Pays: Nouvelle-Zélande
Langue: anglais
Source: Medsafe (Medicines Safety Authority)
Roxithromycin 50mg
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Roxithromycin 50 mg
50 mg
Dispersible tablet
Active: Roxithromycin 50mg Excipient: Colloidal silicon dioxide Crospovidone Fumaric acid Glycyrrhiza glabra Macrogol 6000 Magnesium stearate Methacrylic acid copolymer Microcrystalline cellulose Purified talc Saccharin sodium Sodium hydroxide Sodium laureth sulfate Strawberry Flavour Triethyl citrate
Prescription
Sanofi Chimie
Rulide D 50mg tablets are indicated for the treatment of the following mild to moderately severe infections in children caused by, or likely to be caused by susceptible micro-organisms: - Acute pharyngitis - Acute tonsillitis - Impetigo
Package - Contents - Shelf Life: Blister pack, polyamide/aluminium/PVC laminate blister sheet in carton - 2 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, polyamide/aluminium/PVC laminate blister sheet in carton - 4 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, polyamide/aluminium/PVC laminate blister sheet in carton - 10 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, polyamide/aluminium/PVC laminate blister sheet in carton - 20 tablets - 36 months from date of manufacture stored at or below 30°C
2014-07-09
Rulide ® D Tablets 1 RULIDE® D TABLETS 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 RULIDE D? Rulide D contains the active ingredient roxithromycin. Rulide D is mainly used to treat respiratory tract infections, and skin and soft tissue infections. For more information, see Section 1. Why am I using Rulide D? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE RULIDE D? Do not use if you have ever had an allergic reaction to roxithromycin 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 Rulide D? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Rulide D 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 RULIDE D? • For children weighing less than 40 kg, the dosage can range from one half a tablet, one tablet or two tablets twice a day. • Your doctor will tell you the correct number of tablets to give your child More instructions can be found in Section 4. How do I use Rulide D? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING RULIDE D? THINGS YOU SHOULD DO • Remind any doctor or dentist you visit that your child is taking Rulide D. • If symptoms of your child's infection do not improve with a few days, or if they become worse, tell your doctor. • If your child is about to start taking any new medicine, tell your doctor or pharmacist that they are taking Rulide D THINGS YOU SHOULD NOT DO • Rulide D has been prescribed for your child. Do not give to anyone else, even if they have the same condition as your child. • Do not use Rulide D to treat any other complaints unless your doctor tells you to LOOKIN Lire le document complet
rulide-d-ccdsv8-dsv7-14nov22 Page 1 NEW ZEALAND DATA SHEET 1 PRODUCT NAME Rulide D 50 mg dispersible tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Rulide D tablets contain 50 mg of roxithromycin. For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM Rulide D tablets are practically white, scored, cylindrical tablets, 8mm in diameter. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CHILDREN Rulide D 50mg tablets are indicated for the treatment of the following mild to moderately severe infections in children caused by or likely to be caused by susceptible micro-organisms: • acute pharyngitis • acute tonsillitis • impetigo Appropriate culture and sensitivity tests should be performed when necessary to determine an organism’s susceptibility and thus treatment suitability. Therapy with roxithromycin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued. 4.2 DOSE AND METHOD OF ADMINISTRATION Children rulide-d-ccdsv8-dsv7-14nov22 Page 2 The recommended dose and duration of treatment should NOT be exceeded in children (see Section 4.4 Special Warnings and Precautions for Use). Rulide D should be taken at least 15 minutes before food or on an empty stomach ( _i.e._ more than 3 hours after a meal). Rulide D is administered twice daily at a dose of 5 to 8 mg/kg per day. Recommended dosage regimens are presented in the following table: BODYWEIGHT RULIDE D 50MG TABLETS 6 - 11 KG Half a tablet morning and evening 12 - 23 KG One tablet morning and evening 24 - 40 KG Two tablets morning and evening > 40 KG Three tablets morning and evening Rulide D 50mg tablets are administered to children as an aqueous suspension that is made by adding either a half, one, two or three tablets to a spoonful of water. After waiting for 30 to 40 seconds for the tablet(s) to disintegrate into fine granules, the suspension is given to the child. A drink of water should follow the dose. Note: Rulide D 50mg tablets are desig Lire le document complet