| Customization: | Available |
|---|---|
| Application: | Internal Medicine |
| Usage Mode: | Injection |
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Indications:
Paracetamol injection is indicated for the short-term treatment of moderate pain, especially following surgery, and for the short-term treatment of fever, when administration by intravenous route is clinically justified by an urgent need to treat pain or hyperthermia and/or when other routes of administration are not possible.
Dosage and Administration:
Intravenous use.
The 100 ml vial is restricted to adults, adolescents, and children weighing more than 33 kg. Dosing based on patient weight.
The minimum interval between each administration must be at least 4 hours. No more than 4 doses to be given in 24 hours.
Renal impairment:
The minimum interval between each administration in patients with severe renal impairment must be at least 6 hours.
Hepatic insufficiency:
In patients with chronic or compensated active hepatic disease, hepatocellular insufficiency, chronic alcoholism, chronic malnutrition (low reserves of hepatic glutathione), dehydration, Gilbert's syndrome, weighing less than 50 kg: The maximum daily dose must not exceed 3 g.
Elderly Patients:
No dose adjustment is usually required in geriatric patients.
Precautions & Warning:
Paracetamol should be used with caution in cases of :
• hepatocellular insufficiency,
• severe renal insufficiency (creatinine clearance ≤30 mL/min)
• chronic alcoholism,
• chronic malnutrition (low reserves of hepatic glutathione),
• dehydration.
Contra-indications:
Hypersensitivity to the active substance or to propacetamol hydrochloride (prodrug of paracetamol) or to any of the excipients listed in the product.
In cases of severe hepatocellular insufficiency.
Drug interactions:
Probenecid causes an almost 2-fold reduction in clearance of paracetamol by inhibiting its conjugation with glucuronic acid. A reduction in the paracetamol dose should be considered if it is to be used concomitantly with probenecid.
Salicylamide may prolong the elimination t½ of paracetamol.
Caution should be taken with the concomitant intake of enzyme-inducing substances. Concomitant use of paracetamol (4 g per day for at least 4 days) with oral anticoagulants may lead to slight variations of INR values. In this case, increased monitoring of INR values should be conducted during the period of concomitant use as well as for 1 week after paracetamol treatment has been discontinued.
Storage instructions:
Store below 30ºC. Protect from light. Store in the original package. Do not refrigerate or freeze.
| Testing terms | Standards | Results |
| Characters | A colorless or almost colorless clear liquid | Colorless clear liquid |
| pH | 4.5~6.0 | 5.5 |
| Volume | Not less than the nominal volume | Complies |
| Osmolarity | 285~310 mOsmol/kg | 298mOsmol/kg |
| Particulate matter | Particles≥ 10μm:NMT 25 per ml Particles≥25μm:NMT 3 per ml |
Complies |
| Visible particle | Complies | Complies |
| Bacterial Endotoxin | NMT 0.20 EU/ml | Complies |
| Sterility | Complies | Complies |
| Related substance | 4-Aminophenol:≤0.1% P-Chloroacetanilide:≤0.001% Any impurity:≤0.2% Total impurity:≤0.5% |
0.002% Not detected 0.006% 0.02% |
| Assay | 95.0%-105.0% | 100.7% |
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