Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - spherox

Document Subject

Generated Narrative: MedicinalProductDefinition mpc8b09940edf0aa917a934cf86ca85bbd

identifier: http://ema.europa.eu/identifier/EU/1/17/1181/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Spherox 10-70 spheroids/cm2 implantation suspension

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-c8b09940edf0aa917a934cf86ca85bbd

identifier: http://ema.europa.eu/identifier/EU/1/17/1181/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - spherox

Attesters

What is in this leaflet

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

Spherox is a medicine used to repair damage to the cartilage of the knee in adults and in adolescents whose bones in the joint have finished growing. Cartilage is a hard smooth layer inside your joints, on the ends of the bones. It protects the bones and allows joints to work smoothly. Spherox is used in adults, or adolescents whose bones have finished growing, when the cartilage in the knee joint is damaged, for example by acute injury, such as a fall or long-term wear due to incorrect weight bearing on the joint. Spherox is used to treat defects up to 10 cm in size.

Spherox consists of so-called spheroids. A spheroid looks like a tiny pearl made of cartilage cells and cartilage material derived from your own body. To make the spheroids, a small cartilage sample is taken from one of your joints during a minor operation, and then grown in the laboratory to make the medicine. The spheroids are implanted by surgery to the damaged cartilage area and stick to the damaged part. They are then expected to repair the damage with healthy and functional cartilage over time.

Do not use Spherox if

• the bones in the knee joint have not finished growing
• you have advanced joint and bone inflammation with damage in the affected joint (osteoarthritis)
• you are infected with HIV (the virus that causes AIDS), hepatitis B virus or hepatitis C virus

Warnings and precautions

Talk to your doctor before you are given Spherox, if you have any other joint problems or excess weight, as this may reduce the success of the procedure.

Spherox should preferably be implanted into an otherwise healthy joint. Other joint problems should be corrected before or at the time of Spherox implantation.

After the treatment, bleeding into the knee joint and possibly into the surrounding area may happen, mainly if you have an increased tendency of bleeding or if bleeding during the treatment could not be fully stopped. The physician will check in advance the risk that you may face a bleeding after the treatment. In that case, you will get medicine to decrease the risk of bleeding after the treatment.

Rehabilitation program

Follow the rehabilitation program strictly after implantation. Only resume physical activity when instructed by your doctor. Resuming vigorous activity too soon may reduce the benefit and durability of Spherox.

Other cases in which Spherox cannot be supplied

Even if the cartilage sample has already been taken, it may happen that you cannot be treated with Spherox. This can occur because the sample taken is not of sufficient quality to manufacture the product. Your doctor might have to select an alternative treatment for you.

Children and adolescents

Spherox shall not be used in children or adolescents whose bones in the knee joint have not finished growing.

Other medicines and Spherox

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

Pregnancy and breast-feeding

Spherox is not recommended for pregnant or breast-feeding women, as it is applied during surgery. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

Driving and using machines

The surgical procedure to implant this medicine will have a major influence on your ability to drive and use machines. Driving cars and using machines may be limited during the rehabilitation period. Strictly follow the advice of your doctor or physical therapist.

Spherox can only be implanted by a specialist doctor in a medical facility and must only be used in the patient for whom it has been prepared.

Treatment with Spherox is a two-step procedure:

Visit 1: Evaluation of the damage to the cartilage, sample and blood taking

On the first visit, the doctor will examine the damage to your knee cartilage during an exploratory operation. This is usually done as keyhole surgery through very small incisions (cuts), using a special instrument to look inside the knee (arthroscopy). If Spherox is appropriate for you, the doctor will take a small cartilage sample from your joint. Most likely this will be from the same knee joint that has to be treated. Your cartilage cells are extracted from this sample in a laboratory and are then grown to make the spheroids that constitute Spherox. The process takes about 6 to 8 weeks.

Visit 2: Spherox implantation

Spherox is implanted into the damaged area of cartilage in the knee during a second operation. This may also be carried out by keyhole surgery.

Rehabilitation

In order to allow your knee joint to recover well, you will have to follow an individual rehabilitation program. This may take up to one year. Your doctor or physical therapist will advise you.

Very important: Carefully follow the recommendations of your doctor and physical therapist. The risk of treatment failure may increase if you do not follow your rehabilitation schedule. Be very careful when bending and putting weight on your treated joint. During the rehabilitation period, the amount of weight you can put on the joint will increase gradually. How quickly this occurs depends for example on your body weight and the extent of the damage to the cartilage. Depending on the condition of the treated knee joint, you may have to wear a brace.

