Dianeal PD4 Glucose 1.36% w/v 13.6mg/ml

Χώρα: Μάλτα

Γλώσσα: Αγγλικά

Πηγή: Malta Medicines Authority

Δραστική ουσία:

CALCIUM CHLORIDE; ANHYDROUS GLUCOSE; MAGNESIUM CHLORIDE ANHYDROUS; SODIUM CHLORIDE; SODIUM LACTATE

Διαθέσιμο από:

Baxter Healthcare Limited

Φαρμακολογική κατηγορία (ATC):

B05DB

INN (Διεθνής Όνομα):

CALCIUM CHLORIDE; ANHYDROUS GLUCOSE; MAGNESIUM CHLORIDE ANHYDROUS; SODIUM CHLORIDE; SODIUM LACTATE

Φαρμακοτεχνική μορφή:

SOLUTION FOR PERITONEAL DIALYSIS

Σύνθεση:

CALCIUM CHLORIDE 0.0184 % (W/V); ANHYDROUS GLUCOSE 1.36 % (W/V); MAGNESIUM CHLORIDE ANHYDROUS 0.0051 % (W/V); SODIUM CHLORIDE 0.538 % (W/V); SODIUM LACTATE 0.448 % (W/V)

Τρόπος διάθεσης:

POM

Θεραπευτική περιοχή:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2006-11-27

Φύλλο οδηγιών χρήσης

1
CB-30-02-388
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.
–
If you get any side effects talk to your doctor. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1.
What DIANEAL PD4 is and what it is used for
2. What you need to know before you use DIANEAL PD4
3. How to use DIANEAL PD4
4. Possible side effects
5.
How to store DIANEAL PD4
6.
Contents of the pack and other information
1.
WHAT DIANEAL PD4 IS AND WHAT IT IS USED FOR
DIANEAL PD4 is a solution for peritoneal dialysis.
It removes water and waste products from the blood. It also corrects
abnormal
levels of different blood components. DIANEAL PD4 contains varying
levels of
glucose (1.36%, 2.27% or 3.86%). The higher the strength of glucose in
the
solution, the greater the amount of water that will be removed from
the blood.
DIANEAL PD4 may be prescribed to you if you have:
•
either temporary or permanent kidney failure
•
severe water retention
•
severe disturbances in the acidity or alkalinity and the level of
salts in
your blood
•
certain types of drug intoxication where no other treatments are
available.
DIANEAL PD4 is particularly indicated for the control of your serum
calcium and
phosphate levels if you receive calcium or magnesium containing
phosphate
binders.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DIANEAL PD4
Do not use DIANEAL PD4
•
if you are allergic to active substances or any of the other
ingredients
of this medicine (listed in section 6).
•
if you have severe lactic acidosis (too much acid in the blood) before
you use this solution for the first time.
•
if you have a surgically uncorrectable problem affecting your
abdominal wall or cavity or uncorrectable problem that increases risk
of abdominal infections.
•
if you have documented loss of peritoneal function due to severe
peritoneal

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dianeal PD4 Glucose 1.36% w/v 13.6 mg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Anhydrous Glucose
Ph.Eur.
1.36 % w/v
or
Glucose Monohydrate
Ph.Eur.
1.50 % w/v
Sodium Chloride
Ph.Eur.
0.538 % w/v
Sodium Lactate
Ph.Eur.
0.448 % w/v
Calcium Chloride
Ph.Eur.
0.0184 % w/v
Magnesium Chloride
Ph.Eur.
0.0051 % w/v
3.
PHARMACEUTICAL FORM
Solution for peritoneal dialysis.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Dianeal PD4 is indicated whenever peritoneal dialysis is employed,
including:
1.
Acute and chronic renal failure;
2.
Severe water retention;
3.
Electrolyte disorders;
4.
Drug intoxication, when a more adequate therapeutic alternative is not
available.
Dianeal PD4 is particularly useful for the control of serum calcium
and phosphate levels
in renal failure patients receiving calcium or magnesium-containing
phosphate binders.
Route of administration
Intraperitoneal administration only.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology: _
The mode of therapy, frequency of treatment, exchange volume, duration
of dwell and
length of dialysis should be selected by the attending physician.
Adults
Patients on continuous ambulatory peritoneal dialysis (CAPD) typically
perform 4 cycles
per day (24 hours). Patients on automated peritoneal dialysis (APD)
typically perform 4-5
cycles at night and up to 2 cycles during the day. The fill volume
depends on body size,
usually from 2.0 to 2.5 litres.
Paediatric population (i.e., newborn to 18 years of age)
800 to 1400 ml/m2 per cycle up to a maximum amount of 2000 ml, as
tolerated, is
recommended. Fill volumes of 500 to 1000 ml/m2 are recommended in
children less than
2 years of age.
As the patient’s body weight becomes closer to the ideal dry weight,
lowering the glucose
concentration of DIANEAL is recommended.
To avoid the risk of severe dehydration and hypovolaemia and to
minimise the loss of
proteins, it is advisable to select the peritoneal dialysis solution
with the lowest level of
osmola