Product class:
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Authorized package
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Medicinal product class:
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For human use
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Package code:
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1327722
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Name of medicinal product:
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FLEBOGAMMA DIF
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Active substances:
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|
ATC code:
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J06BA02
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Dosage form:
|
solution for infusion
|
Route of administration:
|
intravenous use
|
Strengh:
|
50mg 1ml
|
Amount in package:
|
50ml 1TK
|
Legal status for supply*:
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Subject to medicinal prescription
|
Class of active substance:
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|
Additional information:
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|
Indication:
|
Replacement therapy in adults, children and adolescents (2 - 18 years) in:
- Primary immunodeficiency syndromes (PID) with impaired antibody production
- Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections,
ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or
serum IgG level of <4 g/l
*PSAF= failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide
and polypeptide antigen vaccines
Measles pre-/post exposure prophylaxis for susceptible adults, children and adolescents (2 - 18 years)
in whom active immunisation is contraindicated or not advised.
Consideration should also be given to official recommendations on intravenous human
immunoglobulin use in measles pre-/post exposure prophylaxis and active immunisation.
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 platelet count
- Guillain Barré syndrome
- Kawasaki disease (in conjunction with acetylsalicylic acid; see 4.2)
- Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
- Multifocal motor neuropathy (MMN)
|
Safety features:
|
Yes
|
Summary of product characteristics (SPC):
|
|
Package information leaflet (PIL):
|
EST
|
Labelling:
|
|
Last imported to Estonia:
|
Never imported to Estonia
|
Marketing authorization holder:
|
Instituto Grifols S.A.
|
Marketing authorization number:
|
EU/1/07/404
|
Marketing authorization issued on:
|
August 23, 2007
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Centralised
|
Reference price:
|
|
Under reference price:
|
|
Reference price of daily dose:
|
|
Description
|
Additional condition
|
Ei ole lubatud väljastada korduvretsepti
|
|
Entry/Changing date:
December 11, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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