Sodium Bicarbonate Injection BP Minijet 8.4% w/v, Solution for Injection

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Sodium bicarbonate

Dostupné z:

DLRC Pharma Services Limited

ATC kód:

B05XA; B05XA02

INN (Medzinárodný Name):

Sodium bicarbonate

Dávkovanie:

8.4 percent weight/volume

Forma lieku:

Solution for injection

Terapeutické oblasti:

Electrolyte solutions; sodium bicarbonate

Stav Autorizácia:

Not marketed

Dátum Autorizácia:

1977-09-08

Príbalový leták

SODIUM BICARBONATE INJECTION BP MINIJET, 4.2 % W/V & 8.4 % W/V
SOLUTION FOR INJECTION
SODIUM BICARBONATE
Patient Information Leaflet
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE.
•
Keep this leaflet. You may need to read it again
•
If you have any further questions, ask your doctor or nurse
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours
•
In this leaflet, Sodium Bicarbonate Injection BP Minijet, Solution for
Injection will be called
Sodium Bicarbonate Injection.
IN THIS LEAFLET:
1. What Sodium Bicarbonate Injection is for
2. Before you are given Sodium Bicarbonate Injection
3. How Sodium Bicarbonate Injection will be given to you
4. Possible side effects
5. How to store Sodium Bicarbonate Injection
6. Further information.
1. WHAT SODIUM BICARBONATE INJECTION IS FOR
Sodium bicarbonate is a simple chemical which is used in medicine when
your blood contains too
much acid.
Sodium bicarbonate is used to reduce the amount of acid in the body
after a heart attack in patients
who have the following conditions: too much acid in their body or too
much potassium in their blood.
It can also be used to treat patients who have taken too much
tricyclic antidepressant medicine.
Sodium Bicarbonate will only be used after other resuscitation methods
have been attempted.
2. BEFORE YOU ARE GIVEN SODIUM BICARBONATE INJECTION
Do not use Sodium Bicarbonate Injection if:
• You are allergic to sodium bicarbonate
• You have kidney failure
• You have heart failure
• You have high blood pressure
• You have low blood calcium, potassium or chloride
• You have high blood sodium or pH
• You have had kidney stones
• You suffer from fluid retention
• You suffer from breathing problems (hypoventilation)
If any of these applies to you talk to your doctor or nurse.
TELL YOUR DOCTOR IF YOU ARE TAKING ANY OF THE FOLLOWING MEDICINES:
• Corticosteroids or Corticotrophin
• Medicines of an acidic nature (e.g. tet

Súhrn charakteristických

HealthProductsRegulatoryAuthority
29May2019
CRN008TLL
Page1of5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
SodiumBicarbonateInjectionBPMinijet8.4%w/v,SolutionforInjection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodiumbicarbonate84mgin1ml.
840mg/10ml inaprefilledsyringe.
Forfulllistofexcipients,seesection6.1. 
3 PHARMACEUTICAL FORM
Solutionforinjection.
Clear,colourlesssolution. 
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
SodiumBicarbonateInjectionisindicatedinadultsandchildrenfor:

-Correctionofmetabolicacidosisassociatedwithcardiacarrestinpatientswithpre-existingmetabolicacidosis

-Cardiacarrestassociatedwithhyperkalaemiawithpre-existingmetabolicacidosis

-Lifethreateninghyperkalaemiawithpre-existingmetabolicacidosis

-Tricyclicantidepressantoverdose.
Sodiumbicarbonateshouldonlybeusedafterotherresuscitativemeasuressuchascardiaccompression,ventilation,
adrenalineandantiarrhythmicagentshavebeenattempted.
Inneonates,SodiumBicarbonateisindicatedfor:

-Correctionofmetabolicacidosisassociatedwithcardiacarrestinpatientswithpre-existingmetabolicacidosis

-Cardiacarrestassociatedwithhyperkalaemiawithpre-existingmetabolicacidosis

-Lifethreateninghyperkalaemiawithpre-existingmetabolicacidosis
Nobenefitshavebeendemonstratedfromtheroutineuseofsodiumbicarbonateinresuscitationofneonates.Inneonates,
sodiumbicarbonateisrecommendedinresuscitationonlyincasesofprolongedcardiacarrest,irresponsivetoothertherapy,
afterestablishmentofadequateventilationandcirculatio