Paracetamol kabi

Package leaflet: Information for the user

Paracetamol Kabi, 10 mg/ml, solution for infusion
Paracetamolum
Please read all of this leaflet carefully before use, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.

Contents of the leaflet

1. What Paracetamol Kabi is and what it is 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 pack and other information

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

This medicine is an analgesic (relieves pain) and antipyretic (reduces fever).
It is indicated for:

• short-term treatment of mild to 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 paracetamol or to any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic (hypersensitive) to propacetamol (another pain-relieving medicine and a precursor of paracetamol);
• if the patient has severe liver disease.

Warnings and precautions
Before starting treatment with Paracetamol Kabi, discuss this with the doctor.
During treatment with Paracetamol Kabi, inform the doctor immediately:

• if the patient has serious medical conditions, including severe kidney dysfunction or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). Cases of a serious condition called metabolic acidosis (an abnormality in blood and body fluids) have been reported in patients who receive paracetamol at recommended doses over a prolonged period or who take paracetamol together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

Exercise particular caution when using Paracetamol Kabi:

• if the patient has liver or kidney disease, or if the patient is alcohol-dependent;
• if the patient has a hereditary liver disorder known as Gilbert’s syndrome;
• if the patient has glucose-6-phosphate dehydrogenase deficiency;
• if the patient is taking other medicines containing paracetamol;
• in patients who are severely malnourished or in patients receiving parenteral nutrition;
• if the patient is dehydrated;
• if the patient is taking or will be taking flucloxacillin, consult a doctor or pharmacist. There is a risk of developing a disturbance in blood and body fluids (metabolic acidosis with a high anion gap) when increased plasma acidity occurs during concomitant use of paracetamol and flucloxacillin, particularly in patients from certain risk groups, e.g. patients with severe renal impairment, sepsis, or malnourished patients, especially if they are receiving maximum daily doses of paracetamol. Metabolic acidosis with a high anion gap is a serious condition requiring urgent treatment.

Inform the doctor before starting treatment if any of the above situations apply to the patient.
It is recommended, whenever possible, to use oral pain-relief tablets or syrup instead of Paracetamol Kabi.

Paracetamol Kabi and other medicines
Do not use Paracetamol Kabi together with other medicines containing paracetamol to avoid exceeding the recommended daily dose (see next section). Inform the doctor if the patient is taking other medicines containing paracetamol.
The doctor should consider reducing the dose of paracetamol if the patient is also taking probenecid (a medicine used in the treatment of gout), as it increases the concentration of paracetamol in the blood.
Paracetamol (another pain-relieving medicine) may increase the blood concentration of paracetamol and therefore may increase the risk of toxic effects.
Rifampicin, isoniazid (antibiotics), barbiturates (sedatives), tricyclic antidepressants, and antiepileptic medicines (e.g. carbamazepine, phenytoin, phenobarbital, primidone) may reduce the analgesic and antipyretic effects of paracetamol and, like alcohol, may increase its hepatotoxic (liver-damaging) effects.
Concomitant use of paracetamol and chloramphenicol (an antibiotic) may prolong the effect of chloramphenicol.
Inform the doctor or pharmacist if the patient is taking oral contraceptives, as they may shorten the duration of action of paracetamol.
Concomitant use of paracetamol and zidovudine (a medicine used in the treatment of HIV) may increase the risk of reduced numbers of certain white blood cells (neutropenia), thereby increasing the risk of infections.
Inform the doctor or pharmacist if the patient is taking oral anticoagulants (medicines to prevent blood clots). It may be necessary to increase the frequency of monitoring tests to assess anticoagulant effect.
Inform the doctor or pharmacist if the patient is taking flucloxacillin (an antibiotic) due to the risk of developing a serious blood and fluid disorder (called metabolic acidosis), which requires urgent treatment (see section 2).
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.

Pregnancy
Paracetamol Kabi may be given to pregnant women if necessary. Use the lowest effective dose sufficient to relieve pain and/or reduce fever, and take the medicine for as short a duration as possible. If pain is not relieved and/or fever does not subside, or if it becomes necessary to increase the frequency of dosing, consult a doctor.

Breastfeeding
Paracetamol Kabi may be used during breastfeeding.

Driving and operating machinery
Paracetamol Kabi has no effect on the ability to drive or operate machinery.

