Paracetamol Kabi

Leaflet accompanying the packaging: information for the user

Paracetamol Kabi, 10 mg/ml, solution for infusion

Paracetamol

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Paracetamol Kabi and what is it used for
• 2. Important information before using Paracetamol Kabi
• 3. How to use Paracetamol Kabi
• 4. Possible side effects
• 5. How to store Paracetamol Kabi
• 6. Contents of the packaging and other information

1. What is Paracetamol Kabi and what is it used for

This medicine is a pain reliever (analgesic) and antipyretic (fever reducer).
It is indicated for:

• short-term treatment of moderate pain, especially in the postoperative period;
• short-term treatment of fever.

2. Important information before using Paracetamol Kabi

When not to use Paracetamol Kabi:

• if the patient is allergic(hypersensitive) to paracetamolor any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic(hypersensitive) to propacetamol(another pain reliever and paracetamol precursor);
• if the patient has severe liver disease.

Warnings and precautions

Before starting treatment with Paracetamol Kabi, you should discuss it with your doctor.
During treatment with Paracetamol Kabi, you should immediately inform your doctor:

• if the patient has severe diseases, including severe kidney function disorders or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition, alcoholism in the chronic phase or when the patient is also taking flucloxacillin (an antibiotic). There have been reports of a severe disease called metabolic acidosis (a blood and fluid disorder) in patients who use paracetamol in recommended doses for a longer period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling of nausea (nausea) and vomiting.

Special caution is required when using Paracetamol Kabi:

• if the patient has liver or kidney disease, or is addicted to alcohol;
• if the patient has a hereditary liver function disorder called Meulengracht-Gilbert syndrome;
• if the patient has a glucose-6-phosphate dehydrogenase deficiency;
• if the patient is taking other medicines containing paracetamol;
• in patients with severe nutritional deficiencies(malnutrition) or in patients who are receiving parenteral nutrition;
• if the patient is dehydrated;
• if the patient is taking or will be taking flucloxacillin, they should consult a doctor or pharmacist. There is a risk of a blood and fluid disorder (metabolic acidosis with a large anion gap) if there is an increase in blood acidity during the use of paracetamol with flucloxacillin, especially in patients at risk, such as those with severe kidney failure, sepsis, or malnutrition, especially if they are taking the maximum daily doses of paracetamol. Metabolic acidosis with a large anion gap is a severe disease that requires emergency treatment.

You should inform your doctor before starting treatment if any of the above cases apply to the patient.
It is recommended to use tablets or syrup instead of Paracetamol Kabi whenever possible.

Paracetamol Kabi and other medicines

Paracetamol Kabi should not be used at the same time as other medicines containing paracetamol,
in order not to exceed the recommended daily dose (see the next point). You should inform your doctor if you are taking other medicines containing paracetamol.
Your doctor should consider reducing the dose of paracetamol if you are also taking probenecid(a medicine used to treat gout), as it increases the concentration of paracetamol in the blood.
Salicylamide(another pain reliever) may increase the concentration of paracetamol in the blood and thus may increase the risk of its toxic effects.
Rifampicin, isoniazid(antibiotics), barbiturates(sedatives), tricyclic antidepressants, antiepileptic drugs(e.g. carbamazepine, phenytoin, phenobarbital, primidone) may reduce the analgesic and antipyretic effects of paracetamol and increase, like alcohol, the toxic effects on the liver.
Concomitant use of paracetamol and chloramphenicol(an antibiotic) may prolong the effect of chloramphenicol.
You should inform your doctor or pharmacist if you are taking oral contraceptives, as they may shorten the duration of action of paracetamol.
Concomitant use of paracetamol and zidovudine(a medicine used to treat HIV) may increase the risk of a decrease in the number of certain white blood cells (neutropenia). This increases the risk of infections.
You should inform your doctor or pharmacist if you are taking oral anticoagulants(medicines that prevent blood clots). It may be necessary to increase the frequency of tests to assess the anticoagulant effect.
You should inform your doctor or pharmacist if you are taking flucloxacillin(an antibiotic) due to the risk of a serious blood and fluid disorder (metabolic acidosis), which requires emergency treatment (see section 2).
You should tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, including those obtained without a prescription.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, you should ask your doctor for advice before taking this medicine.
Pregnancy
Paracetamol Kabi can be given to pregnant women if necessary. You should use the lowest effective dose for the shortest possible duration. If the pain is not relieved and/or the fever does not subside or if it is necessary to increase the frequency of administration, you should consult a doctor.
Breastfeeding
Paracetamol Kabi can be used during breastfeeding.

Driving and using machines

Paracetamol Kabi has no influence on the ability to drive and use machines.

3. How to use Paracetamol Kabi

Intravenous administration.
The administration of Paracetamol Kabi will be decided by your doctor. The medicine is administered by intravenous infusion (drip).
The vial or bag of 100 ml solution is intended for use in adults, adolescents, and children with a body weight of over 33 kg (approximately 11 years old).
The ampoule of 10 ml, vial or bag of 50 ml solution is intended for use in full-term newborns, infants, small children, and children with a body weight of less than 33 kg.
To avoid air embolism in the vein, your doctor will monitor you before the end of the infusion.

