Paracetamol 10mg/Ml Solution For Infusion
PACKAGE LEAFLET: INFORMATION FOR THE USER
Paracetamol 10 mg / ml solution for infusion Paracetamol
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
The name of your medicine is Paracetamol 10 mg / ml solution for infusion.
In the rest of this leaflet this medicine will be called Paracetamol.
What is in this leaflet
1. What Paracetamol is and what it is used for
2. What you need to know before you use Paracetamol
3. How to use Paracetamol
4. Possible side effects
5. How to store Paracetamol
6. Contents of the pack and other information
1. What Paracetamol is and what it is used for
This medicine is an analgesic (it relieves pain) and an antipyretic (it lowers fever). It is indicated for the short-term treatment of moderate pain, especially following surgery, and for the short-term treatment of fever. The 100 ml bottle is restricted to adults, adolescents and children weighing more than 33 kg. The 50 ml bottle is restricted to term newborn infants, infants, toddlers and children weighing less than 33 kg
2. What you need to know before you use Paracetamol Do not use Paracetamol
• if you are allergic to paracetamol or to any of the other ingredients of Paracetamol (listed in section 6);
• if you are allergic to propacetamol (another pain reliever for infusion and a precursor of paracetamol);
• if you suffer from a severe liver disease.
Warnings and precautions
Before using Paracetamol it is important you know:
• use a suitable oral treatment (pain reliever taken by mouth) as soon as possible.
Talk to your doctor or pharmacist before using Paracetamol:
• if you suffer from a liver or kidney disease, or from alcohol abuse.
• if you are taking other medicines containing paracetamol.
• if you have nutrition problems (malnutrition) or dehydration.
Inform your doctor before treatment if any of the above mentioned conditions apply to you.
Other medicines and Paracetamol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Especially tell your doctor if you are taking:
- medicines containing paracetamol or propacetamol; Tell your doctor if you are taking other medicines containing paracetamol or propacetamol. Your doctor will take this into account in order not to exceed the recommended daily dose (listed in section 3).
- probenecid (used for gout). Your doctor may reduce your Paracetamol dose in case you are taking both these medicines at the same time.
- salicylamide (anti-inflammatory drug).
- medicines that induce liver enzymes
- medicines used to thin your blood (anticoagulants), which are taken by mouth. Your doctor may check-up closely the effect of the anticoagulants.
Paracetamol with food and drink
The effect of paracetamol is not influenced by food including dairy products.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Inform your doctor if you are pregnant. Paracetamol may be used during pregnancy. However, in this case your doctor must evaluate if the treatment is advisable. Paracetamol may be used during breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Paracetamol has no influence on the ability to drive and use machines
Paracetamol contains sodium: This medicinal product contains less than 1 mmol sodium (23 mg) per 100 ml of Paracetamol, it is essentially "sodium free".
3. How to use Paracetamol
Paracetamol will be administered to you by a healthcare professional. It will be given directly into a vein, by slow intravenous infusion. The 100 ml bottle is restricted to adults, adolescents and children weighing more than 33 kg. The 50 ml bottle is restricted to term newborn infants, infants, toddlers and children weighing less than 33 kg. Your doctor will monitor you closely before the end of your infusion.
|
Patient Weight |
Dose per administra tion |
Volume per administra tion |
Maximum volume of <Paracetamol> (10 mg/mL) per administration based on 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 |
|
>10kg to <33kg |
15 mg/kg |
1.5 mL/kg |
49.5 mL |
60 mg/kg not exceeding 2g |
|
>33kg to <50kg |
15 mg/kg |
1.5 mL/kg |
75 mL |
60 mg/kg not exceeding 3g |
|
> 50kg with additional risk factors for hepatoxicity |
1g |
100 mL |
100 mL |
3 g |
|
> 50kg and no additional risk factors for hepatoxicity |
1 g |
100 mL |
100 mL |
4g |
* Pre-term newborn infants: No safety and efficacy data are available for pre-term newborn infants.
Dosage: Dosing based on patient weight (please see the following dosing table)_
** Maximum daily dose: The maximum daily dose as presented in the table above is for patients that are not receiving any paracetamol containing products and should be adjusted accordingly taking such products into account.
*** Patients weighing less will require smaller volumes.
The minimum interval between each administration must be at least 4 hours.The minimum interval between each administration in patients with severe renal insufficiency must be at least 6 hours.
No more than 4 doses to be given in 24 hours.
