Страна: Нова Зеландія
мова: англійська
Джерело: Medsafe (Medicines Safety Authority)
Fluconazole 50mg;
Pfizer New Zealand Limited
Fluconazole 50 mg
50 mg
Capsule
Active: Fluconazole 50mg Excipient: Colloidal silicon dioxide Gelatin Lactose monohydrate Magnesium stearate Maize starch
Blister pack, 28 capsules
Prescription
Prescription
Pfizer Pharmaceuticals LLC
Package - Contents - Shelf Life: Blister pack, - 28 capsules - 60 months from date of manufacture stored at or below 30°C
1989-05-15
Diflucan® 1 DIFLUCAN ® 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 BEING TREATED WITH DIFLUCAN? Diflucan contains the active ingredient fluconazole. Diflucan oral suspension is used to treat certain fungal and yeast infections. For more information, see Section 1. Why am I being treated with Diflucan? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE TREATMENT WITH DIFLUCAN? Do not start treatment if you are allergic to any medicine containing fluconazole, any of the ingredients listed at the end of this CMI, or any other similar medicines such as miconazole, ketoconazole or clotrimazole. Tell the doctor if you have had any allergic reaction to any antifungal, or any foods, preservatives or dyes or any other medicines, if you are pregnant, plan to become pregnant or are breastfeeding. You must not be given Diflucan if you are taking certain medicines. For more information, see Section 2. What should I know before treatment with Diflucan? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Diflucan 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 IS DIFLUCAN GIVEN? Diflucan is available as oral suspension (taken by mouth after accurately measuring the dose of the medicine with a medicine measure). Your doctor will decide how much Diflucan will be given to you each day and for how long. It will depend on your condition and other factors. More instructions can be found in Section 4. How is Diflucan given? in the full CMI. 5. WHAT SHOULD I KNOW DURING TREATMENT WITH DIFLUCAN? THINGS YOU SHOULD DO • Tell the doctor if you have any medical conditions, are on any medicines, or if you are pregnant, plan to become pregnant or are breastfeeding • For more information on "Things you should do" can be found in Section 6 in the full CMI THINGS YOU SHOULD NOT DO • Do Прочитайте повний документ
Version:pfddiflb11221 Supersedes: pfddiflb20921 Page 1 of 27 NEW ZEALAND DATA SHEET 1. PRODUCT NAME DIFLUCAN 10 mg/mL, 40 mg/mL powder for oral suspension. DIFLUCAN 50 mg, 100 mg, 150 mg, 200 mg capsules. DIFLUCAN 100 mg/50 mL solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION POWDER FOR ORAL SUSPENSION Each mL of reconstituted suspension contains 10 mg fluconazole. CAPSULES Each gelatin capsule contains 50 mg, 100 mg, 150 mg or 200 mg fluconazole. SOLUTION FOR INFUSION Each vial of 50 mL solution for infusion contains 100 mg fluconazole (2 mg/mL) in 0.9% saline solution. EXCIPIENT(S) WITH KNOWN EFFECT POWDER FOR ORAL SUSPENSION 0.58 g sucrose and 1.13 mg sodium per mL of reconstituted suspension. CAPSULES Each 50 mg, 100 mg, 150 mg and 200 mg capsule contains 49.707, 99.413, 149.12 mg and 198.826 lactose monohydrate, respectively. SOLUTION FOR INFUSION Each mL contains 9 mg sodium chloride (equivalent to 0.154 mmol sodium) (see section 4.4 Special warnings and precautions for use). For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM POWDER FOR ORAL SUSPENSION White to off-white powder for oral suspension providing a white to off-white, orange-flavoured suspension after reconstitution. CAPSULES Diflucan 50 mg capsule has a light turquoise blue opaque cap and white opaque body, marked with the Pfizer logo and FLU-50. Version:pfddiflb11221 Supersedes: pfddiflb20921 Page 2 of 27 Diflucan 100 mg capsule has a standard blue opaque cap and white opaque body, marked with the Pfizer logo and FLU-100. Diflucan 150 mg capsule has a light turquoise blue opaque cap and body, marked with the Pfizer logo and FLU-150. Diflucan 200 mg capsule has purple opaque cap and white opaque body, marked with the Pfizer logo and FLU-200. SOLUTION FOR INFUSION Clear, colourless solution with no visible particles. The pH of the solution is 4.0 - 8.0. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Diflucan is indicated for the treatment of the following conditions: Crypt Прочитайте повний документ