- Approval Id
- 9d9bb7b3448bf786
- Drug Name
- CEFAZOLIN MEVON POWDER FOR SOLUTION FOR INJECTION OR INFUSION 1G/VIAL
- Product Name
- CEFAZOLIN MEVON POWDER FOR SOLUTION FOR INJECTION OR INFUSION 1G/VIAL
- Approval Number
- SIN14846P
- Approval Date
- 2015-09-16
- Registrant
- NOVEM PHARMA PRIVATE LIMITED
- Licence Holder
- NOVEM PHARMA PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><u>Posology</u></p>
<p><em>Recommended dosage for intravenous administration</em></p>
<p>The following doses can be adjusted depending on the severity of the infection:</p>
<img src="/TGIF/CefazolinMevon-Table1_120325.png" alt="Cefazolin Mevon Dosage Table 1" /><br><br>
<p>The safety of cefazolin in pre-term newborns and neonates has not been established. Therefore, the use of cefazolin is not recommended.</p>
<p><em>Recommended dosage for intramuscular administration</em></p>
<p>The following doses can be adjusted depending on the severity of the infection:</p>
<img src="/TGIF/CefazolinMevon-Table2_120325.png" alt="Cefazolin Mevon Dosage Table 2" /><br><br>
<p><em>Recommended dosage in patients with renal impairment</em></p>
<p>Severe infections:</p>
<img src="/TGIF/CefazolinMevon-Table3_120325.png" alt="Cefazolin Mevon Dosage Table 3" /><br><br>
<p>Mild infections:</p>
<img src="/TGIF/CefazolinMevon-Table4_120325.png" alt="Cefazolin Mevon Dosage Table 4" /><br><br>
<p><em>Prophylaxis of post-operative infections</em><br>
Generally, the prophylactic administration of the medicinal product should be short-term – within 24 to 48 hours.</p>
<ul class="dash">
<li>The usual dose is 1 g intravenously administered during the induction of anaesthesia, followed by a dose of 0.5–1 g administered intravenously every 6–8 hours for 24 hours postoperatively.</li>
<li>For operative procedures lasting longer than 2 hours, 0.5–1 g is administered intravenously during surgery.</li>
</ul>
<p><u>Method of administration</u><br>
CEFAZOLIN MEVON is administered by deep intramuscular injection or by intravenous bolus injection or infusion.<br>
The powder for solution for injection or infusion should be initially diluted with 2–3 ml of diluent.<br>
The solution should be further reconstituted as follows:</p>
<p><em>Intramuscular injection:</em><br>
The solution is further reconstituted with water for injection (concentration of the solution 250 mg/ml).</p>
<p><em>Intravenous injection:</em><br>
The solution is further reconstituted with water for injection (concentration of the solution 100 mg/ml).</p>
<p>CEFAZOLIN MEVON may be administered either by slow intravenous injection over a period of 3 to 5 min directly into a vein or <em>via</em> a drip tube.</p>
<p><em>Intravenous infusion:</em><br>
The solution is further reconstituted with one of the following compatible diluents (concentration of the solution 20 mg/ml):</p>
<ul class="dash">
<li>0.9% NaCl Injection,</li>
<li>5% Glucose Injection,</li>
<li>10% Glucose Injection,</li>
<li>5% Glucose and 0.9% NaCl Injection,</li>
<li>5% Glucose and 0.45% NaCl Injection,</li>
<li>5% Glucose and 0.225% NaCl Injection,</li>
<li>4% Glucose and 0.18% NaCl Injection,</li>
<li>Compound sodium chloride injection,</li>
<li>Lactated Ringer’s injection.</li>
</ul>
<p>For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Route Of Administration
- INTRAVENOUS, INTRAMUSCULAR
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>CEFAZOLIN MEVON is indicated in adults and children for the treatment of the following infections due to bacteria which are susceptible to cefazolin:</p>
<ul class="dash">
<li>Respiratory tract infections.</li>
<li>Sepsis.</li>
<li>Skin and soft tissue infections.</li>
<li>Endocarditis.</li>
<li>Urinary tract and genital infections.</li>
<li>Bile duct infections.</li>
<li>Bone and joint infections.</li>
</ul>
<p>Other indications that require <u>only intravenous administration</u>:</p>
<p>CEFAZOLIN MEVON is indicated for pre-operative prophylaxis of post-operative infections in:</p>
<ul class="dash">
<li>Neurosurgery (craniotomy, liquor derivation).</li>
<li>Cardiac surgery.</li>
<li>Thoracic surgery.</li>
<li>Vascular surgery.</li>
<li>Gastro-intestinal surgery.</li>
<li>Hepatobiliary surgery.</li>
<li>Caesarean section.</li>
<li>Abdominal or vaginal hysterectomy.</li>
<li>Surgery of the head and neck with oropharynx opening.</li>
<li>Orthopaedic surgery.</li>
</ul>
<p>Consideration should be given to official guidance on the appropriate use of antibiotics.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Hypersensitivity to the active substance or any other cephalosporins.</p>
<p><u>Pre-term newborns and neonates</u><br>
The safety of cefazolin in pre-term newborns and neonates has not been established. Therefore, the use of cefazolin is not recommended.</p>
- Atc Code
- J01DB04
- Atc Item Name
- cefazolin
- Pharma Manufacturer Name
- LOTUS INTERNATIONAL PTE. LTD.
- Company Detail Path
- /organization/lotus-international-pte-ltd
