English
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Maci (autologous cultured chondrocytes) – Package leaflet - M09AX02

Updated on site: 08-Oct-2017

Medication nameMaci
ATC CodeM09AX02
Substanceautologous cultured chondrocytes
ManufacturerVericel Denmark ApS

Package leaflet: Information for the user

MACI 500,000 to 1,000,000 cells/cm2 for implantation

This medicine is subject to additional monitoring. This will allow quick identification of new safety

information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Matrix applied characterised autologous cultured chondrocytesSuspended

 

Keep this leaflet. You may need to read it again.

 

If you have any further questions, ask your doctor, surgeon or physical therapist.

 

If you get any side effects talk to your doctor, surgeon or physical therapist. This includes any

 

possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

Authorisation

1.

What MACI is and what it is used for

2.

What you need to know before you use MACI

3.

How to use MACI

 

4.

Possible side effects

5.

How to store MACI

6.

Contents of the pack and other information

1.

What MACI is and what it is used for

MACI is used in adults to repair cartilage defects in your knee joint. Cartilage is a tissue that is present in every joint in the body; it protects the ends of bones and allows joints to function smoothly.

MACI is an implant consisting of a porcine derived (derived from pigs) collagen membrane which

contains your own cartilage cells (called autologous chondrocytes) and is implanted into your knee.

“Autologous” means that your own cells are used which have been taken from your knee (through a

Marketing

biopsy) and grown outside the body.

2.

What you need to know before you use MACI

Do NOT use MACI if you:

are allergic to any of the ingredients of MACI (listed in section 6), or porcine products (derived from pigs), bovine serum (a protein derived from cows) or gentamicin (an antibiotic)

have severe osteoarthritis of the knee (disease of the joints with pain and swelling)

currently suffer from inflammatory arthritis or inflammatory joint disease of the knee

have a known, uncorrected bleeding disorder

have a growth plate of the knee that is not fully closed.

Warnings and precautions

Your MACI implant has been manufactured specifically for you and cannot be administered to any other

patient.

Suspended

 

MACI should be implanted in a reasonably healthy joint. This means that other problems in the joint should be corrected before or during MACI implantation.

If you have a sudden occurrence or recent history of bone or joint infections, your MACI treatment should be temporarily delayed until your doctor considers that you have recovered.

Tell your doctor or surgeon if you know you have a predisposition for bleeding or poor bleeding control following surgical procedures.

You may also be given antibiotics or pain-killers to help reduce some of the side effects.

It is important that you closely follow the rehabilitation programme recommended by your doctor. Please

discuss with your doctor or physical therapist when to re-start specific physical activities.

Older people

Authorisation

Your surgeon will give you more information on any special considerations for your particular case.

Other situations in which MACI cannot be given

Even if the surgeon has already taken a small sample of cartilage cells (a biopsy) needed to produce the MACI implant, it is possible that you will not be eligible for treatment with MACI.

This is the case if:

the biopsy is of insufficient quality to produce MACI for you

the cells cannot be grown in the laboratory

the increased cells do not meet all the quality requirements.

In such situations, your surgeon will be informed and might have to select an alternative treatment for you.

MarketingThe use of MACI is not recommended in patients over 65 years of age who have generalised degeneration of the cartilage or osteoarthritis (disease of the joints with pain and swelling).

Children and adolescents

The use of MACI is not recommended in children and adolescents below 18 years.

Other medicines and MACI

Please tell your doctor, surgeon or physical therapist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Ask your doctor or surgeon for more information as to which pain medicine you can safely use. Administration of pain relievers into the joint is not recommended.

Driving and using machines

Pregnancy and breast-feeding

The safe use of MACI has not been demonstrated during pregnancy or breast-feeding.

MACI is not recommended for pregnant women.

Please inform your doctor or surgeon if you are pregnant or think you may be pregnant.

Talk to your doctor or surgeon if you are breast-feeding. Depending on your particular situation, your doctor or surgeon will advise you on whether or not to continue breast-feeding.

The surgical procedure will have a major impact on your ability to drive and use machines. Driving and using machines may be limited during the rehabilitation period, and the advice of your doctor, surgeon or physical therapist should be strictly followed during this period.

Suspended

3.How to use MACI

You will need to have two surgical procedures to receive this treatment:

MACI must only be implantedAuthorisationby surgeons who have been specifically trained for this kind of surgery. A small amount of blood (4 ml) will be taken by a qualified person for testing.

1. During the first procedure, a sample of healthy cartilage cells (a biopsy) will be taken from your joint by arthrotomy or arthroscopy. Your surgeon will explain what arthrotomy and athroscopy procedures are.

The biopsy will be sent to the cell processing facility. At the cell processing facility, your cartilage cells will be grown aseptically (free from germs) in culture, to increase the number of cells, and placed onto a sterile collagen membrane to make MACI.

