Flebogamma DIF 2.5g50ml solution for infusion vials

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Normal immunoglobulin human

Tersedia dari:

Grifols UK Ltd

Kode ATC:

J06BA02

INN (Nama Internasional):

Normal immunoglobulin human

Dosis:

50mg/1ml

Bentuk farmasi:

Solution for infusion

Rute administrasi :

Intravenous

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 09010400; GTIN: 8435308300071

Karakteristik produk

OBJECT 1
FLEBOGAMMA DIF 50MG/ML
Summary of Product Characteristics Updated 03-Mar-2016 | Grifols UK
Ltd
1. Name of the medicinal product
Flebogamma DIF 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% of 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
IgG
2
IgG
3
IgG
4
66.6%
28.5%
2.7%
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 or pale
yellow.
Flebogamma DIF is isotonic, with an osmolality from 240 to 370
mOsm/kg.
4. Clinical particulars
4.1 Therapeutic indications
Replacement therapy in adults, children and adolescents (2-18 years)
in:
- Primary immunodeficiency syndromes with impaired antibody production
(see section 4.4).
- Hypogammaglobulinaemia and recurrent bacterial infections in
patients with chronic lymphocytic
leukaemia, in whom prophylactic antibiotics have failed.
- Hypogammaglobulinaemia and recurrent bacterial infections in plateau
phase multiple myeloma patients
who failed to respond to pneumococcal immunisation.
- Hypogammaglobulinaemia in patients after allogenic haematopoietic
stem cell transplantation (HSCT).
- Congenital AIDS with recurrent bacterial infections.
Immunomodulation in adults, children and adolescents (2-18 years) in:
- Primary immune thrombocytopenia (ITP), in patients at high risk of
bleeding or prior to surgery to
correct the plate