MIDAZOLAM

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

MIDAZOLAM

Dostupno od:

Accord Healthcare Limited

ATC koda:

N05CD08

INN (International ime):

MIDAZOLAM

Doziranje:

5 Mg/Ml

Farmaceutski oblik:

Solution for Injection

Tip recepta:

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

Područje terapije:

midazolam

Status autorizacije:

Marketed

Datum autorizacije:

2009-03-06

Uputa o lijeku

PATIENT INFORMATION LEAFLET
MIDAZOLAM 1 MG/ML SOLUTION FOR INJECTION OR INFUSION
MIDAZOLAM 5 MG/ML SOLUTION FOR INJECTION OR INFUSION
midazolam
Read all of this leaflet carefully before you start taking 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 doctor or your 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 side
effects, talk to your doctor or pharmacist or nurse. This includes any
possible side effects not
listed in this leaflet. See section 4
WHAT IS IN THIS LEAFLET:
1.
What midazolam is and what it is used for
2.
What you need to know before you take midazolam
3.
How to use midazolam
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 1 mg/ml & 5 mg/ml Solution for Injection or Infusion
contains Midazolam. Midazolam belongs to
a group of medicines known as benzodiazepines (sedatives).
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.
-
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 YOU TAKE MIDAZOLAM
DO NOT USE MIDAZOLAM

If you are allergic (hypersensitive) to midazolam, group of medicines
known as benzodiazepines or any
other ingridients in the midazolam solution for injection

If you have severe difficulties with your breathing and that you are
to undergo conscious sedation.
You must not be

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Midazolam 5 mg/ml Solution for Injection or Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for injection or infusion contains 5 mg of
midazolam (as Midazolam hydrochloride)
Excipient: Contains 1.96 mg sodium (as sodium chloride) per ml of
solution for injection or infusion.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for Injection or Infusion.
Clear,
colorless to pale yellow solution with a pH in the range of
2.9-3.7 and 170 mOsm/kg to 230 mOsm/kg
osmolality.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Midazolam is a short acting sleep-inducing active substance that is
indicated:
_In adults:_
CONSCIOUS SEDATION before and during diagnostic or therapeutic
procedures with or without local
anaesthesia.
ANAESTHESIA
–
Premedication before induction of anaesthesia
–
Induction of anaesthesia
–
As a sedative components in combined anaesthesia
SEDATION IN INTENSIVE CARE UNITS
_In children:_
CONSCIOUS SEDATION before and during diagnostic or therapeutic
procedures with or without local
anaesthesia.
ANAESTHESIA
–
Premedication before induction of anaesthesia
SEDATION IN INTENSIVE CARE UNITS
Presentations
1 ml
3 ml
10 ml
Amount of Midazolam
5 mg
15 mg
50 mg
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
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_1_
_9_
_/_
_0_
_7_
_/_
_2_
_0_
_1_
_8_
_C_
_R_
_N_
_ _
_2_
_2_
_0_
_6_
_1_
_9_
_9_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
4.2 POSOLOGY