Method of administration_
RISK OF MEDICATION ERRORS
Take care to avoid dosing errors due to confusion between milligram (mg) and milliliter (mL), which could result in accidental overdose and death.
Paracetamol is administered as an intravenous infusion over 15 minutes. In children, the volume of solution to be infused is 1.5 ml per kg per administration. It can also be diluted in 9 mg/ml (0.9%) sodium chloride or 50 mg/ml (5%) glucose up to one tenth. The diluted solution should be visually inspected and must not be used if the solution is milky (opalescent), or has visible particulate matter or precipitate. If you have the impression that the effect of Paracetamol 10 mg/ml, solution for infusion is too strong or too weak, talk to your doctor.
If you use more Paracetamol than you should: Talk to your doctor or pharmacist immediately. In overdose cases, symptoms generally appear within the first 24 hours and consist of: nausea, vomiting, anorexia, having a pale colour (pallor), abdominal pain and a risk of liver injury. If you have any further questions on the use of this product ask your doctor or pharmacist.
If you forget to use Paracetamol: If you are concerned that you may have missed a dose of Paracetamol, contact your doctor immediately.
If you stop using Paracetamol: If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Possible side effects include:
Very rare (may affect up to 1 in 10,000 people):
Very rare cases of serious skin reactions have been reported.
• allergic reaction. The signs of an allergic reaction include:
- rash
- sudden wheeziness,
- difficulty in breathing,
- swelling of the eyelids, face, lips or throat.
If you experience any of the above symptoms, stop treatment immediately and inform your doctor.
Rare (may affect up to 1 in 1,000 people):
• general feeling of being unwell (malaise),
• a drop in blood pressure,
• changes in laboratory test results: abnormally high levels of hepatic enzymes found during blood checks.
• Should any of the above occur, inform your doctor as regular blood checks may be required later. In isolated cases, other changes in laboratory test results have been observed which have necessitated regular blood checks:
• abnormally low levels of some types of blood cells (platelets, white cells), possibly leading to bleeding from the nose or gums. Should this occur, inform your doctor.
Cases of redness of the skin, flushing, itching and abnormally rapid beating of the heart have been reported. Cases of pain and burning sensation at injection site have been reported.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Paracetamol
Keep this medicine out of the sight and reach of children. Do not use Paracetamol after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of that month. Do not store above 30°C. Do not refrigerate or freeze. For the 50 ml bottle, after dilution in 9 mg/ml (0.9% w/v) sodium chloride or 50 mg/ml (5% w/v) glucose: do not store for more than 1 hour (infusion time included). Before administration, the product should be inspected visually. Do not use Paracetamol if you notice any particulate matter and discoloration. For single use only.
The product should be used immediately after opening. Do not throw away any medicines via household waste. Ask your pharmacist how to throw medicines you no longer use. These measures will help protect the environment
6. Contents of the pack and other information
What Paracetamol contains
• The active substance is paracetamol. Each bottle contains 1 g paracetamol. 1 ml contains 10 mg paracetamol.
• The other ingredients are mannitol, disodium phosphate anhydrous, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment) and water for injections.
What Paracetamol looks like and contents of the pack
Paracetamol is a clear, slightly yellowish solution for infusion. Paracetamol is packaged in carton boxes containing 50 ml polypropylene bottles. Each bottle is placed in a metalized plastic pouch. Paracetamol is packaged in carton boxes containing 100 ml polypropylene bottles. Each bottle is placed in a metalized plastic pouch. The 50 ml and 100 ml bottles are available in packs of 1,5, 10 and 12 bottles. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Noridem Enterprises Ltd., Evagorou & Makariou, Mitsi Building 3, Office 115, 1065 Nicosia, Cyprus.
Manufacturer: DEMO S.A., 21st km National Road Athens-Lamia, 14568 Krioneri, Athens, Greece.
This medicinal product is authorised in the Member States of the EEA under the following names:
Portugal Paracetamol Noridem
United Kingdom Paracetamol 10mg/ml Solution for infusion Germany Paracetamol Noridem 10 mg/ml Infusionslosung
Spain Paracetamol KERN PHARMA 10mg/ml solucion para perfusion
EFG
This leaflet was last revised in 06/2014
If this leaflet is difficult to see or read, please contact the following address for help: Fannin Limited, Fannin House, South County Business Park, Leopardstown, Dublin 18, Ireland Tel +353-1-2907000.