3. How to use Paracetamol Kabi

Intravenous administration.
Paracetamol Kabi will be administered by a physician. The medicine is given as an intravenous infusion (drip).
The 100 ml vial or bag of solution is intended exclusively for use in adults, adolescents, and children with body weight above 33 kg (approximately 11 years of age).
The 10 ml ampoule, as well as the 50 ml vial or bag of solution, are intended exclusively for use in full-term newborns, infants, young children, and children with body weight below 33 kg.
To avoid air embolism in the vein, the physician will monitor the patient before completing the infusion.

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

| Body weight | Dose administered | Volume to be administered | Maximum volume of Paracetamol Kabi calculated for patient with maximum body weight in the given range [ml]*** | Maximum single dose | Maximum daily dose** | |-----------------|------------------------|-------------------------------|--------------------------------------------------|--------------------------|----------------------------| | ≤10 kg* | 7.5 mg/kg b.w. | 0.75 ml/kg b.w. | 7.5 ml | 30 mg/kg b.w. | 60 mg/kg b.w., not more than 2 g | | >10 kg to ≤33 kg | 15 mg/kg b.w. | 1.5 ml/kg b.w. | 49.5 ml | 30 mg/kg b.w. | 60 mg/kg b.w., not more than 3 g | | >33 kg to ≤50 kg | 15 mg/kg b.w. | 1.5 ml/kg b.w. | 75 ml | 30 mg/kg b.w. | 60 mg/kg b.w., not more than 4 g | | >50 kg, patient with additional risk factors for hepatotoxicity | 1 g | 100 ml | 100 ml | 1 g | 3 g | | >50 kg, patient without additional risk factors for hepatotoxicity | 1 g | 100 ml | 100 ml | 1 g | 4 g |

* Preterm infants: Lack of data on safety and efficacy in preterm infants.
** Maximum daily dose: The maximum daily dose shown in the table above applies to patients who are not taking other medications containing paracetamol. This dose should be appropriately reduced if such medications are used.
*** Patients with lower body weight should receive proportionally smaller volumes.

• Minimum interval between doses is at least 4 hours in patients with normal renal function.
• Minimum interval between doses in patients with severe renal impairment is at least 6 hours.
• Minimum interval between doses in patients requiring hemodialysis is at least 8 hours.
• Adult patients with chronic or compensated active liver disease, hepatic insufficiency, chronic alcoholic liver disease, chronic malnutrition (low hepatic glutathione reserves), dehydration, Meulengracht-Gilbert syndrome, or weighing less than 50 kg must not receive a maximum daily dose exceeding 3 g.
• Do not administer more than 4 doses of the medicine within 24 hours.

Method of administration
MEDICATION ERROR RISK
Exercise caution to avoid dosing errors due to confusion between milligrams (mg) and milliliters (ml). Such errors may lead to unintentional overdose and patient death.
Paracetamol Kabi is administered as a 15-minute intravenous infusion (drip). The minimum interval between doses must be at least 4 hours.
If the patient feels that the effect of Paracetamol Kabi is too strong or too weak, the physician should be informed.

Use of a higher than recommended dose of Paracetamol Kabi
Immediately inform the physician or pharmacist if the patient has received more Paracetamol Kabi than recommended.
In case of overdose, symptoms usually occur within the first 24 hours and may include nausea, vomiting, loss of appetite, pallor, and abdominal pain. In the event of overdose, seek immediate medical advice due to the risk of irreversible liver damage.
If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Common (affects fewer than 1 in 10 patients)

• Pain and burning sensation at the site of administration.

Uncommon (affects fewer than 1 in 1,000 patients)

• Changes in laboratory test results (abnormally increased liver enzyme activity detected in blood tests). If this abnormality occurs, the doctor should be informed, as regular blood tests may be required.
• Low blood pressure (hypotension).
• Malaise.

Rare (affects fewer than 1 in 10,000 patients)

• Decrease in the number of certain blood cells (platelets, certain white blood cells), which may lead to nosebleeds or bleeding gums and increased risk of infection. If such symptoms occur, the doctor should be informed, as regular blood tests may be required.
• Hypersensitivity reactions, ranging from skin rash or urticaria to severe allergic reaction (anaphylactic shock). Possible symptoms include swelling of the face, lips, tongue or other body parts, and shortness of breath, wheezing or difficulty breathing, transient narrowing of the airways in the lungs (bronchospasm). If an allergic reaction to Paracetamol Kabi is suspected, the doctor should be informed immediately.
• Very rare cases of severe skin reactions have been observed.
• Very rare cases of a disorder affecting blood and body fluids (metabolic acidosis with a high anion gap) have been observed, occurring when paracetamol is administered concomitantly with flucloxacillin, usually in patients with risk factors (see section 2).

