Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - beromun

Document Subject

Generated Narrative: MedicinalProductDefinition mpa321c1bbb3d0ca5c622bbbc9c0607a43

identifier: http://ema.europa.eu/identifier/EU/1/99/097/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Beromun 1 mg powder for solution for infusion

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-a321c1bbb3d0ca5c622bbbc9c0607a43

identifier: http://ema.europa.eu/identifier/EU/1/99/097/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - beromun

Attesters

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

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.

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
• if you have severe lung disease
• if you have or have recently had a stomach ulcer
• if you have too low numbers of blood cells or bleeding problems
• if you have moderate to severe liver or kidney disease
• if you cannot use vasopressors (used to increase low blood pressure), anticoagulants (used to prevent blood clotting) or radioactive tracers
• if you are also using medicines with heart toxicity
• if you have raised levels of calcium in your blood
• if you have certain infections which do not respond to antibiotics
• if you have severe swelling of the affected arm or leg due to local fluid build-up, or severe fluid build-up in the abdomen
• if you are pregnant or planning to become pregnant.
• if you are breast-feeding, you must stop for at least seven days after receiving Beromun

Warnings and precautions
Beromun will be administered by a doctor who is experienced and skilled in isolated limb perfusion (ILP). This technique ensures that Beromun is kept within the affected arm or leg. It is important that it does not reach other parts of your body, because this so-called systemic leakage could cause serious side effects on the main organs of the body.

During the IPL and the seven to ten day period afterwards you will need to stay in hospital, your doctor will carefully monitor your blood pressure, circulation and any side effects. You may have to stay in an intensive care unit (ICU) directly after the ILP for a short time.

A condition called compartment syndrome may develop within the first three days after Beromun administration. Symptoms of muscle damage at the perfused limb include pain, swelling, as well as neurological symptoms (e. g. paraesthesia, paralysis), all of which should be reported immediately to the attending doctor.

Other medicines and Beromun Tell your doctor if you are using, have recently used or might use any other medicines. In particular, you should tell your doctor if you are using medicines to lower blood pressure (to treat hypertension).

For ILP, you will also receive other medicines to control pain, fever, blood pressure and blood clotting, as well as general anaesthesia.

Pregnancy and breast-feeding You must not use Beromun if you are pregnant. You must not breast-feed for at least seven days after treatment with Beromun.

Driving and using machines Not relevant

Beromun contains sodium This medicine contains 151.27 mg (6.58mmol) sodium in each recommended dose. This is equivalent to 7.6% of the recommended maximum daily dietary intake of sodium for an adult.

Beromun will be administered by isolated limb perfusion (ILP), together with the anti-tumour agent melphalan. This will occur whilst you are unconscious, under the influence of a general anaesthetic.

The blood flow to and from your affected limb will be stopped using a tourniquet. Blood, supplied with oxygen by a heart and lung machine, is pumped into your affected limb via a catheter in the main artery, while it is drained (pumped out) from the main vein. Beromun and then melphalan are injected into this circuit, over a total of 90 minutes the affected limb will be exposed to Beromun.

The recommended dose of Beromun depends on the affected limb, usually 3 mg for the arm and 4 mg for the leg. Beromun powder has to be dissolved before use. The resulting solution will be administered into an artery in your affected arm or leg by ILP for an initial period of 30 minutes.
After that, melphalan will be added and the ILP continued for another 60 minutes.
Finally, your limb will be washed out to remove the rest of Beromun and melphalan.

ILP allows that tumour cells in your limb can be exposed to a very high dose of Beromun and melphalan, enhancing their anti-tumour effect, but without reaching the rest of the body, where they could cause serious side effects.

You will usually not receive a second ILP with Beromun. If you do, this will not be until at least six weeks after your first ILP.

If you use more Beromun than you should As Beromun is always administered by experienced and qualified hospital doctors, accidental overdose is extremely unlikely. However, should this occur, your doctor will immediately wash out your affected limb to remove Beromun, and the ILP will be stopped. If there is any risk of serious side effects, your doctor will immediately transfer you to an intensive care unit to closely monitor you and start adequate treatment.

If there is significant systemic leakage of Beromun If more than 10% of your Beromun dose reaches the main part of your body, your doctor will take similar measures as in the case of overdose.

If you have any further questions on the use of this product, ask your doctor.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects may be caused by Beromun, melphalan, the ILP technique or a combination of these factors. Some of the side effects can be serious, particularly if Beromun reaches other parts of your body (systemic leakage). In approximately 2% of cases, Beromun may cause tissue damage in your affected arm or leg which is severe enough to require amputation. If there is any risk of serious side effects, your doctor will immediately transfer you to an intensive care unit to closely monitor you and start adequate treatment.

The following side effects were observed during treatment with this medicine (grouped by how likely they are to happen).

Very common (may affect more than 1 in 10 people)

• disturbances in your heart beat (arrhythmia)
• feeling sick, vomiting
• liver damage
• blistering of the skin
• fever (usually mild to moderate), chills
• pain in the affected arm or leg
• tiredness (fatigue)

Common (may affect up to 1 in 10 people)

• infections
• local wound infections
• reductions in numbers of certain white blood cells and platelets
• hypersensitivity (allergic) reactions
• nerve damage
• decreased consciouness
• headache
• heart problems which can cause shortness of breath or ankle swelling
• blood clot formation in the artery or vein of the affected arm or leg (thrombosis)
• low blood pressure, shock
• severe breathing problems
• constipation, diarrhoea
• skin necrosis (death of skin cells) in the affected arm or leg
• swelling of the ankles, feet or fingers caused by fluid build up in the affected arm or leg
• compartment syndrome , a medical condition characterised by pain, swelling and neurological symptoms, as well as muscle damage in the affected arm or leg
• muscle pain
• protein in urine
• night sweats
• tissue necrosis (death of tissue cells) in the affected arm or leg, which is severe enough to require amputation

Uncommon (may affect up to 1 in 100 people)

• blood poisoning (sepsis)
• fluid in the lungs
• stomach ache
• inflammation of the gastric mucosa (gastritis)
• temporary loss of finger or toe nails of the affected arm or leg
• kidney failure
• blood tests showing changes in the way the kidneys are working
• narrowing or closing of limb vessels carrying blood from the heart

Reporting of side effects If you get any side effects talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C - 8 C). Upon reconstitution the product should be used immediately.

What Beromun contains

• The active substance is tasonermin. Each vial contains 1 mg tasonermin. The content of one vial of Beromun powder should be reconstituted with 5.3 ml sterile 0.9% sodium chloride solution for injection
• The other ingredients (excipient(s)) are sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate and human serum albumin.

What Beromun looks like and contents of the pack Beromun is a white to off-white powder for solution for infusion (powder for infusion) supplied in a glass vial with rubber stopper and sealed with aluminium flip-off cap. Each pack contains 4 vials of powder.

Marketing Authorisation Holder
BELPHARMA s.a. 2, Rue Albert 1er
L-1117 Luxembourg Grand Duchy of Luxembourg

Manufacturer
Eumedica NV Chemin de Nauwelette 1 B-7170 Manage Belgium
For any information about this medicine, please contact the Marketing Authorisation Holder:

BELPHARMA s.a. 2, Rue Albert 1er
L-1117 Luxembourg Grand Duchy of Luxembourg Tel : +352 27403This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: