PARACETAMOL KABI

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

PARACETAMOL KABI contains the active ingredient paracetamol. PARACETAMOL KABI is used to relieve pain and reduce fever following surgery. For more information, see Section 1. Why am I being given PARACETAMOL KABI? in the full CMI.

Do not use if you have ever had an allergic reaction to PARACETAMOL KABI or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I am given PARACETAMOL KABI? in the full CMI.

Some medicines may interfere with PARACETAMOL KABI and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

Your doctor will decide what dose you will be given, and for how long you will be given PARACETAMOL KABI.

Your doctor will inject the medicine as a slow infusion (drip) into a vein. PARACETAMOL KABI must only be given by a doctor or nurse.

More instructions can be found in Section 4. How is PARACETAMOL KABI given? in the full CMI.

For more information, see Section 5. What should I know after being given PARACETAMOL KABI? in the full CMI.

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary.

The most common side effects are feeling unwell, dizziness, light headedness, bleeding or bruising more easily than normal, vomiting, nausea and constipation.

The serious side effects are allergic reaction such as shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body, rash, itching or hives on the skin.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Paracetamol.

2 Qualitative and Quantitative Composition

Paracetamol Kabi solution for infusion contains 10 mg/mL of paracetamol (50 mL vial/bag contains 500 mg of paracetamol, 100 mL vial/bag contains 1 g of paracetamol).
Paracetamol Kabi solution for infusion contains the excipients mannitol, cysteine hydrochloride, nitrogen (as protective gas), water for injections. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Paracetamol solution for infusion 10 mg/mL is a clear to slightly yellowish solution. Paracetamol is a white crystalline solid or powder chemically described as 4-acetamidophenol. It is soluble in water (1 in 70), soluble in alcohol (1 in 7), acetone (1 in 13), glycerol (1 in 40), propylene glycol (1 in 9) and also soluble in solutions of the alkali hydroxides.

4 Clinical Particulars

4.9 Overdose

There is a risk of poisoning, 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. Poisoning may be fatal in these cases. Acute overdose with paracetamol may also lead to acute renal tubular necrosis.
Symptoms generally appear within the first 24 hours and comprise of nausea, vomiting, anorexia, pallor and abdominal pain. Overdose, 7.5 g or more of paracetamol in a single administration in adults or 140 mg/kg of body weight in a single administration in children, causes cytolytic hepatitis likely to induce complete and irreversible hepatic necrosis, resulting in acute or fulminant hepatic failure, 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.
The Rumack-Matthews nomogram relates plasma levels of paracetamol and the time after oral ingestion to the predicted severity of liver injury. The relation of parenteral paracetamol levels in overdose to liver toxicity has not been examined. Advice or treatment protocols based on oral paracetamol overdoses may not accurately predict the incidence of liver toxicity or need for antidote therapy in paracetamol solution for infusion overdose.
Methaemoglobinaemia has been reported in cases of paracetamol overdose.
Emergency measures. Immediate hospitalisation.
Before beginning treatment, take blood for plasma paracetamol assay, as soon as possible after the overdose.
Treatment of paracetamol overdose may include the antidote N-acetylcysteine (NAC) by the IV or oral route. In overdoses of oral paracetamol NAC is administered, if possible, before 8 hours but may give some degree of protection from liver toxicity even after this time. The optimal time for administration of NAC and necessary duration of therapy have not been established for overdoses of paracetamol solution for infusion.
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 the liver function. In very severe cases, however, liver transplantation may be necessary.
Adults. Keep to the recommended dose. Do not take this medicine for longer than a few days at a time unless advised by a doctor.
Children and adolescents. Keep to the recommended dose.
If an overdose is taken or suspected, go to a hospital straight away even if you feel well because of the risk of delayed, serious liver damage.
Do not take with other products containing paracetamol, unless advised to do so by a doctor or pharmacist.
For information on the management of overdose, contact the Poison Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Paracetamol was not mutagenic in the bacterial mutagenicity assay, but it was clastogenic in mammalian cell assay systems in vitro (mouse TK, human lymphocyte) and in a mouse micronucleus assay in vivo. The clastogenic effect was dose dependent, and the mechanism appears to involve inhibition of replicative DNA synthesis and ribonucleotide reductase at above threshold doses. The clinical significance of clastogenic findings is equivocal as positive findings in vivo only occurred at exposures (ca. 8 times the maximum anticipated clinical exposure, based on C_max) greater than that for hepatotoxicity, and at doses that were associated with significant cytotoxicity.
Carcinogenicity. No evidence of carcinogenic potential was observed for paracetamol in long-term oral studies in mice (up to 3000 mg/m²/day, similar to human exposure) and male rats (up to 1800 mg/m²/day, 0.7 times human exposure). Equivocal evidence of carcinogenic potential (mononuclear cell leukaemia) was observed only in female rats at 1900 mg/m²/day, or 0.7 times the maximum anticipated clinical exposure on a mg/m² basis.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical Name: N-(4-hydroxyphenyl) acetamide.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSPARCET.gif CAS number. CAS Registry Number: 103-90-2.
Molecular weight: 151.2.

7 Medicine Schedule (Poisons Standard)

Schedule 4 (Prescription Medicine).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/PARKABST.gif