Država: Novi Zeland
Jezik: engleski
Izvor: Medsafe (Medicines Safety Authority)
Diclofenac sodium 25mg;
Novartis New Zealand Ltd
Diclofenac sodium 25 mg
25 mg
Suppository
Active: Diclofenac sodium 25mg Excipient: Hard fat
Blister pack, 10 suppositories
Prescription
Prescription
Unique Chemicals (A Division of JB Chemicals & Pharmaceuticals Ltd)
· Treatment of inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and spondylarthritis, painful syndromes of the vertebral column, non-articular rheumatism.
Package - Contents - Shelf Life: Blister pack, - 10 suppositories - 36 months from date of manufacture stored at or below 30°C
1980-05-21
__________________________________________________________________________________________________ VOLTAREN Page 1 of 5 VOLTAREN SUPPOSITORIES _12.5MG, 25MG, 50MG AND 100MG SUPPOSITORIES _ _DICLOFENAC SODIUM _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Voltaren Suppositories . 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 taking it against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT VOLTAREN IS USED FOR Voltaren relieves pain and reduces inflammation (swelling and redness) that may occur in the following: different types of arthritis including rheumatoid arthritis and osteoarthritis other painful conditions where swelling is a problem such as back pain, rheumatism, muscle strains, sprains and tendonitis (eg. tennis elbow) menstrual cramps (period pain) migraine attacks Voltaren belongs to a family of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines can relieve the symptoms of pain and inflammation but they will not cure your condition. Your doctor may prescribe Voltaren for another purpose. Ask your doctor if you have any questions about why it has been prescribed for you. Voltaren is only available with a doctor's prescription. It is not addictive. BEFORE YOU TAKE VOLTAREN _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE VOLTAREN IF YOU HAVE AN ALLERGY TO: diclofenac (the active ingredient in Voltaren) or any of the other ingredients listed at the end of this leaflet other medicines containing diclofenac (eg.Voltaren Emulgel) aspirin/ acetylsalicylic acid any other NSAID medicine Many medicines used to treat headache, period pain and other aches and pains contain aspirin or NSAID medicines. If you are not sure i Pročitajte cijeli dokument
NEW ZEALAND DATA SHEET Page 1 of 15 1 PRODUCT NAME VOLTAREN® 12.5 mg Suppositories VOLTAREN® 25 mg Suppositories VOLTAREN® 50 mg Suppositories VOLTAREN® 100 mg Suppositories 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 12.5 mg suppositories Each suppository contains 12.5 mg of diclofenac sodium. 25 mg suppositories Each suppository contains 25 mg of diclofenac sodium. 50 mg suppositories Each suppository contains 50 mg of diclofenac sodium. 100 mg suppositories Each suppository contains 100 mg of diclofenac sodium. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Suppositories. Suppository strength Approx. weight (mg) Approx. length (cm) 12.5 mg 900 2.5 25 mg 1000 2.5 50 mg 2000 3 100 mg 2140 3 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of: • Inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and spondylarthritis, painful syndromes of the vertebral column, non-articular rheumatism. • Acute attacks of gout. • Post-traumatic and post-operative pain, inflammation, and swelling, e.g. following dental or orthopaedic surgery. • Painful and/or inflammatory conditions in gynaecology, e.g. primary dysmenorrhoea or adnexitis. NEW ZEALAND DATA SHEET Page 2 of 15 • Migraine attacks. • As an adjuvant in severe painful inflammatory infections of the ear, nose or throat, e.g. pharyngotonsillitis, otitis. In keeping with general therapeutic principles, the underlying disease should be treated with basic therapy, as appropriate. Fever alone is not an indication. 4.2 DOSE AND METHOD OF ADMINISTRATION Voltaren should only be prescribed when the benefits are considered to outweigh the potential risks. After assessing the risk/benefit ratio in each individual patient, the lowest effective dose for the shortest possible duration should be used. Adverse effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Dosage Pročitajte cijeli dokument