Iqymune 2g/20ml solution for infusion vials

Country: Միացյալ Թագավորություն

language: անգլերեն

source: MHRA (Medicines & Healthcare Products Regulatory Agency)

active_ingredient:

Normal immunoglobulin human

MAH:

LFB Biopharmaceuticals Ltd

ATC_code:

J06BA02

INN:

Normal immunoglobulin human

dosage:

100mg/1ml

pharmaceutical_form:

Solution for infusion

administration_route:

Intravenous

class:

No Controlled Drug Status

prescription_type:

Caution - AMP level prescribing advised

leaflet_short:

BNF: 14050100; GTIN: 03700386800115

PIL

If an allergy develops you will recognize the initial signs by
dizziness, swelling of
the face/legs, shortness of breath, spots on the skin and/or itching.
In this situation
you must call your doctor or nurse immediately.
Depending on your allergic reaction the doctor may decide to reduce
the rate of
your infusion or to stop it. He/she may also start treatment for the
allergy if he/
she considers this to be necessary.
If you have any doubt, please do not hesitate to ask your doctor or
your nurse for advice.
SPECIAL PATIENT GROUPS
This medicine may very rarely cause or worsen a kidney disease (acute
kidney
failure) or a disease of the heart and blood vessels (myocardial
infarction,
cerebrovascular accident, pulmonary embolism or deep venous
thrombosis).
Patients who are already suffering from a disease or who have certain
risk factors
must take care when using this medicine.
BECAUSE OF THIS YOUR DOCTOR WILL MONITOR YOUR KIDNEYS AND/OR YOUR
HEART AND
YOUR BLOOD VESSELS:
•
if you already have a kidney disease (renal failure),
•
if you are taking certain medicines which may be dangerous for your
kidneys,
•
if you have a high level of sugar (diabetes),
•
if you have an insufficient volume of blood in your body
(hypovolemia),
•
if your weight is too high (obesity),
•
if you are over 65 years old,
•
if you already have a disease of the heart or blood vessels,
•
if you have high blood pressure,
•
if you are at risk of being immobilised for a long period of time,
•
if you are suffering from a disease causing an increase in blood
viscosity.
If you have any of the above predisposing factors, the doctor will
adjust the dose
and infusion rate at which IQYMUNE is administered.
INFORMATION ON SAFETY WITH RESPECT TO INFECTIONS
This medicine is made from human blood plasma (this is the liquid part
of the blood).
When medicines are made from human blood or plasma, certain measures
are put
in place to prevent infections being passed on to patients. These
include:
•
careful selection of blood and plasma donors

SPC

OBJECT 1
IQYMUNE 100 MG/ML, SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 17-Nov-2017 | LFB
Biopharmaceuticals Limited
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
IQYMUNE 100 mg/mL, solution for infusion
2. Qualitative and quantitative composition
Human normal immunoglobulin (IVIg)
One mL contains:
Human normal immunoglobulin 100 mg
(purity of at least 95 % IgG)
Each vial of 20 mL contains: 2 g of human normal immunoglobulin.
Each vial of 50 mL contains: 5 g of human normal immunoglobulin.
Each vial of 100 mL contains: 10 g of human normal immunoglobulin.
Each vial of 200 mL contains: 20 g of human normal immunoglobulin.
Distribution of the IgG subclasses (approx. values):
IgG1
IgG2
IgG3
IgG4
60 - 70 %
30 - 35 %
2 %
1 - 2 %
The maximum IgA content is 28 micrograms/mL.
Produced from the plasma of human donors.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for infusion.
The solution is clear or slightly opalescent, colourless to pale
brown.
4. Clinical particulars
4.1 Therapeutic indications
Replacement therapy in adults, and children and adolescents (0 – 18
years) in:
• Primary immunodeficiency (PID) 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 have failed to respond to pneumococcal immunisation.
• Hypogammaglobulinaemia in patients after allogeneic haematopoietic
stem cell transplantation (HSCT).
• Congenital AIDS with recurrent bacterial infections.
Immunomodulation in adults, and children and adolescents (0 – 18
years) in:
• Pri