Remifentanil 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:

Fresenius Kabi Deutschland GmbH

ATC code:

N01AH; N01AH06

INN (International Name):

Remifentanil

Dosage:

2 milligram(s)

Pharmaceutical form:

Powder for concentrate for solution for injection/infusion

Therapeutic area:

Opioid anesthetics; remifentanil

Authorization status:

Marketed

Authorization date:

2010-10-01

Patient Information leaflet

pil_ie_remifentanil-V22-March-2022-clean.docclean
Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
REMIFENTANIL KABI 1 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INJECTION OR INFUSION
REMIFENTANIL KABI 2 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INJECTION OR INFUSION
REMIFENTANIL KABI 5 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INJECTION OR INFUSION
Remifentanil
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.
-
If you get any 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 Kabi is and what it is used for
2.
What you need to know before you use Remifentanil Kabi
3.
How to use Remifentanil Kabi
4.
Possible side effects
5.
How to store Remifentanil Kabi
6.
Contents of the pack and other information
1.
WHAT REMIFENTANIL KABI IS AND WHAT IT IS USED FOR
Remifentanil Kabi contains a medicine called remifentanil. This
belongs to a group of
medicines known as opioids which are used to reduce pain. It differs
from other medicines in
this group by its very quick onset and very short duration of action.
-
Remifentanil Kabi may be used to stop you feeling pain before or while
you are having an
operation.
-
Remifentanil Kabi may be used to relieve pain while you are under
controlled mechanical
ventilation in an Intensive Care Unit (for patients 18 years of age
and over).
2.
WHAT YOU SHOULD KNOW BEFORE YOU USE REMIFENTANIL KABI
DO NOT USE REMIFENTANIL KABI
-
if you are allergic to remifentanil, fentanyl derivates (such as
alfentanil, fentanyl
sufentanil) or any of the other ingredients of this medicine (listed
in section 6).
-
as injection into the spinal canal
-
as sole medicine to initiate anaesthesia

If you are not sure if any of the above apply to you, talk to your
doctor, pharmacist or
nurse before you are

Summary of Product characteristics

Health Products Regulatory Authority
27 May 2022
CRN00CX7Q
Page 1 of 18
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
One vial contains remifentanil hydrocholoride equivalent to 2 mg
remifentanil.
Each ml of Remifentanil 2 mg powder for concentrate for solution for
injection or infusion contains 1 mg remifentanil when
reconstituted as directed.
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 or yellowish, compact 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 18 years of age and over.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
REMIFENTANIL 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 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 to minimise the potential dead
space (seesection 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).
Care should be taken to avoid obstruction or disconnection of infusion
lines and to adequately clear the lines to remove
residual remifentanil after u