Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
dipyridamole, Quantity: 5 mg/mL
Clinect Pty Ltd
Injection, solution
Excipient Ingredients: macrogol 600; tartaric acid; water for injections; hydrochloric acid
Intravenous
5x2mL
Medicine Registered
(S4) Prescription Only Medicine
INDICATIONS AS AT 29 AUGUST 2000: Persantin Ampoules are indicated as an alternative to exercise in myocardial imaging.
Visual Identification: A clear, yellow solution practically free from suspended particles; Container Type: Ampoule; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1991-09-26
PERSANTIN ® AMPOULES P e r s a n t i n ® A m p o u l e s 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 PERSANTIN AMPOULES? Persantin Ampoules contain the active ingredient dipyridamole. Persantin Ampoules are used as a tool in detecting potential problems on how the heart functions in times of stress. For more information, see Section 1. Why am I using Persantin Ampoules? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE PERSANTIN AMPOULES? Do not use if you have ever had an allergic reaction to dipyridamole or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE 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 Persantin Ampoules? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Persantin Ampoules 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 PERSANTIN AMPOULES? • Your doctor will decide what dose you will receive, based on your body weight. • Persantin Ampoules are given as an infusion (drip) into your veins, over several minutes. More instructions can be found in Section 4. How do I use Persantin Ampoules? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING PERSANTIN AMPOULES? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Persantin. • Tell your doctor if you are pregnant or if you think you may be pregnant or are breast-feeding. • Tell your doctor if you have or have had any of the following medical conditions: • any heart condition or heart disease • asthma, high or low blood pressure • unexplained fainting or mini-stroke • severe muscle disease (myasthenia gravis). THINGS YOU SHOULD NOT DO • You Прочитать полный документ
1 AUSTRALIAN PRODUCT INFORMATION – PERSANTIN® (DIPYRIDAMOLE) INJECTION AMPOULE 1. NAME OF THE MEDICINE Dipyridamole 2. QUALITATIVE AND QUANTITATIVE COMPOSITION PERSANTIN Ampoules contain dipyridamole 10 mg in 2 mL and are intended for intravenous administration. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM PERSANTIN 10 mg/2 mL solution for injection is a clear, yellow solution practically free from suspended particles. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PERSANTIN Ampoules are indicated as an alternative to exercise in myocardial imaging. 4.2 DOSE AND METHOD OF ADMINISTRATION Perfusion imaging: The dose of intravenous PERSANTIN as an adjunct to myocardial perfusion imaging should be adjusted according to the weight of the patient. The recommended dose is 0.14 mg/kg/min (0.56 mg/kg total) infused over 4 minutes. Although the maximum tolerated dose has not been determined, clinical experience suggests that a total dose beyond 60 mg is not needed for any patient. Stress echo: The recommended protocol for intravenous dosing is 0.56 mg/kg over a 4 minute period, followed by 4 minutes of no dose, and if echo monitoring performed and analysed in real time shows no changes, by an additional 0.28 mg/kg over 2 minutes, yielding a cumulative dosage of 0.84 mg/kg over 10 minutes. This “high dose” protocol may also be given in 6 minutes. Most experience has been gained using a total dose of 0.84 mg/kg over 10 minutes or 6 minutes, therefore it is not recommended to exceed this dose for diagnostic testing. Prior to intravenous administration, PERSANTIN should be diluted in at least a 1:2 ratio with sodium chloride 0.45% or 0.9% or glucose 5% to a total volume of approximately 20 to 50 mL. Infusion of undiluted PERSANTIN may cause local irritation. The imaging agent should be injected within 5 minutes following administration of intravenous PERSANTIN. PERSANTIN for intravenous administration should not be mixed with other drugs in the same syringe or infusion Прочитать полный документ