Compound Sodium Lactate Intravenous Infusion BP, Ecobag (Hartmann’s Solution)

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Sodium chloride; Potassium chloride; Sodium lactate solution; Calcium chloride dihydrate

Tersedia dari:

B. Braun Medical Limited

Kode ATC:

B05BB; B05BB01

INN (Nama Internasional):

Sodium chloride; Potassium chloride; Sodium lactate solution; Calcium chloride dihydrate

Dosis:

Per Cent

Bentuk farmasi:

Solution for infusion

Jenis Resep:

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

Area terapi:

Solutions affecting the electrolyte balance; electrolytes

Status otorisasi:

Marketed

Tanggal Otorisasi:

2007-03-30

Selebaran informasi

PACKAGE LEAFLET: INFORMATION FOR THE USER
COMPOUND SODIUM LACTATE INTRAVENOUS INFUSION BP, ECOBAG
(HARTMANN’S SOLUTION)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
●
Keep this leaflet. You may need to read it again.
●
If you have any further questions, ask your doctor or pharmacist.
●
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them even if their signs of illness are the same as yours.
●
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Compound Sodium Lactate is and what it is used for
2.
What you need to know before you use Compound Sodium Lactate
3.
How to use Compound Sodium Lactate
4.
Possible side effects
5.
How to store Compound Sodium Lactate
6.
Contents of the pack and other information
1.
WHAT COMPOUND SODIUM LACTATE IS AND WHAT IT IS USED FOR
Compound Sodium Lactate is a solution for supply of fluid and salts to
the body. It is
supplied to you through a vein drip (an infusion). Its salt
composition is similar to that
of human blood.
You will receive this solution if
●
you need to receive fluids and salts. This applies when your acid-base
balance is
normal or your blood is a little bit too acidic (mild acidosis)
●
you have lost water
●
you have lost water and salts
●
you have lost blood and need this replaced for a short time
●
your doctor wants to give you salts or some drugs that need to be
dissolved or
diluted.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE COMPOUND SODIUM LACTATE
_DO NOT USE COMPOUND SODIUM LACTATE IF YOU HAVE _
●
an impairment to metabolise lactate connected with high levels of
lactate in your
blood (see also section “Take special care with...”)
●
too much water in your body (water intoxication)
_●_
_ _
in premature neonates and neonates (≤ 28 days of age) which are
receiving
ceftriaxone.
_●_
_ _
if you are allergic to S

Karakteristik produk

Health Products Regulatory Authority
10 September 2019
CRN0099LT
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Compound Sodium Lactate Intravenous Infusion BP, Ecobag (Hartmann’s
Solution)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1000 ml of solution contain
Sodium Chloride 6.00 g
Sodium Lactate Solution (50% w/w) 6.24 g
(equivalent to sodium lactate, 3.12 g)
Potassium Chloride 0.40 g
Calcium Chloride Dihydrate 0.27 g
_Electrolyte concentrations:_
Sodium 131 mmol/l
Potassium 5 mmol/l
Calcium 2 mmol/l
Chloride 111 mmol/l
Lactate 29 mmol/l
_Excipients_
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
A clear, colourless, aqueous solution.
Theoretical osmolarity: 278 mOsm/l
Acidity (titration to pH 7.4): < 1 mmol/l
pH: 5.0 - 7.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
• Fluid substitution under the conditions of undisturbed acid-base
balance or mild acidosis
• Isotonic and hypotonic dehydration
• Short-term intravascular volume replacement
• Vehicle solution for compatible electrolyte concentrates and
drugs.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Fluid balance, serum electrolytes and acid-base balance may need to be
monitored before and during administration, with
particular attention to serum sodium in patients with increased
non-osmotic vasopressin release (syndrome of inappropriate
antidiuretic hormone secretion, SIADH) and in patients co-medicated
with vasopressin agonist drugs, due to the risk of hospital
acquired hyponatraemia (see sections 4.4, 4.5 and 4.8).
Monitoring of serum sodium is particularly important for hypotonic
fluids.
Health Products Regulatory Authority
10 September 2019
CRN0099LT
Page 2 of 8
Compound Sodium Lactate Intravenous Infusion BP tonicity: 278 mOsm/l
The infusion rate and volume depend on the age, weight, clinical
condition (e.g. burns, surgery, head injury, infections), and
concomitant therapy should be determined by the consulting physician
experienced in paediatric intravenous fluid