NPLATE 500 MCG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ROMIPLOSTIM

Available from:

AMGEN EUROPE B.V.

ATC code:

B02BX04

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJECTION

Composition:

ROMIPLOSTIM 500 MCG/VIAL

Administration route:

S.C

Prescription type:

Required

Manufactured by:

AMGEN EUROPE B.V., NETHERLANDS

Therapeutic area:

ROMIPLOSTIM

Therapeutic indications:

Nplate is indicated for chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients one year of age and older who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).

Authorization date:

2016-04-30

Patient Information leaflet

Nplate
®
(romiplostim)
Dose Calculator
Israeli Version 1.0 draft December 2019 derived from EU Version 3.0
approved November 2017
Nplate®
single-use
vial
Total
vial
content
of
romiplosti m
Volume of
sterile
water
for injections
Deliverable
product
and volume
Final
concentra ti on
250 mcg
375 mcg
add
0.72 mL
=
250 mcg in 0.50 mL
500 mcg/mL
DIRECTIONS FOR DOSE RECONSTITUTION
AND ADMINISTRATION
This Calculator format and content were approved
by the Ministry of Health in January 2020
Important: This calculator is ONLY to be used by
health care professionals.
This calculator must not be given to patients
who self-inject Nplate.
Israeli Version 1.0 final January 2020 derived from EU Version 3.0
approved November 2017
Israeli Version 1.0 draft December 2019 derived from EU Version 3.0
approved November 2017
Israeli Version 1.0 draft December 2019 derived from EU Version 3.0
approved November 2017
Nplate®
single-use
vial
Total
vial
content
of
romiplosti m
Volume of
sterile
water
for injections
Deliverable
product
and volume
Final
concentra ti on
250 mcg
375 mcg
add
0.72 mL
=
250 mcg in 0.50 mL
500 mcg/mL
DIRECTIONS FOR DOSE RECONSTITUTION
AND ADMINISTRATION
Israeli Version 1.0 final January 2020 derived from EU Version 3.0
approved November 2017
Israeli Version 1.0 final January 2020 derived from EU Version 3.0
approved November 2017
Israeli Version 1.0 draft December 2019 derived from EU Version 3.0
approved November 2017
HANDLING GUIDANCE
Israeli Version 1.0 draft December 2019 derived from EU Version 3.0
approved November 2017
Nplate®
single-use
vial
Total
vial
content
of
romiplosti m
Volume of
sterile
water
for injections
Deliverable
product
and volume
Final
concentra ti on
250 mcg
375 mcg
add
0.72 mL
=
250 mcg in 0.50 mL
500 mcg/mL
DIRECTIONS FOR DOSE RECONSTITUTION
AND ADMINISTRATION
Nplate
®
can only be reconstituted with preservative-free sterile water for
injections.
DO NOT use sodium chloride solution for injection or bacteriostatic
water for
reconstitution of Nplate
®
.
Nplate
®
is available:
– 250 m

Summary of Product characteristics

1
Revised in May 2020
1.
NAME OF THE MEDICINAL PRODUCT
Nplate 250 micrograms powder for solution for injection
Nplate 500 micrograms powder for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nplate 250 micrograms powder for solution for injection
Each vial contains 250 mcg of romiplostim. After reconstitution, a
deliverable volume of
0.5 mL solution contains 250 mcg of romiplostim (500 mcg/mL). An
additional overfill is
included in each vial to ensure that 250 mcg of romiplostim can be
delivered.
Nplate 500 micrograms powder for solution for injection
Each vial contains 500 mcg of romiplostim. After reconstitution, a
deliverable volume of
1 mL solution contains 500 mcg of romiplostim (500 mcg/mL). An
additional overfill is
included in each vial to ensure that 500 mcg of romiplostim can be
delivered.
Romiplostim is produced by recombinant DNA technology in
_Escherichia coli_
(
_E. coli_
).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection (powder for injection).
The powder is white.
4.
CLINICAL PARTICULARS
PEDIATRIC AND ADULT COMBINED DOSE CALCULATOR
The marketing of Nplate is subject to a risk management plan (RMP)
including a 'Pediatric
and adult combined dose Calculator.
Please ensure you are familiar with this material as it contains
important safety
information.
4.1
THERAPEUTIC INDICATIONS
Nplate is indicated for chronic immune (idiopathic) thrombocytopenic
purpura (ITP) patients
one year of age and older who are refractory to other treatments (e.g.
corticosteroids,
immunoglobulins) (see sections 4.2 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should remain under the supervision of a physician who is
experienced in the
treatment of hematological diseases.
2
Posology
Nplate should be administered once weekly as a subcutaneous injection.
_Initial dose _
The initial dose of romiplostim is 1 mcg/kg based on actual body
weight.
_Dose calculation _
The volume of romiplostim to administer is calculated based on body
weight