COMPOUND SODIUM LACTATE BP ( HARTMANN'S SOLUTION)

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CALCIUM CHLORIDE DIHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

Available from:

TEVA MEDICAL MARKETING LTD.

ATC code:

B05XA07

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

SODIUM LACTATE 0.32 %W/V; CALCIUM CHLORIDE DIHYDRATE 0.027 %W/V; POTASSIUM CHLORIDE 0.04 %W/V; SODIUM CHLORIDE 0.6 %W/V

Administration route:

I.V

Prescription type:

Required

Manufactured by:

BAXTER HEALTHCARE LTD.UK

Therapeutic group:

CALCIUM CHLORIDE

Therapeutic area:

CALCIUM CHLORIDE

Therapeutic indications:

Source of water and electrolytes. Regulation or maintenance of metabolic acidosis ( except lactic acidosis).

Authorization date:

2015-09-30

Patient Information leaflet

_ :_ךיראת
רבוטקוא
_ _
_2019_
_ _
ה
/
דבכנ
ת
/
חקור ,
ה
/
אפור
העידומ
עבט
תרבח
לע
ולעב
םיאבה
םינוכדעה
ן
:
רישכתה
לש
אפורל
_ _
COMPOUND
SODIUM
LACTATE
BP
(HARTMANN'S
SOLUTION)
SOLUTION
FOR
INFUSION
טטקל םוידוס תבוכרת
BP
)
ןמטרה תסימת
(
היזופיאל הסימת
CONTAINS:
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
_ _
_ _
אפורל ןולעב םינוכדע
------------------------------------------------------------------------------------------------------------ :
םושירה
תדועתב
הרשואש
יפכ
היוותה
Source of water and electrolytes.
Regulation or maintenance of metabolic acidosis (except lactic
acidosis).
ל
ןולעהש
עידוהל
וננוצרב
אפור
כדוע
ן ,
דבלב
םיירקיעה
םינוכדעה
םילולכ
ןלהלש
טוריפב
)
תונמוסמ
תופסות
םודאב
קוחמ
טסקטכ
עדימ
תורסהו :(
4.3. CONTRAINDICATIONS
As for other calcium-containing infusion solutions, concomitant
administration of ceftriaxone
and Compound Sodium Lactate solution is contraindicated in newborns
(≤28 days of age), even
if separate infusion lines are used (risk of fatal ceftriaxone-calcium
salt precipitation in the
neonate’s bloodstream). For patients over 28 days of age please see
section 4.4.
Compound Sodium Lactate solution is also contraindicated in patients
with
•
A known hypersensitivity to sodium lactate.
•
Conditions
associated
with
increased
lactate
levels
(hyperlactataemia)
including
lactic
acidosis, or impaired lactate utilization, such as severe hepatic
insufficiency.
4.4.SPECIAL WARNINGS AND PRECAUTIONS FOR USE
HYPERSENSITIVITY REACTIONS
The
infusion
must
be
stopped
immediately
if
any
signs
or
symptoms
of
a
suspected
hypersensitivity reaction develop. Appropriate therapeutic
countermeasures must be instituted
as clinically indicated.
INCOMPATIBILITIES
_Ceftriaxone_
In
patients
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Summary of Product characteristics

Compound Sodium Lactate BP (Hartmann's Solution) N.A 09/2022 Minor
changes - clean
SUMMARY
OF
PRODUCT
CHARACTERISTICS
COMPOUND
SODIUM
LACTATE
BP
(HARTMANN'S
SOLUTION)
SOLUTION
FOR
INFUSION
1.
NAME OF THE MEDICINAL PRODUCT
Compound Sodium Lactate BP (Hartmann's Solution)
(Synonyms: - Ringer Lactate Solution for Infusion
- Hartmann’s Solution for Infusion)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Clear solution, free from visible particles.
278 mOsm/l (approx.)
pH: 5.0 – 7.0
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
-
Source of water and electrolytes.
-
Regulation or maintenance of metabolic acidosis (except lactic
acidosis).
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults, the elderly and children: _
THE DOSAGE DEPENDS ON THE AGE, WEIGHT, CLINICAL AND BIOLOGICAL
(ACID-BASE BALANCE) CONDITIONS
OF THE PATIENT, AND CONCOMITANT THERAPY.
_Recommended dosage: _
The amount of Compound Sodium Lactate BPsolution (Hartmann's Solution)
needed to restore
normal blood volume is 3 to 5 times the volume of lost blood.
Compound Sodium Lactate BP (Hartmann's Solution) N.A 09/2022 Minor
changes - clean
The recommended dosage is:
-
for adults: 500 ml to 3 l/24h
-
for babies and children: 20 ml to 100 ml/kg/24 h
_Administration rate: _
The infusion rate is usually 40 ml/kg/24h in adults.
In pediatric patients the infusion rate is 5 ml/kg/h on average but
the value
_ _
varies with age: 6-8
ml/kg/h for infants, 4-6 ml/kg/h for toddlers, and 2-4 ml/kg/h for
schoolchildren. In children with
burns, the dose is on average 3.4 ml/kg/per cent burn at 24 h
post-burn and 6.3 ml/kg/per cent
burn at 48 h. In severely head-injured children the dose is on average
2850 ml/m².
Infusion rate and total volume can be higher in