Midazolam 5 mg/ml Solution for injection or infusion

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

MIDAZOLAM HYDROCHLORIDE

Tersedia dari:

Martindale Pharmaceuticals Ltd

Kode ATC:

N05CD; N05CD08

INN (Nama Internasional):

MIDAZOLAM HYDROCHLORIDE

Dosis:

5 milligram(s)/millilitre

Bentuk farmasi:

Solution for injection/infusion

Jenis Resep:

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

Area terapi:

Benzodiazepine derivatives; midazolam

Status otorisasi:

Not marketed

Tanggal Otorisasi:

2011-01-14

Selebaran informasi

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Midazolam 5 mg/ml Solution for injection or infusion
Midazolam (as Midazolam Hydrocloride)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFOMRAITON 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 or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
IN THIS LEAFLET:
1.
What Midazolam is and what it is used for
2.
What you need to know before Midazolam is given
3.
How Midazolam will be given
4.
Possible side effects
5.
How to store Midazolam
6.
Contents of the pack and other information
1.
WHAT MIDAZOLAM IS AND WHAT IT IS USED FOR
Midazolam belongs to a group of medicines known as benzodiazepines. It
is a short-acting medicine that is
used to induce sedation (a very relaxed state of calm, drowsiness or
sleep) and relieves anxiety and muscle
tension.
This medicine is used for:
· Conscious sedation (an awake but very relaxed state of calm or
drowsiness during a medical test or
procedure) in adults and children.
· Sedation of adults and children, in intensive care units.
· Anaesthesia in adults, used alone or with other medicines.
· Premedication (medicine used to cause relaxation, calm and
drowsiness before an anaesthetic) in adults and
children
2.
WHAT YOU NEED TO KNOW BEFORE MIDAZOLAM IS GIVEN
YOU SHOULD NOT BE GIVEN MIDAZOLAM IF:
-
you are allergic (hypersensitive) to Midazolam hydrochloride or any of
the other ingredients in this
medicine (listed in section 6).
-
you are allergic to other benzodiazepine medicines, such as diazepam
or nitrazepam.
-
you have severe breathing
problems and you are going to have Midazolam for conscious sedation.
You must not be given Midazolam if any of the above apply to you. If
you are not sure, talk to your
doctor or nurse before you are given this medicine.
TAKE SPECIAL CARE WITH MIDAZOLAM
CHILDREN AND B

Karakteristik produk

Health Products Regulatory Authority
24 September 2019
CRN008MQ1
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Midazolam 5 mg/ml Solution for injection or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: midazolam as hydrochloride.
Ampoules 5mg/ml; for IV., IM and rectal administration.
Each ml of solution for injection or infusion contains 5mg midazolam
(as the hydrochloride).
Each 2ml of solution for injection or infusion contains 10mg midazolam
(as the hydrochloride).
Each 5ml of solution for injection or infusion contains 25mg midazolam
(as the hydrochloride).
Excipient(s) with known effect:
Sodium 1.97 mg/ml.
For a full list of Excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection or infusion.
Clear, colourless solution.
pH 2.9-3.7
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Midazolam Solution for Injection or Infusion 5 mg/ml is a short-acting
sedative and sleep-inducing drug. The indications are as
follows:
In adults and children

Conscious sedation before and during diagnostic or therapeutic
procedures with or without local anaesthesia,

Premedication before induction of anaesthesia,

Sedation in Intensive Care Units.
In adults

Induction of anaesthesia,

As an induction agent or as a sedative component in combined
anaesthesia
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Midazolam is a potent sedative that requires dose titration and slow
administration. Dose titration is required to optimize
safety whilst achieving the desired level of sedation according to the
clinical need, physical status, age and concomitant
medication. In adults over 60 years, debilitated or chronically ill
patients and paediatric patients, the dose should be
determined with caution and risk factors related to each patient
should be taken into account. Standard dosages are shown in
the table below; additional details are provided in the text following
the table.
Standard Dosage:
INDICATION
ADULTS<60 YEARS
ADULTS 60
YEARS+/DEBILITATED
OR SE