Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Diclofenac sodium
Rowex Ltd
M01AB; M01AB05
Diclofenac sodium
25 milligram(s)/millilitre
Solution for injection
Product subject to prescription which may be renewed (B)
Acetic acid derivatives and related substances; diclofenac
Marketed
1992-08-26
PACKAGE LEAFLET: INFORMATION FOR THE USER DICLAC 25MG/ML SOLUTION FOR INJECTION 3ML AMPOULE DICLOFENAC SODIUM WHAT IS IN THIS LEAFLET 1. What Diclac is and what it is used for 2. What you need to know before you take Diclac 3. How to take Diclac 4. Possible side effects 5. How to store Diclac 6. Contents of the pack and other information. 1 WHAT DICLAC IS AND WHAT IT IS USED FOR Diclofenac sodium, the active ingredient in Diclac Solution for Injection, is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation. Diclac Injection can either be given as an injection into the muscle, or as a slow infusion into a vein. The intramuscular injection is used to treat a number of painful conditions including: • acute back pain • attacks of gout • pain caused by gallstones or kidney stones • pain due to osteo- and rheumatoid arthritis • pain caused by injuries, acute trauma and fractures • pain following surgery. The intravenous infusion is used in hospital to prevent or treat pain following an operation. 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE DICLAC • SOME PEOPLE MUST NOT USE DICLAC. TALK TO YOUR DOCTOR IF: • you think you may be allergic to diclofenac sodium, aspirin, ibuprofen or any other NSAIDs, or to any of the other ingredients of Diclac. (These are listed at the end of the leaflet). Signs of a hypersensitivity reaction include swelling of the face and mouth (angioedema), breathing problems, chest pain, runny nose, skin rash or any other allergic type reaction. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist or nurse. This includes an Pročitajte cijeli dokument
Health Products Regulatory Authority 07 December 2022 CRN00D6H1 Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diclac 25 mg/ml Solution for Injection 3 ml Ampoule 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 3ml ampoule contains 75 mg Diclofenac Sodium (25 mg/ml) EXCIPIENTS WITH KNOWN EFFECT: Each 3 ml ampoule contains 120 mg of benzyl alcohol (40 mg/ml) and 600 mg propylene glycol (200 mg/ ml). For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Solution for Injection. Colourless to slightly yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS INTRAMUSCULAR INJECTION: Treatment of • exacerbation of inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, osteoarthritis • renal colic and biliary colic • acute attacks of gout • acute trauma and fractures • post traumatic and post-operative pain, inflammation and swelling. INTRAVENOUS INFUSION: • For treatment or prevention of post-operative pain in the hospital setting 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (See section 4.4 Special warnings and special precautions for use). Diclac ampoules should not be given for more than 2 days, if necessary treatment can be continued with tablets or suppositories. ROUTE OF ADMINISTRATION: FOR INTRAVENOUS INFUSION OR INTRAMUSCULAR USE ONLY INTRAVENOUS USE: Diclac should not be administered by intravenous bolus injection Immediately before starting an intravenous infusion, diclofenac solution for injection must be diluted. For Instruction on dilution of the product before administration, see section 6.6. Two alternative dosage regimens of diclofenac solution for injection are recommended. For the treatment of moderate to severe post-operative pain, 75 mg should be infused continuously over a period of 30 minutes to 2 hours. If necessary, treatment may be repeated after 4-6 hours, but the dose should not ex Pročitajte cijeli dokument