Frequency not known (cannot be estimated from available data)

• Rapid heartbeats (tachycardia).
• Flushing, facial redness, itching.
• Serious condition that may cause the blood to become more acidic (so-called metabolic acidosis) in patients with severe illness receiving paracetamol (see section 2).

Effect on laboratory tests
Treatment with Paracetamol Kabi may affect the results of certain laboratory tests for uric acid, as well as glucose tests.

If serious adverse reactions occur, or any adverse reactions not listed in this leaflet, inform a doctor or pharmacist.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Paracetamol Kabi

Keep the medicine 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 the stated month.
Do not store in a refrigerator. Do not freeze.
Inspect the medicine before administration.
Do not use Paracetamol Kabi if visible solid particles are present or if the colour has changed to anything 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 must not be stored for longer than 24 hours. The diluted solution must not be stored for longer than 6 hours (including infusion time). They are also responsible for the proper disposal of any unused Paracetamol Kabi.
Medicines must not be disposed of via the sewage system or household waste. Unused medicines will be disposed of by the doctor, nurse, or pharmacist. This helps protect the environment.

6. Contents of the packaging and other information

What Paracetamol Kabi contains

• The active substance is paracetamol. One millilitre contains 10 mg of paracetamol.
• Each 10 ml ampoule of solution contains 100 mg of paracetamol.
• Each 50 ml vial or bag of solution contains 500 mg of paracetamol.
• Each 100 ml vial or bag of 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, slightly yellowish solution for infusion.
Paracetamol Kabi 10 mg/ml, solution for infusion, is available:

• in 10 ml colourless glass ampoules, packed 10 in a cardboard box;
• in 50 ml or 100 ml colourless glass vials, closed with bromobutyl rubber stoppers and aluminium flip-off seals, packed in cardboard boxes containing 1, 10, 12 or 20 vials;
• in 50 ml or 100 ml bags closed with rubber stoppers and plastic caps, placed individually in transparent and/or aluminium outer bags with an oxygen-absorbing agent, packed in cardboard boxes containing 20, 50 or 60 bags.

Marketing Authorisation 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
For further information, please contact the Marketing Authorisation Holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Tel.: +48 22 345 67 89
This medicinal product is authorised in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:
Austria Paracetamol Kabi 10 mg/ml Infusionslösung
Belgium Paracetamol Fresenius Kabi 10 mg/ml oplossing voor infusie
Cyprus Kabimol
Czech Republic Paracetamol Kabi
Denmark Kabimol
Estonia Paracetamol Kabi 10 mg/ml
Finland Paracetamol Fresenius Kabi
Greece Kabimol
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 Kabimol 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 10 mg/ml solution for infusion
(Northern Ireland)
Italy Paracetamolo Kabi 10 mg/ml

Information intended exclusively for medical professionals:

Administration
For single use only. Any unused portions of the solution must be discarded.
Before administration, inspect the solution for visible particulate matter and (or) discoloration.
The 100 ml vial or bag is intended exclusively for use in adults, adolescents, and children with body weight above 33 kg.
The 10 ml ampoule, as well as the 50 ml vial or bag, are intended exclusively for use in full-term newborns, infants, young children, and children with body weight up to 33 kg.
As with all infusion solutions available in vials or bags, careful monitoring of the infusion is required regardless of the route of administration, especially towards the end of the infusion. This monitoring at the end of the infusion is particularly important when administering via central venous access to avoid air embolism.

Compatibility
Paracetamol Kabi may be diluted with 9 mg/ml (0.9%) sodium chloride solution or 50 mg/ml (5%) glucose solution at a 1:10 ratio (one volume of Paracetamol Kabi and nine volumes of diluent). In this case, the diluted solution must be used within 6 hours after preparation (including infusion time).
The diluted solution should be inspected visually and must not be used if opalescence, visible particles, or precipitate occur.

Disposal
Any unused portions of the medicinal product or waste material must be disposed of in accordance with local regulations.