of the active components
Quantity (g/L)
Sodium Chloride
6
Sodium Lactate
3.22
Potassium Chloride
0.4
Calcium Chloride Dihydrate
0.27
Glucose
50
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion (intravenous).
COMPOUND SODIUM LACTATE (HARTMANN’S SOLUTION) AND 5% GLUCOSE
infusion solutions are clear
liquid, sterile, non‐pyrogenic solutions. They are _hypertonic_
intravenous solutions (osmolality of
563mOsmol/kg) with pH of 4.0 – 6.5.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
COMPOUND SODIUM LACTATE (HARTMANN’S SOLUTION) AND 5% GLUCOSE IV
infusion solution is indicated
as a source of water and electrolytes. It is also used in patients as
a source of bicarbonate in the
treatment of mild to moderate metabolic acidosis associated with
dehydration or associated with
potassium deficiency. These solutions are indicated as methods of
intravenous drug delivery, if the
drugs are compatible with the solutions.
4.2
Dose and method of administration
To be used as directed by the physician. The dosage, rate and duration
of administration of
COMPOUND SODIUM LACTATE (HARTMANN’S SOLUTION) AND 5% GLUCOSE
infusion solution is to be
individualised and depend upon the indication for use, the patient’s
age, weight, concomitant
treatments and clinical condition, as well as laboratory
determinations and response.
The infusion rate should not exceed the patient’s ability to utilise
glucose in order to avoid
hyperglycaemia. The infusion rate of intravenous solutions containing
glucose should be selected
with caution in children (see Section 4.4/_Paediatric use). _
Parenteral medicinal products should be ins