Paracetamol Kabi 10 mg/ml solution for infusion EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Paracetamol Kabi 10 mg/ml, solution for infusion EFG
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you:
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Paracetamol Kabi is and what it is used for
- What you need to know before using Paracetamol Kabi
- How to use Paracetamol Kabi
- Possible side effects
- How to store Paracetamol Kabi
- 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 an antipyretic (reduces fever).
It is indicated
- for the short-term treatment of moderate pain, especially after surgery, and
- for the short-term treatment of fever.
2. What you need to know before using Paracetamol Kabi
Do not use Paracetamol Kabi
- If you are allergic to paracetamol or to any of the other components of this medicine (listed in section 6).
- If you have an allergy (hypersensitivity) to propacetamol (another injectable analgesic and paracetamol precursor).
- If you have severe liver disease.
Warnings and precautions
Talk to your doctor before using Paracetamol Kabi.
During treatment with Paracetamol Kabi, inform your doctor immediately if:
You have serious medical conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients under these conditions when paracetamol is used at regular doses for prolonged periods or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.
Take special care with Paracetamol Kabi
- If you have any liver or kidney disease, or chronic alcoholism.
- If you have a hereditary liver function disorder called Gilbert’s syndrome.
- If you have glucose-6-phosphate dehydrogenase deficiency.
- If you are taking other medicines containing paracetamol.
- If you are in a state of chronic malnutrition or are receiving parenteral nutrition.
- If you are dehydrated.
- Consult your doctor or pharmacist if you are taking or are about to take flucloxacillin. There is a risk of blood and fluid disturbances (metabolic acidosis with high anion gap) caused by increased plasma acidity when paracetamol is used concomitantly with flucloxacillin, especially in certain high-risk patient groups, for example: patients with severe renal failure, sepsis, or malnutrition, particularly if maximum daily doses of paracetamol are used. Metabolic acidosis with high anion gap is a serious condition requiring urgent treatment.
Before starting treatment, inform your doctor if any of the above conditions apply to you.
You should switch to oral analgesics (tablets or syrup) instead of Paracetamol Kabi as soon as possible.
Other medicines and paracetamol:
During treatment with Paracetamol Kabi, other medicines containing paracetamol should not be taken. This must be considered to avoid exceeding the recommended daily dose (see next section). Inform your doctor if you are taking other medicines containing paracetamol.
If you are being treated with probenecid (a medicine used to treat gout), your doctor should consider reducing the required dose of paracetamol, as probenecid increases paracetamol blood levels.
Salicylamide (another pain-relieving medicine) may increase paracetamol blood levels and therefore increase the risk of toxic effects.
Rifampicin, isoniazid (antibiotics), barbiturates (sedatives), tricyclic antidepressants, and medicines for treating epileptic seizures (antiepileptics such as carbamazepine, phenytoin, phenobarbital, primidone) may reduce the analgesic and antipyretic effects of paracetamol and, like alcohol, may increase its toxic effects on the liver.
If paracetamol is taken together with chloramphenicol (an antibiotic), the action of chloramphenicol may be prolonged.
Please inform your doctor or pharmacist if you are taking oral contraceptives, as they may reduce the effect of paracetamol.
Taking paracetamol together with zidovudine (a medicine used to treat HIV) increases the risk of reduced numbers of certain white blood cells (neutropenia). Therefore, the risk of infections is increased.
Please inform your doctor or pharmacist if you are taking oral anticoagulants (substances that reduce the speed of blood clotting). Additional blood tests may be needed to monitor the anticoagulant effect.
Inform your doctor or pharmacist if you are taking flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) that require urgent treatment (see section 2).
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines, including those obtained without a prescription.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
Paracetamol Kabi may be used during pregnancy if necessary. Use the lowest possible dose that relieves pain or fever, and use it for the shortest possible time. Contact your doctor if pain or fever do not improve or if you need to take the medicine more frequently.
Breastfeeding
Paracetamol Kabi may be used during breastfeeding.
Driving and using machines
No effects on driving and using machines have been reported.
3. How to use Paracetamol Kabi
This medicine is administered intravenously.
Paracetamol Kabi will be given to you by your doctor. It is administered via an infusion (perfusion).
The 100 ml vial or bag is restricted to adults, adolescents, and children weighing more than 33 kg (approximately 11 years of age).
The 10 ml ampoule, the 50 ml vial or bag is restricted to term newborns, infants, and children weighing less than 33 kg.
Careful monitoring is required before completion of the infusion to prevent air from entering the vein.
