Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - bekemv

Document Subject

Generated Narrative: MedicinalProductDefinition mp1c1262aecbe28e7e1156f50a5c6d2fe6

identifier: http://ema.europa.eu/identifier/EU/1/23/1727/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: BEKEMV 300 mg concentrate 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-1c1262aecbe28e7e1156f50a5c6d2fe6

identifier: http://ema.europa.eu/identifier/EU/1/23/1727/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - bekemv

Attesters

What is in this leaflet:

1. What BEKEMV is and what it is used for
2. What you need to know before you use BEKEMV
3. How to use BEKEMV
4. Possible side effects
5. How to store BEKEMV
6. Contents of the pack and other information

What is BEKEMV

BEKEMV contains the active substance eculizumab and it belongs to a class of medicines called monoclonal antibodies. Eculizumab binds to and inhibits a specific protein in the body that causes inflammation and so prevents your body s systems from attacking and destroying vulnerable blood cells.

What is BEKEMV used for

Paroxysmal nocturnal haemoglobinuria

BEKEMV is used to treat adults and children with a certain type of disease affecting the blood system called Paroxysmal Nocturnal Haemoglobinuria (PNH). In patients with PNH, their red blood cells can be destroyed which can lead to low blood counts (anaemia), tiredness, difficulty in functioning, pain, dark urine, shortness of breath, and blood clots. Eculizumab can block the body s inflammatory response, and its ability to attack and destroy its own vulnerable PNH blood cells.

Do not use BEKEMV

• If you are allergic to eculizumab or any of the other ingredients of this medicine (listed in section 6).
• If you have fructose intolerance, a quite rare genetic condition where the enzyme for breaking down fructose is not produced.
• Children below 2 years of age must not receive this medicine. This medicine contains sorbitol and sorbitol may be fatal in hereditary fructose intolerance (HFI). In babies and children below 2 years of age HFI may not yet be diagnosed. (See special warnings at the end of this section under subtitle BEKEMV contains sorbitol ).
• If you have not been vaccinated against meningococcal infection unless you take antibiotics to reduce the risk of infection until 2 weeks after you have been vaccinated.
• If you have a meningococcal infection.

Warnings and precautions

Meningococcal and other Neisseria infections alert

BEKEMV treatment may reduce your natural resistance to infections, especially against certain organisms that cause meningococcal infection (severe infection of the linings of the brain and sepsis) and other Neisseria infections including disseminated gonorrhoea.

Consult your doctor before you take BEKEMV to be sure that you receive vaccination against Neisseria meningitidis, an organism that causes meningococcal infection, at least 2 weeks before beginning therapy, or that you take antibiotics to reduce the risk of infection until 2 weeks after you have been vaccinated.

Ensure that your current meningococcal vaccination is up to date. You should also be aware that vaccination may not prevent this type of infection. In accordance with national recommendations, your doctor might consider that you need supplementary measures to prevent infection.

If you are at risk of gonorrhoea, ask your doctor or pharmacist for advice before using this medicine.

Meningococcal infection symptoms

Because of the importance of rapidly identifying and treating certain types of infection in patients who receive BEKEMV, you will be provided a card to carry with you, listing specific trigger symptoms. This card is named: Patient Safety Card .

If you experience any of the following symptoms, you should immediately inform your doctor:

• headache with nausea or vomiting
• headache with a stiff neck or back
• fever
• rash
• confusion
• severe muscle aches combined with flu-like symptoms
• sensitivity to light

Treatment for meningococcal infection while travelling

If you are travelling in a remote region where you are unable to contact your doctor or in which you find yourself temporarily unable to receive medical treatment, your doctor can make arrangements to issue, as a preventive measure, a prescription for an antibiotic to counter Neisseria meningitidis that you keep with you. If you experience any of the symptoms amongst those cited above, you should take the antibiotics as prescribed. You should bear in mind that you should see a doctor as soon as possible, even if you feel better after having taken the antibiotics.

Infections

Before starting BEKEMV, inform your doctor if you have any infections.

Allergic reactions

BEKEMV contains a protein and proteins can cause allergic reactions in some people.

