Negara: Australia
Bahasa: Inggris
Sumber: Department of Health (Therapeutic Goods Administration)
apomorphine hydrochloride hemihydrate, Quantity: 10 mg
Interpharma Pty Ltd
Injection, solution
Excipient Ingredients: sodium metabisulfite; water for injections; sodium hydroxide; hydrochloric acid
Subcutaneous
5 x 3mL
(S4) Prescription Only Medicine
Apomorphine Injection is indicated to reduce the number and severity of "off" phases in patients with Parkinson's disease severely disabled by motor fluctuations refractory to conventional therapy. Initiation of therapy with Apomorphine Injection should be undertaken by a specialist unit in a hospital setting. Conventional therapy should be continued during "on" phases.
Visual Identification: A clear colourless or almost colourless solution.; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2018-06-07
APOMINE ® INTERMITTENT _Apomorphine hydrochloride hemihydrate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about APOMINE Intermittent. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using APOMINE Intermittent against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET IN A SAFE PLACE. You may need to read it again. For further information on APOMINE Intermitent please contact your health care professional. WHAT APOMINE INTERMITTENT IS USED FOR APOMINE Intermittent contains apomorphine, which belongs to a group of medicines called dopaminergic compounds. Apomorphine is used in the treatment of Parkinson's disease to reduce the number and severity of bouts of freezing and stiffness (or "off" periods). This medicine works by acting on dopamine receptors. These receptors help control movement by the body. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. This medicine is available only with a doctor's prescription. There is not enough information to recommend the use of this medicine in children under 18 years. BEFORE YOU USE APOMINE INTERMITTENT _WHEN YOU MUST NOT USE IT_ DO NOT USE APOMINE INTERMITTENT IF YOU HAVE AN ALLERGY TO: • apomorphine • sodium metabisulfite (E223) • certain types of pain killers such as morphine, or other opioid analgesics Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin. DO NOT USE THIS MEDICINE IF YOU HAVE OR HAVE HAD ANY OF THE FOLLOWING MEDICAL CONDITIONS: • certain forms of dementia eg. Alzheim Baca dokumen lengkapnya
Version: pfpapoci10321 Supercedes: : pfpapoci11020 Page 1 of 11 AUSTRALIAN PRODUCT INFORMATION – APOMINE ® INTERMITTENT (APOMORPHINE HYDROCHLORIDE HEMIHYDRATE) INJECTION CARTRIDGE 1. NAME OF THE MEDICINE Apomorphine hydrochloride hemihydrate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Apomine ® Intermittent is a sterile solution for injection containing 10 mg/mL of apomorphine hydrochloride hemihydrate in Water for Injections BP. Each 3 mL cartridge contains 30 mg apomorphine hydrochloride hemihydrate. Sodium metabisulfite 1 mg/mL is included in the formulation as an antioxidant. Excipient(s) with known effect: Sodium metabisulfite For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Apomine ® Intermittent is a clear, colourless to slightly yellow sterile solution for subcutaneous injection, free from visible particles. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Apomine ® Intermittent is indicated to reduce the number and severity of ‘off’ phases in patients with Parkinson’s disease severely disabled by motor fluctuations refractory to conventional therapy. Initiation of therapy with Apomine ® Intermittent should be undertaken in a specialist unit in a hospital setting. Conventional therapy should be continued during ‘on’ phases. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE The optimal dosage of Apomine ® Intermittent has to be determined on an individual patient basis. Hospital admission under appropriate specialist supervision is advised when establishing a patient’s therapeutic regime. It is essential that the patient is established on the antiemetic domperidone for at least 48 - 72 hours prior to initiation of therapy. Version: pfpapoci10321 Supercedes: : pfpapoci11020 Page 2 of 11 METHOD OF ADMINISTRATION PATIENT SELECTION: For patients in whom conventional therapy has failed, Apomine ® Intermittent injections are only considered to be suitable for Parkinson’s disease patients capable of recognising and anticipating ‘off’ phases in mo Baca dokumen lengkapnya