COMPOUND SODIUM LACTATE INTRAVENOUS INFUSION BP (H 1 Solution for Infusion

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

SODIUM CHLORIDE SODIUM LACTATE POTASSIUM CHLORIDE CALCIUM CHLORIDE DIHYDRATE

Boleh didapati daripada:

Baxter Healthcare Limited

INN (Nama Antarabangsa):

SODIUM CHLORIDE SODIUM LACTATE POTASSIUM CHLORIDE CALCIUM CHLORIDE DIHYDRATE

Dos:

1

Borang farmaseutikal:

Solution for Infusion

Jenis preskripsi:

Product subject to prescription which may not be renewed (A)

Status kebenaran:

Authorised

Tarikh kebenaran:

0000-00-00

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Compound Sodium Lactate Intravenous Infusion BP, (Hartmann’s Solution) Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each litre provides the following concentration of electrolytes:
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
Sterile, non-pyrogenic, clear, colourless, aqueous solution for infusion.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For prophylactic and replacement therapy requiring the use of Sodium Chloride and lactate, with minimal amounts of
calcium and potassium.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
4.2.1
DOSAGE
The dosage is dependant upon the age, weight and clinical condition of the patient.
4.2.2
ADMINISTRATION
Intravenous.
4.3 CONTRAINDICATIONS
4.3.1
Administration in congestive heart failure, or in conditions of severe impairment of renal function, or in oedema
with sodium retention.
4.3.2
Lactate containing solutions are contraindicated in patients with liver disease.
Sodium Chloride
6.0
g/l
Sodium Lactate
3.22
g/l
Potassium Chloride
400
mg/l
Calcium Chloride Dihydrate
270
mg/l
Na
+
131 mmol/l
K
+
5 mmol/l
Cl
¯
111 mmol/l
Lactate
29 mmol/l
Ca
+
2 mmol/l
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 05/08/2014_
_CRN 2150440_
_page number: 1_
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
4.4.1
Administration should be carried out under regular and careful surveillance; plasma electrolyte levels should be
monitored during use.
4.4.2
This fluid should be administered with great care to patients with renal insufficiency.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
None known.
4.6 FERTILITY, PREGNANCY AND LACTATION
The safet