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HOSPASOL 167 MMOL/L SOLUTION FOR INFUSION

Active substance(s): SODIUM HYDROGEN CARBONATE

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Hospasol® 167 mmol/l
Solution for infusion

Package Leaflet: Information for the user

Sodium hydrogen carbonate

Using other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription. This is because the
concentration in your blood of some of these
medicines may be reduced during treatment
with Hospasol® 167 mmol/l. Your doctor will
decide if any of the other medicines should be
changed.

Read all of this leaflet carefully before you
start using this medicine.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor or pharmacist.
• If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Hospasol® 167 mmol/l is and
what it is used for
2. Before you use
Hospasol® 167 mmol/l
3. How to use Hospasol® 167 mmol/l
4. Possible side effects
5. How to store
Hospasol® 167 mmol/l
6. Further information
1. What Hospasol 167 mmol/l is and
what it is used for?
Hospasol® 167 mmol/l is used in hospitals or
special centres during dialysis session to
correct chemical imbalance of the blood which
is caused by kidney failure.
®

It replaces bicarbonate (hydrogen
carbonate), which is lost from the body
during:
• Acetate-Free Biofiltration (AFB) or
• Acetate-Free Continuous Venous-Venous
Haemofiltration (AFCVVH).
It also helps restore the body’s bicarbonate
levels, which becomes depleted when the
kidneys are not working properly (renal failure).
2. BEFORE YOU ARE GIVEN
HOSPASOL® 167 MMOL/L
You must not receive Hospasol® 167 mmol/l
• if a dialysis method with buffer
supplementation is already used.
Take special care with
Hospasol® 167 mmol/l
It is important to monitor the concentration of
salts (electrolytes) in your blood and also the
acid-base balance of your body. The
composition of your blood will, therefore, be
checked at regular intervals.
Special attention should be given to:
• the pH value of your blood. In case of high
pH (alkalosis), Hospasol® 167 mmol/l shall
not be used.
• the level of sodium in your blood if you have
heart problem and/or renal failure. An
overdose of sodium may lead to fluid
retention within the body (hypervolemia) and
particularly in the lungs (pulmonary oedema).
• your blood vessels as an inflammation
associated with clot formation
(thrombophlebitis) can be induced if the
product is administered to a smaller
(peripheral) vein.
• your blood level of proteins, amino acids and
water-soluble vitamins, as significant losses
can occur during dialysis.

Pregnancy and breast-feeding
There are no adequate data from the use of
Hospasol® 167 mmol/l in pregnant or breastfeeding women. Your doctor will decide
whether you should be given
Hospasol® 167 mmol/l if you are pregnant or
breast-feeding.

UK

5. HOW TO STORE
HOSPASOL® 167 MMOL/L
Keep out of the reach and sight of children.
Do not use Hospasol® 167 mmol/l after the
expiry date which is stated on the label and the
packaging. The expiry date refers to the last
day of that month.
Do not store below +4°C.
Hospasol® 167 mmol/l can be disposed of via
wastewater without harming the environment.
6. FURTHER INFORMATION
What Hospasol® 167 mmol/l contains
The active substance is:
1000 ml of solution contains:
Sodium hydrogen carbonate

14.0 g

3. HOW TO USE HOSPASOL® 167 MMOL/L
Hospasol® 167 mmol/l is a product to be used
in hospitals or special centres with dialysis
machines. It shall be administered by medical
professionals only.

Corresponding to
Sodium, Na+


167 mmol/l
(167 mEq/l)

Hydrogen carbonate, HCO3-


167 mmol/l
(167 mEq/l)

The volume of Hospasol® 167 mmol/l, and
therefore the dose used, will depend on your
condition. The dose volume will be determined
by the physician responsible for your
treatment.

