Methoxyflurane Mundipharma 99.9%, 3 ml inhalation vapour, liquid

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Methoxyflurane

זמין מ:

Mundipharma Pharmaceuticals Limited

קוד ATC:

N02BG09

INN (שם בינלאומי):

Methoxyflurane

כמות:

99.9 %, 3 millilitre(s)

טופס פרצבטיות:

Inhalation vapour, liquid

סוג מרשם:

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

איזור תרפויטי:

methoxyflurane

מצב אישור:

Not marketed

תאריך אישור:

2019-02-15

עלון מידע

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
_METHOXYFLURANE MUNDIPHARMA_ 99.9%, 3 ML INHALATION VAPOUR, LIQUID
methoxyflurane
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects
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 healthcare professional.

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 side effects, talk to your healthcare professional.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What
_METHOXYFLURANE MUNDIPHARMA_
is and what it is used for
2.
What you need to know before you use
_METHOXYFLURANE MUNDIPHARMA_
3.
How to use
_METHOXYFLURANE MUNDIPHARMA_
4.
Possible side effects
5.
How to store
_METHOXYFLURANE MUNDIPHARMA_
6.
Contents of the pack and other information
1.
WHAT _METHOXYFLURANE MUNDIPHARMA_ IS AND WHAT IT IS USED FOR
_METHOXYFLURANE MUNDIPHARMA_
contains the active substance methoxyflurane. It is a medicine which
is used to reduce pain. It is inhaled through the custom-built
_METHOXYFLURANE MUNDIPHARMA _
Inhaler.
_METHOXYFLURANE MUNDIPHARMA_
is intended to reduce the severity of pain, rather than stop it
completely.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE _METHOXYFLURANE MUNDIPHARMA_
DO NOT USE _METHOXYFLURANE MUNDIPHARMA_ IF YOU:

are allergic to methoxyflurane, any inhalation anaesthetics or any of
the other ingredients of
this medicine (listed in section 6).

have a history or family history of malignant hyperthermia. Malignant
hyperthermia is a
condition where symptoms such as a very high fever, fast, irregular
heartbeat, muscle spasms
and breathing p

מאפייני מוצר

Health Products Regulatory Authority
29 September 2020
CRN009MMF
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
▼ This medicinal product is subject to additional monitoring. This
will allow quick identification of new safety information.
Healthcare professionals are asked to report any suspected adverse
reactions. See section 4.8 for how to report adverse
reactions.
1 NAME OF THE MEDICINAL PRODUCT
Methoxyflurane Mundipharma 99.9%, 3 ml inhalation vapour, liquid
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each bottle contains 3 ml of methoxyflurane 99.9%.
Excipients with known effect: Butylated hydroxytoluene (E321) (0.01%
w/w)
3 PHARMACEUTICAL FORM
Inhalation vapour, liquid.
Clear, almost colourless, volatile liquid, with a characteristic
fruity odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Emergency relief of moderate to severe pain in conscious adult
patients with trauma and associated pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Methoxyflurane Mundipharma should be self-administered under
supervision of a person trained in its administration, using
the hand held Methoxyflurane Mundipharma inhaler. It is inhaled
through the custom –built Methoxyflurane Mundipharma
inhaler.
Posology
Adults
_ _
One bottle of 3 ml Methoxyflurane Mundipharma as a single dose,
administered using the device provided. A second bottle
should only be used where needed.
The frequency at which Methoxyflurane Mundipharma can be safely used
is not established (see section 4.4). The following
administration schedule is recommended: no more than 6 ml in a single
day, administration on consecutive days is not
recommended, and the total dose to a patient in a week should not
exceed 15 ml.
Onset of pain relief is rapid and occurs after 6‑10 inhalations.
Patients should be instructed to inhale intermittently to achieve
adequate analgesia. Patients are able to assess their own level of
pain and titrate the amount of Methoxyflurane Mundipharma
inhaled for adequate pain control. Continuous inhalation of a bottle
containing 3 ml