País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
amifampridine, Quantity: 10 mg
Lacuna Pharma Pty Ltd
Tablet
Excipient Ingredients: magnesium stearate; colloidal anhydrous silica; sodium starch glycollate type A; calcium hydrogen phosphate dihydrate; microcrystalline cellulose
Oral
100 tablets
(S4) Prescription Only Medicine
RUZURGI is indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults and children aged 6 years and above.
Visual Identification: Scored, oval, white to off-white, debossed with '10 | 110' on one side and 'JACOBUS' on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Child resistant closure
Registered
2021-09-14
Ruzurgi® 1 RUZURGI® 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. This medicine is new. Please report side effects. See the full CMI for further details. 1. WHY AM I TAKING RUZURGI? RUZURGI contains the active ingredient amifampridine. RUZURGI is used to treat Lambert-Eaton myasthenic syndrome (LEMS) in adults and children aged 6 years and above. For more information, see Section 1. Why am I taking RUZURGI? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I TAKE RUZURGI? Do not take if you have ever had an allergic reaction to amifampridine, fampridine or other aminopyridines, or any of the ingredients listed at the end of the CMI. Do not take if you have a history of seizures, fits or convulsions. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, INCLUDING PROBLEMS WITH YOUR KIDNEYS OR LIVER, HEART, 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 take RUZURGI? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with RUZURGI and increase the side effects of RUZURGI when taken together. See Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I TAKE RUZURGI? • Follow the instructions provided and use until your doctor tells you to stop. • How much RUZURGI you should take will depend upon your weight and whether you have any other medical conditions such as problems with your liver or kidneys. Your doctor will determine the right dose for you and how often you should take it. • You may need to split the tablets or prepare an oral suspension of RUZURGI tablets to get the right dose for you. • If you have problems taking tablets or require a feeding tube, you may need to prepare an oral suspension of RUZURGI tablets. More instructions can be found in Section 4. How do I take RUZURGI? in the full CMI. 5. WHAT Leia o documento completo
RUZURGI PI September 2022 version 1.1 1 This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at https://www.tga.gov.au/reporting-problems AUSTRALIAN PRODUCT INFORMATION – RUZURGI (AMIFAMPRIDINE) TABLETS 1 NAME OF THE MEDICINE Amifampridine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each RUZURGI tablet contains 10 mg of amifampridine. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Tablets Each tablet is functionally scored, oval, white to off-white, and debossed with “10 | 110” on one side and “JACOBUS” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS RUZURGI is indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults and children aged 6 years and above. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE Dosing should be individualised based on clinical circumstances, patient response, and patient population. The dose should be gradually titrated to the optimal effective dose with the minimum of side effects. Once achieved, this optimal dose should be maintained, and dosing frequency should be adjusted, as needed. The recommended oral dose is based on body weight (see Table 1). ▼ RUZURGI PI September 2022 version 1.1 2 Safety and effectiveness in paediatric patients below the age of 6 years have not been established. If a dose is missed by a few hours, patients who experience weakness should take their usual dose as soon as possible. If it is close to their next dose, they should take their medication at the next regular interval. Patients should not take double or extra doses. TABLE 1: RECOMMENDED DOSE FOR PATIENTS 6 YEARS OF AGE AND OLDER AGE INITIAL DOSE TITRATION REGIMEN MAXIMUM RECOMMENDED SINGLE DOSE MAXIMUM TOTAL DAILY MAINTENANCE DOSE All patients weighing less than 45 kg 5 mg to 10 mg daily, in divided doses (2 to 3 times per day) Increase daily in 2.5 mg Leia o documento completo