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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Remifentanil

Available from:

Noridem Enterprises Limited

ATC code:

N01AH; N01AH06

INN (International Name):

Remifentanil

Dosage:

2 milligram(s)

Pharmaceutical form:

Powder for concentrate for solution for injection/infusion

Prescription type:

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

Therapeutic area:

Opioid anesthetics; remifentanil

Authorization status:

Marketed

Authorization date:

2011-12-21

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
REMIFENTANIL NORIDEM 1 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INJECTION OR INFUSION
REMIFENTANIL NORIDEM 2 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INJECTION OR INFUSION
REMIFENTANIL NORIDEM 5 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INJECTION OR INFUSION
REMIFENTANIL HYDROCHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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, pharmacist or
nurse.

If you get any side effects talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
See section 4.
THE NAME OF YOUR MEDICINE IS REMIFENTANIL NORIDEM 1 MG, 2 MG, 5 MG
POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION OR INFUSION
_In the rest of this leaflet Remifentanil Noridem 1 m, 2 mg, 5 mg
Powder for Concentrate for Solution for Injection or Infusion is
called Remifentanil. _
_ _
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 other information
1.
WHAT REMIFENTANIL IS AND WHAT IT IS USED FOR
Remifentanil contains a medicine called remifentanil. This belongs to
a group of medicines known as opioids.
Remifentanil is used together with other medicines called
anaesthetics:

to help put you to sleep BEFORE an operation

to keep you asleep and stop you feeling pain DURING an operation

to make you feel sleepy and stop you feeling pain while you receive
treatment in an Intensive Care Unit.

2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN REMIFENTANIL
DO NOT HAVE REMIFENTANIL IF:

you are allergic (hypersensitive) to remifentanil or any of the other
ingredients of Remifentanil (listed in section 6)

you are allergic (hypersensitive) to any other pain-relieving
medicines which

Summary of Product characteristics

Health Products Regulatory Authority
14 June 2022
CRN00CYMH
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Remifentanil Noridem 2 mg powder for concentrate for solution for
injection or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
When reconstituted as directed, solutions of Remifentanil Noridem are
clear and colourless and contain 1mg/mL of
remifentanil base as remifentanil hydrochloride.
Remifentanil Noridem 2 mg is available in glass vials containing 2 mg
of remifentanil base.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for concentrate for solution for injection or infusion
Sterile, endotoxin-free, preservative-free, white to off white,
lyophilized powder, to be reconstituted before intravenous (IV)
administration.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Remifentanil Noridem is indicated as an analgesic agent for use during
induction and/or maintenance of general anaesthesia,
under close supervision.
Remifentanil Noridem is indicated for provision of analgesia and
sedation in mechanically ventilated intensive care patients 18
years of age and over.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
REMIFENTANIL NORIDEM SHOULD 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 Noridem 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 he