Ülke: İsrail
Dil: İngilizce
Kaynak: Ministry of Health
BENRALIZUMAB
ASTRAZENECA (ISRAEL) LTD
R03DX10
SOLUTION FOR INJECTION
BENRALIZUMAB 30 MG / 1 ML
S.C
Required
CATALENT INDIANA LLC, USA
BENRALIZUMAB
Fasenra is indicated as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists.
2018-10-09
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only FASENRA® SOLUTION FOR INJECTION IN PRE-FILLED PEN FOR SUBCUTANEOUS INJECTION COMPOSITION: Each pre-filled pen (1 ml) contains: Benralizumab 30 mg For inactive ingredients, refer to section 6 – further information. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE YOU START TAKING THIS MEDICATION. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them even if it seems to you that their ailment/medical condition is similar. 1. WHAT FASENRA IS AND WHAT THE MEDICINE IS INTENDED FOR? Fasenra is indicated as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids and long-acting β-agonists. THERAPEUTIC GROUP: Anti-interleukin-5 receptor α monoclonal antibody. What Fasenra is Fasenra is a medicine containing the active substance benralizumab, which is a monoclonal antibody, a type of protein that recognises and attaches to a specific target site in the body. The target site of benralizumab is a protein called interleukin-5 receptor, which is found particularly on a type of white blood cell called an eosinophil. How Fasenra works Eosinophils are white blood cells involved in asthma inflammation in eosinophilic asthma. By attaching to the eosinophils, Fasenra helps to reduce their numbers. Eosinophilic asthma is a type of asthma characterized by high levels of eosinophils-type white blood cells in the blood or lungs. What are the benefits of using Fasenra: Fasenra may reduce the number of asthma attacks you are experiencing, help you breathe better and decrease your asthma symptoms. If you are taking medicines called ‘oral corticosteroids’, using Fasenra may also allow you to reduce Belgenin tamamını okuyun
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Fasenra 30 mg solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled pen contains 30 mg benralizumab* in 1 mL *Benralizumab is a humanised monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection in pre-filled pen. Clear to opalescent, colourless to yellow solution and may contain translucent or white to off-white particles. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Fasenra is indicated as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists. 4.2 Posology and method of administration Fasenra treatment should be initiated by a physician experienced in the diagnosis and treatment of severe asthma. After proper training in the subcutaneous injection technique and education about signs and symptoms of hypersensitivity reactions, patients with no known history of anaphylaxis or their caregivers may administer Fasenra if their physician determines that it is appropriate, with medical follow-up as necessary. Self-administration should only be considered in patients already experienced with Fasenra treatment. Posology The recommended dose of benralizumab is 30 mg by subcutaneous injection every 4 weeks for the first 3 doses, and then every 8 weeks thereafter. If an injection is missed on the planned date, dosing should resume as soon as possible on the indicated regimen; a double dose must not be administered. Fasenra is intended for long-term treatment. A decision to continue the therapy should be made at least annually based on disease severity, level of exacerbation control and blood eosinophil counts. Elderly No dose adjustment is required for elderly patients (see section 5.2). Renal and hepatic impairment No dose adjustment is required fo Belgenin tamamını okuyun