Proleukin 18million unit powder for solution for injection vials

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Aldesleukin

可用日期:

Clinigen Healthcare Ltd

ATC代码:

L03AC01

INN（国际名称）:

Aldesleukin

剂量:

18mega unit

药物剂型:

Powder for solution for injection

给药途径:

Intravenous; Subcutaneous

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 08020400; GTIN: 8714023000405 8714023000412

资料单张

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROLEUKIN
® 18 MILLION IU POWDER FOR SOLUTION FOR INJECTION OR INFUSION
aldesleukin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.

If you get any side effects talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Proleukin is and what it is used for
2.
What you need to know before you are given Proleukin
3.
How Proleukin is used
4.
Possible side effects
5.
How to store Proleukin
6.
Contents of the pack and other information
1.
WHAT PROLEUKIN IS AND WHAT IT IS USED FOR
Proleukin is the brand name of
_aldesleukin_
. It is a synthetic protein, very similar to a protein produced by
the body called interleukin-2 (IL-2). This protein is part of the
immune system. IL-2 activates certain white
blood cells in the body called lymphocytes, which fight against
diseases and infections. IL-2 stimulates the
production of lymphocytes in the body, and enhances the body’s
defences.
PROLEUKIN IS USED TO TREAT KIDNEY CANCER WHICH HAS SPREAD
to other organs (also called
_metastatic renal _
_cell carcinoma_
).
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PROLEUKIN
Follow carefully all instructions given to you by your doctor.
Your doctor may carry out tests before you are treated with Proleukin.
He/she may perform a blood test
to check the level of sugar in your blood and check your kidney and
liver function. He/she may also test
your heart, respiratory and mental performance
.
He/she will check your response to the treatment at
regular intervals and take any necessary action.
YOU SHOULD NOT BE GIVEN PROLEUKIN

If you are ALLERGIC
(hypersensitive) to aldes

产品特点

OBJECT 1
PROLEUKIN
Summary of Product Characteristics Updated 25-Sep-2017 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
PROLEUKIN
®
18 x 10
6
IU
Powder for solution for injection or infusion
2. Qualitative and quantitative composition
After reconstitution with 1.2 ml water for injections, according to
the instructions (see section 6.6), each 1
ml solution contains 18 x 10
6
IU (1.1 mg) aldesleukin.
Each vial of Proleukin powder for solution for injection or infusion
contains 22 x 10
6
IU aldesleukin.
Aldesleukin is produced by recombinant DNA technology using an
_Escherichia coli_ strain which contains
a genetically engineered modification of the human Interleukin-2
(IL-2) gene.
Proleukin contains less than 23mg sodium per 1ml, and can be
considered as 'sodium-free'.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for solution for injection or infusion.
The powder is sterile, white and lyophilized.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of metastatic renal cell carcinoma.
Risk factors associated with decreased response rates and median
survival are:
- A performance status of ECOG
*)
1 or greater
- More than one organ with metastatic disease sites
- A period of < 24 months between initial diagnosis of primary tumour
and the date the patient is
evaluated for Proleukin treatment.
*) ECOG (Eastern Cooperative Oncology Group) performance status: 0 =
normal activity, 1 = symptoms
but ambulatory; 2 = in bed less than 50% of time; 3 = in bed more than
50% of time, limited self-care; 4 =
completely disabled, no self-care.
Response rates and median survival decrease with the number of risk
factors present. Patients positive for
all three risk factors should not be treated with Proleukin.
4.2 Posology and method of administration
Proleukin should be administered intravenously by continuous infusion
or by subcutaneous injection. The
following dosage regimen is recommended to treat adult patients with
metastatic renal cell carcinoma.
Continuous intra