Midazolam Viatris

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Midazolam 1 mg/mL;  

Available from:

Viatris Limited

INN (International Name):

Midazolam 1 mg/mL

Dosage:

1 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Midazolam 1 mg/mL   Excipient: Hydrochloric acid Sodium chloride Sodium hydroxide Water for injection

Units in package:

Ampoule, glass, 5 mL, type I, clear, colourless, with coloured break, 5 dose units

Class:

Class C5 Controlled Drug

Prescription type:

Class C5 Controlled Drug

Manufactured by:

Cambrex Profarmaco Milano Srl

Therapeutic indications:

Conscious sedation before diagnostic or surgical interventions carried out under local anaesthesia (intravenous administration), or in children intranasal or oral administration. Long-term sedation in intensive care units (intravenous administration as bolus injection or continuous infusion).

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, 5 mL, type I, clear, colourless, with coloured break - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light - Ampoule, glass, 5 mL, type I, clear, colourless, with one-point cut - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light - Ampoule, glass, 5 mL, type I, clear, colourless, with one-point cut - 10 dose units - 36 months from date of manufacture stored at or below 25°C protect from light - Ampoule, glass, 5 mL, type I, clear, colourless, with coloured break - 10 dose units - 36 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

2010-12-10

Patient Information leaflet

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
MIDAZOLAM VIATRIS
_MIDAZOLAM 1 MG/ML AND 5 MG/ML AMPOULES_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about MIDAZOLAM
VIATRIS.
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 MIDAZOLAM
VIATRIS against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET. You may need to
read it again.
WHAT MIDAZOLAM
VIATRIS IS USED FOR
MIDAZOLAM VIATRIS is used for
the following_._

may be given as a sedative
during some short medical
procedures.

may be given before an
operation to produce
sleepiness or drowsiness
and to relieve anxiety. It
may also be used in
combination with other
anaesthetic agents to keep
you asleep during an
operation.

If you are in an intensive
care unit, you may receive
MIDAZOLAM VIATRIS as a
sedative.
This medicine belongs to a group of
medicines called benzodiazepines.
They are thought to work by their
action on brain chemicals.
MIDAZOLAM VIATRIS can cause
sedation (sleepiness), short term
amnesia (no memory of events
around the time you are given
MIDAZOLAM VIATRIS, and/or
anaesthesia (heavy sleep for
surgery) depending on the dose you
are given.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU ARE GIVEN
MIDAZOLAM
VIATRIS
_WHEN YOU MUST NOT USE _
_IT_
DO NOT HAVE MIDAZOLAM
VIATRIS IF YOU HAVE AN ALLERGY TO:

any medicine containing
midazolam or any other
benzodiazepine medicine.

any of the ingredients listed
at the end of this leaflet.

Some of the symptoms of
an allergic reaction may
include: shortness of
breath; wheezing or
difficulty breathing; swelling
of the face, lips, tongu

Summary of Product characteristics

Page 1 of 22
NEW ZEALAND DATA SHEET
MIDAZOLAM VIATRIS
1. PRODUCT NAME
Midazolam Viatris, 1 mg/mL or 5 mg/mL, ampoules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule contains 1 mg/mL or 5 mg/mL of midazolam
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Midazolam Viatris solution for injection is a clear, colourless
solution, packaged in a clear colourless
ampoule.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Premedication before induction of anaesthesia (intramuscular or,
especially in children, rectal,
intranasal or oral administration).
Conscious sedation before diagnostic or surgical interventions carried
out under local anaesthesia
(intravenous administration), or in children intranasal or oral
administration.
Long-term sedation in intensive care units (intravenous administration
as bolus injection or
continuous infusion).
Induction and maintenance of anaesthesia. As an induction agent in
inhalation anaesthesia or a
sleep-inducing
component
in
combined
anaesthesia,
including
total
intravenous
anaesthesia
(intravenous injection, intravenous infusion).
Ataralgesia in combination with ketamine in children (intramuscular
administration).
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
This product is for single patient use only. Use once and discard any
residue.
In the case of elderly patients with organic cerebral changes or
impaired cardiac and respiratory
function, the dosage should be determined with caution, the special
factors relating to each patient
being taken into consideration.
Initial and subsequent intravenous injections must be given slowly
(approximately 2.5 mg in 10
seconds for induction of anaesthesia and 1 mg in 30 seconds for
conscious sedation). The medicine
takes effect about two minutes after the injection is started. Dosage
should be individualised.
Page 2 of 22
PREMEDICATION BEFORE AN OPERATION
_INTRAMUSCULAR ADMINISTRATION_
In patients suffering from pain before an intervention.
Administration alone or in combination with anticholinergics and
poss