8.4% w/v Sodium Bicarbonate Intravenous Infusion BP

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Sodium bicarbonate

可用日期:

B. Braun Medical Limited

ATC代码:

B05XA; B05XA02

INN（国际名称）:

Sodium bicarbonate

剂量:

8.4 percent weight/volume

药物剂型:

Solution for infusion

处方类型:

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

治疗领域:

Electrolyte solutions; sodium bicarbonate

授权状态:

Marketed

授权日期:

1983-04-01

资料单张

0d0d1d0d0d0d1d1d1d1d0
0d0d1d0d0d0d1d1d1d1d0
201/12262692/0416
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 nurse.
• If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1. What 8.4% w/v Sodium Bicarbonate Intravenous Infusion BP is and
what it is used for
2. What you need to know before you receive 8.4% w/v Sodium Bicar-
bonate Intravenous Infusion BP
3. How to use 8.4% w/v Sodium Bicarbonate Intravenous Infusion BP
4. Possible side effects
5. How to store 8.4% w/v Sodium Bicarbonate Intravenous Infusion BP
6. Contents of the pack and other information
1. WHAT 8.4 % W/V SODIUM BICARBONATE INTRA-
VENOUS INFUSION BP IS AND WHAT IT IS USED FOR
This medicine contains sodium bicarbonate (bicarbonate of soda), a
sub-
stance that is able to neutralise acidic substances.
8.4% w/v Sodium Bicarbonate Intravenous Infusion BP is used:
• to neutralise excess acidic (= sour) substances in the blood
• to render the urine more basic (or alkaline) in the case of
poisoning with
acidic substances, e.g. phenobarbital or acetylsalicylic acid, in
order to
accelerate their excretion
• to render the urine more basic (or alkaline) in order to make some
drug
substances, e.g. methotrexate, sulfadiazine, more soluble to improve
their excretion in urine to render the urine more basic (or alkaline)
in
order to prevent blocking of the kidneys by haemoglobin fragments in
the case of a massive breakdown of red blood cells (haemolysis).
2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE
8.4 % W/V SODIUM BICARBONATE INTRAVENOUS
INFUSION BP
YOU SHOULD NOT RECEIVE 8.4% W/V SODIUM BICARBONATE INTRA-
VENOUS INFUSION BP
• if you are allergic to sodium bicarbonate or any of the other
ingredients
of this medicine (listed in section 6)
• if your blood is already too

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
8.4% w/v Sodium Bicarbonate Intravenous Infusion BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 ml of solution contains:
_Active ingredient:_
Sodium Hydrogen Carbonate (Sodium Bicarbonate)
8.4 g
_Electrolyte concentrations:_
_mmol/100 ml_
Na
+
100
HCO
3
-
100
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for infusion (Infusion)
A clear, colourless, sterile aqueous solution.
_Theoretical osmolarity:_
2000 mOsm/l
pH
7.0-8.5
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
Correction of metabolic acidosis.
•
Urine alkalinisation:
•
as part of the management strategy for enhanced elimination in the
case of intoxication with weak organic
acids, e.g. phenobarbital or acetylsalicylic acid (depending on the
clinical condition, time course of
intoxication and type of poison other options to enhance elimination
(e.g. dialysis, hemoperfusion, single-
dose or repeated-dose activated charcoal) might be considered as
well);
•
in order to improve the solubility of drug substances that are poorly
soluble in neutral or acid medium, e.g.
methotrexate, sulfadiazine;
•
in the case of haemolysis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Correction of metabolic acidosis_
Correction of metabolic acidosis should not be effected too rapidly.
It is advisable to start administering only half of
the calculated dose and adjust further doses according to the actual
results of blood gas analysis.
The dose depends on the degree of the disorder of the acid-base
status.
According to the blood gas values the amount to be administered is
calculated applying the following formula:
#
mmol sodium bicarbonate = base deficit × kg body weight × 0.2**
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