SPC. vka (3 týždne) *podmienky pre úpravu dávky a dávkovacia schéma sú uvedené v časti o úprave dávky Tabuľka 2: Liečebné cykly 4. až 6. s liekom Ceplene a IL-2, rovnako ako v tabuľke 1, s výnimkou počtu cyklov a trvania prestávok.

HISTAMINUM, SOL. INJ., ATC L03AX14, RCP (Rezumatul caracteristicilor produsului) Indicații: Tratamentul de întreţinere cu Ceplene este indicat pentru pacienţii adulţi cu leucemie mieloidă acută (LMA) în primă remisie trataţi concomitent cu interleukină 2 (IL-2). Eficacitatea Ceplene nu a fost pe deplin demonstrată la pacienţi cu vârsta peste 60 ani.

Solution for injection. Clear, colourless aqueous solution. 4. Clinical Particulars 4.1 Therapeutic Exhibit 10.1 Confidential June 15, 2017 MEDA PHARMA SARL - and - IMMUNE PHARMACEUTICALS, INC. ASSET PURCHASE AGREEMENT Concerning Ceplene and Certain Related Assets Project Ceplene APA (Execution Version) Page 1 of 70 Confidential Contents Clause Page 1. Interpretation 5 2.

Ceplene spc

Ceplene(histamine dihydrochloride) An overview of Ceplene and why it is authorised in the EU . What is Ceplene and what is it used for? Ceplene is a medicine used in combination with interleukin -2 (a cancer medicine) as maintenance treatment in adults with acute myeloid leukaemia (AML), a type of cancer affe cting the white blood cells. the Summary of Product Characteristics, Labelling and Package Leaflet. C.I.4 - Change(s) in the SPC, Labelling or PL due to new quality, preclinical, clinical or pharmacovigilance data 20/02/2014 06/02/2015 SmPC, Labelling and PL Based on the safety information available from study EPC2008-02, an open-label, multicentre study of the histamine dihydrochloride, 500 microgram/0.5ml, vial (Ceplene®) SMC No. (666/10) Meda Pharmaceuticals Ltd 17 December 2010 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHS Scotland. Ceplene is an immunomodulator that is administered subcutaneously as an adjunct to Interleukin-2 therapy and is available in single/unit dose vials.

The recommended starting dose of anagrelide is 1 mg/day, which should be administered orally in two divided doses (0.5 mg/dose).

Ceplene is administered 1 to 3 minutes after each injection of IL-2. Each 0.5 ml Ceplene dose is injected slowly, over 5-15 minutes. Treatment cycles Ceplene and IL-2 are administered for 10 treatment cycles: each cycle consists of a treatment period of 21 days (3 weeks) followed by a three-week or six-week treatment-free period.

Resepti . Celecoxib Orion 100 mg, 200 mg kapseli, kova PL 2017-11-15 SPC . Resepti .

Revised SPC: Xyzal (levocetirizine) 5mg tablets and 0.5 mg/ml oral solution Published by Glenmark Pharmaceuticals Europe Ltd, 10 March 2017 Pruritus may occur when levocetirizine is stopped even if they were not present before treatment initiation and may resolve spontaneously.

Ceplene is a medicine used in combination with interleukin-2 (a cancer medicine) as maintenance treatment in adults with acute myeloid leukaemia (AML), a type of cancer affecting the white blood cells. It is used during the patients’ first ‘remission’ (a period without symptoms of the disease after the first course of treatment). Ceplene(histamine dihydrochloride) An overview of Ceplene and why it is authorised in the EU . What is Ceplene and what is it used for? Ceplene is a medicine used in combination with interleukin -2 (a cancer medicine) as maintenance treatment in adults with acute myeloid leukaemia (AML), a type of cancer affe cting the white blood cells.

histamine dihydrochloride, 500 microgram/0.5ml, vial (Ceplene®) SMC No. (666/10) Meda Pharmaceuticals Ltd 17 December 2010 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHS Scotland. Histamindihydroklorid . | Fraktfritt Tryggt Hållbart SPC 1 Refusjon 2 Byttegruppe Pris (kr) 3 R.gr. 4; 25 mg: 10 stk. (blister) 165787--* F: 100 stk. (blister) 165761: Blå resept-141,50: C 1 Lenkene går til godkjente preparatomtaler (SPC) på Legemiddelverkets nettside.
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Posology.

Legemidler sentralt godkjent i EU/EØS lenkes til preparatomtaler på nettsiden til The European Medicines Agency (EMA). SPC 1 Refusjon 2 Byttegruppe Pris (kr) 3 R.gr.
Lars meaning

For dosing instructions for CEPLENE in combination with IL-2, see dosage below. IL-2 is administered twice daily as a subcutaneous injection 1 to 3 minutes prior to the administration of CEPLENE; each dose of IL-2 is 16 400 IU/kg. CEPLENE 0.5 ml solution is sufficient for a single dose.