Dosage

The dosage is determined based on the patient's body weight (see the dosing table below):

Maximum volume of a single dose of Paracetamol Kabi

Maximum

Body weight of the patient Administered volume of Paracetamol Kabi calculated for a patient with a maximum body weight

daily dose**
of the patient
single dose
of administration
from the given range [ml]***
≤10 kg*
7.5 mg/kg body weight.
0.75 ml/kg body weight.
7.5 ml
30 mg/kg body weight.
60 mg/kg body weight,
>10 kg to ≤33 kg
15 mg/kg body weight.
1.5 ml/kg body weight.
49.5 ml
not more than
2 g
60 mg/kg body weight,
>33 kg to ≤50 kg
15 mg/kg body weight.
1.5 ml/kg body weight.
75 ml
not more than
3 g
>50 kg, patient
with additional
risk factors for
toxic liver damage
1 g
100 ml
100 ml
3 g
>50 kg, patient without
additional risk factors
for toxic liver damage
1 g
100 ml
100 ml
4 g
*
Preterm infants:there are no data on the safety and efficacy of use in preterm infants.
** Maximum daily dose:the maximum daily dose presented in the table above has been given for patients who do not use other medicines containing paracetamol in their composition. It should be reduced accordingly, taking into account the use of these medicines.
*** Patients with a lower body weight are given smaller volumes.

• The minimum interval between each administration is at least 4 hours in patients with normal kidney function.
• The minimum interval between each administration in patients with severe kidney failure is at least 6 hours.
• The minimum interval between each administration in patients requiring hemodialysis is at least 8 hours.
• Adult patients with chronic or compensated liver disease, liver failure, chronic alcoholism, chronic malnutrition (low glutathione reserves in the liver), dehydration, Meulengracht-Gilbert syndrome, weighing less than

50 kg, should not be given a maximum daily dose greater than 3 g.

• Do not administer more than 4 doses of the medicine in 24 hours.

Method of administration

RISK OF MEDICATION ERRORS
Caution should be exercised to avoid dosing errors due to confusion between milligrams (mg) and milliliters (ml). These errors can lead to unintentional overdose and death of the patient.
Paracetamol Kabi is administered by intravenous infusion (drip) over 15 minutes. The minimum interval between doses must be at least 4 hours.
If you feel that the effect of Paracetamol Kabi is too strong or too weak, you should inform your doctor.

Using a higher dose of Paracetamol Kabi than recommended

You should immediately inform your doctor or pharmacist if you have received more Paracetamol Kabi than prescribed.
In case of overdose, symptoms usually occur within the first 24 hours and include:
nausea, vomiting, loss of appetite, pallor, and abdominal pain. In case of overdose, you should immediately consult a doctor due to the risk of irreversible liver damage.
If you have any further questions about the use of this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common (less than 1 in 10 patients)

• Pain and burning sensation at the injection site.

Uncommon (less than 1 in 1,000 patients)

• Changes in laboratory test results (abnormally elevated liver enzyme activity detected in blood tests). If this abnormality occurs, you should inform your doctor, as regular blood tests may be required.
• Decreased blood pressure (hypotension).
• Malaise.

Rare (less than 1 in 10,000 patients)

• Decrease in the number of certain blood cells (platelets, some white blood cells), which can lead to nosebleeds or bleeding from the gums and an increased risk of infections. If such symptoms occur, you should inform your doctor, as regular blood tests may be required.
• Hypersensitivity reactions, from a simple skin rash or urticaria to a severe allergic reaction (anaphylactic shock). Possible symptoms include swelling of the face, lips, tongue, or other parts of the body and shortness of breath, wheezing, or difficulty breathing, temporary constriction of the airways in the lungs (bronchospasm). You should immediately inform your doctor if you suspect that Paracetamol Kabi is causing an allergic reaction.
• Very rare cases of severe skin reactions have been observed.
• Very rare cases of a blood and fluid disorder (metabolic acidosis with a large anion gap) have been observed, which occurs if there is an increase in blood acidity during the use of paracetamol with flucloxacillin, usually in patients at risk (see section 2).