Dosage
Dose according to patient's weight (see the dosing table below)
Patient weight | Dose per administration | Volume per administration | Maximum volume of Paracetamol Kabi (10 mg/ml) per administration according to upper weight limits of group (ml)*** | Maximum Daily Dose ** |
≤ 10 kg* | 7.5 mg/kg | 0.75 ml/kg | 7.5 ml | 30 mg/kg |
> 10 kg to ≤33 kg | 15 mg/kg | 1.5 ml/kg | 49.5 ml | 60 mg/kg not exceeding 2 g |
> 33 kg to ≤50 kg | 15 mg/kg | 1.5 ml/kg | 75 ml | 60 mg/kg not exceeding 3 g |
> 50 kg with additional risk factors for hepatotoxicity | 1 g | 100 ml | 100 ml | 3 g |
> 50 kg and without additional risk factors for hepatotoxicity | 1 g | 100 ml | 100 ml | 4 g |
*Premature children: Safety and efficacy data are not available in premature children.
**Maximum daily dose: The maximum daily dose indicated in the table above applies to patients who are not taking other paracetamol-containing medications and should be adjusted accordingly based on these medications.
***Patients with lower body weight will require smaller volumes.
- The minimum interval between doses should be at least 4 hours in patients with normal renal function.
- The minimum interval between doses should be at least 6 hours in patients with severe renal impairment.
- The minimum interval between doses should be at least 8 hours in patients requiring hemodialysis.
- The maximum daily dose must not exceed 3 g in adult patients with chronic active or compensated liver disease, hepatocellular insufficiency, chronic alcoholism, chronic malnutrition (low hepatic glutathione reserves), dehydration, Gilbert's syndrome (Meulengracht syndrome), or who weigh less than 50 kg.
Do not administer more than 4 doses within 24 hours.
Administration method
RISK OF MEDICATION ERRORS Take care to avoid dosing errors due to confusion between milligrams (mg) and milliliters (ml), which may result in accidental overdose and death. |
Paracetamol Kabi solution is administered by infusion (via an infusion set) into your vein over approximately 15 minutes. There should be an interval of at least 4 hours between each administration.
If you feel that the effect of Paracetamol Kabi is too strong or too weak, tell your doctor.
If you use more Paracetamol Kabi than you should
If you have used more Paracetamol Kabi than you should have, contact your doctor or pharmacist immediately.
The most common symptoms in case of overdose occur within the first 24 hours and include: nausea, vomiting, anorexia, pallor, and abdominal pain. In case of overdose, notify medical personnel immediately due to the risk of irreversible liver damage.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Paracetamol Kabi can have adverse effects, although not everyone experiences them.
Frequent (may affect up to 1 in 10 people)
- Pain or burning sensation at the injection site.
Uncommon (may affect up to 1 in 1,000 people)
- Changes in blood test results (abnormally high levels of liver enzymes). If this occurs, consult your doctor, as you may need additional blood tests.
- Low blood pressure (hypotension)
- Malaise
Rare (may affect up to 1 in 10,000 people)
- Decrease in levels of certain blood cells (platelets, certain white blood cells), possibly causing nosebleeds or bleeding gums and increasing the risk of infections. If this occurs, inform your doctor, as you may need additional blood tests.
- Allergic reactions, ranging from simple skin rash or itching to generalized allergic reaction (anaphylactic shock). Possible symptoms include swelling of the face, lips, tongue or other body parts, wheezing or difficulty breathing, and temporary narrowing of the airways in the lungs (bronchospasm).
- If you suspect that Paracetamol Kabi is causing an allergic reaction, inform your doctor immediately.
- Very rare cases of serious skin reactions have been reported.
- Very rare cases of blood and fluid disturbances (metabolic acidosis with high anion gap) due to increased plasma acidity have been reported when paracetamol is used concomitantly with flucloxacillin, usually in the presence of risk factors (see section 2).
Frequency not known (cannot be estimated from available data):
- Increased heart rate (tachycardia)
- Skin redness, flushing, pruritus
- A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in critically ill patients receiving paracetamol (see section 2).
Effects on laboratory tests
Treatment with Paracetamol Kabi may alter the results of certain laboratory tests, such as serum uric acid and blood glucose measurements.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Paracetamol Kabi
Keep Paracetamol Kabi out of the sight and reach of children.
Do not use Paracetamol Kabi after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month.
Do not refrigerate or freeze.
The product should be inspected visually before administration.
Do not use Paracetamol Kabi if you observe the presence of particles or if the solution has discolored beyond a slight yellowish tint.
