| Generic Name |
Celecoxib Capsules |
| Strength |
200mg |
| Packing |
2*10 Capsules/box |
| Origin |
China |
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Registration service by our team
Registration dossier available by our team
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Product name:
Celecoxib Capsules
Character:
This product is a capsule with white powder content.
Indications:
The potential benefits and risks of this and other treatment options should be carefully considered before deciding to use this product. According to the treatment goals of each patient, the lowest effective dose is used for the shortest duration of treatment (see [Precautions]- Warnings).
1) Used to relieve the signs and symptoms of osteoarthritis.
2) Used to relieve the signs and symptoms of rheumatoid arthritis in adults.
3) For the treatment of acute pain in adults. (See [Clinical trials])
Adverse reactions:
In controlled clinical studies, approximately 4250 patients with osteoarthritis (OA), 2100 patients with rheumatoid arthritis (RA), and 1050 patients with postoperative pain have been treated with this product. More than 8,500 of these patients received a total daily dose of 200mg (100mg twice daily or 200mg once daily) or higher, including more than 400 patients receiving a total daily dose of 800mg (400mg twice daily). About 3,900 patients received these doses for six months or more, including about 2,300 patients for one year or more and 124 patients for two years or more.
Due to the different circumstances of each clinical study, it is not appropriate to directly compare the incidence of adverse reactions of two drugs in different clinical studies, and the incidence of adverse reactions in clinical studies may be different from that in clinical practice. However, adverse event information from clinical trials does provide a reference for identifying the association of adverse events with drug use and estimating their incidence.
Pharmacology and toxicology:
Pharmacological effects
This product is the third generation of oral cephalosporin, with a wide antibacterial spectrum, and has antibacterial activity against some Gram-positive and negative bacteria, especially against streptococcus (except enterococcus) and pneumococcus in Gram-positive bacteria, gonococcus, Branham's coccus, Coliform bacteria, Klebsiella, Scharella, Proteus, influenzae and other gram-negative bacteria. The mechanism of action is bactericidal.
This product has strong stability against the β-lactamase produced by various bacteria, and shows superior antibacterial power against the β-lactamase producing bacteria.
The mechanism of action of this product is to prevent the synthesis of bacterial cell walls, and its application point varies according to the species of bacteria, and it has a high affinity with 1 (1a, 1b, 1c) and 3 of penicillin binding proteins (PBP).
antigenicity
The antigenicity of this drug to various animals is the same or slightly weaker than that of cephalexin. This drug does not induce antigenicity, nor does it have immunocross-correlation with cefalexin, cephalox and cefotaxime.
Storage:
Sealed, store below 25ºC.
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