Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Apis mellifera; Apis mellifera; Apis mellifera; Apis mellifera
ALK-Abello A/S
V01AA07
Apis mellifera; Apis mellifera; Apis mellifera; Apis mellifera
100,000
Suspension for injection
insects
Marketed
2019-04-12
_ _ 1 PACKAGE LEAFLET: INFORMATION FOR THE USER ALUTARD SQ BEE 100 000 SQ-U/ML ALUTARD SQ BEE INITIAL PACK (100 SQ-U/ML, 1 000 SQ-U/ML, 10 000 SQ-U/ML AND 100 000 SQ-U/ML) SUSPENSION FOR INJECTION ALLERGEN FROM HONEY BEE VENOM (_APIS MELLIFERA_) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What ALUTARD SQ Bee is and what it is used for 2. What you need to know before you are given ALUTARD SQ Bee 3. How to use ALUTARD SQ Bee 4. Possible side effects 5. How to store ALUTARD SQ Bee 6. Contents of the pack and other information 1. WHAT ALUTARD SQ BEE IS AND WHAT IT IS USED FOR ALUTARD SQ Bee contains allergen (the substance that cause the allergic reaction) from honey bee venom and is used as preventive treatment for allergy against honey bee stings. This treatment is used for patients who are known to have serious allergic reactions to honey bee stings. The aim of the treatment is to address the underlying cause of the allergy. It works by gradually increasing the immune system’s tolerance to honey bee venom. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ALUTARD SQ BEE DO NOT USE ALUTARD SQ BEE - if you are allergic to any of the other ingredients of this medicine (listed in section 6) - if you have a disease which affects the immune system - if you have recently had an asthma attack and/or have recently _ _ experienced worsening of your asthma symptoms e.g. increase in daytime symptoms, nightly wakening, increased need for medication and/or activity limitations - if you suffer from severe heart or blood vessel d Læs hele dokumentet
Health Products Regulatory Authority 19 January 2022 CRN00C7F2 Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ALUTARD SQ Bee Initial Pack (100 SQ-U/ml, 1 000 SQ-U/ml, 10 000 SQ-U/ml and 100 000 SQ-U/ml) suspension for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ALUTARD SQ Bee contains allergen from honey bee venom (_Apis mellifera_) adsorbed to aluminium hydroxide, hydrated. The biological activity of ALUTARD SQ Bee is related to the concentration of the allergen and is expressed in SQ-U/ml. The vials are distinguished by differently coloured vial numbers. Table 1: Vial number and strength Vial No. (Colour code) Strength (SQ-U/ml) Aluminium content in adjuvant (mg/ml) 1 (Grey) 100 0.00113 2 (Green) 1000 0.0113 3 (Orange) 10 000 0.113 4 (Red) 100 000 1.13 For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection. Clear liquid with or without a precipitate. The precipitate might be white to faintly brown or green. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Allergy immunotherapy for patients with a documented history of generalised and/or systemic IgE-mediated allergic reactions due to sensitisation to honey bee venom (_Apis mellifera_), confirmed by skin prick test and/or intradermal test and/or specific IgE test. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with ALUTARD SQ Bee should be carried out under the supervision of a doctor experienced in specific immunotherapy. After each injection, the patient must be observed for at least 30 minutes. _Posology_ The treatment is divided into two phases; an up-dosing phase and a maintenance phase. The aim is to gradually increase the dose until the highest tolerated maintenance dose is reached. The highest recommended maintenance dose is 1 ml of 100 000 SQ-U/ml (vial 4). The dosing of ALUTARD SQ Bee must always be adjusted according to the allergenic anamnesis and the patient's sensitivity to the specific allergen (see 4.4). Up-dosing phase: Recommendations for up-dosing are give Læs hele dokumentet