◾If you have a heart disease, the flu-like symptoms which often occur at the start of treatment may prove stressful to you. Extavia must be used with caution, and your doctor will monitor you for worsening of your heart condition, particularly at the start of treatment. Extavia itself does not affect the heart directly.

◾The functioning of your thyroid gland will be checked regularly or whenever thought necessary by your doctor for other reasons.

◾Extavia contains human albumin and therefore carriesa potential risk for transmission of viral diseases. A risk of transmission of Creutzfeld-Jacob disease (CJD) cannot be ruled out.

◾During treatment with Extaviayour body may produce substances calledneutralising antibodies, which may react with Extavia (neutralising activity). It is not yet clear whether these neutralising antibodies reduce the effectiveness of the treatment. Neutralising antibodies are not produced in all patients. Currently it is not possible to predict which patients belong to this group.

Injection site reactions:During Extavia treatment you are likely to experience injection site reactions. Symptoms include redness, swelling, change in the skin colour, inflammation, pain, and hypersensitivity. Dead skin and tissue around the injection site (necrosis) are reported less frequently. Injection site reactions usually become less frequent over time.

Injection site skin and tissue breakdown can result in scars forming. If this is severe a doctor may have to remove foreign matter and dead tissue (debridement) and, less often, skin grafting is required and healing may take up to 6 months.

To reduce the risk of getting injection site reaction you must:

◾use a sterile (aseptic) injection technique,

◾rotate the injection sites with each injection (see Annex Self-Injection procedure).

Injection site reactions may occur less frequently if you use an auto-injector device. Your doctor can tell you more about this.

If you experience any break in the skin, which may be associated with swelling or fluid leaking out from the injection site:

Stp injections with Extavia and talk to your doctor.

If you have only one sore injection site lesion and the tissue damage necrosis is not too extensive you may continue using Extavia.

If you have more than one sore injection sites multiple lesions you must stop using Extavia until your skin has healed.

Your doctor will regularly check the way you inject yourself, particularly if you have experienced injection site reactions.

Children and adolescents

There have been no formal clinical trials undertaken in children or adolescents.

However, there is some data available in children and adolescents from 12 to 16 years. This data suggests that the safety profile from this age is the same as in adults for use of Extavia 8 million IU under the skin (subcutaneously) every other day. Extavia should not be used in children under 12 years of age as there is no information on this use.

Using other medicines

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