Subcuvia 1.6g/10ml 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:

Intramuscular; Subcutaneous

Class:

No Controlled Drug Status

Prescription type:

Caution - AMP level prescribing advised

Product summary:

BNF: 14050100; GTIN: 5413760205441

Patient Information leaflet

PATIENT LEAFLET: INFORMATION FOR THE USER
SUBCUVIA 160 G/L SOLUTION FOR INJECTION
Human Normal Immunoglobulin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, please ask your doctor or your
pharmacist.
-
This medicine has been prescribed for you personally and you should
not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What SUBCUVIA is and what it is used for
2.
Before you use SUBCUVIA
3.
How to use SUBCUVIA
4.
Possible side effects
5
Storing SUBCUVIA
6.
Further information
1.
WHAT SUBCUVIA IS AND WHAT IT IS USED FOR
SUBCUVIA belongs to a class of medicines called immunoglobulins. These
medicines contain
antibodies which are normally found in your blood. Antibodies are
proteins that help you to fight
infection by neutralizing bacteria, viruses, and other foreign bodies.
SUBCUVIA is used in the
treatment of certain diseases that are caused by a lack of antibodies
in your blood. These types of
diseases are called antibody deficiency syndromes. If you do not have
enough antibodies, you
become vulnerable to frequent infections. Regular and sufficient doses
of SUBCUVIA can correct
this lack of antibodies.
SUBCUVIA is used in antibody replacement therapy. The medicine is used
in adults, children and
adolescents (0 – 18 years) in the following patient groups:

patients with an inborn inability or reduced ability to produce
antibodies (primary
immunodeficiencies),

patients with a certain type of blood cancer (chronic lymphocytic
leukaemia) which leads to a lack
of antibody production and recurrent infections when preventative
antibiotics have failed,

patients with a specific cancer of the bone marrow (multiple myeloma)
and lack of antibody
production with recurrent infections who have failed to respo

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