Remifentanil 2 mg powder for concentrate for solution for injection or infusion

Држава: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Remifentanil hydrochloride

Доступно од:

Pinewood Laboratories Ltd,

АТЦ код:

N01AH; N01AH06

INN (Међународно име):

Remifentanil hydrochloride

Дозирање:

2 milligram(s)

Фармацеутски облик:

Powder for concentrate for solution for injection/infusion

Терапеутска област:

Opioid anesthetics; remifentanil

Статус ауторизације:

Marketed

Датум одобрења:

2010-10-08

Информативни летак

PACKAGE LEAFLET: INFORMATION FOR THE USER
REMIFENTANIL 1 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION OR
INFUSION
REMIFENTANIL 2 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION OR
INFUSION
REMIFENTANIL 5 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION OR
INFUSION
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.
-
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 of the side effects talk to your doctor. This includes
any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Remifentanil is and what it is used for
2. What you need to know before you are given Remifentanil
3. How Remifentanil is given
4. Possible side effects
5. How to store Remifentanil
6. Contents of the pack and any other information
1. WHAT REMIFENTANIL IS AND WHAT IT IS USED FOR
Remifentanil belongs to a group of medicines known as opioids. These
medicines are used widely to
cause anaesthesia and or/ to relieve pain during an operation.
Remifentanil is used:
• as an analgesic, which helps to relieve pain, for use at the onset
or during anaesthesia in conjunction
with anaesthetic agents
• as an analgesic for patients 18 years of age or older who are
mechanically ventilated in the intensive
care unit.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN REMIFENTANIL
REMIFENTANIL MUST NOT BE GIVEN
- if you are allergic to Remifentanil or any of the other ingredients
of this medicine (listed in section 6).
- if you are allergic to any medicine used in operations or if you had
a side effect during an operation.
- Remifentanil must not be administered by epidural or intrathecal
injection, because this medicine
contains glycine.
- as sole medicine to initiate anaesthesia.
WARNINGS AND PRECAUTIONS
Tell y

Карактеристике производа

Health Products Regulatory Authority
24 May 2022
CRN00CXJ8
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Remifentanil 2 mg powder for concentrate for solution for injection or
infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Remifentanil 2 mg powder for concentrate for solution for injection or
infusion
1 vial contains 2 mg remifentanil (as remifentanil hydrochloride).
After reconstitution the solution contains 1 mg/ml, if prepared as
recommended (see section 6.6).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for concentrate for solution for injection or infusion.
White to off white, powder
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Remifentanil is indicated as an analgesic agent for use during
induction and/or maintenance of general anaesthesia.
Remifentanil is indicated for provision of analgesia in mechanically
ventilated intensive care patients of 18 years of age and
over.
This medicinal product is exclusive for hospital use.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
REMIFENTANIL SHALL BE ADMINISTERED ONLY IN A SETTING FULLY EQUIPPED
FOR THE MONITORING AND SUPPORT OF RESPIRATORY AND
CARDIOVASCULAR FUNCTION, AND BY PERSONS SPECIFICALLY TRAINED IN THE
USE OF ANAESTHETIC DRUGS AND THE RECOGNITION AND
MANAGEMENT OF THE EXPECTED ADVERSE EFFECTS OF POTENT OPIOIDS,
INCLUDING RESPIRATORY AND CARDIAC RESUSCITATION. SUCH
TRAINING MUST INCLUDE THE ESTABLISHMENT AND MAINTENANCE OF A PATENT
AIRWAY AND ASSISTED VENTILATION.
Continuous infusions of remifentanil must be administered by a
calibrated infusion device into a fast flowing IV line or via a
dedicated IV line. This infusion line should be connected at, or close
to, the venous cannula and primed to minimise the
potential dead space (see section 6.6 for additional information,
including tables with examples of infusion rates by body
weight to help titrate remifentanil to the patient’s anaesthetic
needs).
Remifentanil may be given by target controlled infusion (TCI) with an
approved infusi