Children and adolescents

Patients less than 18 years of age must be vaccinated against Haemophilus influenzae and pneumococcal infections.

Older people

There are no special precautions needed for the treatment of patients aged from 65 years and over.

Other medicines and BEKEMV

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Women of childbearing potential

The use of effective contraception during treatment and up to 5 months after treatment should be considered in women who are able to get pregnant.

Driving and using machines

BEKEMV has no or negligible influence on the ability to drive and use machines.

BEKEMV contains sorbitol

This medicine contains 50 mg sorbitol in each mL.

Sorbitol is a source of fructose. If you (or your child) have hereditary fructose intolerance (HFI), a rare genetic disorder, you (or your child) must not receive this medicine. Patients with HFI cannot break down fructose, which may cause serious side effects.

You must tell your doctor before receiving this medicine if you (or your child) have HFI or if your child can no longer take sweet foods or drinks because they feel sick, vomit or get unpleasant effects such as bloating, stomach cramps or diarrhoea.

Sodium

BEKEMV contains sodium when diluted with sodium chloride. This medicine contains less than 1 mmol of sodium (23 mg) per dose, that is to say essentially sodium free .
Once diluted with sodium chloride 9 mg/mL (0.9%) solution for injection, this medicinal product contains 0.34 g sodium (main component of cooking/table salt) per 180 mL at the maximal dose. This is equivalent to 17.0% of the recommended maximum daily dietary intake of sodium for an adult. You should take this into consideration if you are on a controlled sodium diet. Once diluted with sodium chloride 4.5 mg/mL (0.45%) solution for injection, this medicinal product contains 0.18 g sodium (main component of cooking/table salt) per 180 mL at the maximal dose, equivalent to 9.0% of the recommended maximum daily dietary intake of sodium for an adult. You should take this into consideration if you are on a controlled sodium diet.
If your health care professional dilutes BEKEMV vials with 5% glucose solution, the medicinal product is essentially sodium free .

At least 2 weeks before you start treatment with BEKEMV, your doctor will administer a vaccine against meningococcal infection if it was not previously administered or if your vaccination is outdated. If your child is below the age of vaccination or if you are not vaccinated at least 2 weeks before you start treatment with BEKEMV, your doctor will prescribe antibiotics to reduce the risk of infection until 2 weeks after you have been vaccinated.

Your doctor will administer a vaccine to your child aged less than 18 years against Haemophilus influenzae and pneumococcal infections according to the national vaccination recommendations for each age group.

Instructions for proper use

The treatment will be given by your doctor or other health care provider by infusing a dilution of the BEKEMV vial from a drip bag through a tube directly into one of your veins. It is recommended that the beginning of your treatments, called the initial phase, will extend over 4 weeks, followed by a maintenance phase.

If you use this medicine to treat PNH

For adults:

• Initial phase:

Every week for the first four weeks, your doctor will administer an intravenous infusion of diluted BEKEMV. Each infusion will consist of a dose of 600 mg (2 vials of 30 mL) and will take 25 - 45 minutes (35 minutes 10 minutes).

• Maintenance phase:

• In the fifth week, your doctor will administer an intravenous infusion of diluted BEKEMV at a dose of 900 mg (3 vials of 30 mL) over a 25 45 minute (35 minutes 10 minutes) period.
• After the fifth week, your doctor will administer 900 mg of diluted BEKEMV every two weeks as a long-term treatment.

For children and adolescents:

• Children and adolescents with PNH and who are 40 kg weight and over are treated with the adult dosing.
• Children and adolescents with PNH and who are under 40 kg weight require a lower dose based on how much they weigh. Your doctor will calculate this.

For children and adolescents with PNH above 2 years of age and with body weight below 40 kg:

Patient body weight Initial phase Maintenance phase 30 to < 40 kg 600 mg weekly for the first 2 weeks 900 mg at week 3; then 900 mg every 2 weeks 20 to < 30 kg 600 mg weekly for the first 2 weeks 600 mg at week 3; then 600 mg every 2 weeks 10 to < 20 kg 600 mg single dose at week 1 300 mg at week 2; then 300 mg every 2 weeks Patient body weight Initial phase Maintenance phase 5 to < 10 kg 300 mg single dose at week 1 300 mg at week 2; then 300 mg every 3 weeks

Following each infusion, you will be monitored for about one hour. Your doctor s instructions should be carefully observed.