Ask your doctor or physical therapist if you have any further questions about treatment with Spherox.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects appearing after the implantation of Spherox are mostly related to the surgery. The recorded side effects, either caused by the medicine or the surgery, were in most cases not serious.

If you get any of the following serious side effects, you should immediately contact a doctor:

• hypersensitivity (allergy) (one or more of the following symptoms may occur: skin redness, swelling in the treated area, low blood pressure, difficulties to breathe, swollen tongue or throat, weak and rapid pulse, sickness, vomiting, diarrhoea, dizziness, fainting, fever)
• blood clot in a vein (one or more of the following symptoms may occur: swelling in the leg, pain, increased warmth in the leg)

Other side effects

Side effects can occur with the following frequencies: Common: may affect up to 1 in 10 people

• accumulation of fluid in the knee
• pain in the knee
• swelling in the knee
• accumulation of excess fluid in the bone marrow
• pain

Uncommon: may affect up to 1 in 100 people

• increase in size of the cartilage cells, softening of cartilage. You may notice symptoms, for example swelling or pain of the tissues around the knee.
• cracking sounds in the knee
• joint lock in the knee
• impairment of walking
• tissue lump that may occur in the knee, fragment of cartilage or bone that freely floats in the knee joint space. You may notice symptoms, for example a painless heavy swelling of the treated knee, sudden pain or problems to move the treated knee.
• cartilage cells in Spherox do not survive and grow
• any damage of knee cartilage
• ligament disorder
• tendon inflammation
• muscle weakness
• pain in the front of the knee or kneecap
• swelling of the treated leg due to obstructed flow of tissue fluid via the lymph vessels
• scar tissue pain
• blockage of a blood vessel in the lung
• inflammation of the inner layer of the joint capsule

Rare: may affect up to 1 in 1000 people

• disorder of bone formation, death of bone tissue, bone formation outside the skeleton. You may notice symptoms, for example swelling or pain of the tissues around the knee.
• infection at the site of implantation
• inflammation of the knee joint caused by bacteria or fungi
• partial or complete detachment of the tissue beneath the bone and surrounding cartilage
• inflammation of the bone marrow caused by bacteria or fungi
• inflammation of the skin and/or the soft tissue caused by bacteria or fungi
• pain below the kneecap due to inflammation of the soft tissue
• inflammation of veins combined with the formation of a blood clot located near the surface of the skin (symptoms: e.g. redness and/or warmth of the skin along the vein, tenderness, pain)
• healing complication in the area of treatment
• reopening of a closed wound
• bruising

Very rare: may affect up to 1 in 10.000 people

• discomfort

Not known: frequency cannot be determined

• excessive scar tissue formation within the knee joint and/or surrounding of soft tissues
• infection of the lungs

Reporting side effects

If you get any side effects, talk to your doctor 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 system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

This product will be carefully stored by medical staff in the hospital where the medicine will be given to you, and the storage instruction for them are as follow:

Do not use this medicine after the expiry date which is stated on the label after EXP. Store and transport refrigerated (1 C to 10 C). Do not freeze. Do not irradiate. Do not open the outer packaging before use to prevent microbial contamination.

What Spherox contains

• The active substance of Spherox are spheroids that consist of cartilage cells and cartilage material derived from your own body. Spherox contains 10-70 spheroids per cm of the cartilage defect.
• The other ingredient is sodium chloride used as transport solution.

What Spherox looks like and contents of the pack

Implantation suspension.

Spherox contains so-called spheroids that consist of living cartilage cells with a non-cellular portion for the repair of cartilage defects. The spheroids look like small white to yellowish pearls. They are transported in a clear colourless solution. Spherox is delivered to the doctor in a container ready for application. The container may be a syringe or a special application system called co.fix that is a catheter (narrow tube) with a stem length of 150 mm. The applicator co.fix 150 is packed in a sterile tube and additionally surrounded by an extra bag. The pre-filled syringe is packed in a sterile tube and additionally surrounded by an extra bag.

Marketing Authorisation Holder

CO.DON GmbH
Deutscher Platz 5d 04103 Leipzig, Germany Tel.: +49 341 99190 Fax: +49 341 99190 E-mail: info@codon.de

Manufacturer

CO.DON GmbH Warthestra e 14513 Teltow, Germany

CO.DON GmbH Deutscher Platz 5d 04103 Leipzig, Germany

This leaflet was last revised in

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