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Treść ulotki
Plerixafor Accord 20 mg/mL
injectable solution
plerixafor
Read this leaflet carefully before you start using this medicine as it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Plerixafor Accord is and what it is used for
- 2. What you need to know before you use Plerixafor Accord
- 3. How to use Plerixafor Accord
- 4. Possible side effects
- 5. How to store Plerixafor Accord
- 6. Contents of the pack and other information
1. What is Plerixafor Accord and what is it used for
Plerixafor Accord contains the active substance plerixafor, which blocks a protein on the surface
of blood stem cells. This protein “binds” blood stem cells to the bone
marrow.
Plerixafor improves the release of stem cells into the bloodstream (mobilization). The stem
cells can then be collected using a machine that separates the components of the blood
(apheresis machine) to be frozen and stored until transplantation.
If mobilization is poor, Plerixafor Accord is used to promote the collection of stem
cells from the patient’s blood, for collection, storage and reintroduction (transplantation)
- in adults with lymphoma (a cancer of white blood cells) or multiple myeloma (a cancer that attacks plasma cells in the bone marrow);
- in children aged 1 year and under 18 years with lymphoma or solid tumors.
2. What you need to know before you use
Plerixafor Accord Do not use Plerixafor
Accord
if you are allergic to plerixafor or to any of the other ingredients of this medicine
(listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Plerixafor Accord.
Tell your doctor:
if you have or have had heart problems;
if you have kidney problems. Your doctor may adjust the dose;
if you have a high number of white blood cells;
if you have a low number of platelets;
if you have previously experienced feelings of fainting or dizziness when standing or sitting or if you have fainted during injections;
Your doctor may perform blood tests on a regular basisto check your blood cell count.
Plerixafor Accord is not recommended for stem cell mobilization if you are
suffering from leukemia (a cancer of the blood or bone marrow).
Other medicines and Plerixafor Accord
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Pregnancy and breastfeeding
Do not use Plerixafor Accord if you are pregnant as there is no experience of the effects of
Plerixafor Accord in pregnant women. It is important that you tell your doctor if you are
pregnant, if you think you might be or if you are planning a pregnancy. It is recommended to
use a contraceptive method if you are a woman of childbearing potential.
Do not breastfeed if you are using Plerixafor Accord, as it is not known whether Plerixafor Accord is
excreted in human milk.
Driving and using machines
Plerixafor Accord can cause dizziness and fatigue. Therefore, you should not drive if you feel
unwell, tired or dizzy.
Plerixafor Accord contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially
sodium-free.
3. How to use Plerixafor Accord
The medication will be injected by a doctor or a nurse.
You will first receive G- CSF, then you will be administered Plerixafor Accord
Mobilization will be initiated by administering another medicine called G-
CSF (granulocyte colony-stimulating factor) first. G-CSF will promote the correct action of
Plerixafor Accord in your body. If you would like more information about G-CSF, contact your
How much Plerixafor Accord is administered?
The recommended dose of Plerixafor Accord for adults is 20 mg (fixed dose) or 0.24 mg/kg
of body weight per day.
The recommended dose for children aged between 1 and less than 18 years is 0.24 mg/kg of
body weight/day.
The dose will therefore depend on your body weight, which must be measured the week before
receiving your first dose. If you have moderate or severe kidney problems, your doctor will reduce the dose.
How is Plerixafor Accord administered?
Plerixafor Accord is administered by subcutaneous injection (under the skin).
When is Plerixafor Accord administered for the first time?
You will receive your first dose 6 to 11 hours before apheresis (the collection of your stem cells
from the blood).
For how long will you be administered Plerixafor Accord?
