Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
benralizumab, Quantity: 30 mg
AstraZeneca Pty Ltd
Injection, solution
Excipient Ingredients: polysorbate 20; trehalose; histidine; histidine hydrochloride monohydrate; water for injections
Subcutaneous
1 pen
(S4) Prescription Only Medicine
FASENRA PEN is indicated as add-on therapy in patients aged 12 years and over with severe eosinophilic asthma (blood eosinophil count greater than or equal to 300 cells/microlitre or greater than or equal to150 cells/microlitre if on oral corticosteroid treatment) (see Section 5.1 Pharmacodynamic properties [Clinical Trials]).
Visual Identification: FASENRA PEN is a clear to opalescent, colourless to yellow solution for injection in a prefilled pen.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2019-12-10
Fasenra® prefilled syringe and Fasenra Pen™ 1 FASENRA® PREFILLED SYRINGE AND FASENRA PEN™ 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. This medicine is new or being used differently. Please report side effects. See the full CMI for further details. 1. WHY AM I USING FASENRA? FASENRA contains the active ingredient benralizumab. FASENRA is used to treat a type of asthma - eosinophilic asthma – in adults and children aged 12 years and over. For more information, see Section 1. Why am I using FASENRA? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE FASENRA? Do not use if you have ever had an allergic reaction to FASENRA or any of the ingredients listed at the end of the CMI. Do not use to treat acute asthma symptoms such as a sudden asthma attack. You will still need your reliever puffer/inhaler. Tell your doctor if you have, or have had, an infection caused by parasites (eg parasitic worms) or if you live in/are travelling to an area where parasitic infections are common. 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 FASENRA? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with FASENRA and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW FASENRA IS GIVEN? Your doctor or nurse may have recommended that you/your caregiver can give your subcutaneous (under the skin) injection, or it may be given to you by a healthcare professional. The recommended dose is 30 mg (one injection - as either FASENRA PEN or FASENRA prefilled syringe) every 4 weeks for the first 3 doses, then one injection every 8 weeks after that. Continue FASENRA for as long as your doctor tells you More instructions can be found Прочетете целия документ
1 of 18 This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems . AUSTRALIAN PRODUCT INFORMATION FASENRA ® (BENRALIZUMAB) SOLUTION FOR INJECTION PREFILLED SYRINGE AND PREFILLED PEN (FASENRA PEN™) 1 NAME OF THE MEDICINE Benralizumab 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each FASENRA prefilled syringe contains 30 mg benralizumab in 1 mL (30 mg/mL). Each FASENRA PEN prefilled pen contains 30 mg benralizumab in 1 mL (30 mg/mL). For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Solution for injection Clear to opalescent, colourless to yellow solution for injection in a prefilled syringe (FASENRA) or prefilled pen (FASENRA PEN). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS FASENRA is indicated as add-on therapy in patients aged 12 years and over with severe eosinophilic asthma (blood eosinophil count ≥300 cells/µL or ≥150 cells/µL if on oral corticosteroid treatment) (see Section 5.1 Pharmacodynamic properties [ _Clinical Trials_ ]). 4.2 DOSE AND METHOD OF ADMINISTRATION FASENRA should be prescribed by a health care professional in consultation with a specialist physician experienced in the diagnosis and treatment of severe asthma. Treatment with high-dose inhaled corticosteroids (ICS) and long-acting β-agonists (LABA) should be optimised prior to commencement of treatment with FASENRA. ADULTS AND ADOLESCENTS (12 YEARS AND OVER) The recommended dose is 30 mg of FASENRA by subcutaneous injection every 4 weeks for the first 3 doses, and then every 8 weeks thereafter. If an injection is missed on a planned date, dosing should resume as soon as possible on the indicated regime; a double dose must not be administered. FASENRA is intended for long-term treatment. A decision to continue therapy should be made at least annually based on disease severity and level of exacerbatio Прочетете целия документ