Aprotinin 500,000 Kallikrein inactivator units/50ml solution for infusion vials

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Aprotinin

Tilgjengelig fra:

Nordic Pharma Ltd

ATC-kode:

B02AB01

INN (International Name):

Aprotinin

Dosering :

10000Kallikrein inactivator unit/1ml

Legemiddelform:

Solution for infusion

Administreringsrute:

Intravenous

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 02110000; GTIN: 5015919121840

Preparatomtale

OBJECT 1
APROTININ 10,000 KIU/ML INJECTION BP
Summary of Product Characteristics Updated 08-Mar-2017 | Nordic Pharma
Limited
1. Name of the medicinal product
Aprotinin 10,000 KIU/ml Injection BP
2. Qualitative and quantitative composition
Each 50ml vial contains aprotinin solution corresponding to 500,000
Kallikrein Inactivator Units, KIU (=
277.8 European Pharmacopoeia, E.P. units) aprotinin in 0.9% sodium
chloride solution.
Each 100ml vial contains aprotinin solution corresponding to 1.000,000
Kallikrein Inactivator Units, KIU
(= 555.6 European Pharmacopoeia, E.P. units) aprotinin in 0.9% sodium
chloride solution.For a full list
of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection
4. Clinical particulars
4.1 Therapeutic indications
Aprotinin is indicated for prophylactic use to reduce blood loss and
blood transfusion in adult patients
who are at high risk of major blood loss undergoing isolated
cardiopulmonary bypass graft surgery (i.e.
coronary artery bypass graft surgery that is not combined with other
cardiovascular surgery).
Aprotinin should only be used after careful consideration of the
benefits and risks, and the consideration
that alternative treatments are available (see section 4.4 and 5.1).
4.2 Posology and method of administration
An appropriate aprotinin-specific IgG antibody test may be considered
before administration of aprotinin
(see section 4.3).
Adult:
Owing to the risk of allergic/anaphylactic reactions, a 1ml (10,000
KIU) test dose should be administered
to all patients at least 10 minutes prior to the remainder of the
dose. After the uneventful administration of
the 1ml test dose, the therapeutic dose may be given. A H1 antagonist
and a H2 antagonist may be
administered 15 minutes prior to the test dose of aprotinin. In any
case standard emergency treatments for
anaphylactic and allergic reactions should be readily available (see
section 4.4).
A loading dose of 1 - 2 million KIU is administered as a slow
intravenous injection or infusion over 20 -
30 minutes after