Frequency not known (cannot be estimated from the available data)

• Rapid heartbeat (tachycardia).
• Flushing, reddening of the face, itching.
• A serious condition that can make the blood more acidic (so-called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

Effect on laboratory tests

Treatment with Paracetamol Kabi may affect the results of some laboratory tests for uric acid, as well as glucose tests.
If you experience any serious side effects or side effects not listed in this leaflet, you should tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Paracetamol Kabi

The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after EXP.
The expiry date refers to the last day of that month.
Do not store in a refrigerator. Do not freeze.
Before administration, the medicine should be inspected.
Do not use Paracetamol Kabi if you notice the presence of visible particles or a change in color to other than slightly yellow.
Usually, the doctor or hospital medical staff store Paracetamol Kabi and are responsible for the quality of the medicine after opening, if the medicine is not used immediately. However, if the medicine is not used immediately, it cannot be stored for more than 24 hours. The diluted solution cannot be stored for more than 6 hours (including infusion time). They are also responsible for the proper disposal of any unused Paracetamol Kabi.
Medicines should not be disposed of via wastewater or household waste. Your doctor, nurse, or pharmacist will dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Paracetamol Kabi contains

• The active substance of the medicine is paracetamol. One milliliter contains 10 mg of paracetamol.
• Each ampoule of 10 ml solution contains 100 mg of paracetamol.
• Each vial or bag of 50 ml solution contains 500 mg of paracetamol.
• Each vial or bag of 100 ml solution contains 1000 mg of paracetamol.
• The other ingredients are: cysteine, mannitol, water for injections.

What Paracetamol Kabi looks like and contents of the pack

Paracetamol Kabi, 10 mg/ml, solution for infusion is a clear and slightly yellowish solution for infusion.
Paracetamol Kabi, 10 mg/ml, solution for infusion is available:

• in ampoules of 10 ml, packed in cartons of 10;
• in vials of 50 ml or 100 ml solution, closed with bromobutyl rubber stoppers and aluminum flip-off seals, packed in cartons of 1, 10, 12, or 20 vials;
• in bags of 50 ml or 100 ml solution, closed with rubber stoppers and plastic caps, placed in transparent and/or aluminum outer bags, packed in cartons of 20, 50, or 60 bags.

Marketing authorization holder

Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw

Manufacturer

Fresenius Kabi Deutschland GmbH
Plant Friedberg
Freseniusstraße 1
61169 Friedberg
Germany
Fresenius Kabi Austria GmbH
Hafnerstraße 36
8055 Graz
Austria
Fresenius Kabi France
6, Rue de Rempart
F-27400 Louviers
France
To obtain more detailed information, you should contact the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria
Paracetamol Kabi 10 mg/ml Infusionslösung
Belgium
Paracetamol Fresenius Kabi 10 mg/ml oplossing voor infusie
Bulgaria
Парацетамол Кabi 10 мг/мл разтвор за инфузия
Cyprus
Paracetamol/Kabi
Czech Republic
Paracetamol Kabi
Denmark
Paracetamol "Fresenius Kabi"
Estonia
Paracetamol Kabi 10 mg/ml
Finland
Paracetamol Fresenius Kabi
Greece
Paracetamol/Kabi
Spain
Paracetamol Kabi 10 mg/ml solución para perfusión
Netherlands
Paracetamol Fresenius Kabi 10 mg/ml oplossing voor infusie
Ireland
Paracetamol Kabi 10 mg/ml solution for infusion
Lithuania
Paracetamol Kabi 10 mg/ml infuzinis tirpalas
Luxembourg
Paracetamol Kabi 10 mg/ml Infusionslösung
Latvia
Paracetamol Kabi 10 mg/ml šķīdums infūzijam
Germany
Paracetamol Kabi 10 mg/ml Infusionslösung
Norway
Paracetamol “Fresenius Kabi” 10 mg/ml infusjons-væske, oppløsning
Poland
Paracetamol Kabi
Portugal
Paracetamol Kabi
Romania
Paracetamol Kabi 10 mg/ml, soluţie perfuzabilă
Slovakia
Paracetamol Kabi 10 mg/ml
Slovenia
Paracetamol Kabi 10 mg/ml raztopina za infundiranje
Sweden
Paracetamol Fresenius Kabi
Hungary
Paracetamol Kabi 10 mg/ml
United Kingdom
Paracetamol Kabi 10 mg/ml solution for infusion
Italy
Paracetamolo Kabi 10 mg/ml
Date of last revision of the leaflet:20.01.2025
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Information intended for healthcare professionals only:
Administration
For single use only. Any unused solution should be discarded.
Before administration, you should check if the solution contains visible particles or discoloration.
The vial or bag of 100 ml solution is intended for use in adults, adolescents, and children with a body weight of over 33 kg.
The ampoule of 10 ml, vial or bag of 50 ml solution is intended for use in full-term newborns, infants, small children, and children with a body weight of up to 33 kg.
As with all infusion solutions available in vials or bags, you should remember to carefully monitor the infusion, regardless of the route of administration, especially just before its end. This monitoring at the end of the infusion is especially important for infusions through a central venous catheter to avoid air embolism.
Compatibility
Paracetamol Kabi can be diluted with 9 mg/ml (0.9%) sodium chloride solution or 50 mg/ml (5%) glucose solution in a ratio of 1:10 (one volume of Paracetamol Kabi and nine volumes of diluent). In this case, the diluted solution should be used within 6 hours of preparation (including infusion time).
The diluted solution should be inspected and not used if opalescence, visible particles, or sediment appear.
Disposal
Any unused medicine or waste material should be disposed of in accordance with local regulations.