Šalis: Didžioji Britanija
kalba: anglų
Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)
Wasp venom
ALK-Abello Ltd
V01AA07
Wasp venom
120microgram
Powder and solvent for solution for injection
Subcutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 03040200
1 PL10085/0003, PL10085/0004-1313-v1-uk PACKAGE LEAFLET: INFORMATION FOR THE USER PHARMALGEN® BEE VENOM PHARMALGEN® WASP VENOM 100μg/ml powder and solvent for solution for injection 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. - 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 Pharmalgen is and what it is used for 2. What you need to know before you use Pharmalgen 3. How to use Pharmalgen 4. Possible side effects 5. How to store Pharmalgen 6. Contents of the pack and other information 1. WHAT PHARMALGEN IS AND WHAT IT IS USED FOR Pharmalgen Bee Venom and Pharmalgen Wasp Venom can be used in two ways: FOR TREATMENT • Pharmalgen Bee Venom and Pharmalgen Wasp Venom are treatments to reduce your body’s reaction to bee or wasp stings. In the rest of this leaflet, these medicines will be called Pharmalgen. FOR DIAGNOSIS • Pharmalgen is also used to test if a person will react too strongly to bee or wasp stings. • No specific indication for children can be made. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE PHARMALGEN DO NOT USE PHARMALGEN IF: • If you are allergic to any of the ingredients of this medicine apart from the active substance (listed in section 6) • You have a disease of, or a problem with, your immune system • You have a chronic heart or lung disease or severe arterial hypertension or are being treated with β-blockers • You are being treated with tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs) • You currently have cancer • You have severe asthma (seasonal or chronic) • You are being treated with ACE inhibitors (medicines for heart or blood pressure) 2 PL10085/0003, PL10085/0004-1313-v1-uk WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before using P Perskaitykite visą dokumentą
OBJECT 1 PHARMALGEN WASP VENOM Summary of Product Characteristics Updated 10-May-2017 | ALK-Abello Ltd 1. Name of the medicinal product Pharmalgen Wasp Venom powder and solvent for solution for injection 2. Qualitative and quantitative composition The active ingredient is freeze-dried _Vespula spp._ (Wasp) venom. Content of active ingredient in Pharmalgen Wasp Venom is 120 μg For a full list of excipients, see section 6.1 3. Pharmaceutical form Powder and solvent for solution for injection. 4. Clinical particulars 4.1 Therapeutic indications Diagnosis and treatment of IgE-mediated allergy to wasp venom. 4.2 Posology and method of administration DIAGNOSIS Diagnosing allergy to wasp venom using Pharmalgen Wasp Venom should be carried out using either a skin prick test or an intracutaneous test. Skin prick test: A concentration of 100 μg venom/ml is recommended for use in a skin prick test. However, for extremely sensitive patients, testing with a lower concentration (e.g. 1 or 10 μg venom/ml) is advisable. For instructions on reconstitution and dilution of the product before administration, see section 6.6. Alternatively, an end-point titration test can be used to determine individual starting concentrations for specific immunotherapy. The end-point titration test is performed using concentrations of venom from 0.01 μg venom/ml. If a positive reaction is observed at 0.01 μg venom/ml, retesting must be performed using a lower concentration. The lowest concentration resulting in a positive reaction is used as the end- point. The reaction is read after 15-20 minutes. A reaction is considered positive when a weal with a diameter of more than 3 mm is observed. Albumin Diluent should be used for dilution and as control. Intracutaneous test: The intracutaneous test is 100-1000 times more sensitive than the skin prick test. The intracutaneous test should always be performed as an end-point titration test. It is recommended to start with a concentration of 0.0001 μg venom/ml and increase the concentration stepwise by Perskaitykite visą dokumentą