Granocyte 13million unit powder and solvent for solution for injection vials

Country: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)

সক্রিয় উপাদান:

Lenograstim

থেকে পাওয়া:

Chugai Pharma UK Ltd

এটিসি কোড:

L03AA10

INN (International Name):

Lenograstim

ডোজ:

13.4mega unit

ফার্মাসিউটিকাল ফর্ম:

Powder and solvent for solution for injection

প্রশাসন রুট:

Subcutaneous; Intravenous

শ্রেণী:

No Controlled Drug Status

প্রেসক্রিপশন টাইপ:

Valid as a prescribable product

পণ্য সারাংশ:

BNF: 09010600; GTIN: 5013011003354 5060069012005

তথ্য লিফলেট

1.3.1 Spc, Labelling and Package Leaflet -
UK and IE approved leaflet
INN
_: _
lenograstim
_ _
Approved –
Jan 2018
CONFIDENTIAL
Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GRANOCYTE 13 MILLION IU/ML, POWDER AND SOLVENT FOR SOLUTION FOR
INJECTION/INFUSION IN A PRE-
FILLED SYRINGE
GRANOCYTE 34 MILLION IU/ML, POWDER AND SOLVENT FOR SOLUTION FOR
INJECTION/INFUSION IN A PRE-
FILLED SYRINGE
Lenograstim
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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. See section 4.
WHAT IS IN THIS LEAFLET
:
1. What Granocyte is and what it is used for
2. What you need to know before you take Granocyte
3. How to take Granocyte
4. Possible side effects
5. How to store Granocyte
6. Contents of the pack and other information
1. WHAT GRANOCYTE IS AND WHAT IT IS USED FOR
The name of your medicine is Granocyte, powder and solvent for
injection/infusion (called Granocyte
in this leaflet). Granocyte contains a medicine called lenograstim.
This belongs to a group of medicines
called cytokines.
Granocyte works by helping your body to make more of the blood cells
which fight infection.
• These blood cells are made in your bone marrow.
• Granocyte encourages your bone marrow to make more cells called
‘blood stem cells’.
• It then helps turn these young blood cells into fully working
blood cells.
• In particular, it helps produce more white blood cells called
neutrophils. Neutrophils are
important in fighting infections.
GRANOCYTE IS USED:
•
AFTER CANCER TREATMENT, IF THE LEVEL OF YOUR WHITE BLOOD CELLS IS TOO
LOW (CALLED ‘NEUTROPENIA’)
Some

পণ্য বৈশিষ্ট্য

OBJECT 1
GRANOCYTE 13 MILLION IU/ML, POWDER AND
SOLVENT FOR SOLUTION FOR INJECTION/INFUSION
Summary of Product Characteristics Updated 23-Feb-2018 | Chugai Pharma
UK Limited
1. Name of the medicinal product
GRANOCYTE 13 million IU/mL, powder and solvent for solution for
injection/infusion.
GRANOCYTE 13 million IU/mL, powder and solvent for solution for
injection/infusion in a pre-filled
syringe.
GRANOCYTE 34 million IU/mL, powder and solvent for solution for
injection/infusion.
GRANOCYTE 34 million IU/mL, powder and solvent for solution for
injection/infusion in a pre-filled
syringe.
2. Qualitative and quantitative composition
Lenograstim* (rHuG-CSF) 13.4 million International Units (equivalent
to 105 micrograms) per mL after
reconstitution
Lenograstim* (rHuG-CSF) 33.6 million International Units (equivalent
to 263 micrograms) per mL after
reconstitution
*Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO)
cells.
Excipients with known effect:
Phenylalanine
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder and solvent for solution for injection/infusion.
Powder and solvent for solution for injection/infusion in a pre-filled
syringe.
- White powder
- _Solvent_: clear, colourless solution
4. Clinical particulars
4.1 Therapeutic indications
GRANOCYTE is indicated in adults, adolescents and children aged older
than 2 years for:
▪ The reduction of the duration of neutropenia in patients (with non
myeloid malignancy) undergoing
myeloablative therapy followed by bone marrow transplantation (BMT)
and considered to be at increased
risk of prolonged severe neutropenia.
▪ The reduction of the duration of severe neutropenia and its
associated complications in patients
undergoing established cytotoxic therapy associated with a significant
incidence of febrile neutropenia.
▪ The mobilisation of peripheral blood progenitor cells (PBPCs), for
patients as well as healthy donors.
4.2 Posology and method of administration
Method of administration
GRANOCYTE can be administered by