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SODIUM BICARBONATE 1.26% SOLUTION FOR INFUSION

Active substance(s): SODIUM BICARBONATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Sodium Bicarbonate 1.26%
solution for infusion
Sodium Bicarbonate 1.4%
solution for infusion
Sodium Bicarbonate 2.74%
solution for infusion
Sodium Bicarbonate 4.2%
solution for infusion
Sodium Bicarbonate 8.4%
solution for infusion
Read all of this leaflet carefully before you are given 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.
• If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet:
1. What Sodium Bicarbonate infusion is and what it is used for
2. What you need to know before you are given Sodium Bicarbonate infusion
3. How you are given Sodium Bicarbonate infusion
4. Possible side effects
5. How Sodium Bicarbonate infusion is stored
6. Contents of the pack and other information

1. What Sodium Bicarbonate Infusion is
and what is it used for
Sodium Bicarbonate Infusion is an intravenous infusion (into a vein).
Sodium Bicarbonate Infusion is used when your blood and urine
contain too much acid.
The full names of the medicines covered by this leaflet are:
Sodium Bicarbonate 1.26% solution for infusion
Sodium Bicarbonate 1.4% solution for infusion
Sodium Bicarbonate 2.74% solution for infusion
Sodium Bicarbonate 4.2% solution for infusion
Sodium Bicarbonate 8.4% solution for infusion
In this leaflet they are jointly referred to as Sodium Bicarbonate Infusion.

2. What you need to know before you are
given Sodium Bicarbonate Infusion
You should not receive Sodium Bicarbonate Infusion if you:
• suffer from high blood pressure (hypertension)
• suffer from kidney disease
• suffer from heart disease
• have fluid in the lungs (pulmonary oedema)
• have above normal pH levels in your body (respiratory or metabolic
alkalosis)
• are overbreathing (hyperventilating)
• have high levels of sodium in your blood (hypernatraemia)
• have complications in your pregnancy called eclampsia (symptoms
include: convulsions, increased blood pressure, circulatory problems,
severe headaches, vision problems, pain in the upper abdomen,
vomiting, sudden swelling of your feet, ankles, face and hands and
excessive weight gain).
Warnings and precautions
Sodium Bicarbonate Infusion must be given directly into a vein and not
into body tissue.
Patients receiving resuscitation may risk the possibility of fluid in their
lungs if they are given Sodium Bicarbonate Infusion.
Prolonged use of sodium bicarbonate should be avoided because it
may cause hypokalaemia (condition in which the body fails to retain
sufficient potassium levels)
The doctor or nurse will check that the solution is free from particles before use.
Other Medicines and Sodium Bicarbonate Infusion
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
The following drugs should not be mixed with Sodium Bicarbonate Infusion:
• Vitamin c (ascorbic acid)
• benzylpenicillin, oxytetracycline, tetracycline, streptomycin,
vancomycin (antibiotics)
• calcium chloride
• calcium gluconate (used in effervescent calcium tablets)
• calcium salts of drugs
• carmustine, cisplatin (used in chemotherapy)
• codeine phosphate (painkiller, anti-diarrhoeal
• adrenaline, corticotrophin, noradrenaline (hormone)
• dobutamine (used for heart disease)
• insulin (used in treatment of diabetes)
• labetalol (high blood pressure)
• levorphanol, pethidine, morphine sulphate (used to treat severe pain)
• magnesium salts
• methadone (used in the treatment of drug addiction)
• pentobarbitone (tranquilizer and anticonvulsive medicine)
• procaine (a local anesthetic drug)
• suxamethonium (muscle relaxant)
• vitamin B complex with c
• lithium (used in the treatment of mania, antidepressant)
• hexamine based drugs (urinary antiseptics)
• amphetamine (prescription stimulant used to treat attention-deficit
hyperactivity disorder (ADHDD
• quinidine (antiarrhythmic agent)
• quinine (fever-reducing, painkiller and anti-inflammatory medicine)

If you are unsure whether you are taking one of the above
drugs, ask your doctor or pharmacist. These medicines may be
affected by sodium bicarbonate or may affect how well it works.

5. How Sodium Bicarbonate Infusion is stored

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine.
Sodium Bicarbonate Infusion is considered safe to use during
pregnancy and breastfeeding.

Keep out of the sight and reach of children.
Your doctor and hospital pharmacist are responsible for the correct
storage, use and disposal of Sodium Bicarbonate Infusion.
Sodium Bicarbonate Infusion should be stored between 2°C and 25°C.
The solutions must not be used after the expiry date shown on the
label. The expiry date refers to the last day of that month.
Any solution remaining after treatment should be disposed of via
approved hospital procedures.

Driving and using machines
Sodium Bicarbonate Infusion should not affect your ability to drive or
operate machinery.

6. Contents of the pack and other
information

3. How you are given Sodium Bicarbonate
Infusion

What Sodium Bicarbonate Infusion contains
Sodium Bicarbonate Infusions contain:
Sodium Bicarbonate
The concentration of sodium bicarbonate in the infusion can be seen
in the name of the product. The following concentrations are available:
Sodium Bicarbonate 1.26% solution for infusion
Sodium Bicarbonate 1.4% solution for infusion
Sodium Bicarbonate 2.74% solution for infusion
Sodium Bicarbonate 4.2% solution for infusion
Sodium Bicarbonate 8.4% solution for infusion
The infusions also contain water for injections, disodium edetate,
carbon dioxide.

Sodium Bicarbonate Infusion will be given to you in hospital by a
healthcare professional via intravenous infusion (into a vein).
The amount and rate at which the infusion is given depends on your
requirements.
Your doctor will decide on the correct dose for you
If you receive more Sodium Bicarbonate Infusion than you should
It is very unlikely that you will receive more infusion than you should.
If you suspect that you received too much sodium bicarbonate you
should immediately inform your doctor describing the symptoms.
Excessive amounts of infused Sodium Bicarbonate Infusion may result in:
• abnormally fast breathing (hyperpnoea)
• nausea (feeling sick)
• convulsions (fits)
If Sodium Bicarbonate Infusion is administered too quickly it may result
in chemical imbalance in the body (hyperosmolarity).

4. POSSIBLE SIDE EFFECTS
Like all medicines, Sodium Bicarbonate Infusion can cause side effects,
although not everybody gets them.
Thrombosis (the formation of a clot) may occur in the vein where the
infusion is given. The symptoms of thrombosis include:
•pain, swelling and redness at the blood clot site.
•an itchy rash at the clot site
•warm skin around the clot
•a mild fever
•major veins that stand out from your skin.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on
the safety of this medicine.

What Sodium Bicarbonate Infusions look like and contents of
the pack
Sodium Bicarbonate Infusions come in a sealed semi-rigid, cylindrical
plastic container with a ‘Twist-off’ seal at one end and a ring tab at
the opposite end. The solutions are available in 500ml size. Sodium
Bicarbonate Intravenous Infusion BP 8.4% is available in 200 ml size.
Marketing authorisation holder
Fresenius Kabi Limited
Cestrian Court
Eastgate Way
Manor Park
Runcorn
Cheshire
WA7 1NT
UK
Manufacturer:
Terumo BCT Limited,
Old Belfast Road, Millbrook,
Larne, Co. Antrim, BT40 2SH. UK.
This leaflet was last revised in September 2014.

LEAF/BICAR/0
V003/TM

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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