PARACETAMOL BAXTER Solution for infusion Ref.[50860] Active ingredients: Paracetamol

Intravenous use.

Newborn infants, infants, toddlers and children (less than or equal to 33 kg)

Use 50 ml fill vial.

Adults, adolescents and children (above 33 kg)

Use 100 ml fill vial.

Posology

Dosing based on patient weight (please see the dosing table here below).

^* Pre-term newborn infants: No safety and efficacy data are available for pre-term newborn infants (see section 5.2).
^** Patients weighing less will require smaller volumes. The minimum interval between each administration must be at least 4 hours. No more than 4 doses to be given in 24 hours. The minimum interval between each administration in patients with severe renal impairment must be at least 6 hours.
^*** Maximum daily dose: The maximum daily dose as presented in the table above is for patients that are not receiving other paracetamol containing products and should be adjusted accordingly taking such products into account.

Renal impairment

In patients with renal impairment, the minimum interval between each administration should be modified according to the following schedule:

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 (see section 4.4).

Elderly Patients

No dose adjustment is usually required in geriatric patients.

Method of administration

Take care when prescribing and administering Paracetamol to avoid dosing errors due to confusion between milligram (mg) and milliliter (mL), which could result in accidental overdose and death. Take care to ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total dose in volume.

The paracetamol solution is administered as a 15-minute intravenous infusion.

Patients weighing ≤10 kg:

• The glass vial of Paracetamol should not be hung as an infusion due to the small volume of the medicinal product to be administered in this population
• The volume to be administered should be withdrawn from the vial and could be administered undiluted or diluted (from one to nine volumes diluent) in a 0.9% sodium chloride solution or 5% glucose solution and administered in 15-minute.
• A 5 or 10 ml syringe should be used to measure the dose as appropriate for the weight of the child and the desired volume. The volume administered to this weight group should never exceed 7.5ml per dose
• The user should refer to the dosage recommendations in the summary of product characteristics.

To remove solution, use a 0.8 mm needle (21gauge needle) must be use and the stopper vertically perforated at the spot specifically indicated.

As for all solutions for infusion presented in glass vials, it should be remembered that close monitoring is needed notably at the end of the infusion, regardless of administration route. This monitoring at the end of the perfusion applies particularly for central route infusion, in order to avoid air embolism.

For instructions on dilution of the medicinal product before administration, see section 6.6.

There is a risk of liver injury (including fulminant hepatitis, hepatic failure, cholestatic hepatitis, cytolytic hepatitis), particularly in elderly subjects, in young children, in patients with liver disease, in cases of chronic alcoholism, in patients with chronic malnutrition and in patients receiving enzyme inducers. Overdosing may be fatal in these cases.

Symptoms generally appear within the first 24 hours and comprise: nausea, vomiting, anorexia, pallor, abdominal pain. Overdose, 7.5 g or more of paracetamol in a single administration in adults and 140 mg/kg of body weight in a single administration in children, causes hepatic cytolysis likely to induce complete and irreversible necrosis, resulting in hepatocellular insufficiency, metabolic acidosis and encephalopathy which may lead to coma and death. Simultaneously, increased levels of hepatic transaminases (AST, ALT), lactate dehydrogenase and bilirubin are observed together with decreased prothrombin levels that may appear 12 to 48 hours after administration.

Clinical symptoms of liver damage are usually evident initially after two days, and reach a maximum after 4 to 6 days.

Emergency measures:

• Immediate hospitalisation.
• Before beginning treatment, take a tube of blood for plasma paracetamol assay, as soon as possible after the overdose.
• The treatment includes administration of the antidote, N-acetylcysteine (NAC), by the intravenous or oral route, if possible before the 10th hour. NAC can, however, give some degree protection even after 10 hours, but in these cases prolonged treatment is given.
• Symptomatic treatment.
• Hepatic tests must be carried out at the beginning of treatment and repeated every 24 hours. In most cases hepatic transaminases return to normal in one to two weeks with full restitution of liver function. In very severe cases, however, liver transplantation may be necessary.

2 years.

Chemical and physical in-use stability in the solutions listed in section 6.6 has been demonstrated for 48 hours at 20-25°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

Do not refrigerate or freeze.

For storage conditions after dilution of the medicinal product, see section 6.3.

50 ml fill volume in 100 ml Type II clear glass vial with chlorobutyl rubber stopper and red color aluminium flip-off cap.

100 ml fill volume in 100 ml Type II clear glass vial with chlorobutyl rubber stopper and blue color aluminium flip-off cap.

Pack size: pack of 25 vials.

Use a 0.8 mm needle and vertically perforate the stopper at the spot specifically indicated.

Before administration, the product should be visually inspected for any particulate matter and discoloration. For single use only. Any unused solution should be discarded.

Paracetamol can be diluted in a 0.9% sodium chloride solution or 5% glucose solution up to one tenth (one volume Paracetamol into nine volumes diluent). The diluted solution should be visually inspected and should not be used in presence of opalescence, visible particulate matters or precipitate.

No special precautions for disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.