If you receive more BEKEMV than you should

If you suspect that you have been accidentally administered a higher dose of BEKEMV than prescribed, please contact your doctor for advice.

If you forget an appointment to receive BEKEMV

If you forget an appointment, please contact your doctor immediately for advice and see section below If you stop using BEKEMV .

If you stop using BEKEMV for PNH

Interrupting or ending treatment with BEKEMV may cause your PNH symptoms to come back more severely soon. Your doctor will discuss the possible side effects with you and explain the risks. Your doctor will want to monitor you closely for at least 8 weeks.

The risks of stopping BEKEMV include an increase in the destruction of your red blood cells, which may cause:

• A significant fall in your red blood cell counts (anaemia),
• Confusion or change in how alert you are,
• Chest pain, or angina,
• An increase in your serum creatinine level (problems with your kidneys), or
• Thrombosis (blood clotting). If you have any of these symptoms, contact your doctor.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Your doctor will discuss the possible side effects with you and explain the benefits and risks of BEKEMV with you prior to treatment.

The most serious side effect was meningococcal sepsis. If you experience any of the meningococcal infection symptoms (see section 2 Meningococcal and other Neisseria infections alert), you should immediately inform your doctor.

If you are not sure what the side effects below are, ask your doctor to explain them to you.

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

• headache

Common (may affect up to 1 in 10 people)

• infection of the lung (pneumonia), common cold (nasopharyngitis), infection of the urinary system (urinary tract infection)
• low white blood cell count (leucopenia), reduction in red blood cells which can make the skin pale and cause weakness or breathlessness
• inability to sleep
• dizziness, high blood pressure
• upper respiratory tract infection, cough, throat pain (oropharyngeal pain), bronchitis, cold sores (herpes simplex)
• diarrhoea, vomiting, nausea, abdominal pain, rash, hair loss (alopecia), itchy skin (pruritus)
• pain in the joints (arms and legs), pain in the limbs (arms and legs)
• fever (pyrexia), feeling tired (fatigue), influenza like illness
• infusion related reaction

Uncommon (may affect up to 1 in 100 people)

• severe infection (meningococcal infection), sepsis, septic shock, viral infection, lower respiratory tract infection, stomach flu (gastrointestinal infection), cystitis
• infection, fungal infection, collection of pus (abscess), type of infection of the skin (cellulitis), influenza, sinusitis, tooth infection (abscess), gum infection
• relatively few platelets in blood (thrombocytopenia), low level of lymphocytes a specific type of white blood cells (lymphopenia), feeling your heartbeat
• serious allergic reaction which causes difficulty in breathing or dizziness (anaphylactic reaction), hypersensitivity
• loss of appetite
• depression, anxiety, mood swings, sleep disorder
• tingling in part of the body (paraesthesia), shaking, taste disorders (dysgeusia), fainting
• vision blurred
• ringing in the ears, vertigo
• sudden and rapid development of extremely high blood pressure, low blood pressure, hot flush, vein disorder
• dyspnoea (difficulty breathing), nose bleed, stuffy nose (nasal congestion), throat irritation, runny nose (rhinorrhoea)
• inflammation of the peritoneum (the tissue that lines most of the organs of the abdomen), constipation, stomach discomfort after meals (dyspepsia), abdominal distension
• hives, redness of the skin, dry skin, red or purple spots under the skin, increased sweating, inflammation of the skin
• muscle cramp, muscle aches, back and neck pain, bone pain
• kidney disorder, difficulties or pain when urinating (dysuria), blood in urine
• spontaneous penile erection
• swelling (oedema), chest discomfort, feeling of weakness (asthaenia), chest pain, infusion site pain, chills
• increase of liver enzymes, decrease of the proportion of blood volume that is occupied by red blood cells, decrease in the protein in red blood cells that carries oxygen

Rare (may affect up to 1 in 1,000 people)

