Zemaira

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

Werkstoffen:

alpha1-Proteinase inhibitor 1000mg (Human)

Beschikbaar vanaf:

CSL Behring (NZ) Ltd

INN (Algemene Internationale Benaming):

alpha1-Proteinase inhibitor 1000 mg (Human)

Dosering:

1000 mg

farmaceutische vorm:

Powder for infusion

Samenstelling:

Active: alpha1-Proteinase inhibitor 1000mg (Human) Excipient: Hydrochloric acid Mannitol Monobasic sodium phosphate monohydrate Sodium chloride Sodium hydroxide Water for injection

Eenheden in pakket:

Vial, glass, 1 vial + vial diluent + transfer device, 1 dose unit

klasse:

Prescription

Prescription-type:

Prescription

Geproduceerd door:

CSL Behring LLC

therapeutische indicaties:

Zemaira is indicated for maintenance treatment, to slow the progression of emphysema in adults with documented severe A1-PI deficiency (A1-PI < 11 µM) and progressive lung disease. Patients are to be under optimal pharmacologic and non-pharmacologic treatment.

Product samenvatting:

Package - Contents - Shelf Life: Combination pack, 1 vial active + 1 vial diluent + transfer device - 1 dose units - 36 months from date of manufacture stored at or below 25°C protect from light. Do not freeze. 3 hours reconstituted stored at or below 25°C protect from light. Do not freeze. - Vial, glass, (Type I) of diluent with a rubber stopper, aluminium seal & polypropylene flip-off cap - 20 mL - 42 months from date of manufacture stored at or below 30°C - Vial, glass, (Type I) of active with a rubber stopper, aluminium seal & polypropylene flip-off cap - 1000 mg - 36 months from date of manufacture stored at or below 25°C protect from light. Do not freeze.

Autorisatie datum:

2008-01-11

Productkenmerken

NEW ZEALAND DATA SHEET
Zemaira NZ DS 7.00
Page 1 of 16
1 PRODUCT NAME
Zemaira
®
1000 mg, powder and diluent for solution for infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Zemaira
®
is a highly purified, pasteurised, nanofiltered, lyophilised, stable
human plasma
alpha
1
-proteinase inhibitor (A
1
-PI) concentrate.
One vial contains approximately 1000 mg of A
1
-PI, as determined by its capacity to neutralise human
neutrophil elastase (NE). Zemaira
®
is produced from the plasma of human donors.
The specific activity of Zemaira
®
is ≥0.7 mg of functional A
1
-PI per milligram of total protein. The
purity is ≥92% A
1
-PI of total protein.
The total protein content is approximately 1100 mg per vial.
After reconstitution with 20 mL of diluent (Water for Injection
[WFI]), the solution contains
approximately 50 mg/mL of A
1
-PI.
EXCIPIENTS WITH KNOWN EFFECT:
Zemaira
®
contains approximately 37 mg of sodium per vial.
Zemaira
®
contains no preservatives.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and diluent for solution for infusion.
Powder: white to off-white
Diluent (WFI): clear, colourless
The reconstituted solution has an approximate osmolality of 223–335
mOsm/kg and a pH of 7.0.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zemaira
®
is indicated for maintenance treatment, to slow the progression of
emphysema in adults with
documented severe A
1
-PI deficiency (A
1
-PI <11 µM) and progressive lung disease. Patients are to be
under optimal pharmacologic and non-pharmacologic treatment.
NEW ZEALAND DATA SHEET
Zemaira NZ DS 7.00
Page 2 of 16
4.2
DOSE AND METHOD OF ADMINISTRATION
Treatment should be initiated and supervised by a healthcare
professional experienced in the use of
A
1
-PI or in the treatment of A
1
-PI deficiency.
Zemaira
®
is administered intravenously by a doctor or nurse. If
self-administration and home-
treatment is considered appropriate, refer to HOME-TREATMENT /
SELF-ADMINISTRATION below and in
section 4.4.
DOSE
The rec