2. The final MACI implant will be sent back to your surgeon. The MACI will then be implanted

into the cartilage defect in your joint by a second procedure. MACI will be secured in place Marketingusing a fibrin sealant. A fibrin sealant is a type of glue that is made from human blood-clotting

proteins.

The length of time between your biopsy and the implantation of MACI can vary depending on the procedure date and the quality and number of cells in the biopsy. On average this will be 6 weeks, however, cells can also be frozen and held in storage for up to 2 years until a convenient date for surgery is agreed between you and your surgeon. Your surgeon will organise the date for implantation.

In rare cases the cell processing facility will not be able to produce MACI from your cells. If this happens, your surgeon will advise you on the best course of action.

Your doctor will discuss with you the specific rehabilitation programme that follows your surgery.

4.Possible side effects

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

Your doctor may give you other medicines to help reduce any side effects (see section 2 “Warnings and precautions”).

When you receive MACI, you may experience side effects soon after theSuspendedimplantation. These effects will gradually reduce over time.

Complications may be related to MACI or to the surgical procedure, or both. Complications related to knee surgery in general may include deep vein thrombosis (blood clotting in a deep vein) and pulmonary embolism (blood clotting in the lung due to blockage of a lung artery). If you notice any of the following, please contact your doctor immediately, since these may be symptoms of blood clotting:

difficulty breathing, chest pain and palpitations

leg swelling, leg pain and redness

Risks involved with implantation of MACI:

The following uncommon side effect may affect up to 1 in 100 people:

too much cartilage growth.

the graft may detach completely or partially from the defect in the joint. You may require more surgery to correct this

Risks involved with arthrotomy or arthroscopy or MACI

All surgical procedures carry a certain risk. Your surgeon can explain these to you.

The following rare side effects may affect up to 1 in 1,000 people:

infection

 

 

inflammation

post-operative pain

bleeding in the joint

 

Authorisation

joint stiffness/numbness

swelling of the joint

fever

 

 

Marketingsystem listed in Appendix V. By reporting side effects you can help provide

 

 

more information on the

Your surgeon or anaesthetist will explain to you the risks involved with the procedures as well as any additional specific risks that are applicable to you because of your medical history and current medical status.

Reporting of side effects

If you get any side effects, talk to your doctor, surgeon or physical therapist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting

safety of this medicine.

MACI should be used within 6 days after the date of release.

5. How to store MACI

Any spillage or waste material should be disposed as surgical waste material in compliance with local practice.

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

 

Do not use MACI after the expiry date which is stated on the outer carton and the dish after EXP.

Do not refrigerate or freeze. Store below 37°C in the outer carton until ready to use.

6.

Contents of the pack and other information

Suspended

Since this product will be used during your knee surgery, the hospital staff is responsible for the correct storage of the product both before and during its use, as well as for the correct disposal.

What MACI contains

Authorisation

 

The active substance of MACI consists of viable autologous human cartilage cells on a 14.5 cm² Type I/III collagen membrane, at a density of between 0.5 and 1 million cells per cm2.

The other ingredients are Dulbecco’s Modified Eagles Medium (DMEM) with 4-(2-

Hydroxyethyl)piperazine-1-ethanesulfonic acid sodium (HEPES).

What MACI looks like and contents of the pack

The implant is an opaque, off-white membrane supplied in 18 ml of colourless solution in a dish.

Marketing Authorisation Holder

Vericel Denmark ApS, Amaliegade 10, DK-1256 Copenhagen K, Denmark

MarketingManufacturer

Genzyme Biosurgery ApS, Oliefabriksvej 51B, DK-2770 Kastrup, Denmark

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

__________________________________________________________________________________

The following information is intended for medical or healthcare professionals only:

During the first procedure a sample of healthy cartilage cells (a biopsy) will be taken from the affected joint by an arthrotomy or arthroscopy.

The biopsy will be sent to the cell processing facility. At the cell processing facility, the cartilage cells will be grown aseptically in culture to expand the number of cells and placed onto a sterile collagen membrane, to make MACI.

Please consult the Surgical Technique Manual for further information. Suspended

MACI will be sent back to the surgeon. At this time MACI will be implanted into the cartilage defect in the affected joint via a second procedure. The MACI implant will be secured in place using a fibrin sealant.

The timing between the removal of the biopsy and the implantation of the MACI implant can vary depending on logistics and the quality and number of cells in the biopsy. On average this will be 6 weeks, however, cells can also be cryopreserved and held in storage for up to 2 years until a convenient date for surgery is agreed between the patient and surgeon.

The surgeon will organise the date for implantation in consultation with the Marketing Authorisation Holder (MAH) or its local representative. In rare cases the MAH will not be able to produce a MACI implant from the available cells. If this occurs the surgeon will advise the patient on the best course of action.

Marketing

Authorisation

 

 

Comments

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
  • Help
  • Get it on Google Play
  • About
  • Info on site by:

  • Presented by RXed.eu

  • 27558

    prescription drugs listed