Patient leaflet - PARACETAMOL ACCORD 10 MG / ML SOLUTION FOR INFUSION
3. how to use paracetamol
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Paracetamol – If you suffer from a liver or kidney disease, or from alcohol abuse, – If you are taking other medicines containing paracetamol, – In cases of nutrition problems (malnutrition) or dehydration.
It is recommended that a suitable analgesic oral treatment be used as soon as this route of administration is possible.
RISK OF MEDICATION ERRORS
Take care to avoid dosing errors due to confusion between milligram (mg) and millilitre (ml), which could result in accidental overdose and death.
Paracetamol will be given by infusion into one of your veins. The infusion will last approximately 15 minutes.
If you have the impression that the effect of your medicine is too strong or too weak, talk to your doctor.
Other medicines and Paracetamol
Tell your doctor or pharmacist if you are taking or have recently taken any other medicine.
Do not give anything else containing paracetamol while giving this medicine. This medicine contains paracetamol and this must be taken into account if other medicines containing paracetamol or propacetamol are taken, in order not to exceed the recommended daily dose (see following section). Inform your doctor if you are taking other medicines containing paTacetamolrorpropacetamot.
A dose reduction should be considered for concomitant treatment with probenecid.
Please inform your doctor or pharmacist if you are taking oral anticoagulants. More check-ups to look at the effect of the anticoagulant might be needed.
Pregnancy and Breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Inform your doctor if you are pregnant. Paracetamol may be used during pregnancy. However, in this case the doctor must evaluate if the treatment is advisable.
Paracetamol may be used during breast-feeding.
Driving and using machines
The product does not affect the ability to drive or use machines For the 100 ml vials, a 0.8 mm needle (21 gauge needle) has to be used and the stopper vertically perforated at the spot indicated.
If you take more Paracetamol Acccord than you should
If you or your child use more Paracetamol 10 mg/ml solution for infusion than if you or your child should use, talk to a doctor at once if you or your child take too much of this medicine even if you or your child seem feel well. This is because too much paracetamol can cause_de.lay.edj serious liver damage…_____________
In overdose cases, symptoms generally appear within the first 24 hours and comprise: nausea, vomiting, anorexia, pallor, abdominal pain and risk of liver injury. Immediate medical advice should be sought in the event of overdosage, because of the risk of irreversible liver damage. Please inform your doctor if you notice any of these symptoms.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In very rare cases (may affect up to 1 in 10,000 people, including isolated reports), a serious skin rash or allergic reaction may occur. Stop the treatment immediately and inform your doctor.
In rare cases (may affect up to 1 in 1,000 people), the following may occur: a malaise, a drop in blood pressure or changes in laboratory test results: abnormally high levels of hepatic enzymes found during blood checks. Should this occur, inform your doctor as regular blood checks
| Artwork No. | – | Colours Used | |||||
| Customer | Accord (Combino) | ■ | Pantone Black | ||||
| Description | Paracetamol Solution | ||||||
| Market | UK-MT | ||||||
| Language | English | ||||||
| V | Size | 210 × 297 mm (PIL) | |||||
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| Min. Font Size | 6.5 | |||||
| Version No. | 3 (Page 2 of 2) | ||||||
| Date | 20_06_19 (Paracetamol Solution (ACC-UK-MT)PIL- | TP) | |||||
| Prepared By Regulatory Affairs | Checked By Regulatory Affairs | Approved By Quality Assurance | |||||
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 via the national reporting system listed in below. By reporting side effects you can help provide more information on the safety of this medicine.
For UK – You can also report side effects directly via Yellow Card Scheme,Website: or search for MHRA Yellow Card in the Google Play or Apple App Store.
For Malta – You can also report side effects directly via ADR Reporting, ---Website:.--------
5. how to store paracetamol
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of that month. Glass vials: Do not refrigerate or freeze. Store in the original package in order to protect from light.
Plastic bags: Do not store above 25°C. Do not refrigerate or freeze. Store in the original package in order to protect from light
For single use only. The product should be used immediately after opening. Any unused solution should be discarded.
Before administration the product should be visually inspected. Do not use this medicine if you notice any particulate matter and discolouration.
Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. contents of the pack and other information
What Paracetamol contains
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– The active substance is paracetamol. One ml contains 10 mg paracetamol, this container contains 1000 mg paracetamol in 100 ml.
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– The other ingredients are mannitol, sodium dihydrogen phosphate dihydrate, sodium hydroxide (for pH adjustment), povidone K-12 and water for injections.
What Paracetamol looks like and contents of the pack
Paracetamol is a clear, free from visible particles and colourless to slightly brownish solution for infusion.
Paracetamol is supplied in packs of 1, 10, 12 and 20 glass vials of 100 ml or 10, 12 and 50 polyolefin plastic bags of 100 ml with a plastic overpouch.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
United Kingdom
Accord Healthcare Limited
Sage House, 319 Pinner Road
---North Harrow, Middlesex, HA1 4HF-------■ United Kingdom
Malta
Accord Healthcare Ireland Limited
Euro House
Euro Business Park
Little Island
Cork T45 K857
Ireland
Manufacturer
Industria Farmaceutica Galenica Senese S.r.l.
Via Cassia Nord, 351, Monteroni d’Arbia (SI) 53014, Italy
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria Belgium Bulgaria Cyprus
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| Czech Paracetamol Accord Germany Paracetamol Accord 10 mg/ml Infusionslosung Croatia Paracetamol Accord 10 mg/ml otopina za infuziju Hungary Paracetamol Accord 10 mg/ml oldatos infuzio Ireland Paracetamol 10 mg/ml solution for infusion Malta Paracetamol 10 mg/ml solution for infusion Netherland Paracetamol Accord 10 mg/ml oplossing voor infusie Poland Paracetamol Accord Romania Paracetamol Accord 10 mg/ml solutie perfuzabila Slovenia Paracetamol Accord 10 mg/ml raztopina za infundiranje United Paracetamol 10 mg/ml solution for infusion Kingdom Spain Paracetamol Accord10 mg/ml solucion para perfusion Portugal Paracetamol Accord 10 mg/ml solupao para perfusao This leaflet was last revised in 03/2019. | ||||
| The following information is intended for healthcare professionals only: Below is a summary of the dosage, dilution, administration and storage details for Paracetamol 10 mg/ml solution for infusion. Reference should be made to the Summary of Product Characteristics for full prescribing information. Intravenous use. The product is restricted to adults, adolescents and children weighing more than 33 kg. Close monitoring is needed before the end of infusion. Dosage Dosing based on patient weight (please see the dosing table here below) | ||||
| Patient weight | Dose per administ ration | Volume per administ ration | Maximum volume of Paracetamol (10 mg/ml) per administration based on upper weight limits of group (ml) | Maximum Daily Dose |
| > 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 hepatotox icity | 1 g.--- | .100 ml_ | 100_ml_. | 3 g----- |
| >50 kg and no additional risk factors for hepatotox icity | 1 g | 100 ml | 100 ml | 4 g |
| Maximum daily dose: The maximum daily dose as presented in the table above is for patients that are not receiving other 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 millilitre (ml), which could result in accidental overdose and death. The paracetamol solution is administered in intravenous infusion over 15 minutes. | ||||