Angiomax

Страна: Нова Зеландия

Език: английски

Източник: Medsafe (Medicines Safety Authority)

Активна съставка:

Bivalirudin 250mg

Предлага се от:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (Международно Name):

Bivalirudin 250 mg

дозиране:

250 mg

Лекарствена форма:

Powder for injection

Композиция:

Active: Bivalirudin 250mg Excipient: Mannitol Sodium hydroxide

Броя в опаковка:

Vial, glass, single dose, Type I colourless glass, 250 mg

Клас:

Prescription

Вид предписание :

Prescription

Произведено от:

PolyPeptide SA

Терапевтични показания:

Angiomax is indicated for use as an anticoagulant: · in the treatment of patients with moderate to high risk acute coronary syndromes (ACS) (unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) who are undergoing early invasive management, and · in patients undergoing percutaneous coronary intervention (PCI). Angiomax is intended for use with aspirin. A P2Y12 antagonist (eg clopidogrel or ticlopidine) may be used in addition to aspirin.

Каталог на резюме:

Package - Contents - Shelf Life: Vial, glass, single dose, Type I colourless glass - 250 mg - 48 months from date of manufacture stored at or below 25°C

Дата Оторизация:

1998-05-15

Данни за продукта

Angiomax
®
Data sheet
Page 1
NEW ZEALAND DATA SHEET
ANGIOMAX

NAME OF THE MEDICINE
Angiomax
®
(bivalirudin) Powder for Injection 250 mg and 100 mg (lyophilised
product). DESCRIPTION
Angiomax
®
(bivalirudin) is a specific and reversible direct thrombin inhibitor.
Bivalirudin is
a synthetic, 20 amino acid residue peptide. Its chemical name is
D-phenylalanyl-L-prolyl-L-
arginyl-L-prolyl-glycyl-glycyl-glycyl-glycyl-L-asparagyl-glycyl-L-aspartyl-L-phenylalanyl-
L-glutamyl-L-glutamyl-L-isoleucyl-L-prolyl-L-glutamyl-L-glutamyl-L-tyrosyl-L-leucine
(Figure 1). Its molecular weight is 2180 daltons. The substance
isolated from the synthesis
and used in the manufacture of Angiomax
®
is bivalirudin trifluoroacetate (salt) hydrate.
Angiomax
®
is supplied in single-use vials as a white lyophilised cake, which is
sterile. Each
vial contains either: 250 mg bivalirudin present as bivalirudin
trifluoroacetate (salt) hydrate
and 125 mg mannitol; or 100 mg bivalirudin present as bivalirudin
trifluoroacetate (salt)
hydrate and 50 mg mannitol. Both presentations also contain sodium
hydroxide.
When reconstituted with Water for Injections the product yields a
clear to opalescent,
colourless to slightly yellow solution, pH 5 to 6.
FIGURE 1. STRUCTURAL FORMULA FOR BIVALIRUDIN
OH
O
NH
CH
3
CH
3
O
NH
O
H
O
O
NH
O
H
O
O
NH
OH
O
N
O
NH
CH
3
CH
3
O
O
NH
OH
O
O
NH
O
H
O
NH
O
O
NH
O
H
O
NH
O
O
NH
2
NH
O
NH
O
NH
O
NH
O
NH
O
N
N
H
O
NH
NH
2
NH
O
N
O
N
H
2
PHARMACOLOGY
Angiomax
®
directly inhibits thrombin by binding both to the catalytic site and
to the anion-
binding exosite of circulating and clot-bound thrombin.
Thrombin is a serine proteinase that plays a central role in the
thrombotic process. It acts to
cleave fibrinogen into fibrin monomers and activates Factor XIII to
Factor XIIIa, allowing
fibrin to develop a covalently cross-linked framework which stabilises
the thrombus.
Thrombin also activates Factors V and VIII, promoting further thrombin
generation, and
activates platelets, stimulating aggregation and granule release.
The bin