Subcuvia 800mg/5ml solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Normal immunoglobulin human

Available from:

Baxalta UK Ltd

ATC code:

J06BA01

INN (International Name):

Normal immunoglobulin human

Dosage:

160mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Subcutaneous; Intramuscular

Class:

No Controlled Drug Status

Prescription type:

Caution - AMP level prescribing advised

Product summary:

BNF: 14050100; GTIN: 5413760205434

Summary of Product characteristics

OBJECT 1
SUBCUVIA 160 G/L SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 21-Mar-2018 | Shire
Pharmaceuticals Limited
1. Name of the medicinal product
SUBCUVIA 160 g/l Solution for Injection
2. Qualitative and quantitative composition
Human Normal Immunoglobulin
1 l solution contains:
human protein 160 g
(of which at least 90% are immunoglobulin G)
Distribution of IgG subclasses:
IgG1 45-75%
IgG2 20-45%
IgG3 3-10%
IgG4 2-8%
Maximum IgA content:
4.8 g/l of total protein
Excipient with known effects:
This medicinal product contains 1.4 mg sodium per ml.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for subcutaneous or intramuscular administration.
4. Clinical particulars
4.1 Therapeutic indications
Replacement therapy in adults, children and adolescents (0-18) in:
• Primary immunodeficiency syndromes with impaired antibody
production (see section 4.4),
• Hypogammaglobulinaemia and recurrent bacterial infections in
patients with chronic lymphocytic
leukemia (CLL), in whom prophylactic antibiotics have failed or are
contra-indicated.
• Hypogammaglobulinaemia and recurrent bacterial infections in
multiple myeloma (MM) patients
• Hypogammaglobulinaemia in patients pre- and post- allogenic
haematopoietic stem cell transplant
(HSCT).
4.2 Posology and method of administration
Replacement therapy
Treatment should be initiated and monitored under the supervision of a
physician experienced in the
treatment of immunodeficiency.
The dosage may need to be individualised for each patient dependent on
the pharmacokinetic and clinical
response. The following dosage regimens are given as a guideline.
Adults and elderly:
The dosage should be adjusted to maintain trough level of at least 4-6
g/L of circulating IgG.
The dosage regimen using the subcutaneous route should achieve a
sustained level of IgG (measured
before the next infusion). A loading dose of at least 0.2-0.5 g/kg
given over the course of one week (0.1 –
0.15 g/kg bodyweight on any given day) may be required