Lapainol 10 mg/ml solution for injection

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Nalbuphine hydrochloride

Tilgjengelig fra:

Orpha-Devel Handels und Vertriebs GmbH

ATC-kode:

N02AF; N02AF02

INN (International Name):

Nalbuphine hydrochloride

Dosering :

10 milligram(s)/millilitre

Legemiddelform:

Solution for injection

Resept typen:

Product subject to prescription which may not be renewed (A)

Terapeutisk område:

Morphinan derivatives; nalbuphine

Autorisasjon status:

Not marketed

Autorisasjon dato:

2007-08-03

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
LAPAINOL 10 MG/ML SOLUTION FOR INJECTION
nalbuphine hydrochloride
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 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.
WHAT IS IN THIS LEAFLET
:
1.
WHAT LAPAINOL 10 MG/ML SOLUTION FOR INJECTION IS AND WHAT IT IS USED
FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LAPAINOL 10 MG/ML SOLUTION FOR
INJECTION
3.
HOW TO USE LAPAINOL 10 MG/ML SOLUTION FOR INJECTION
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE LAPAINOL 10 MG/ML SOLUTION FOR INJECTION
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT LAPAINOL 10 MG/ML SOLUTION FOR INJECTION IS AND WHAT IT IS USED
FOR
LAPAINOL 10 mg/ml solution for injection is a medicinal product that
belongs to a group of pain killers
(analgesics) with opioid properties.
It is used for short-term treatment of moderate to severe pain. It can
also be used before or after an
operation.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LAPAINOL 10 MG/ML SOLUTION FOR
INJECTION
DO NOT USE LAPAINOL 10 MG/ML SOLUTION FOR INJECTION
-
if you are allergic to nalbuphine hydrochloride or any of the other
ingredients of this medicine (listed
in section 6)
- if you have severe renal impairment
- if you have hepatic impairment
- if you use other opioids
WARNINGS AND PRECAUTIONS
TAKE SPECIAL CARE WITH LAPAINOL 10 MG/ML SOLUTION FOR INJECTION
-
if you suffer from head injury, inner head injury or already existing
increased intracranial pressure,
LAPAINOL 10 mg/ml solution for injection might intensify this. It is
also possible that the use of
LAPAINOL 10 mg/ml solution for injection in patients with

Preparatomtale

Health Products Regulatory Authority
30 April 2020
CRN009JCY
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lapainol 10 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injection contains 10 mg nalbuphine hydrochloride.
1 ampoule of 2 ml contains 20 mg nalbuphine hydrochloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
The solution is clear and colourless, pH = 3.0-4.2, osmolality = 0.3
Osmol/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lapainol 10 mg/ml solution for injection is indicated for the
short-term relief of moderate to severe pain. It can also be used for
pre- and postoperative analgesia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults
The usual recommended dose for adults is 10 - 20 mg for patients with
70 kg body weight, which is equivalent to 0.1 – 0.3
mg/kg body weight. This dose may be administered intravenously,
intramuscularly or subcutaneously and may be repeated
after 3 to 6 hours, if necessary. The maximum single dose in adults
must not exceed 20 mg. The posology must be adapted to
the intensity of pain and the physical status of the patient.
Children and adolescents
The usual recommended dose for children is 0,1 - 0,2 mg/kg body
weight. This dose may be administered intravenously,
intramuscularly or subcutaneously. Intramuscular as well as
subcutaneous administration might be painful and should be
avoided in children.
The dose may be repeated after 3 to 6 hours, if necessary. The single
maximum dose is fixed with 0,2 mg nalbuphine
hydrochloride per kilogram body weight.
There are no adequate data for the treatment of children younger than
1.5 years.
Elderly people
Due to increased bioavailability and decreased systemic clearance it
is suggested to start with the lowest dose of nalbuphine
hydrochloride.
Patients with hepatic / renal impairment
Patients with moderate and mild renal impairment may show an abnormal
reaction upon standard dosages. Therefore, t