COMPOUND SODIUM LACTATE INTRAVENOUS INFUSION BP 500ml,1000 %v/v Solution for Infusion

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

SODIUM CHLORIDE POTASSIUM CHLORIDE SODIUM LACTATE SOLUTION CALCIUM CHLORIDE DIHYDRATE

Dostupné z:

B. Braun Medical Limited

INN (Medzinárodný Name):

SODIUM CHLORIDE POTASSIUM CHLORIDE SODIUM LACTATE SOLUTION CALCIUM CHLORIDE DIHYDRATE

Dávkovanie:

500ml,1000 %v/v

Forma lieku:

Solution for Infusion

Typ predpisu:

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

Stav Autorizácia:

Authorised

Dátum Autorizácia:

0000-00-00

Príbalový leták

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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 com-
position 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
dis-
solved 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
lac-
tate 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 Sodium chloride, S

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Compound Sodium Lactate Intravenous Infusion BP, Solution for Infusion (Hartmann’s Solution).
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1000 ml of solution contains
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
111mmol/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
Titration acidity: (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
POSOLOGY
The dosage of the solution depends on the fluid and electrolyte requirements of the patient, his/her age, weight, clinical
condition and physiological (acid-base) status.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 25/10/2013_
_CRN 2134417_
_page number: 1_
The recommended dosages are:
_ADULTS AND ADOLESCENTS_
_Maximum daily dose_
Up to 40 ml per kg body weight (BW) per day, corresponding to 5.24 mmol sodium per kg BW per day and max.
0.22 mmol potassium per kg BW per day.
_Maximum infusion rate:_
The infusion rate should be adjusted according to the patient’s clinical condition.
The infusion rate should normally not exceed the following values:5