Soliris 300Mg Vial Of 30Ml Solution For Infusion

• Paroxysmal nocturnal haemoglobinuria (a rare blood disorder in which red blood cells are easily destroyed, which can cause anaemia and blood clots).
• Atypical haemolytic uraemic syndrome (a rare condition in which small blood clots form in blood vessels and can damage the kidneys and other organs).
• Refractory generalised myasthenia gravis (a long-term condition that causes muscle weakness and does not respond adequately to standard treatment).
• Neuromyelitis optica spectrum disorder (a rare condition in which the immune system attacks the optic nerves and spinal cord, causing vision problems and weakness or other neurological symptoms).

• If you have an unresolved serious Neisseria meningitidis infection, treatment must not be started. If you are allergic to Eculizumabor any other ingredients of this medicine.

• Headache
• Common cold symptoms (nasopharyngitis)
• Back pain
• Nausea
• Diarrhoea
• Raised blood pressure
• Upper respiratory tract infection
• Abdominal pain
• Vomiting
• Anaemia
• Cough
• Swelling of the ankles or feet
• Urinary tract infection
• Fever
• Musculoskeletal pain

Other General Warnings

• You have any infection now, or you develop a fever, headache with a stiff neck, a rash, sensitivity to light or confusion at any point during treatment.
• You have not completed your meningococcal vaccination, as it must be completed or updated at least two weeks before the first dose.
• You are due any vaccination, including pneumococcal and Haemophilus influenzae type b vaccines, which are particularly important for children.
• You are having plasmapheresis, plasma exchange or fresh frozen plasma infusion, as an extra dose may be needed.
• You are taking a neonatal Fc receptor blocker.
• You have a history of blood clots, as your doctor will advise on prevention and management.
• You feel unwell at any point during the infusion.
• You are pregnant, think you may be pregnant or are planning a baby.
• You are breastfeeding.
• You are thinking of stopping treatment, as your condition must be monitored afterwards.

• Soliris 300 Injection is given by a healthcare professional as an infusion into a vein.
• Your meningococcal vaccination must be completed or updated at least two weeks before the first dose, unless your doctor judges that delaying treatment is the greater risk.
• The dose and the schedule are decided by your doctor and depend on the condition being treated.
• If a reaction happens during the infusion, your doctor may slow it down or stop it.
• You will be monitored for at least one hour after the infusion finishes, for signs of an infusion-related reaction.
• Never try to change, delay or skip an infusion on your own.
• Do not stop treatment without speaking to your doctor, as your condition needs to be monitored afterwards.

• Soliris 300 Injection is a hospital-administered medicine, so the pharmacy handles its storage, preparation and disposal.
• Store the vials in a refrigerator, between 2 and 8 degrees Celsius, in the original carton to protect them from light until they are used.
• Vials may be kept in the original carton at controlled room temperature, not more than 25 degrees Celsius, for a single short period only.
• Do not freeze. Do not shake.
• Do not use beyond the expiry date stamped on the carton.
• Unused product and waste are disposed of by the hospital. Do not dispose of it yourself.

• Inform your doctor and get medical help immediately for fever, headache with a stiff neck, a rash, sensitivity to light or confusion. Meningococcal infection can move very fast and is the single most important risk with this medicine.
• Complete your meningococcal vaccination at least two weeks before your first dose, and keep it up to date afterwards.
• Remember that vaccination reduces the risk but does not remove it. Serious infection can still occur in vaccinated patients.
• Stay for the full hour of monitoring after each infusion.
• Do not stop treatment on your own.

Overdose

Missed a Dose

Interactions with other medicines

• Tell your doctor about all the medicines you take, including ones bought without a prescription.
• Plasmapheresis, plasma exchange or fresh frozen plasma infusion can reduce the level of Soliris 300 Injection in the body, and your doctor may need to give a supplemental dose.
• Neonatal Fc receptor blockers may lower the level of Soliris 300 Injection in the body. Your doctor might require to change or adjust the dose as required .
• Tell your doctor about any vaccination you are due, particularly meningococcal, pneumococcal and Haemophilus influenzae type b vaccines.

Interactions with food items

• Soliris 300 Injection is given into a vein by a healthcare professional, so interactions with food do not occur.