Gamunex

Maa: Uusi-Seelanti

Kieli: englanti

Lähde: Medsafe (Medicines Safety Authority)

Aktiivinen ainesosa:

Normal immunoglobulin 100 mg/mL

Saatavilla:

Pharmaco (NZ) Ltd

INN (Kansainvälinen yleisnimi):

Normal immunoglobulin 100 mg/mL

Annos:

100 g/L

Lääkemuoto:

Solution for infusion

Koostumus:

Active: Normal immunoglobulin 100 mg/mL Excipient: Glycine Water for injection

Prescription tyyppi:

Prescription

Valmistaja:

Grifols Therapeutics LLC

Käyttöaiheet:

Replacement therapy indications: - Primary Immunodeficiency (PI) Diseases - Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.

Tuoteyhteenveto:

Package - Contents - Shelf Life: Vial, glass, - 10 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 6 months from date of manufacture stored at or below 25°C. anytime during the 36 mos refrigerated shelf life, no return to refrigeration - Vial, glass, - 25 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 6 months from date of manufacture stored at or below 25°C. anytime during the 36 mos refrigerated shelf life, no return to refrigeration - Vial, glass, - 50 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 6 months from date of manufacture stored at or below 25°C. anytime during the 36 mos refrigerated shelf life, no return to refrigeration - Vial, glass, - 100 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 6 months from date of manufacture stored at or below 25°C. anytime during the 36 mos refrigerated shelf life, no return to refrigeration - Vial, glass, - 200 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 6 months from date of manufacture stored at or below 25°C. anytime during the 36 mos refrigerated shelf life, no return to refrigeration

Valtuutus päivämäärä:

2015-10-13

Pakkausseloste

New Zealand Consumer Medicine Information
GAMUNEX
®
_Normal Immunoglobulin (Human), 10% _
for Intravenous or Subcutaneous
Administration
______________________________________________________
WHAT IS IN THIS LEAFLET
______________________________________________________
This leaflet answers some common questions about GAMUNEX
®
. It does not contain all
the available information. It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you receiving
GAMUNEX
®
against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT RECEIVING THIS MEDICINE, ASK YOUR
DOCTOR OR
PHARMACIST.
Keep this leaflet. You may need to read it again.
______________________________________________________
WHAT GAMUNEX
® IS USED FOR
______________________________________________________
GAMUNEX
®
is used to replace antibodies (used to fight infections) in people
with
conditions that impair the body’s ability to make antibodies. These
conditions include:
•
Primary Immunodeficiency Diseases.
•
Symptomatic Hypogammaglobulinaemia secondary to underlying disease or
treatment.
GAMUNEX
®
is also used to modulate the immune system in people whose immune
systems are not working well. These conditions include
GAMUNEX
®
1
•
Idiopathic Thrombocytopaenic Purpura (ITP), in patients at high risk
of bleeding or
prior to surgery to correct the platelet count.
People with ITP have antibodies that do not work properly and may need
treatment with
GAMUNEX
®
to raise blood platelet counts to prevent bleeding or prior to
undergoing
surgery.
•
Guillain Barré Syndrome (GBS).
•
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
•
Kawasaki disease.
This medicine belongs to a group of medicines called immunoglobulins.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS
BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed it for another reason.
______________________________________________________
BEFORE YOU

Valmisteyhteenveto

NEW ZEALAND DATA SHEET
1. PRODUCT NAME
GAMUNEX®, Normal Immunoglobulin (Human), 10%,
100 mg/mL, Solution for Intravenous or
Subcutaneous Administration
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Normal Immunoglobulin (Human), 10%
One ml contains:
Normal immunoglobulin (human)
...............................................................................100
mg
(purity of at least 98% IgG)
One vial of 10 mL contains: 1 g
One vial of 25 mL contains: 2.5 g
One vial of 50 mL contains: 5 g
One vial of 100 mL contains: 10 g
One vial of 200 mL contains: 20 g
Distribution of the IgG subclasses (average values):
IgG
1
.................... 62.8%
IgG
2
.................... 29.7%
IgG
3
...................... 4.8%
IgG
4
.......................2.7%
1 ml GAMUNEX® contains 100 mg protein with an IgG content of at least
98%. GAMUNEX® contains
trace levels of fragments and IgA (≤ 0.084 mg/mL) and IgM.
Produced from plasma of human donors.
GAMUNEX® contains 0.16–0.24 M glycine. The pH of GAMUNEX® is 4.0
– 4.5. GAMUNEX® contains no
preservative.
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Solution for intravenous or subcutaneous administration
The solution is clear to opalescent, and colourless to pale yellow.
The measured buffer capacity is 35 mEq/L and the osmolality is 258
mOsmol/kg solvent, which is
close to physiological osmolality (285 - 295 mOsmol/kg).
GAMUNEX®
, 10%
Page 1 of 23
NEW ZEALAND DATA SHEET
4. CLINICAL PARTICULARS
4.1
Therapeutic indications
Replacement therapy in:
-
Primary Immunodeficiency (PI) diseases.
-
Symptomatic Hypogammaglobulinaemia secondary to underlying disease or
treatment.
Immunomodulation in:
-
Idiopathic Thrombocytopaenic Purpura (ITP), in patients at high risk
of bleeding or prior to
surgery to correct the platelet count.
-
Guillain Barré Syndrome (GBS).
-
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
-
Kawasaki disease.
4.2
Dose and method of administration
GAMUNEX® is recommended for administration by intravenous infusion
for all indications