Safety Warning of accidental overdose reported in infants and children with intravenous paracetamol (Perflgan®)

2013-02-10

Dear Healthcare Provider :

Saudi Food and Drug Authority would like to draw the attention of healthcare professionals to the risk of accidental overdose in neonates and infants during treatment with intravenous paracetamol 10 mg/ml solution for infusion which is marketed in Saudi Arabia as PERFALGAN®; available in 100 ml vials. The warning of risk of overdose is based on information available from the company (Bristol Myers Squibb).

Perfalgan® can be indicated for the short-term treatment of moderate pain, especially following surgery, and for the short-term treatment of fever, when administration by intravenous use is clinically justified by an urgent need to treat pain or hyperthermia and/or when other routes of administration are not possible in children weighing less than 33 kg.

o Up to 31 March 2010, the company received 23 worldwide cases of intravenous paracetamol overdose had been reported in children aged less than 1 year old. One child subsequently died. 
o There are concerns regarding the possible confusion between the prescription of PERFALGAN® being issued in mg and then administered in ml.

With this in mind, we would like to remind you that the strength of PERFALGAN® solution for infusion is 10 mg paracetamol per 1 ml solution and encourage you to be extremely vigilant when prescribing and administering PERFALGAN® 10mg/ml solution for infusion to infants and children.

Posology information from the Summary of Product Characteristics (SmPC) is summarized below:

<table align="center" border="1" cellpadding="0" cellspacing="0" rules="all" width="520">
<tbody>
<tr>
<td valign="top" width="80">
 
</td>
<td valign="top" width="257">
Term newborn infants*, infants, toddlers and children weighing <10 kg (up to approx 1 year old) 
</td>
<td valign="top" width="282">
Children weighing >10 kg and <33 kg 
</td>
</tr>
<tr>
<td width="80">
Dose
</td>
<td width="257">
7.5 mg/kg per administration i.e. 0.75 ml solution per kg
</td>
<td width="282">
15 mg/kg per administration i.e. 1.5 ml solution per kg
</td>
</tr>
<tr>
<td width="80">
Dosing

schedule
</td>
<td width="257">
One IV infusion of 7.5mg/kg (0.75 ml

per kg) up to four times a day, with a

minimum interval of 4 hours between

each administration.
</td>
<td width="282">
One IV infusion of 15mg/kg (1.5 ml per

kg) up to four times a day with a minimum

interval of 4 hours between each

administration.
</td>
</tr>
<tr>
<td width="80">
Maximum

daily dose
</td>
<td width="257">
The maximum daily dose must not

exceed 30mg/kg.
</td>
<td width="282">
The maximum daily dose must not exceed

60mg/kg (without exceeding 2g)
</td>
</tr>
</tbody>
</table>

* Efficacy and safety data is not available for premature neonates.

An example dosing table is also provided below:

Example Dosing Table for PERFALGAN® for children weighing less than 33kg

<table align="center" border="1" cellpadding="0" cellspacing="0" rules="all" width="520">
<tbody>
<tr>
<td width="162">
Paracetamol (mg/kg) 
</td>
<td width="98">
Weight (kg) 
</td>
<td width="162">
Calculated Dose (mg) 
</td>
<td width="181">
Volume of solution (ml) 
</td>
</tr>
<tr>
<td rowspan="4" width="162">
7.5
</td>
<td width="98">
3
</td>
<td width="162">
22.5
</td>
<td width="181">
2.25
</td>
</tr>
<tr>
<td width="98">
5
</td>
<td width="162">
37.5
</td>
<td width="181">
3.75
</td>
</tr>
<tr>
<td width="98">
7
</td>
<td width="162">
52.5
</td>
<td width="181">
5.25
</td>
</tr>
<tr>
<td width="98">
10
</td>
<td width="162">
75
</td>
<td width="181">
7.5
</td>
</tr>
<tr>
<td width="162">
 
</td>
<td width="98">
 
</td>
<td width="162">
 
</td>
<td width="181">
 
</td>
</tr>
<tr>
<td rowspan="3" width="162">
15
</td>
<td width="98">
15
</td>
<td width="162">
225
</td>
<td width="181">
22.5
</td>
</tr>
<tr>
<td width="98">
20
</td>
<td width="162">
300
</td>
<td width="181">
30
</td>
</tr>
<tr>
<td width="98">
30
</td>
<td width="162">
450
</td>
<td width="181">
45
</td>
</tr>
</tbody>
</table>

Report Adverse Drug Reactions to the SFDA:

The SFDA urges both healthcare professionals and patients to report side effects or product quality issues to the SFDA either online, by regular mail or by fax, using the following contact information : 
National Pharmacovigilance Center (NPC) 
Saudi Food and Drug Authority-Drug sector 
3292 Northern Ring Road 
Al Nafal District 
Riyadh 13312 – 6288 
Kingdom of Saudi Arabia 
Email : 
Website:

An official government website affiliated with the Government of the Kingdom of Saudi Arabia.

Official Saudi government website domains end with gov.sa

Government websites use the protocol. HTTPS for encryption and security.

Registered with the Digital Government Authority under number:

Suggestions

Safety Warning of accidental overdose reported in infants and children with intravenous paracetamol (Perflgan®)

Safety Warning of accidental overdose reported in infants and children with intravenous paracetamol (Perflgan®)