Země: Izrael
Jazyk: angličtina
Zdroj: Ministry of Health
ROMIPLOSTIM
AMGEN EUROPE B.V.
B02BX04
POWDER FOR SOLUTION FOR INJECTION
ROMIPLOSTIM 250 MCG/VIAL
S.C
Required
AMGEN EUROPE B.V., NETHERLANDS
ROMIPLOSTIM
ROMIPLOSTIM
Adults:Nplate is indicated for the treatment of primary immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).Paediatrics:Nplate is indicated for the treatment of chronic primary immune thrombocytopenia (ITP) in paediatric patients one year of age and older who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).
2016-04-30
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 Přečtěte si celý dokument
1 Revised in January 2022 according to MoHs guidelines. 1. NAME OF THE MEDICINAL PRODUCT Nplate 250 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. 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 Adults: Nplate is indicated for the treatment of primary immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1). Pediatrics: Nplate is indicated for the treatment of chronic primary immune thrombocytopenia (ITP) in pediatric 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. Posology Nplate should be administered once weekly as a subcutaneous injection. 2 _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, dose required, and concentration of product. _ _ TABLE 1. GUIDELINES FOR CALCULATING INDI Přečtěte si celý dokument