GRANOCYTE 13 million IU/mL, powder and solvent for solution for injection/infusion, in a pre-filled syringe

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lenograstim

Available from:

Chugai Pharma UK Ltd

ATC code:

L03AA; L03AA10

INN (International Name):

Lenograstim

Dosage:

105mcg microgram(s)

Pharmaceutical form:

Powder and solvent for solution for injection/infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Colony stimulating factors; lenograstim

Authorization status:

Marketed

Authorization date:

1996-07-25

Patient Information leaflet

1.3.1 Spc, Labelling and Package Leaflet -
UK and IE proposed leaflet
INN_: _lenograstim
_ _
Proposed – March 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 t

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
GRANOCYTE 13 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
*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, 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 sub-cutaneous injection or by
intravenous infusion. Particular handling of the
product or instructions for preparation are given in sections 6.6.
Posology
Therapy should only be given in collaboration with an experienced
oncology and/or haematology centre.
The recommended dose of GRANOCYTE is 19.2 MIU (150 µg) per m
2
per day, therapeutically equivalent to 0.64
MIU (5 µg) per kg per day for:
Peripheral Stem Cells or bone marrow transplantation,
established cytotoxic chemotherapy
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
_