IMMUNOGLOBULINS SG INJECTION 50mgml

Pays: Singapour

Langue: anglais

Source: HSA (Health Sciences Authority)

Ingrédients actifs:

Human Immunoglobulin G

Disponible depuis:

THE REG CONSULTANTS PTE. LTD.

Code ATC:

J06BA02

forme pharmaceutique:

INJECTION

Composition:

Human Immunoglobulin G 50mg/ml

Mode d'administration:

INTRAVENOUS

Type d'ordonnance:

Prescription Only

Fabriqué par:

SK Plasma Co.,Ltd.

Statut de autorisation:

ACTIVE

Date de l'autorisation:

2023-04-20

Résumé des caractéristiques du produit

210Ⅹ200mm
[
COMPOSITION] Each 1mL contains
Human normal immunoglobulin G 0.05 g
Maltose hydrate 0.1 g
Water for injection q.s.
The maximum IgA content is 60µg/mL.
[PRODUCT DESCRIPTION]
Colourless and transparent liquid in a colourless and transparent vial
Immunoglobulins SG Injection 5% is manufactured from human plasma
donated by Singapore's voluntary and non-remunerated
donors.
[INDICATIONS]
Replacement therapy in adults, children, and adolescents (0–18
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
4g/L
* PSAF= failure to mount at least a 2-fold rise in IgG antibody titre
to pneumococcal polysaccharide and polypeptide antigen vaccines
Immunomodulation in adults, children and adolescents (0–18 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
“Dosage and Administration”)
[DOSAGE AND ADMINISTRATION]
IVIg therapy should be initiated and monitored under the supervision
of a physician experienced in the treatment of immune system
disorders.
Posology
The dose and dose regimen are dependent on the indication.
The dose may need to be individualised for each patient dependent on
the clinical response. Dose based on body weight may require
adjustment in underweight or overweight patients.
The following dose regimens are given as guidance.
_Replacement therapy in primary immunodeficiency syndromes_
The dose regimen should achieve a trough level of IgG (measured before
the next infusion) of at least 6 g/ L or within the normal reference
range for the population age. 3–6 months are required after the
initiation of therapy for equilibration (steady-state IgG levels) to
occur.
The reco