PROPOFOL HOSPIRA 1 %w/v Emulsion for Inj/Inf

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

PROPOFOL

제공처:

Hospira UK Limited

ATC 코드:

N01AX10

INN (International Name):

PROPOFOL

복용량:

1 %w/v

약제 형태:

Emulsion for Inj/Inf

처방전 유형:

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

치료 영역:

Other general anesthetics

승인 상태:

Authorised

승인 날짜:

2014-12-05

환자 정보 전단

Page 1 of 9
PFLEET 2016-0022545
PACKAGE LEAFLET: INFORMATION FOR THE USER
REMIFENTANIL 1 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INJECTION/INFUSION
REMIFENTANIL 2 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INJECTION/INFUSION
REMIFENTANIL 5 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INJECTION/INFUSION
Remifentanil
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT IMFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor,
pharmacist or nurse.
-
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, pharmacist or
nurse. This includes any 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 use Remifentanil
3.
How to use Remifentanil
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
belongs to a group called opioids. It differs from other medicines in
this group by its very
quick onset and very short duration of action.
-
Remifentanil may be used to stop you feeling pain before or while you
are having an operation.
-
Remifentanil 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 NEED TO KNOW BEFORE YOU USE REMIFENTANIL
DO NOT USE REMIFENTANIL
-
if you are allergic (hypersensitive) to remifentanil, any of the other
ingredients of this medicine
(see list of ingredients in Section 6) or fentanyl derivates (such as
alfentanil, fentanyl, sufentanil).
An allergic reaction may include rash, itching, difficulty of
breathing or swelling of the face, lips,
throat or tongue. You may know this from earlier experience
-
as injection i

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Propofol Hospira 1% w/v emulsion for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of emulsion for injection/infusion contains 10 mg of propofol.
Each 20 ml vial contains 200 mg of propofol.
Each 50 ml vial contains 500 mg of propofol.
Each 100 ml vial contains 1000 mg of propofol.
Excipient with known effect:
Each ml of emulsion for injection/infusion contains 100 mg of
soya-bean oil and approximately 0.016 mmol (0.4 mg)
of sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Emulsion for Injection /Infusion.
White or slightly off-white emulsion, having a milk-like appearance
with no evidence of oiling-out of the emulsion and
free from visible particulate.
pH: 6.0 - 8.5
Osmolality: 300-330 mOsm/kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Propofol Hospira 1% w/v is a short-acting intravenous general
anaesthetic for:
Induction and maintenance of general anaesthesia in adults and
children over 1 month.
Sedation for diagnostic and surgical procedures, alone or in
combination with local or regional anaesthesia in
adults and children over 1 month.
Sedation of ventilated patients over 16 years of age in the intensive
care unit.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Lower doses of propofol may be necessary when general anaesthesia is
used in addition to regional anaesthesia.
Posology
ADULTS
_Induction of General Anaesthesia_
In un-premedicated and premedicated patients, it is recommended that
propofol should be titrated (approximately 4 ml
[40 mg] every 10 seconds in an average healthy adult by bolus
injection or infusion) against the response of the patient
until the clinical signs show the onset of anaesthesia. Most adult
patients aged less than 55 years are likely to require
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
__