Flebogamma 5% DIF

Страна: Нова Зеландія

мова: англійська

Джерело: Medsafe (Medicines Safety Authority)

Активний інгредієнт:

Normal immunoglobulin 50 mg/mL

Доступна з:

Pharmaco (NZ) Ltd

ІПН (Міжнародна Ім'я):

Normal immunoglobulin 50 mg/mL

Дозування:

50 g/L

Фармацевтична форма:

Solution for infusion

Склад:

Active: Normal immunoglobulin 50 mg/mL Excipient: Sorbitol Water for injection

Одиниць в упаковці:

Vial, glass, single dose, 1xType II glass with Chloro-butyl rubber stopper and aluminium cap, 10 mL

Клас:

Prescription

Тип рецепту:

Prescription

Виробник:

Instituto Grifols S.A

Терапевтичні свідчення:

Flebogamma 5% DIF is indicated for: Replacement therapy in: Primary immunodeficiency syndromes such as: - congenital agammaglobulinaemia and hypogammaglobulinaemia - common variable immunodeficiency - severe combined immunodeficiency - Wiskott Aldrich syndrome Myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections. Children with congenital AIDS and recurrent infections. Immunomodulation Idiopathic thrombocytopenic purpura (ITP), in children or adults at high risk of bleeding or prior to surgery to correct the platelet count. Guillain Barr? syndrome. Allogeneic bone marrow transplantation.

Огляд продуктів:

Package - Contents - Shelf Life: Vial, glass, single dose, 1xType II glass with Chloro-butyl rubber stopper and aluminium cap - 10 mL - 24 months from date of manufacture stored at or below 30°C protect from light. Do not freeze - Vial, glass, single dose, 1xType II glass with Chloro-butyl rubber stopper and aluminium cap - 50 mL - 24 months from date of manufacture stored at or below 30°C protect from light. Do not freeze - Vial, glass, single dose, 1xType II glass with Chloro-butyl rubber stopper and aluminium cap - 100 mL - 24 months from date of manufacture stored at or below 30°C protect from light. Do not freeze - Vial, glass, single dose, 1xType II glass with Chloro-butyl rubber stopper and aluminium cap - 200 mL - 24 months from date of manufacture stored at or below 30°C protect from light. Do not freeze - Vial, glass, single dose, 1xType II glass with Chloro-butyl rubber stopper and aluminium cap - 400 mL - 24 months from date of manufacture stored at or below 30°C protect from light. Do not freeze

Дата Авторизація:

2010-05-20

інформаційний буклет

New Zealand Consumer Medicine Information
FLEBOGAMMA 5% DIF
_HUMAN NORMAL IMMUNOGLOBULIN (IVIG) _
50 mg/ml – Solution for infusion
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using Flebogamma
5% DIF.
This leaflet answers some common questions about Flebogamma 5% DIF. 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 using
Flebogamma 5% DIF against the benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with the medicine. You may need to read it again.
WHAT FLEBOGAMMA 5% DIF IS USED FOR
Treatment of patients who do not have sufficient antibodies
(replacement therapy):
•
Primary immunodeficiency syndromes such as:
•
congenital agammaglobulinaemia and hypogammaglobulinaemia
•
common variable immunodeficiency
•
severe combined immunodeficiency
•
Wiskott Aldrich syndrome
•
Myeloma or chronic lymphocytic leukaemia with severe secondary
hypogammaglobulinaemia and recurrent infections.
•
Children with congenital AIDS and recurrent infections.
Treatment of patients with certain inflammatory disorders
(immunomodulation):
•
Idiopathic thrombocytopenic purpura (ITP), in children or adults at
high risk of
bleeding or prior to surgery to correct the platelet count.
•
Guillain Barré syndrome.
v1
1
Treatment or prevention of infections after a bone marrow
transplantation (allogeneic
bone marrow transplantation).
Your doctor may have prescribed Flebogamma 5% DIF for another reason.
Ask your doctor if you have any questions about why Flebogamma 5% DIF
has been
prescribed for you.
BEFORE YOU USE FLEBOGAMMA 5% DIF
_ _
_WHEN YOU MUST NOT USE IT _
DO NOT USE FLEBOGAMMA 5% DIF
•
if you are allergic (hypersensitive) to human normal immunoglobulin or
any of the
other ingredients of Flebogamma 5% DIF.
(See special warnings about excipients at the e

Характеристики продукта

NEW ZEALAND DATA SHEET
1. PRODUCT NAME
Flebogamma 5% DIF
Human normal immunoglobulin (IVIg) 50 mg/ml - Solution for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Human normal immunoglobulin (IVIg)
One ml contains:
Human normal immunoglobulin…………..50 mg
(purity of at least 97% IgG)
Each vial of 10 ml contains: 0.5 g of human normal immunoglobulin
Each vial of 50 ml contains: 2.5 g of human normal immunoglobulin
Each vial of 100 ml contains: 5 g of human normal immunoglobulin
Each vial of 200 ml contains: 10 g of human normal immunoglobulin
Each vial of 400 ml contains: 20 g of human normal immunoglobulin
Distribution of the IgG subclasses (approx. values):
IgG
1
66.6%
IgG
2
28.5%
IgG
3
2.7%
IgG
4
2.2%
The maximum IgA content is 50 micrograms/ml.
Produced from the plasma of human donors.
Excipient with known effect:
_ _
One ml contains 50 mg of D-sorbitol.
_ _
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for infusion.
The solution is clear or slightly opalescent and colourless to pale
yellow.
Flebogamma DIF is isotonic, with an osmolality from 250 to 350
mOsm/kg.
v1
Page 1 of 11
NEW ZEALAND DATA SHEET
4. CLINICAL PARTICULARS
4.1
Therapeutic indications
Flebogamma 5% DIF is indicated for:
Replacement therapy in:
Primary immunodeficiency syndromes such as:
-
congenital agammaglobulinaemia and hypogammaglobulinaemia
-
common variable immunodeficiency
-
severe combined immunodeficiency
-
Wiskott Aldrich syndrome
Myeloma or chronic lymphocytic leukaemia with severe secondary
hypogammaglobulinaemia and
recurrent infections.
Children with congenital AIDS and recurrent infections.
Immunomodulation
Idiopathic thrombocytopenic purpura (ITP), in children or adults at
high risk of bleeding or prior to
surgery to correct the platelet count.
Guillain Barré syndrome.
Allogeneic bone marrow transplantation.
4.2
Dose and method of administration
DOSE
The dose and dosage regimen is dependent on the indication.
In replacement therapy the dosage may need to be individualised for
eac