Theoretical osmolarity:

Do not use Hospasol® 167 mmol/l if the
solution is cloudy or if the over wrap is
damaged. All seals must be intact.
If you are given more Hospasol® 167 mmol/l
than you should be given
Overdose may result in too low concentration of
potassium (hypokalaemia) and/or glucose
(hypoglycaemia) in the blood. If overdose
occurs, administration of Hospasol® 167 mmol/l
should immediately be discontinued and dialysis
performed. Repeated blood-gas monitoring
should be performed.
Your doctor will take the necessary corrective
measures and adjust your dose.
If you have any further questions on the use of
this product, please ask your doctor or your
pharmacist.
4. Possible SIDE EFFECTS
Like all medicines, Hospasol® 167 mmol/l can
cause side effects, although not everybody
gets them.
There are some side effects which can be
caused by the process of haemodialysis,
such as:
• feeling sick (nausea)
• being sick (vomiting)
• muscle cramps
• high blood pressure (hypertension)
• chills
• fever
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

334 mOsm/l

The other ingredients are:
• carbon dioxide (for pH adjustment)
• water for injections.
What Hospasol® 167 mmol/l looks like and
contents of the pack
Hospasol® 167 mmol/l is presented in a one
compartment bag. The solution is clear and
colourless.
Each bag contains 3000 ml or 5000 ml
solution for infusion. The bag is over wrapped
with a transparent film.
Each box contains three bags of 3000 ml or
two bags of 5000 ml and one package leaflet.
Marketing Authorisation Holder
Gambro Lundia AB, Magistratsvägen 16,
SE- 226 43 Lund, SWEDEN
Manufacturer
Gambro Dasco S.p.A. Sondalo Plant,
Via Stelvio 94, IT-23035 Sondalo (SO), ITALY
This leaflet was last approved in 11/2009.

Hospasol® 167 mmol/l
Solution for infusion

The following information is intended for
medical or healthcare professionals only

Hospasol® 167 mmol/l solution for
infusion

The solution is for single use only. Discard any
unused solution immediately after use.

The use of a buffer-free dialysis solution (which
does not contain acetate or hydrogen
carbonate) is essential. A dialysis solution with
an appropriate composition for Acetate-Free
Biofiltration should be selected.

From a microbiological point of view, once
opened, the product should be used
immediately. If not used immediately, in-use
storage times and conditions prior to use are
the responsibility of the user.

The use of a buffer-free substitution fluid (which
does not contain acetate or hydrogen
carbonate) is essential. A substitution fluid with
an appropriate composition for Acetate-Free
Continuous Veno-Venous Haemofiltration
should be selected.
Hospasol® 167 mmol/l must be administered
alone without addition of any other medicinal
products, in particular calcium or magnesiumcontaining solutions which could result in
precipitation of calcium or magnesium
carbonate.
Hospasol® 167 mmol/l is injected into the
venous return line or is injected into the
extracorporeal circuit before (pre-dilution) or
after the haemofilter (post-dilution).
The volume, flow rate and duration of dialysis
should be determined by the responsible
physician.
Commonly used flow rates in Acetate-Free
Biofiltration are:
Adults, adolescents and elderly:
from 1 500 to 2 000 ml/hour
Children:
from 30 to 40 ml/kg/hour
Commonly used flow rates in Acetate-Free
Continuous Veno-Venous Haemofiltration are:
Adults, adolescents and elderly:
from 85 to 530 ml/hour
Children:
from 1.70 to 10.5 ml/kg/hour
INSTRUCTIONS FOR USE / HANDLING
Hospasol® 167 mmol/l is only intended for use
with dialysis machines which have been
specially designed to carry out Acetate-Free
Biofiltration (special haemodialysis technique) or
Acetate-Free Continuous Veno-Venous
Haemofiltration.
Consult the instructions for use for the dialysis
machine before you start the treatment with
Hospasol® 167 mmol/l.
Do not remove unit from over wrap until ready
for use.
Hospasol® 167 mmol/l should be used only if
the solution is clear, free of particles and all seals
intact.
Aseptic techniques must be used throughout
the administration to the patient.
Before connection and after removing the cap
of the bag connector (safelink), disinfectant
should be applied to the interior of the safelink.
Prior to disconnection, it is recommended that
the external surfaces of the line connector and
the safelink should be disinfected.

UK

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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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