देश: मलेशिया
भाषा: अंग्रेज़ी
स्रोत: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CELECOXIB
Asumed Biotech Sdn. Bhd.
CELECOXIB
30 Capsules; 10 Capsules; 100 Capsules
Chen Ho Pharmaceutical Co., Ltd. Sinying Plant
_Consumer Medication Information Leaflet_ _(RiMUP) _ VOBRAX 200MG CAPSULES _Celecoxib 200mg _ Page 1 of 4 pages WHAT IS IN THIS LEAFLET:_ _ 1. What Vobrax is used for 2. How Vobrax works 3. Before you use Vobrax 4. How to use Vobrax 5. While you are using Vobrax 6. Side effects 7. Storage and disposal of Vobrax 8. Product description 9. Manufacturer & Product Registration Holder 10. Date of revision 11. Serial Number WHAT VOBRAX IS USED FOR The name of your medicine is Vobrax 200mg Capsules (called ‘Vobrax’ in this leaflet). Vobrax contains a medicine called Celecoxib. Celecoxib is used for the management of acute pain in adults and for the treatment of primary dysmenorrhea, relief of the acute and chronic pain and inflammation of rheumatoid arthritis and osteoarthritis; relief of signs and symptoms of ankylosing spondylitis; and for the management of low back pain. HOW VOBRAX WORKS Vobrax belongs to a group of medicinal products called nonsteroidal anti-inflammatory drugs (NSAID), and specifically a sub- group known as (COX-2) inhibitors. Your body makes prostaglandins that may cause pain and inflammation. In conditions, such as osteoarthritis and rheumatoid arthritis your body makes more of these. Vobrax acts by reducing the production of prostaglandins, thereby reducing the pain and inflammation. BEFORE YOU USE VOBRAX WHEN YOU MUST NOT USE IT: Do not take Vobrax unless you have been prescribed Vobrax by your doctor Do not take Vobrax: • If you have severe kidney disease. • If you are allergic to celecoxib or any of the other ingredients of this medicine • If you currently have an ulcer in your stomach or intestines, or bleeding in your stomach or intestines. • If as a result of taking acetylsalicylic acid or any other anti-inflammatory and pain- relieving medicine (NSAID) you have had asthma, nose polyps, severe nose congestion, or an allergic reaction such as an itchy skin rash, swelling of the face, lips, tongue or throat, breathing difficulties or wheezing. • If you have severe liver disease. पूरा दस्तावेज़ पढ़ें
COMPOSITION Each capsule contains: Celecoxib 200mg PRODUCT DESCRIPTION #2 white capsules characterized with yellow ribbon ring and CH91 on surface, filled with white to off white granular powder inside for oral administration. INDICATION 1) For the management of acute pain in adults and for the treatment of primary dysmenorrhoea. 2) Relief of the acute and chronic pain and inflammation of rheumatoid arthritis and osteoarthritis. 3) Relief of signs and symptoms of ankylosing spondylitis. 4) For the management of low back pain PHARMACOLOGICAL PROPERTIES ATC code: M01AH01 Pharmacotherapeutic group: anti-inflammatory and anti- rheumatic products, non-steroids, coxibs. PHARMACODYNAMIC PROPERTIES _MECHANISM OF ACTION: _ Celecoxib is an oral, selective, cyclooxygenase2 (COX-2) inhibitor within the clinical dose range (200-400 mg daily). No statistically significant inhibition of COX-1 (assessed as ex vivo inhibition of thromboxane B2 [TxB2] formation) was observed in this dose range in healthy volunteers. _ _ _PHARMACODYNAMIC _ _EFFECTS:_ Cyclooxygenase is responsible for generation of prostaglandins. Two isoforms, COX-1 and COX-2, have been identified. COX-2 is the isoform of the enzyme that has been shown to be induced by pro-inflammatory stimuli and has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. COX-2 is also involved in ovulation, implantation and closure of the ductus arteriosus, regulation of renal function, and central nervous system functions (fever induction, pain perception and cognitive function). It may also play a role in ulcer healing. COX-2 has been identified in tissue around gastric ulcers in human but its relevance to ulcer healing has not been established. The difference in antiplatelet activity between some COX-1 inhibiting NSAIDs and COX-2 selective inhibitors may be of clinical significance in patients at risk of thrombo-embolic reactions. COX-2 selective inhibitors reduce the formation of systemic (and therefore possibly पूरा दस्तावेज़ पढ़ें