COMPOUND SODIUM LACTATE & GLUCOSE 5% %v/v Solution for Infusion

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

SODIUM CHLORIDE POTASSIUM CHLORIDE CALCIUM CHLORIDE DIHYDRATE SODIUM LACTATE GLUCOSE MONOHYDRATE

Boleh didapati daripada:

Baxter Healthcare Limited

INN (Nama Antarabangsa):

SODIUM CHLORIDE POTASSIUM CHLORIDE CALCIUM CHLORIDE DIHYDRATE SODIUM LACTATE GLUCOSE MONOHYDRATE

Dos:

%v/v

Borang farmaseutikal:

Solution for Infusion

Jenis preskripsi:

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

Status kebenaran:

Withdrawn

Tarikh kebenaran:

2012-05-18

Ciri produk

IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0167/063/005
Case No: 2069237
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
BAXTER HEALTHCARE LIMITED
CAXTON WAY, THETFORD, NORFOLK IP24 3SE, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
COMPOUND SODIUM LACTATE & GLUCOSE 5% W/V SOLUTION FOR INFUSION.
The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as
may be specified in the said Regulations as listed on the reverse of this document.
This authorisation, unless previously revoked, shall continue in force from 10/03/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 15/03/2010_
_CRN 2069237_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Compound Sodium Lactate & Glucose 5% w/v Solution for Infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Glucose (as monohydrate)
50.0 g/l
Sodium Chloride:
6.00 g/l
Potassium Chloride:
0.40 g/l
Calcium Chloride dihydrate:
0.27 g/l
Sodium Lactate:
3.20 g/l
Na
+
K
+
Ca
++
Cl
-
C
3
H
5
O
3
-
(lactate)
mmol/l
131
5
2
111
29
mEq/l
131
5
4
111
29
200 kcal/L (840 kJ/L)
For a full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear solution, free from visible particles.
555 mOsm/l (approx). pH: 4.0 – 6.5
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Compound Sodium