Inductos 1,5 mg/ml polvo, disolvente y matriz para matriz de implantaciÓn

Patient Information Leaflet

InductOs 1.5 mg/ml powder, solvent and matrix for preparation of matrix for implantation

dibotermina alfa

Read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any side effects, consult your doctor, even if they are not listed in this leaflet. See section 4.

InductOs contains the active ingredient, dibotermina alfa. It is a copy of a protein called bone morphogenetic protein 2 (BMP-2), which is naturally produced by the body and helps in the formation of new bone tissue.

InductOs may be used in both lower back spinal fusion surgery and to repair tibial fractures.

Lower back spinal fusion surgery

If you have a lot of pain due to a damaged disc in the lower part of your spine and other treatments have not been effective, your case may be considered for lower back spinal fusion surgery. InductOs is used instead of using a bone graft from your hip, which avoids the problems and pain that can be caused by a surgery to obtain the bone graft.

When used in lower back spinal fusion surgery, InductOs is combined with a medical device that corrects the position of your spine. If you have any questions about the medical device, ask your doctor.

Tibial fractures

If you have broken the tibial bone, InductOs is used to help in the healing of the fracture and to reduce the need for subsequent surgical procedures. It is used in conjunction with standard treatment and care for tibial fractures.

You should not apply InductOs

• If you are allergic to dibotermina alfa, or bovine collagen, or any of the other components of this medication (listed in section 6).
• If you are in a growth period (immature skeleton).
• If you have an active infection at the surgery site.
• If your doctor decides that you have inadequate blood supply to the fracture site.

• For the treatment of a fracture related to a disease (e.g. fractures due to Paget's disease or cancer).

• If you have been diagnosed or are being treated for cancer.

Warnings and precautions

• You should inform your doctor if you have an autoimmune disease, such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren's disease, and dermatomyositis/polymyositis.
• You should inform your doctor if you have any bone disease.
• You should inform your doctor if you have a history of cancer.
• The product should not be placed in direct contact with certain types of bones. Your surgeon will know which bones to avoid.
• The use of InductOs may cause bone formation (heterotopic ossification) in underlying tissues, which may lead to complications.
• Some patients may develop pain in a nerve as a result of localized fluid accumulation, which may require drainage or surgical removal of the fluid.
• Some patients may develop antibodies (produced by the body to fight a foreign protein) to InductOs. Although no adverse effects have been noted, the long-term effects are unknown.
• You should inform your doctor if you have any kidney or liver problems.
• Cases of localized swelling have been reported, which in some cases have caused respiratory difficulty, in cases where InductOs was used in cervical spine surgery. The safety and efficacy of InductOs in cervical spine surgery are unknown, and therefore InductOs should not be used in these cases.

Other medications

You should inform your doctor if you are using or have recently used other medications, including those obtained without a prescription.

Pregnancy and breastfeeding

The effects of InductOs during pregnancy are unknown. The use of the product is not recommended in pregnant women.

The passage of InductOs into breast milk is unknown.

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor before receiving this medication.

Driving and operating machinery

InductOs does not affect your ability to drive and operate machinery.

InductOs contains bovine collagen, a protein obtained from cattle

Some patients may develop antibodies (produced by the body to fight a foreign protein) to the collagen in the medication. In clinical trials, the presence of antibodies to collagen was not associated with adverse effects such as allergies, and did not demonstrate that the presence of these antibodies reduced the efficacy of InductOs. Contact your doctor if you think you have an allergic reaction to collagen.

InductOs contains sodium

This medication contains less than 23 mg (1 mmol) of sodium per maximum dose (two packs of 12 mg), that is, it is practically "sodium-free".

The doctor treating you will implant InductOs during the operation. The medical team will prepare InductOs in the operating room. The powder will dissolve in sterile water to form a solution that is used to soak the sponge. The soaked sponge is then implanted where new bone growth is needed. Over time, the sponge will gradually disappear as new bone forms.

If you are receiving InductOs for lower back spinal fusion, your surgeon will remove the damaged disc causing you pain and replace it with a medical device filled with InductOs. The medical device corrects the position of your spinal column and InductOs promotes bone growth between the two vertebrae to permanently fix them in the correct position.

If you are receiving InductOs for the treatment of a tibia fracture, your doctor will place InductOs around the fractured bone when treating the fracture. Your doctor will determine the amount of InductOs you will receive, depending on the size and number of fractures. Generally, a single 12 mg container is used; however, up to a maximum of two 12 mg containers may be used.

Like all medications, InductOs may cause adverse effects, although not everyone will experience them.

Severe Adverse Effects

Inform your doctor immediately or go to the nearest hospital emergency department if you experience localized swelling, which could cause breathing difficulties, after using InductOs in a procedure for the upper region (neck) of the spine. The frequency of this adverse effect is unknown and cannot be estimated from available data.

Other Adverse Effects

Spinal Fusion Surgery

Consult your doctor if you experience any of the following effects:

• Frequent (may affect up to 1 in 10 people):

Bone growth, movement of the implanted medical device, localized fluid accumulation, and back pain radiating to the leg (sciatica)

• Unknown frequency (cannot be estimated from available data): Increased bone resorption

Fractures of the Tibial Bone

Consult your doctor if you experience any of the following effects:

• Very frequent (may affect more than 1 in 10 people): Localized infection

• Frequent (may affect up to 1 in 10 people): Localized fluid accumulation

• Unknown frequency (cannot be estimated from available data): Increased bone resorption

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through thenational notification system included in theAnnex V.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

You do not need to keep this medication

Composition of InductOs

• The active principle of InductOs is dibotermina alfa (also known as recombinant human bone morphogenetic protein 2) 4 mg (4 mg package) or 12 mg (12 mg package).
• The other components are: sucrose, glycine, glutamic acid, sodium chloride, sodium hydroxide, and polisorbate 80, water for injection and bovine type I collagen.

Appearance of the product and contents of the packaging

InductOs is provided to your doctor as a kit for surgical implantation.

• Dibotermina alfa is a white powder presented in a glass vial
• Water for injection is a transparent and colorless liquid presented in a glass vial
• The sponge is white and presented in a plastic blister

Holder of the marketing authorization and responsible manufacturer

Medtronic BioPharma B.V.

Earl Bakkenstraat 10

6422 PJ Heerlen

Netherlands

Last review date of this leaflet

The detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu/