| Customization: | Available |
|---|---|
| Application: | Internal Medicine |
| Usage Mode: | Internal Use |
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| ITEMS | SPECIFICATION | RESULT |
| Identification | Complies | Complies |
| Tests | ||
| pH value | 7.3~8.3 | 8.06 |
| Loss on drying | 9.0%~12.0% | 10.17% |
| Uniformity of dosage units | AV≤15.0 | 3.74 |
| Sub-visible particles | ≥10um,≤6000Particles/Bottle | 277.9Particles/Bottle |
| ≥25um,≤600Particles/Bottle | 1.0Particles/Bottle | |
| Formulated solution | ||
| Completeness solubility | No visible residue as undissolved matter | No visible residue as undissolved matter |
| Clarity of solution | Clarified | Clarified |
| Particulate matter | Not detected | Not detected |
| Bacterial endotoxins | Not more than 0.125EU per mg of meropenem | <0.125EU/mg |
| Related substances | ||
| The impurity with a retention time of about 0.45 relative to that of meropenem | ≤0.8% | Not detected |
| The impurity with a retention time of about 1.9 relative to that of meropenem | ≤0.6% | Not detected |
| Sterility | Complies | Complies |
| Sodium content | NLT 80% and NMT 120% of the labeled amount of sodium | 89.17% |
| Assay | NLT 90.0% and NMT 120.0% of the labeled amount of meropenem | 96.01% |
Meronem is indicated for the treatment of the following infections in adults and children over 3 months of age:Pneumonia, including community acquired pneumonia and nosocomial pneumonia.
Broncho-pulmonary infections in cystic fibrosis
- Complicated urinary tract infections
- Complicated intra-abdominal infections- Intra- and post-partum infections
- Complicated skin and soft tissuc infections.Acute bacterial meningitis
Meronem may be used in the management of neutropenic patients with fever that is suspected to be due to abacterial infection.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Reyoung Pharmaceutical Co., Ltd., established in 1966, is one of the leading manufacturer and distributor of pharmaceutical products in China. Reyoung Pharma is certificated by GMP, ISO9001, ISO14001, OHS18001. The trademark "REYOUNG" is famous trademark of China.
This product is used for treatment of moderate to severe infections caused by β-lactamase-producing bacteria that are resistant to cefoperazone monotherapy and sensitive to this product. When used for the treatment of mixed infections caused by cefoperazone single-drug-sensitive bacteria and cefoperazone single-drug-resistant β-lactamase-producing bacteria sensitive to this product, no additional antibiotics are required. Lower respiratory tract infection: susceptible to β-lactamase-producing Pseudomonas aeruginosa, Streptococcus pneumoniae and other Streptococcus, Klebsiella pneumoniae and other Klebsiella species, Haemophilus influenzae, Staphylococcus aureus, etc. bacterial pneumonia, acute exacerbations of chronic bronchitis, acute bronchitis, lung abscesses and other lung infections. Urogenital infection: acute pyelonephritis, acute pyelonephritis caused by sensitive bacteria such as β-lactamase-producing Escherichia coli, Proteus, Klebsiella, Pseudomonas aeruginosa, and Staphylococcus Exacerbations, complicated urinary tract infections, endometritis, gonorrhea, and other reproductive tract infections. Abdominal and pelvic infections.
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