Patient Leaflet Updated 19-May-2021 | Bristol Myers Squibb Pharmaceuticals limited
Perfalgan 10mg/ml Solution for Infusion
Perfalgan 10 mg/ml, solution for infusion
Paracetamol
1. What PERFALGAN 10 mg/ml, solution for infusion is and what it is used for
2. Before you use PERFALGAN 10 mg/ml, solution for infusion
3. How to use PERFALGAN 10 mg/ml, solution for infusion
4. Possible side effects
5. How to store PERFALGAN 10 mg/ml, solution for infusion
6. Further information
This medicine is an analgesic (it relieves pain) and an antipyretic (it lowers fever).
The 100 ml vial is restricted to adults, adolescents and children weighing more than 33 kg.
The 50 ml vial is adapted to term newborn infants, infants, toddlers and children weighing less than 33 kg.
It is indicated for the short-term treatment of moderate pain, especially following surgery, and for the short-term treatment of fever.
Inform your doctor before treatment if any of the above mentioned conditions apply to you.
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 paracetamol or propacetamol.
A dose reduction should be considered for concomitant treatment with Probenecid.
Please inform your doctor or pharmacist if you are taking oral anticoagulants. Closer check-ups of the effect of the anticoagulant might be necessary.
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Pregnancy
Inform your doctor if you are pregnant. PERFALGAN may be used during pregnancy. However, in this case the doctor must evaluate if the treatment is advisable.
Ask your doctor or pharmacist for advice before taking any medicine.
Breast-feeding
PERFALGAN may be used during breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
This medicinal product contains less than 1 mmol sodium (23mg) per 100 ml of Perfalgan, i.e. essentially "sodium free".
You should not be given more medicine than the label says. Do not exceed the stated dose.
Intravenous use.
Perfalgan will be administered to you by a healthcare professional by infusion into one of your veins.
The dose will be individually adjusted by your doctor, based on your weight and general condition.
The 100 ml vial is restricted to adults, adolescents and children weighing more than 33 kg.
The 50 ml vial is adapted to term newborn infants, infants, toddlers and children weighing less than 33 kg.
Dosing based on patient weight (please see the dosing below)
If your body weight is ≤10 kg* the following dosing will apply:
Dose per administration - 7.5 mg/kg
Volume per administration - 0.75 mL/kg
**Maximum volume of Perfalgan (10 mg/mL) per administration based on upper weight limits of group (mL) - 7.5mL
***Maximum Daily Dose - 30 mg/kg
If your body weight is > 10 kg to ≤33kg the following dosing will apply:
Dose per administration - 15 mg/kg
Volume per administration - 1.5 mL/kg
**Maximum volume of Perfalgan (10 mg/mL) per administration based on upper weight limits of group (mL) - 49.5mL
***Maximum Daily Dose - 60mg/kg not exceeding 2g
If your body weight is > 33 kg to ≤50kg the following dosing will apply:
Dose per administration - 15 mg/kg
Volume per administration - 1.5mL/kg
**Maximum volume of Perfalgan (10 mg/mL) per administration based on upper weight limits of group (mL) - 75 mL
***Maximum Daily Dose - 60mg/kg not exceeding 3g
If your body weight is >50kg with additional risk factors for hepatotoxicity the following dosing will apply:
Dose per administration - 1g
Volume per administration - 100mL
**Maximum volume of Perfalgan (10 mg/mL) per administration based on upper weight limits of group (mL) - 100mL
***Maximum Daily Dose - 3g
If your body weight is >50kg and no additional risk factors for hepatotoxicity the following dosing will apply:
Dose per administration - 1g
Volume per administration - 100mL
**Maximum volume of Perfalgan (10 mg/mL) per administration based on upper weight limits of group (mL) - 100mL
***Maximum Daily Dose - 4g
* Pre-term newborn infants: No safety and efficacy data are available for pre-term newborn.
**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.
*** 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.
If you have the impression that the effect of PERFALGAN 10 mg/ml, solution for infusion is too strong or too weak, talk to your doctor.
If you or your child use more PERFALGAN 10mg/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 delayed, serious liver damage.
In overdose cases, symptoms generally appear within the first 24 hours and comprise: nausea, vomiting, anorexia, 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.
Like all medicines, PERFALGAN 10 mg/ml, solution for infusion can cause side effects, although not everybody gets them.
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
Keep out of the reach and sight of children.
Do not use PERFALGAN 10 mg/ml, solution for infusion 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 50ml vial, after dilution in 0.9% sodium chloride or 5% glucose: do not store for more than 1 hour (infusion time included).
Before administration, the product should be inspected visually. Do not use PERFALGAN if you notice any particulate matter and discoloration.
For single use only. The product should be used immediately after opening. Any unused solution should be discarded.
Vials of 50 ml and 100 ml
PERFALGAN 10 mg/ml solution for infusion is a clear and slightly yellowish solution.
PERFALGAN 10 mg/ml solution for infusion vials are supplied in packs of 12 vials.
Not all pack sizes or presentation may be marketed.
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This medicinal product is authorised in the Member States of the EEA under the following names:
France: PERFALGAN
Italy: PERFALGAN
U.K.: PERFALGAN 10 mg/ml
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in May 2021.
Bristol-Myers Squibb, ARC Uxbridge, Sanderson Road, New Denham, Denham, Buckinghamshire, UB8 1DH, UK
https://www.bmsmedinfo.co.uk/
+44 (0)1895 523 000
+44 (0) 800 731 1736
