View drug registration information details.
Items | Registration information |
ID | 1182 |
No | 1182 |
Brand Name | PENEM M.H. |
Ingredients | MEROPENEM TRIHYDRATE 570.475 MG EQ.TO MEROPENEM 500 MG, SODIUM CARBONATE ANHYDROUS 104 MG |
Dosage Form | POWDER FOR SOLUTION FOR INJECTION |
Primary Packaging | VIAL |
Storage | STORE BELOW 30 C |
Shelf Life | 3 YEARS |
Pack Size | BOX OF 500 MG/VIAL |
Dispensing Category | Prescription only |
ATC Classification | J01DH02 |
Pharmaceutical Class | ANTIBACTERIA |
Indications | FOR TREATMENT IN ADULTS AND CHILDREN OF FOLLOWING INFECTIONS CAUSED BY BACTERIA SENSITIVITY TO MEROPENEM: PNEUMONIAS AND NOSOCOMIAL PNEUMONIAS, URINARY TRACT INFECTIONS, GYNAECOLOGICAL INFECTIONS SUCH AS ENDOMETRITIS AND PELVIC INFLAMMATORY DISEASE, SKIN AND SKIN STRUCTURE INFECTIONS, MENINGITIS, SEPTICAEMIA, EMPIRIC TREATMENT FOR PRESUMED INFECTIONS IN PATIENTS WITH FEBRILE NEUTROPENIA, USED AS MONOTHERAPY OR IN COMBINATION WITH ANTI-VIRAL OR ANTI-FUNGAL AGENT. PENEM M.H HAS PROVED EFFICACIOUS ALONE OR IN COMBINATION WITH OTHER ANTIMICROBIAL AGENT IN THE TREATMENT OF POLYMICROBIAL INFECTION |
Contraindications | PATIENT WHO HAVE DEMONSTRATED HYPERSENSITIVITY TO THIS PRODUCT |
Side Effects | -RASH, PRURITUS, URTICARIA, AT THE SITE OF INJECTION : INFLAMMATION, THROMBOPHLEBITIS, PAIN AT THE SITE OF INJECTION, HEADACHE, ABDOMINAL PAIN, NAUSEA, VOMITING, DIARRHEA, ORAL AND VAGINAL CANDIDOSIS, |
Unit Price | |
EDL |
No |
Description | WHITE TO YELLOWISH WHITE POWDER |
Note | |
License Owner | KARNYA VIENGNAKORN EXPORT-IMPORT |
Manufacturer | M & H MANUFACTURING CO., LTD |
Country | THAILAND |
Import Registration No | 1A 14/50(NG) |
Import Registration Date | 2007-04-30 |
Activity | CERTIFICATE RELEASED |
Applied Date | 2023-05-19 |
FDD Registration No | 07 I 4979/20 |
FDD Registration Date | 2023-07-17 |
Expiry Date | 2026-07-16 |
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