RiaSTAP

Страна: Нова Зеландия

Език: английски

Източник: Medsafe (Medicines Safety Authority)

Активна съставка:

Fibrinogen 900mg - 1300mg (Human)

Предлага се от:

CSL Behring (NZ) Ltd

INN (Международно Name):

Fibrinogen 900 mg - 1300 mg (Human)

дозиране:

1 g

Лекарствена форма:

Powder for injection

Композиция:

Active: Fibrinogen 900mg - 1300mg (Human) Excipient: Albumin Arginine hydrochloride Sodium chloride Sodium citrate

Броя в опаковка:

Vial, glass, Type II with rubber stopper and cap, 1 dose unit

Клас:

General sale

Вид предписание :

General sale

Произведено от:

CSL Behring GmbH

Терапевтични показания:

Treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenaemia and hypofibrinogenaemia.

Каталог на резюме:

Package - Contents - Shelf Life: Vial, glass, Type II with rubber stopper and cap - 1 dose units - 60 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. do not freeze 6 hours reconstituted stored at or below 25°C. do not refrigerate

Дата Оторизация:

2011-02-14

Данни за продукта

NEW ZEALAND DATA SHEET
RiaSTAP NZ DS v8.00b
Page
1
of
11
1 PRODUCT NAME
RiaSTAP
®
1 g, powder for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
RiaSTAP
®
is a freeze-dried fibrinogen (coagulation factor I) concentrate
derived from human plasma.
It is produced as a sterile white powder for intravenous injection
after reconstitution with Water for
Injections.
RiaSTAP
®
is presented as:
•
1 vial of powder for injection containing 1 g of human fibrinogen
The reconstituted solution contains approximately 20 mg/mL of human
fibrinogen.
_EXCIPIENT WITH KNOWN EFFECT: _
Sodium up to 164 mg (7.1 mmol) per vial.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for injection
Powder: white
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of acute bleeding episodes in patients with congenital
fibrinogen deficiency, including
afibrinogenaemia and hypofibrinogenaemia.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
Treatment should be initiated under the supervision of a physician
experienced in the treatment of
coagulation disorders.
The dosage and duration of the substitution therapy depend on the
severity of the disorder, location
and extent of bleeding and the patient’s clinical condition.
The (functional) fibrinogen level should be determined in order to
calculate individual dosage and the
amount and frequency of administration should be determined on an
individual patient basis by
regular measurement of plasma fibrinogen level and continuous
monitoring of the clinical condition
of the patient and other replacement therapies used.
NEW ZEALAND DATA SHEET
RiaSTAP NZ DS v8.00b
Page
2
of
11
Only general dosage guidelines are given below. Normal plasma
fibrinogen level is in the range of
2.0–4.5 g/L. The critical plasma fibrinogen level below which
haemorrhages may occur is
approximately 1.0 g/L.
Clinical data on the use of RiaSTAP
®
in patients undergoing surgical procedures are very limited. In
case of surgical intervention, precise monitoring of replacement
therapy by coagula