• infection by fungi (Aspergillus infection), infection of the joint (arthritis bacterial), Haemophilus influenzae infection, impetigo, bacterial sexual transmitted disease (gonorrhoea)
• skin tumour (melanoma), bone marrow disorder
• destruction of red blood cells (haemolysis), clumping of cells, abnormal clotting factor, abnormal blood clotting
• disease with thyroid overactivity (Basedow s disease)
• abnormal dreams
• irritation of eye
• bruise
• unusual backflow of food from stomach, gum pain
• yellowing of the skin and/or eyes (jaundice)
• skin colour disorder
• spasm of mouth muscle, joint swelling
• menstrual disorder
• abnormal leakage of the infused drug out of the vein, infusion site abnormal sensation, feeling hot Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. 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). Do not freeze.

BEKEMV vials in the original package may be removed from refrigerated storage for only one single period of up to 7 days. At the end of this period the product can be put back in the refrigerator. Store in the original package in order to protect from light. After dilution, the product should be used within 24 hours.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What BEKEMV contains

• The active substance is eculizumab (300 mg/30 mL in a vial corresponding to 10 mg/mL).

• The other ingredients are:

• acetic acid,

• sodium hydroxide,

• disodium edetate (EDTA),

• sorbitol (E420, see section 2 BEKEMV contains sorbitol ),

• polysorbate 80,

• water for injections

What BEKEMV looks like and contents of the pack

BEKEMV is presented as a concentrate for solution for infusion (30 mL in a vial pack size of 1).
BEKEMV is a clear to opalescent, colourless to slightly yellow solution.

Marketing Authorisation Holder and Manufacturer
Amgen Technology (Ireland) UC Pottery Road, Dun Laoghaire Co. Dublin,
A96 F2A8 Ireland

Marketing Authorisation Holder
Amgen Technology (Ireland) UC Pottery Road, Dun Laoghaire Co. Dublin,
A96 F2A8 Ireland
Manufacturer
Amgen NV Telecomlaan 5-7 1831 Diegem Belgium

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien s.a. Amgen n.v. T l/Tel: +32 (0)2 7752Lietuva Amgen Switzerland AG Vilniaus filialas Tel: +370 5 219 7

.: +359 (0)2 424 7Luxembourg/Luxemburg s.a. Amgen Belgique/Belgien T l/Tel: +32 (0)2 7752 esk republika Amgen s.r.o. Tel: +420 221 773 Magyarorsz g Amgen Kft. Tel.: +36 1 35 44 Danmark Amgen, filial af Amgen AB, Sverige Tlf: +45 39617Malta Amgen S.r.l. Italy Tel: +39 02 6241Deutschland Amgen GmbH Tel.: +49 89 1490Nederland Amgen B.V. Tel: +31 (0)76 5732Eesti Amgen Switzerland AG Vilniaus filialas Tel: +372 586 09Norge Amgen AB Tlf: +47 23308
Amgen . . . : +30 210 3447 sterreich Amgen GmbH Tel: +43 (0)1 50 Espa a Amgen S.A. Tel: +34 93 600 18 Polska Amgen Biotechnologia Sp. z o.o. Tel.: +48 22 581 3France Amgen S.A.S. T l: +33 (0)9 69 363 Portugal Amgen Biofarmac utica, Lda. Tel: +351 21 422 06 Hrvatska Amgen d.o.o. Tel: +385 (0)1 562 57 Rom nia Amgen Rom nia SRL Tel: +4021 527 3Ireland Amgen Ireland Limited Tel: +353 1 8527Slovenija AMGEN zdravila d.o.o. Tel: +386 (0)1 585 1 sland Vistor hf. S mi: +354 535 7Slovensk republika Amgen Slovakia s.r.o. Tel: +421 2 321 114 Italia Amgen S.r.l. Tel: +39 02 6241Suomi/Finland Amgen AB, sivuliike Suomessa/Amgen AB, filial i Finland Puh/Tel: +358 (0)9 54900K
C.A. Papaellinas Ltd : +357 22741 Sverige Amgen AB Tel: +46 (0)8 6951Latvija Amgen Switzerland AG R gas fili le Tel: +371 257 25United Kingdom (Northern Ireland) Amgen Limited Tel: +44 (0)1223 420This leaflet was last revised in

Other sources of information

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