ACETYLCYSTEINE 20% W/V SOLUTION FOR INFUSION

Country: Կիպրոս

language: հունարեն

source: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

active_ingredient:

ACETYLCYSTEINE

MAH:

AURUM PHARMACEUTICALS LTD (0000003323) BAMPTON ROAD, HAROLD HILL, ROMFORD, ESSEX , RM3 8UG

ATC_code:

V03AB23

INN:

ACETYLCYSTEINE

dosage:

20% W/V

pharmaceutical_form:

SOLUTION FOR INFUSION

composition:

ACETYLCYSTEINE (0000616911) 20% W/V

administration_route:

INTRAVENOUS USE

prescription_type:

Ειδική άδεια άρθρο 126A

therapeutic_area:

ACETYLCYSTEINE

leaflet_short:

Νομικό καθεστώς: Με Ιατρική Συνταγή; 10 AMPS X 10ML (26S002101) 10 AMPOULE - Εγκεκριμένο - Με Ιατρική Συνταγή

PIL

ADMINISTRATION INFORMATION FOR THE
HEALTHCARE PROFESSIONAL
Acetylcysteine should be administered by intravenous
infusion preferably using Glucose 5% as the infusion fl uid.
Sodium Chloride 0.9% solution may be used if Glucose 5%
is not suitable.
The full course of treatment with acetylcysteine comprises
3 consecutive intravenous infusions. Doses should be
administered sequentially with no break between the
infusions. The patient should receive a total dose of 300
mg/kg body weight over a 21 hour period.
Continued treatment with acetylcysteine (given at the
dose and rate as used in the third infusion) may be
necessary depending on the clinical evaluation of the
individual patient.
ADULTS
• Weigh the patient to determine the correct weight
band.
• Use the adult dosage table to determine the
appropriate volume of acetylcysteine (ampoule volume)
to be added to the infusion fl uid for each of the 3
infusion periods.
First infusion
Add the appropriate volume of acetylcysteine injection to
200 ml of infusion fl uid and infuse over 1 HOUR.
Second infusion
Add the appropriate volume of acetylcysteine injection to
500 ml of infusion fl uid and infuse over the next 4 HOURS.
Third infusion
Add the appropriate volume of acetylcysteine injection to
1 L of infusion fl uid and infuse over the next 16 HOURS.
ADULT DOSAGE TABLE
1
Dose calculations are based on the weight in the middle of each band.
If the
patient weighs less than 40kg use the paediatric dosage table.
2
Ampoule volume has been rounded up to the nearest whole number.
The Summary of Product Characteristics should be
referred to for full prescribing information.
CHILDREN
Children are treated with the same doses and regimen as
adults. However, the quantity of intravenous fl uid used
has been modifi ed to take into account age and weight,
as fl uid overload is a potential danger. Doses should be
administered sequentially using an appropriate infusion
pump.
PREPARATION AND ADMINISTRATION OF PAEDIATRIC INFUSIONS
• Weigh the child to determine the correct wei