Hemosol B0 solution for haemodialysis/haemofiltration

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Magnesium chloride hexahydrate; Calcium chloride dihydrate; Lactic acid; Sodium hydrogen carbonate; Sodium chloride; Sodium chloride; Calcium chloride dihydrate; Magnesium chloride hexahydrate; Sodium lactate ; Sodium hydrogen carbonate

متاح من:

Baxter Holding B.V.

ATC رمز:

B05ZB

INN (الاسم الدولي):

Magnesium chloride hexahydrate; Calcium chloride dihydrate; Lactic acid; Sodium hydrogen carbonate; Sodium chloride; Sodium chloride; Calcium chloride dihydrate; Magnesium chloride hexahydrate; Sodium lactate ; Sodium hydrogen carbonate

الشكل الصيدلاني:

Solution for haemodialysis/haemofiltration

المجال العلاجي:

Hemofiltrates

الوضع إذن:

Marketed

تاريخ الترخيص:

1999-06-11

نشرة المعلومات

PACKAGE LEAFLET: INFORMATION FOR THE USER
HEMOSOL B0 SOLUTION FOR HAEMODIALYSIS/HAEMOFILTRATION
Sodium chloride/calcium chloride dihydrate/magnesium chloride
hexahydrate/lactic acid/sodium
hydrogen carbonate.
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, pharmacist or
nurse.
• If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Hemosol B0 is and what it is used for
2. What you need to know before you use Hemosol B0
3. How to use Hemosol B0
4. Possible side effects
5. How to store Hemosol B0
6. Contents of the pack and other information
1. WHAT HEMOSOL B0 IS AND WHAT IT IS USED FOR
Hemosol B0 is used in hospitals in intensive care treatments to
correct chemical imbalance of the
blood which is caused by kidney failure. The treatments are designed
to remove accumulated waste
products from the blood when the kidneys are not functioning.
Hemosol
B0 is used in the following types of treatment in adult and children
of all ages:
• haemofiltration,
• haemodiafiltration and
• haemodialysis.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE HEMOSOL B0
DO NOT USE HEMOSOL B0:
If you are allergic to one of the active substances or any of the
other ingredients (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Hemosol B0.
Hemosol B0 is a product to be used in hospitals and administered by
medical professionals only. They
will ensure a safe use of the medicine.
Before and during treatment, your blood condition will be checked,
e.g. your acid-base balance and
concentrations of salts in the blood (electrolytes) will be monitored,
including all fluid you are given
(intravenous infusion) and that you produce (urine production), even
those not directly related to the
the

خصائص المنتج

Health Products Regulatory Authority
21 March 2024
CRN00F6WN
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hemosol B0 solution for haemodialysis/haemofiltration
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Hemosol B0 consists of a two compartment PVC bag containing the
electrolyte solution in the small compartment
(compartment A) and the buffer solution in the large compartment
(compartment B).
BEFORE RECONSTITUTION
1 000 ml of electrolyte solution (small
compartment A) contains:
active substances:
Calcium chloride, 2H
2
O
Magnesium chloride, 6H
2
O
Lactic acid
5,145 g
2,033 g
5,4 g
1 000 ml of buffer solution (large
compartment B) contains:
active substances:
Sodium hydrogen carbonate
Sodium chloride
3,09 g
6,45 g
AFTER RECONSTITUTION
The small and the large compartments are mixed to give one
reconstituted solution whose ionic composition is:
IN MMOL/L
IN MEQ/L
Calcium Ca
2+
1,75
3,50
Magnesium Mg
2+
0,5
1,0
Sodium Na
+
140
140
Chloride Cl
-
109,5
109,5
Lactate
3
3
Hydrogen carbonate HCO
3
-
32
32
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for haemodialysis/haemofiltration.
Clear and colourless reconstituted solution.
Theoretical Osmolarity: 287 mOsm/l
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As substitution solution in continuous haemofiltration and
haemodiafiltration and as dialysis solution in continuous
haemodialysis for acute renal failure in adult and children of all
ages.
Health Products Regulatory Authority
21 March 2024
CRN00F6WN
Page 2 of 7
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
The rate at which Hemosol B0 is administered depends on the blood
concentration of electrolytes, acid-base balance, fluid
balance and overall clinical condition of the patient. The volume of
replacement solution and/or dialysate to be administered
will also depend on the desired intensity (dose) of the treatment. The
solution should be prescribed and administration (dose,
infusion rate, and cumulative volume) should be established only b