מדינה: ניו זילנד
שפה: אנגלית
מקור: Medsafe (Medicines Safety Authority)
Risankizumab 90 mg/mL;
AbbVie Limited
75 mg/0.83mL
Solution for injection
Active: Risankizumab 90 mg/mL Excipient: Polysorbate 20 Sodium succinate Sorbitol Succinic acid Water for injection
Prescription
Psoriasis: Skyrizi is Indicated for the treatment of moderate to severe plaque psoriasis in adults.
Package - Contents - Shelf Life: Syringe, glass, Type 1 clear, with fluoropolymer coated bromobutyl rubber stopper and needle - 2 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light
2018-06-26
Skyrizi® 12 July 2023 Version 8 1 SKYRIZI® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING SKYRIZI? Skyrizi contains the active ingredient risankizumab. Skyrizi is used to treat moderate to severe plaque psoriasis and active psoriatic arthritis in adults and moderate to severe Crohn's disease in patients from 16 years of age. For more information, see Section 1. Why am I using Skyrizi? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE SKYRIZI? Check the list of ingredients at the end of the CMI. Do not use Skyrizi if you have ever had an allergic reaction to any of them. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use Skyrizi? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Skyrizi and affect how it works or Skyrizi may interfere with other medicines and affect how they work. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE SKYRIZI? • Skyrizi is injected under the skin. More instructions can be found in Section 4. How do I use Skyrizi? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING SKYRIZI? THINGS YOU SHOULD DO • Ensure you are up to date with your immunisations before you start therapy with Skyrizi. • Speak to your doctor if you think you have an infection. • Remind any doctor, dentist or pharmacist you visit that you are using Skyrizi. THINGS YOU SHOULD NOT DO • Do not stop using this medicine or change the dose without checking with your doctor. DRIVING OR USING MACHINES • Skyrizi is not expected to have any effect on your ability to drive or use machines. DRINKING ALCOHOL • There is no information on the effects of using Skyrizi with alcohol. LOOKING AFTER YOUR MEDICINE קרא את המסמך השלם
SKYRIZI Data Sheet Version 10 12 October 2023 1 of 38 NEW ZEALAND DATA SHEET 1 SKYRIZI ® 75mg/0.83mL solution for injection SKYRIZI ® 150 mg/mL solution for injection SKYRIZI ® 360 mg/2.4 mL solution for injection SKYRIZI ® 600 mg/10.0 mL concentrate for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 75 mg/0.83 mL pre-filled syringe contains 75 mg risankizumab in 0.83 mL solution. Each 150 mg/mL pre-filled pen or pre-filled syringe contains 150 mg risankizumab in 1 mL solution. Each 360 mg/2.4 mL pre-filled cartridge contains 360 mg risankizumab in 2.4 mL solution. Each 600 mg/10.0 mL single-dose vial contains 600 mg risankizumab in 10.0 mL solution. Skyrizi (risankizumab), an interleukin-23 blocker, is a humanised immunoglobin G1 (IgG1) monoclonal antibody. Risankizumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells using recombinant DNA technology. Excipients with known effect Skyrizi 75 mg/0.83 mL contains 68 mg sorbitol per 150 mg dose. Skyrizi 150 mg/mL and Skyrizi 75 mg/0.83 mL contains less than 1 mmol sodium (23 mg) per 150 mg dose and is essentially sodium free. Skyrizi 360 mg/2.4 mL contains less than 1 mmol sodium (23 mg) per 360 mg dose and is essentially sodium free. Skyrizi 600 mg/10.0 mL contains less than 1 mmol sodium (23 mg) per 600 mg dose and is essentially sodium free. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. SKYRIZI Data Sheet Version 10 12 October 2023 2 of 38 3 PHARMACEUTICAL FORM 75 mg/0.83 mL: Solution for injection in a pre-filled syringe. The solution is colourless to slightly yellow and clear to slightly opalescent. The solution may contain tiny white or clear particles. 150 mg/ mL: Solution for injection in a pre-filled syringe or pre-filled pen. The solution is colourless to yellow and clear to slightly opalescent. The solution may contain tiny white or clear particles. 360 mg/2.4 mL: Solution for subcutaneous injection in a pre-filled cartridge with an on-body injector. Solution is colourless to yel קרא את המסמך השלם