Χώρα: Αυστραλία
Γλώσσα: Αγγλικά
Πηγή: Department of Health (Therapeutic Goods Administration)
adrenaline (epinephrine), Quantity: 150 microgram
Allergy Concepts Pty Ltd
Injection, solution
Excipient Ingredients: sodium metabisulfite; water for injections; sodium chloride; hydrochloric acid
Intramuscular
1 x syringe, 2 x syringes
(S3) Pharmacist Only Medicine
For the emergency treatment of anaphylaxis (acute severe allergic reactions) due to insect stings, drugs or other allergens.
Visual Identification: Clear, colourless solution practically free from visible particles; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 21 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2021-03-23
ANAPEN ® CMI Version 1.3, Mar 2021 1 ANAPEN 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 ANAPEN®? ANAPEN® contains the active ingredient adrenaline(epinephrine). ANAPEN® is used for the immediate EMERGENCY TREATMENT of a SEVERE ALLERGIC REACTION (also known as ANAPHYLAXIS). For more information, see Section 1. Why am I using ANAPEN®? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE ANAPEN®? It is important to know how to use an ANAPEN® BEFORE a severe allergic reaction causes a medical emergency. Ask your doctor or pharmacist how you can get an ANAPEN® Training Device for practice. Do not use if you have ever had an allergic reaction to adrenaline(epinephrine) or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, USE 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 ANAPEN®? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with ANAPEN® 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 DO I USE ANAPEN®? For single use only, please ensure you discard safely immediately after use. Inject into outer part of thigh. If necessary, you can use ANAPEN ® through light clothing, such as denim, cotton or polyester. It is important to know how to use your ANAPEN® in an emergency. Read the instructions in the full CMI carefully. Always carry 2 units of auto-injectors in case the first administration fails or if one dose is not sufficient. More instructions can be found in Section 4. How do I use ANAPEN®? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING ANAPEN®? THINGS YOU SHOULD DO Remind any doctor, dentist or pharmacist you visit that you are using adrenaline(epinephrine) • Y Διαβάστε το πλήρες έγγραφο
Version 1.5, Mar 2021 1 AUSTRALIAN PRODUCT INFORMATION – ANAPEN ® (ADRENALINE (EPINEPHRINE)) 1 NAME OF THE MEDICINE Adrenaline (epinephrine) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ANAPEN Junior 150 micrograms Each 0.3 mL contains 150 micrograms of adrenaline (epinephrine) ANAPEN 300 micrograms Each 0.3 mL contains 300 microgram of adrenaline (epinephrine) ANAPEN 500 micrograms Each 0.3 mL contains 500 microgram of adrenaline (epinephrine) Excipients with known effect: sodium chloride, sodium metabisulfite FOR FULL LIST OF EXCIPIENTS, SEE SECTION 6.1 3 PHARMACEUTICAL FORM Solution for injection in a pre-filled syringe (Auto-injector). 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS For the emergency treatment of anaphylaxis (acute severe allergic reactions) due to insect stings, drugs or other allergens. 4.2 D OSE AND METHOD OF ADMINISTRATION Product is for single use in one patient only. Discard any residue The patient should always carry 2 units of auto injectors in case the first administration fails or if one dose is not sufficient. The effective dose is typically in the range 5-10 micrograms per kilogram of bodyweight but higher doses may be necessary in some cases. USE IN ADULTS: The usual dose is 300 micrograms. The recommended dose is 300 micrograms for individuals under 60 kg bodyweight. The recommended dose is 300 to 500 micrograms for individuals over 60 kg bodyweight, depending on clinical judgement. Larger adults may require more than one injection to reverse the effect of an allergic reaction. Version 1.5, Mar 2021 2 In the absence of clinical improvement or if deterioration occurs, a second injection with an additional Anapen may be administered 5-15 minutes after the first injection. It is recommended that patients are prescribed two Anapen which they should carry at all times. In case of a second injection needed it is recommended to inject in the opposite thigh. Patients must be shown how to use the Anapen device at the time a prescription is written. USE IN CHILDREN: ANAPEN 500 MICROG Διαβάστε το πλήρες έγγραφο