Piramal Sevoflurane

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Sevoflurane 100%{vol}

Available from:

Device Technologies New Zealand

INN (International Name):

Sevoflurane 100% v/v

Dosage:

100% v/v

Pharmaceutical form:

Volatile liquid for inhalation

Composition:

Active: Sevoflurane 100%{vol}

Prescription type:

Prescription

Manufactured by:

Piramal Critical Care Inc

Therapeutic indications:

Piramal Sevoflurane may be used for the induction and maintenance of general anaesthesia in adult and paediatric patients undergoing surgery.

Product summary:

Package - Contents - Shelf Life: Bottle, glass, multi-unit self-sealing HDPE/EPDM valve with stainless steel spring attached with Al crimp ring - 250 mL - 60 months from date of manufacture stored at or below 25°C - Bottle, glass, Type III Amber Coloured - 250 mL - 60 months from date of manufacture stored at or below 25°C

Authorization date:

2014-09-11

Patient Information leaflet

Piramal Sevoflurane New Zealand CMI
Version 03 – 16 March 2015
Page
1 of 2
PIRAMAL SEVOFLURANE
_SEVOFLURANE _
_ _
Liquid for inhalation, anaesthetic 100% v/v bottle CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This leaflet answers some
common questions about Piramal
Sevoflurane.
It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits
.
Your doctor has
weighed the risks of you taking
Piramal Sevoflurane against the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET. You may need
to read it again.
WHAT PIRAMAL
SEVOFLURANE IS USED
FOR?
Piramal Sevoflurane belongs to a
group of medicines called
halogenated anaesthetic agents,
which are breathed in to induce
and/or maintain anaesthesia.
This medicine is administered by
an anaesthetist in the air you
breathe when you go for surgery. It
is a colourless liquid supplied in a
glass bottle. It is given by your
anaesthetist using a vaporiser,
which turns the liquid into a gas so
that you can breathe it in.
Piramal Sevoflurane is used for
inducing and maintaining heavy
sleep needed during surgery. The
medicine produces loss of
consciousness and pain
sensations during surgery.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU
.
BEFORE YOU RECEIVE
PIRAMAL SEVOFLURANE
_BEFORE YOU ARE DUE TO _
_RECEIVE PIRAMAL _
_SEVOFLURANE_
YOU MUST TELL YOUR DOCTOR IF:
1. YOU HAVE PREVIOUSLY HAD
ANY PROBLEMS WITH A GENERAL
ANAESTHETIC.
2. YOU OR ANYONE IN YOUR
FAMILY HAS MALIGNANT
HYPERTHERMIA (A RARE TYPE OF
SEVERE FEVER).
3. YOU HAVE RECENTLY HAD ANY
OTHER GENERAL ANAESTHETIC, OR
HAD MORE THAN ONE GENERAL
ANAESTHETIC OVER A SHORT
PERIOD OF TIME
4. YOU HAVE HAD PIRAMAL
SEVOFLURANE BEFORE AND
EXPERIENCED AN ALLERGIC
REACTION.
5. YOU HAVE OR HAVE HAD THE
FOLLOWING MEDICAL
CONDITIONS:

Any problems with your
liver including hepatitis

Growths

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Piramal Sevoflurane NZ Data Sheet
VERSION 6, 10
th
November 2020
Page 1 of 15
1 PRODUCT NAME
Piramal Sevoflurane Liquid for Inhalation 100 % v/v
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 250 mL bottle contains sevoflurane 100 % v/v.
3 PHARMACEUTICAL FORM
Sevoflurane is a fluorinated derivative of methyl isopropyl ether. The
chemical name is fluoromethyl
2, 2, 2-trifluoro-1-(trifluoromethyl) ethyl ether.
The structural formula is:
Molecular weight: 200.05
CAS Number: 28523-86-6
Sevoflurane is a non-flammable and non-explosive liquid administered
by vaporisation. Piramal
Sevoflurane is a clear, colourless, non-pungent and stable liquid. Not
more than 130ppm of water is
present to provide protection from environmental Lewis acids. No other
additives or chemical
stabilisers are used. It is miscible with ethanol, ether, chloroform
and petroleum benzene and is
slightly soluble in water. Some physical constants of the compound
are:
Distribution Partition Coefficients at 37

C:
Blood / Gas
0.63 - 0.69
Water / Gas
0.36
Olive Oil / Gas
47.2 - 53.9
Brain / Gas
1.15
Mean Component / Gas Partition Coefficient at 25

C:
Conductive rubber
14.0
Butyl rubber
7.7
Polyvinyl chloride
17.4
Polyethylene
1.3
Specific gravity at 20

C
1.520 - 1.525
Boiling point (760 mmHg)
58.6

C
Vapour pressure in mmHg
157 mmHg at 20

C
197mmHg at 25

C
317mmHg at 36

C
CF
3
CF
3
H-C-OCH
2
F
NEW ZEALAND DATA SHEET
Piramal Sevoflurane NZ Data Sheet
VERSION 6, 10
th
November 2020
Page 2 of 15
Sevoflurane is non-flammable and non-explosive as defined by the
requirements of International
Electrotechnical Commission 601-2-13.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
Piramal Sevoflurane may be used for induction and maintenance of
general anaesthesia in adult and
paediatric patients undergoing surgery.
4.2
Dose and method of administration
The concentration of sevoflurane being delivered from a vaporiser
during anaesthesia should be
known. This may be accomplished by using a vaporiser calibrated
sp