Beromun 1mg powder for solution for infusion vials

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Tasonermin

Disponible depuis:

Boehringer Ingelheim Ltd

DCI (Dénomination commune internationale):

Tasonermin

Dosage:

1mg

forme pharmaceutique:

Powder for solution for infusion

Mode d'administration:

Regional perfusion

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: ; GTIN: 5012816002159

Notice patient

1600161/1
1
20
PACKAGE LEAFLET: INFORMATION FOR THE USER
BEROMUN
®
1 MG
abcd
POWDER FOR SOLUTION FOR INFUSION
Tasonermin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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.
- If you get any side effects , talk to your doctor. This includes any
possible
side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1. What Beromun is and what it is used for
2. What you need to know before you use Beromun
3. How to use Beromun
4. Possible side effects
5. How to store Beromun
6. Contents of the pack and other information
1. WHAT BEROMUN IS AND WHAT IT IS USED FOR
Beromun contains the active substance tasonermin (tumor necrosis
factor
alfa-1a), produced by recombinant DNA technology. It belongs to a
class
of medicines known as immunostimulants, which help your body’s
immune system fight cancer cells.
Beromun is used, together with melphalan containing medicine, for the
treatment of soft tissue sarcoma of the arms and legs. By reducing the
size
of the tumour, the treatment is intended to facilitate the removal of
the
tumor by surgery or to prevent severe damage to the surrounding
healthy
tissue and thus to delay or prevent the need for arm or leg
amputation.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE BEROMUN
DO NOT USE BEROMUN
- if you are allergic to tasonermin or any of the other ingredients of
this
medicine (listed in section 6).
- if you have significant heart problems
FILE INFORMATION
ISSUE DATE OF TD:
PPM SKU:
PPM SKU VERSION:
ISSUE DATE OF ARTWORK:
PRINT COLORS:
Pan Black
13/Mar/2017
001
P040079
31/Jan/2013
YES
YES
NO
YES
NO
YES
NO
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NO
NO
YES
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TD
PRINTFILE
MANDATORY IN
MAT. NO. PACK. SITE:
MIN. FONT SIZE:
1600161/1
6 pt
LEGEND CASE VERSION:
P2E:
V4.0 01/OCT/2012 (please do not change or remove it)
901767 / 70644
Template number: 0007-TD-PI-LX-PX-105x148-V01
The order of pages have to be IMPOSED during the artwork creation.
The i

Résumé des caractéristiques du produit

OBJECT 1
BEROMUN 1 MG
Summary of Product Characteristics Updated 24-May-2017 | Boehringer
Ingelheim Limited
1. Name of the medicinal product
Beromun 1 mg powder for solution for infusion
2. Qualitative and quantitative composition
Each vial contains 1 mg tasonermin*, corresponding to 3.0-6.0 x 10
7
IU (International Units).
*tumor necrosis factor alfa-1a (TNFα-1a) produced by recombinant DNA
technology in _E. coli_.
Excipient(s) with known effect:
Each vial contains 20.12 mg (0.87 mmol) sodium. After reconstitution
in 0.9 % physiological sodium
chloride solution the amount is 37.82 mg (1.64 mmol) sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for solution for infusion (powder for infusion).
The powder is white to off-white.
4. Clinical particulars
4.1 Therapeutic indications
Beromun is indicated in adults. as an adjunct to surgery for
subsequent removal of the tumour so as to
prevent or delay amputation, or in the palliative situation, for
irresectable soft tissue sarcoma of the limbs,
used in combination with melphalan via mild hyperthermic isolated limb
perfusion (ILP).
4.2 Posology and method of administration
This treatment should be undertaken in specialised centres by surgical
teams experienced in the
management of limb sarcomas and ILP procedure, with an intensive care
unit readily available and with
the facilities for continuous monitoring for medicinal product leakage
into the systemic circulation.
Posology
_Beromun: _
Upper limb: 3 mg total dose by ILP
Lower limb: 4 mg total dose by ILP
_Melphalan:_
Melphalan dose should be calculated according to the litre-volume
method of Wieberdink (Wieberdink J,
Benckhuysen C, Braat RP, van Slooten EA, Olthius GAA. Dosimetry in
isolation perfusion of the limbs
by assessments of perfused tissue volume and grading of toxic tissue
reactions. _Eur J Cancer Clin Oncol_
1982; 18: 905-910.), to a maximum dose of 150 mg.
13 mg/l perfused upper limb volume
10 mg/l perfused lower limb volume
_Paediatric population_
The safety and effi