DBL™ Acetylcysteine

Ülke: Yeni Zelanda

Dil: İngilizce

Kaynak: Medsafe (Medicines Safety Authority)

Aktif bileşen:

Acetylcysteine 200 mg/mL

Mevcut itibaren:

Pfizer New Zealand Limited

INN (International Adı):

Acetylcysteine 200 mg/mL

Doz:

2 g/10mL

Farmasötik formu:

Concentrate for injection

Kompozisyon:

Active: Acetylcysteine 200 mg/mL Excipient: Disodium edetate dihydrate Sodium hydroxide 5 M: 14.557 - 43.671 mg/mL Sodium hydroxide Water for injection

Paketteki üniteler:

Ampoule, BP/Ph Eur Type I glass one point cut ampoule, 10 x 10 mL, 100 mL

Sınıf:

Prescription

Reçete türü:

Prescription

Tarafından üretildi:

PharmaZell GmbH

Terapötik endikasyonlar:

N-acetylcysteine is indicated for the treatment of paracetamol overdose in patients: - who present within 8 hours after an acute overdose of immediate-release paracetamol, with a serum paracetamol level on or over the nomogram line, or - who present more than 8 hours after an acute overdose of immediate-release paracetamol, or - who have ingested >= 200 milligrams/kg or >= 10 g (whichever is less) of modified-release paracetamol, or - who have ingested < 200 milligrams/kg and < 10 g of modified-release paracetamol, with serum paracetamol level over the nomogram line, or - who have ingested >= 200 milligrams/kg or >=10 g (whichever is less) of paracetamol over a single 24 hour period, and have an ALT >=50 U/L or serum paracetamol concentration >=20 milligrams/L (132 micromol/L), or - who have ingested >=300 milligrams/kg or >=12 g (whichever is less) of paracetamol over a single 48 hour period, and have an ALT >=50 U/L or serum paracetamol concentration >=20 milligrams/L (132 micromol/L), or - who have ingested the equivalent or more of a daily therapeutic dose of paracetamol per day for more than 48 hours and also have abdominal pain or nausea or vomiting, and have an ALT >=50 U/L or serum paracetamol concentration >=20 milligrams/L (132 micromol/L), or - where there is any doubt over the time of an acute overdose, irrespective of serum paracetamol level, or - where serum paracetamol concentration is >=150 milligrams/L 4 hours post-ingestion in children less than 6 years of age.

Ürün özeti:

Package - Contents - Shelf Life: Ampoule, BP/Ph Eur Type I glass one point cut ampoule, 10 mL - 10 dose units - 15 months from date of manufacture stored at or below 25°C protect from light

Yetkilendirme tarihi:

2006-04-18

Ürün özellikleri

Version: pfdaceti10721
Supersedes: 6.0
Page 1 of 13
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME_ _
DBL™ ACETYLCYSTEINE INJECTION CONCENTRATE
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Acetylcysteine 20% w/v or 200 milligrams in 1 mL
Each 10 mL ampoule contains 2 g Acetylcysteine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for Solution for Infusion
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
N-acetylcysteine is indicated for the treatment of paracetamol
overdose in patients:
•
who present within 8 hours after an acute overdose of
immediate-release paracetamol, with
a serum paracetamol level on or over the nomogram line. or
•
who present more than 8 hours after an acute overdose of
immediate-release paracetamol.
or
•
who have ingested ≥200 milligrams/kg or ≥10 g (whichever is less)
of modified-release
paracetamol. or
•
who have ingested <200 milligrams/kg and <10 g of modified-release
paracetamol, with
serum paracetamol level over the nomogram line. or
•
who have ingested ≥200 milligrams/kg or ≥10 g (whichever is less)
of paracetamol over a
single 24 hour period, and have an ALT ≥50 U/L or serum paracetamol
concentration
≥20 milligrams/L (132 μmol/L). or
•
who have ingested ≥300 milligrams/kg or ≥12 g (whichever is less)
of paracetamol over a
single 48 hour period, and have an ALT ≥50 U/L or serum paracetamol
concentration
≥20 milligrams/L (132 μmol/L). or
•
who have ingested the equivalent or more of a daily therapeutic dose
of paracetamol per
day for more than 48 hours and also have abdominal pain or nausea or
vomiting, and have
an ALT ≥50 U/L or serum paracetamol concentration ≥20 milligrams/L
(132 μmol/L). or
•
where there is any doubt over the time of an acute overdose,
irrespective of serum
paracetamol level. or
•
where serum paracetamol concentration is ≥150 milligrams/L 4 hours
post-ingestion in
children less than 6 years of age.
Version: pfdaceti10721
Supersedes: 6.0
Page 2 of 13
FIGURE 1. PARACETAMOL TREATMENT N