Your doctor or hospital healthcare staff will normally be responsible for storing Paracetamol Kabi and therefore for ensuring the quality of the product once it has been opened and not used immediately. However, if not used immediately, the product may be stored for up to 24 hours. After dilution, the solution should not be kept for more than 6 hours (including infusion time). They are also responsible for the proper disposal of any remaining Paracetamol Kabi.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Paracetamol Kabi
- The active substance is paracetamol. Each ml contains 10 mg of paracetamol.
- Each 10 ml ampoule contains 100 mg of paracetamol.
- Each 50 ml vial or bag contains 500 mg of paracetamol.
- Each 100 ml vial or bag contains 1000 mg of paracetamol.
- The other components are cysteine, mannitol (E421), and water for injections.
Appearance of Paracetamol Kabi and contents of the pack
Paracetamol Kabi 10 mg/ml, solution for infusion is a slightly yellowish, clear solution.
Paracetamol Kabi 10 mg/ml, solution for infusion is available in 10 ml glass ampoules and 50 ml or 100 ml glass vials closed with stoppers and aluminium/plastic “flip-off” caps, or in 50 ml and 100 ml bags with plastic closures and covers allowing visual detection of prior opening.
Pack sizes:
Ampoules:
10 ampoules
Vials:
1 vial
10 vials
12 vials
20 vials
Bags:
20 bags
50 bags
60 bags
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Fresenius Kabi España, S.A.U.
Marina 16-18
08005 – Barcelona (Spain)
Manufacturer:
Fresenius Kabi Deutschland GmbH
Plant Friedberg
Freseniusstrasse 1
D-61169 Friedberg
Germany
Fresenius Kabi Austria GmbH
Hafnerstrasse, 36 - A-8055
Austria (GRAZ)
Fresenius Kabi France
6, Rue de Rempart
F-27400 Louviers
This medicinal product is authorised in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Austria | Paracetamol Kabi 10 mg/ml infusion solution |
Belgium | Paracetamol Fresenius Kabi 10 mg/ml solution for infusion |
Cyprus | Kabimol |
Czech Republic | Paracetamol Kabi |
Denmark | Kabimol |
Estonia | Paracetamol Kabi 10 mg/ml |
Finland | Paracetamol Fresenius Kabi |
Germany | Paracetamol Kabi 10 mg/ml infusion solution |
Greece | Kabimol |
Hungary | Paracetamol Kabi 10 mg/ml |
Ireland | Paracetamol 10 mg/ml solution for infusion |
Italy | Paracetamol Kabi 10 mg/ml |
Latvia | Paracetamol Kabi 10 mg/ml infusion solution |
Lithuania | Paracetamol Kabi 10 mg/ml infusion solution |
Luxembourg | Paracetamol Kabi 10 mg/ml infusion solution |
Norway | Kabimol 10 mg/ml infusion solution |
Poland | Paracetamol Kabi |
Portugal | Paracetamol Kabi |
Romania | Paracetamol Kabi 10 mg/ml, infusion solution |
Slovakia | Paracetamol Kabi 10 mg/ml |
Slovenia | Paracetamol Kabi 10 mg/ml infusion solution |
Spain | Paracetamol Kabi 10 mg/ml solution for infusion |
Sweden | Paracetamol Fresenius Kabi |
The Netherlands | Paracetamol Fresenius Kabi 10 mg/ml solution for infusion |
United Kingdom (Northern Ireland) | Paracetamol 10 mg/ml solution for infusion |
This patient information leaflet has been reviewed in January 2025
The following information is intended for healthcare professionals only:
Handling
This medicinal product is for single use only. Any unused solution must be discarded.
Prior to administration, the product should be visually inspected to ensure the absence of particles or discoloration.
The 100 ml vial or bag is restricted to adults, adolescents and children weighing more than 33 kg.
The 10 ml ampoule and the 50 ml vial or bag are restricted to term newborns, infants and children weighing less than 33 kg.
As with all infusion solutions presented in glass vials or bags, careful monitoring is required, especially towards the end of the infusion, regardless of the infusion route. This monitoring at the end of the infusion is particularly important in the case of central infusions, to prevent gaseous embolism.
Compatibility
Paracetamol Kabi 10 mg/ml solution for infusion may be diluted in sodium chloride 9 mg/ml (0.9%) solution or glucose 50 mg/ml (5%) solution up to one-tenth (one volume of Paracetamol Kabi 10 mg/ml solution for infusion in 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 visually inspected and must not be used if opalescence, visible particles or precipitate are observed.
Disposal
Any unused product or waste material must be disposed of in accordance with local regulations.