País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
apomorphine hydrochloride hemihydrate, Quantity: 10 mg/mL
Wockhardt Bio Pty Ltd
Injection, solution
Excipient Ingredients: sodium metabisulfite; sodium hydroxide; hydrochloric acid; water for injections
Subcutaneous
5 x 5mL ampoules, 10 x 5mL ampoules, 1 x 5 mL ampoules
(S4) Prescription Only Medicine
APOWOK Solution for Injection or Infusion 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 should be undertaken in a specialist unit in a hospital setting. Conventional therapy should be continued during ?on? phases.
Visual Identification: The solution is clear and colourless to slightly yellow, sterile, free from visible particles; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2018-03-14
APOWOK (Apomorphine) CMI V1.2 Page 1 APOWOK ™ SOLUTION FOR INJECTION OR INFUSION Apomorphine _(a-poe-MOR-feen) _hydrochloride hemihydrate CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about APOWOK TM Solution for Injection or Infusion. 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 APOWOK TM Solution for Injection or Infusion 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. WHAT APOWOK TM SOLUTION FOR INJECTION OR INFUSION IS USED FOR APOWOK TM Solution for Injection or Infusion 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 APOWOK TM SOLUTION FOR INJECTION OR INFUSION _WHEN YOU MUST NOT USE IT _ DO NOT USE APOWOK TM SOLUTION FOR INJECTION OR INFUSION IF YOU HAVE AN ALLERGY TO: • apomorphine • sodium metabisulfite • 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 Llegiu el document complet
Apowok Product Information - Australia Version 1.4 Page 1 APOWOK TM SOLUTION FOR INJECTION OR INFUSION NAME OF THE MEDICINE Apomorphine hydrochloride hemihydrate The CAS registry number of apomorphine hydrochloride, hemihydrate is 41372-20-7 and the chemical structure is shown below: DESCRIPTION APOWOK TM Solution for Injection or Infusion is a clear and colourless to slightly yellow sterile solution, free from visible particles and containing apomorphine hydrochloride hemihydrate in Water for Injections. Sodium metabisulfite 1 mg/ mL is included in the formulation as an antioxidant. Sodium hydroxide and hydrochloric acid are also included in the formulation. The pH of the injection is 3.0 to 4.0. Each 5 mL ampoule contains 50 mg apomorphine hydrochloride hemihydrate, hence 1mL of solution contains 10 mg apomorphine hydrochloride hemihydrate (10 mg/mL). APOWOK TM Solution for Injection or Infusion is for subcutaneous use only and must not be administered via intravenous infusion. This product may be diluted prior to administration with sodium chloride 0.9% for use as a continuous subcutaneous infusion with suitable pumps/syringe drivers. See DOSAGE AND ADMINISTRATION for Dilution Instructions” PHARMACOLOGY Apomorphine is a directly acting dopamine receptor agonist, structurally related to dopamine. Apomorphine has high _in vitro _ binding affinity for the dopamine D 4 and D 5 receptor ( _K_ _i_ : 4 and 14 nM respectively), moderate affinity ( _K_ _i_ : 26 to 130 nM) for the dopamine D 2 and D 3 , adrenergic α 1D , α 2B, α 2C receptors, serotonin 5HT 1A , 5HT 2A , 5HT 2B , and 5HT 2C receptors and low affinity for the dopamine D 1 receptor ( _K_ _i_ : 370 nM). Apomorphine exhibits no affinity for the adrenergic ß 1 and ß 2 or histamine H 1 receptors. Apowok Product Information - Australia Version 1.4 Page 2 The effect of apomorphine as an antiparkinsonian agent is believed to be the result of direct stimulation of postsynaptic D 2 dopamine receptors, but stimulation of presynaptic D 2 dopamine receptors and Llegiu el document complet