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

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

Compra'l ara

Fitxa tècnica Fitxa tècnica (SPC)
07-04-2018

ingredients actius:

Sodium bicarbonate

Disponible des:

International Medication Systems (UK) Ltd

Codi ATC:

B05XA; B05XA02

Designació comuna internacional (DCI):

Sodium bicarbonate

Dosis:

8.4 percent weight/volume

formulario farmacéutico:

Solution for injection

tipo de receta:

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

Área terapéutica:

Electrolyte solutions; sodium bicarbonate

Estat d'Autorització:

Not marketed

Data d'autorització:

1977-09-08

Informació per a l'usuari

                                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
                                
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Fitxa tècnica

                                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 acidosis 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.
In neonates, Sodium Bicarbonate is indicated for:
Correction of metabolic acidosis 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
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
circulation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The posology depends largely on the extent of the acid-base imbalance.
This should be checked
regularly. Administration is via slow intravenous injection.
For intravenous administration only.
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