Novo Eight 1500Iu Dry Vial Of 1 Powder For Injection

• Novo Powder For Injection is used in adults and children with haemophilia A (congenital factor VIII deficiency) for:
• On-demand treatment and control of bleeding episodes.
• Perioperative management of bleeding.
• Routine prophylaxis to reduce the frequency of bleeding episodes.

• Patients who have had life-threatening hypersensitivity reactions, including anaphylaxis, to Novo Powder For Injection or any of its components, including hamster proteins.

• Injection site reactions
• Fever (pyrexia)
• Development of inhibitors in previously untreated patients

Other General Warnings

• You have ever had a hypersensitivity reaction to Novo Powder For Injection or to any of its components, including hamster proteins.
• You develop a rash, hives, tightness of the chest, wheezing, dizziness, swelling of the face, or lightheadedness during or after a dose.
• Your bleeding is not controlled by the dose that usually works for you.
• Your expected factor VIII activity levels are not being reached.
• You have von Willebrand disease, as this medicine is not indicated for it.
• You are pregnant, think you may be pregnant, or are planning a baby.
• You are breastfeeding.
• You are having surgery or a dental procedure planned.

• Novo Powder For Injection is given as an injection into a vein, after the powder has been made up with the supplied liquid.
• A healthcare professional prepares and gives it, or you or your carer can if you have been trained to do so.
• Use the reconstituted solution as directed and do not keep it beyond the period stated in the product information.
• Never attempt to change, delay, skip, or repeat a dose on your own.

• Store Novo Powder For Injection in the original package in order to protect it from light.
• Store it in a refrigerator at 2°C to 8°C until the expiry date stated on the carton.
• During its shelf life, it may be kept at room temperature up to 30°C, or at up to 40°C, each for only the limited period stated in the product information.
• Clearly record the date the product was taken out of the refrigerator in the space provided on the outer carton. Do not put it back in the refrigerator afterwards.
• Do not freeze it.
• Keep it out of the sight and reach of children.
• Do not throw medicines away with household waste. Ask your pharmacist how to dispose of medicines you no longer need.

• Tell your doctor straight away if your usual dose does not control bleeding. This can be the sign that inhibitors have developed.
• Attend the blood tests your doctor arranges, including factor VIII activity levels and inhibitor tests.
• Note the date you take the product out of the refrigerator on the carton, and follow the storage instructions for the product after removal from refrigeration.
• Tell your doctor if you have ever reacted to this medicine or to hamster protein.
• Keep a record of your bleeding episodes and the doses you use, and take it to appointments.
• This medicine does not treat von Willebrand disease. Make sure your diagnosis is clear.

Overdose

Missed a Dose

Interactions with other medicines

• Tell your doctor about all prescription medicines, over-the-counter medicines, supplements and herbal products you are taking before and during treatment with Novo Powder For Injection.
• Tell your doctor if you are taking anything that affects bleeding or clotting.

Interactions with food items

• Novo Powder For Injection is given into a vein, so interactions with food are not expected.