Compound Sodium Lactate (Hartmanns)

Kraj: Nowa Zelandia

Język: angielski

Źródło: Medsafe (Medicines Safety Authority)

Składnik aktywny:

Calcium chloride dihydrate 0.27 g;  ;  ;  ;  ; Potassium chloride 0.4 g;  ;  ;  ; Sodium chloride 6 g;  ;  ;  ;  ;  ; Sodium lactate 3.17 g (as 6.34g sodium lactate solution 50%);  

Dostępny od:

Fresenius Kabi New Zealand Limited

INN (International Nazwa):

Calcium chloride dihydrate 0.27 g

Forma farmaceutyczna:

Solution for infusion

Skład:

Active: Calcium chloride dihydrate 0.27 g         Potassium chloride 0.4 g       Sodium chloride 6 g           Sodium lactate 3.17 g (as 6.34g sodium lactate solution 50%)   Excipient: Hydrochloric acid Sodium hydroxide Water for injection

Sztuk w opakowaniu:

Bag, 10 x 1000mL, 10 L

Klasa:

General sale

Typ recepty:

General sale

Wyprodukowano przez:

Merck KGaA

Wskazania:

Compound Sodium Lactate (Hartmann's) is used for intravenous fluid and electrolyte replacement.

Podsumowanie produktu:

Package - Contents - Shelf Life: Bag, 20 x 250mL - 5 L - 3 years from date of manufacture stored at or below 25°C - Bag, 30 x 250mL - 7.5 L - 3 years from date of manufacture stored at or below 25°C - Bag, 35 x 250mL - 8.75 L - 3 years from date of manufacture stored at or below 25°C - Bag, 40 x 250mL - 10 L - 3 years from date of manufacture stored at or below 25°C - Bag, 10 x 1000mL - 10 L - 3 years from date of manufacture stored at or below 25°C - Bag, 20 x 500mL - 10 L - 3 years from date of manufacture stored at or below 25°C

Data autoryzacji:

2007-12-03

Ulotka dla pacjenta

CMI FOR COMPOUND SODIUM LACTATE (HARTMANN’S)
OCTOBER 2021
1
COMPOUND SODIUM LACTATE
(HARTMANN’S) SOLUTION FOR INJECTION
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common
questions
about
Compound
Sodium
Lactate
(Hartmann’s). It does not contain
all the information. It does not take
the place of talking to your doctor.
All
medicines
have
risks
and
benefits. Your doctor has weighed
the
risks
of
you
being
given
Compound
Sodium
Lactate
(Hartmann’s)
against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING
THIS
MEDICINE,
ASK
YOUR
DOCTOR OR PHARMACIST.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may need to read it again.
WHAT COMPOUND
SODIUM LACTATE
(HARTMANN’S) IS USED
FOR
Compound
Sodium
Lactate
(Hartmann’s)
is
used
to
replace
body fluid and mineral salts that
may be lost for a variety of medical
reasons.
It
is
especially suitable
when the losses result in too much
acid being present in the blood.
YOUR
DOCTOR
MAY
HAVE
PRESCRIBED IT FOR ANOTHER REASON.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS
ABOUT
WHY
THIS
MEDICINE
HAS
BEEN
PRESCRIBED
FOR YOU.
BEFORE YOU ARE GIVEN
COMPOUND SODIUM
LACTATE (HARTMANN’S)
_WHEN YOU SHOULD NOT BE GIVEN _
_IT _
COMPOUND
SODIUM
LACTATE
(HARTMANN’S)
SHOULD
NOT
BE
GIVEN;

If the solution is not clear.

Through
the
same
tubing
as
those containing blood.

After the expiry date printed on
the pack.

If
the
packaging
is
torn
or
shows sign of tempering.

To others.
For
use
in
one
patient
on
one
occasion only.
It
may
have no effect at all, or
worse,
an
entirely
unexpected
effect if you are given it after the
expiry date has passed.
COMPOUND
SODIUM
LACTATE
(HARTMANN’S)
SHOULD
NOT
BE
GIVEN IF YOU HAVE AN ALLERGY TO:

Any ingredient listed at the end
of this leaflet

Any similar medicines to
Compound Sodium Lactate
(Hartmann’s)
Some
symptoms
of
an
allergic
reaction may include:

Shortness of breath

Wheezing
or
difficulty
breathing

Swelling
of
the
face,
lips,
tongue or other p

Charakterystyka produktu

Page 1 of 9
NEW ZEALAND DATA SHEET
1.
COMPOUND SODIUM LACTATE (HARTMANN’S)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Molecular formulae. Potassium chloride: KCl; sodium chloride: NaCl;
calcium
chloride dihydrate: CaCl
2
; sodium S- lactate (chemical name, sodium 2-
hydroxypropionate): C
3
H
5
O
3
Na.
Sterile solution intended for intravenous use containing Sodium
Lactate (3.17
g/L), Sodium Chloride (6.0 g/L), Potassium Chloride (400 mg/L) and
Calcium
Chloride Dihydrate (270 mg/L). Sodium Hydroxide and Hydrochloric acid
is
added for pH adjustment.
3. PHARMACEUTICAL FORM
The total amount of electrolytes per litre are: sodium 131 mmol,
potassium 5
mmol, chloride 112 mmol, calcium 2 mmol, bicarbonate (as lactate) 28
mmol.
The
osmolality
is
approximately
255
mOsm/kg
water.The
solutions
are
isotonic, sterile, non-pyrogenic and do not contain antimicrobial
agent or
added buffers. The pH range is 5.0 to 7.0. Compound Sodium Lactate
(Hartmann's) Solution for Injection is also known as Ringer-Lactate.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Compound Sodium Lactate (Hartmann's) is used:

for intravenous fluid and electrolyte replacement

as a source of bicarbonate in the treatment of mild to moderate
metabolic
acidosis
associated
with
dehydration
or
associated
with
potassium
deficiency

as a vehicle for 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 of Compound Sodium
Lactate (Hartmann’s) is dependent upon the age, weight and
concomitant
conditions of the patient as well as laboratory determinations and
response.
Parenteral drug products should be inspected visually for particulate
matter
and discolouration prior to administration whenever solution and
container
permit
as only sterile and non-pyrogenic equipment must be used for
intravenous administration. Do not administer unless the solution is
clear and
the seal is intact.
As with all parental solutions compatibility with additi