Biphozyl Solution for haemodialysis / haemofiltration

Страна: Мальта

Язык: английский

Источник: Medicines Authority

Активный ингредиент:

DISODIUM PHOSPHATE, DIHYDRATE, MAGNESIUM CHLORIDE, HEXAHYDRATE, SODIUM CHLORIDE, SODIUM HYDROGEN, CARBONATE, POTASSIUM CHLORIDE

Доступна с:

Gambro Lundia AB

код АТС:

B05ZB

ИНН (Международная Имя):

DISODIUM PHOSPHATE, DIHYDRATE, MAGNESIUM CHLORIDE, HEXAHYDRATE, SODIUM CHLORIDE, SODIUM HYDROGEN, CARBONATE, POTASSIUM CHLORIDE

Фармацевтическая форма:

SOLUTION FOR HAEMODIALYSIS, SOLUTION FOR HAEMOFILTRATION

состав:

DISODIUM PHOSPHATE DIHYDRATE 0.187 gram(s)/litre ; MAGNESIUM CHLORIDE HEXAHYDRATE 3.05 gram(s)/litre ; SODIUM CHLORIDE 7.01 gram(s)/litre ; SODIUM HYDROGEN CARBONATE 2.12 gram(s)/litre ; POTASSIUM CHLORIDE 0.314 gram(s)/litre

Тип рецепта:

POM

Терапевтические области:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Статус Авторизация:

Authorised

Дата Авторизация:

2015-02-19

тонкая брошюра

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PACKAGE LEAFLET: INFORMATION FOR THE USER
BIPHOZYL SOLUTION FOR HAEMODIALYSIS / HAEMOFILTRATION
MAGNESIUM CHLORIDE HEXAHYDRATE, SODIUM CHLORIDE, SODIUM HYDROGEN
CARBONATE, POTASSIUM
CHLORIDE, DISODIUM PHOSPHATE DIHYDRATE
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 Biphozyl is and what it is used for
2.
What you need to know before you use Biphozyl
3.
How to use Biphozyl
4.
Possible side effects
5.
How to store Biphozyl
6.
Contents of the pack and other information
1.
WHAT BIPHOZYL IS AND WHAT IT IS USED FOR
This
medicine
is
a
solution
for
dialysis
treatment
(haemofiltration,
haemodialysis
and
haemodiafiltration) which is used to remove waste products from the
blood when the kidneys are
not functioning. This medicine is used in hospitals during intensive
care treatment using Continuous
Renal Replacement Therapy (CRRT). This medicine is particularly used
to treat critically ill
patients with acute kidney injury having:
•
a normal concentration of potassium (normal kalaemia) in the blood
•
a normal pH in the blood
•
a normal or low concentration of phosphate (normal or
hypophosphataemia) in the blood
•
a high concentration of calcium (hypercalcaemia) in the blood
This medicine may also be used
•
when
other
bicarbonate
sources
are
available
or
when
extracorporeal
circuit
is
anticoagulated with citrate.
•
in case of drug poisoning or intoxications with dialysable or
filterable substances.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BIPHOZYL
_ _
DO NOT USE BIPHOZYL IN CASE OF:
•
allergy to one of the active substances or any of the other
ingredients (listed in section 6)
•
a low concentration of calcium (hypo

Характеристики продукта

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Biphozyl Solution for haemodialysis / haemofiltration
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Biphozyl is presented in a two-compartment bag. The final
reconstituted solution is obtained after
opening the peel seal and mixing the contents of the two compartments.
BEFORE RECONSTITUTION
Composition in the small compartment:
Magnesium chloride hexahydrate
3.05 g/l
Composition in the large compartment:
Sodium chloride
7.01 g/l
Sodium hydrogen carbonate
2.12 g/l
Potassium chloride
0.314 g/l
Disodium phosphate dihydrate
0.187 g/l
AFTER RECONSTITUTION
Composition of the reconstituted solution:
-
Active substances
mmol/l
mEq/l
-
Sodium
Na
+
140
140
-
Potassium
K
+
4
4
-
Magnesium
Mg
2+
0.75
1.5
-
Chloride
Cl
-
122
122
-
Hydrogen phosphate
HPO
4
2-
1
2
-
Hydrogen carbonate
HCO
3
-
22
22
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for haemodialysis / haemofiltration
Clear and colourless solution
Theoretical osmolarity: 290 mOsm/l
pH = 7.0 – 8.0
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Biphozyl is used as replacement solution and as dialysate for
treatment of acute kidney injury
during continuous renal replacement therapy (CRRT). Biphozyl is used
in a post-acute phase after
initiation of renal replacement therapy when pH, potassium and
phosphate concentration have
returned to normal. Biphozyl is also used when other buffer sources
are available as well as during
regional citrate anticoagulation.
Moreover, Biphozyl is used in patients with hypercalcaemia.
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Biphozyl may also be used in cases of drug poisoning or intoxications
when the substances are
dialysable or filterable.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The volume and rate at which Biphozyl is administered depends on the
blood concentration of
phosphate and other electrolytes, acid–base balance,
fluid balance and overall clinical condition of
the patient. The volume of replacement solution and/or