Treatment lasts for 2 to 4 consecutive days (in some cases up to 7 days), until a sufficient
amount of stem cells has been collected for transplantation. In limited cases,
sufficient stem cells may not be collected, so the collection attempt
will be discontinued.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if
shortly after receiving plerixafor, you develop skin rash, swelling around the
eyes, shortness of breath or lack of oxygen, a feeling of dizziness when standing
or sitting, a feeling of fainting or fainting
if you have pain in the upper left side of your abdomen (stomach) or your left shoulder
Very common side effects(may affect more than 1 in 10 people)
diarrhoea, nausea (feeling sick), redness or irritation at the injection site
low red blood cell count in laboratory tests (anaemia in children)
Common side effects(may affect up to 1 in 10 people)
headache
dizziness, feeling tired or unwell
insomnia
flatulence, constipation, indigestion, vomiting
stomach symptoms such as pain, bloating or discomfort
dry mouth, numbness around the mouth
sweating, widespread skin redness, joint pain, muscle
and bone pain
Uncommon side effects(may affect up to 1 in 100 people)
allergic reactions such as skin rash, swelling around the eyes, shortness of breath
anaphylactic reactions, including anaphylactic shock
abnormal dreams, nightmares
Rarely, gastrointestinal side effects can be serious (diarrhoea, vomiting, stomach pain and nausea).
Heart attacks
In clinical studies, patients with risk factors for a heart attack have experienced heart attacks with
uncommon frequency after receiving Plerixafor Accord and G-CSF.
Tell your doctor immediately if you experience chest discomfort.
Tingling and numbness
Tingling and numbness are common in patients treated for cancer. About one in five patients experience these sensations. However, these effects do not appear to occur more
frequently when taking Plerixafor Accord.
A blood test may show an increase in white blood cell count (leukocytes).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Plerixafor Accord
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 label after “EXP”. The
expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions. After opening
the vial, Plerixafor Accord must be used immediately.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
information
What Plerixafor Accord contains
- The active ingredient is plerixafor. Each mL of injectable solution contains 20 mg of plerixafor. Each vial contains 24mg of plerixafor in a 1.2 mL solution.
- The other ingredients are: sodium chloride, hydrochloric acid (concentrated) and sodium hydroxide and water for injectable preparations (see section 2 “Plerixafor Accord contains sodium”).
Description of the appearance of Plerixafor Accord and package contents
Plerixafor Accord presents as a clear, colorless or pale yellow injectable solution
in a glass vial with a rubber stopper, aluminum tear-off seal and
blue plastic PP cap. Each vial contains 1.2 mL of solution.
Each pack contains 1 vial.
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona,
s/n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain
Manufacturer
Accord Healthcare Polska Sp.z o.o.
ul. Lutomierska 50,
95-200 Pabianice, Poland
Or
Laboratori Fundació Dau
C/ C, 12-14 Pol. Ind.
Zona Franca, Barcelona, 08040,
Spain
Or
Accord Healthcare B.V.
Winthontlaan 200, 3526KV Utrecht
Netherlands
Or
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park, Paola
PLA 3000, Malta
For further information on this medicine, contact the local representative of the marketing
authorisation holder:
AT / BE / BG / CY / CZ / DE / DK / EE / FI / FR / HR / HU / IE / IS / IT / LT / LV / LX / MT / NL
/ NO / PT / PL / RO / SE / SI / SK / UK(NI) / ES
Accord Healthcare S.L.U.
Tel: +34 93 301 00 64
EL
Win Medica Pharmaceutical S.A.
Tel: : +30 210 7488 821

- Kraj rejestracji
- Postać farmaceutycznaInjectable solution, 20 mg/ml
- Kod ATCL03AX16
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki PLERIXAFOR AKKORDPostać farmaceutyczna: Injectable solution, 20 MG/MLSubstancja czynna: plerixaforProducent: SANOFI B.V.Wymaga receptyPostać farmaceutyczna: Injectable solution, 20 MG/MLSubstancja czynna: plerixaforProducent: EG S.P.A.Wymaga receptyPostać farmaceutyczna: Injectable solution, 20 MG/MLSubstancja czynna: plerixaforProducent: TILLOMED ITALIA SRLWymaga recepty
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PLERIXAFOR AKKORD wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w PLERIXAFOR AKKORD jest plerixafor. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
PLERIXAFOR AKKORD jest produkowany przez ACCORD HEALTHCARE, S.L.U.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie PLERIXAFOR AKKORD jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić PLERIXAFOR AKKORD w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (plerixafor) to m.in. MOTSOBIL, PLERIXAFOR EG, PLERIXAFOR TILLOMED. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
















