Products Specications
| Products | Specification | Volume of vials | Packing form |
| Ceftriaxone Sodium and Sulbactam Sodium for inection | CP;USP | 10ml mould vial | 50vials/box |
| 10vials/box | |||
| 1vials/box | |||
| (1vial+1 solvent)/box | |||
| 12ml mould vial | 50vials/box | ||
| 10vials/box | |||
| 1vials/box | |||
| (1vial+1 solvent)/box | |||
| 15ml mould vial | 50vials/box | ||
| 10vials/box | |||
| 1vials/box | |||
| (1vial+1 solvent)/box | |||
| 20ml mould vial | 50vials/box | ||
| 10vials/box | |||
| 1vials/box | |||
| (1vial+1 solvent)/box |
COMPOSITION：
Ceftriaxone and Sulbactam for Injection 1.5 g
Each Vial contains：
Ceftriaxone Sodium (Sterile) equivalent to Ceftriaxone 1g
Sulbactam Sodium (Sterile) equivalent to Sulbactam 0.5g
Dosage Form
Powder for injection
Route Of Administration
Intramuscular/Intravenous.
CLINICAL PHARMACOLOGY
Rophasyn is an anti-infective, combination of Ceftriaxone with Sulbactam. Ceftriaxone is a broad-spectrum semi-synthetic third-generation cephalosporin with a potent bactericidal activity against a wide range of gram-positive and gram-negative bacteria. Sulbactam is β-lactamase inhibitor.
Indications(s)
Ceftriaxone sodium and Sulbactam sodium Injection is indicated for the treatment of the bacterial infections in conditions as mentioned below where ceftriaxone-resistant β-lactamase-producing strains are suspected as the cause. In other situations, ceftriaxone alone should be considered.
Ceftriaxone sodium and Sulbactam sodium injection is indicated in the treatment of the following infections:
• Lower Respiratory Tract Infections
• Acute Bacterial Otitis Media
• Skin and Skin Structure Infections
• Urinary Tract Infections
• Uncomplicated Gonorrhea
• Pelvic Inflammatory Disease
• Bacterial Septicemia
• Bone and Joint Infections
• Intra-Abdominal Infections
• Meningitis
• Surgical Prophylaxis
Dosage And Administration (directions For Use)
The recommended adult dosage is 1.5 g (1g Ceftriaxone as the sodium salt plus 0.5g Sulbactam as the sodium salt) to 3 g (2g Ceftriaxone as the sodium salt plus 1 g sulbactam as the sodium salt) daily.
This 1.5 to 3 g range represents the total of Ceftriaxone content plus the sulbactam content and corresponds to a range of 1 g Ceftriaxone /0.5 g sulbactam to 2g Ceftriaxone /1g sulbactam. The total dose of sulbactam should not exceed 4 grams per day.
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