Midazolam 1 mg/ml solution for injection/infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Midazolam

Available from:

Baxter Holding B.V.

ATC code:

N05CD; N05CD08

INN (International Name):

Midazolam

Dosage:

1 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection/infusion

Therapeutic area:

Benzodiazepine derivatives; midazolam

Authorization date:

2019-09-13

Patient Information leaflet

ARTWORK CODE : 1400007592
REF. CODE CREATION/BLOCKAGE NOTE:
“CONTROLLED COPY” HOLDER (1)
(2)
(3)
(4)
(5)
SIZE OF ARTWORK (IN MM) : 600X175
QUALITY OF PAPER/BOARD : SUPER SUN SHINE
GSM OF PAPER/BOARD : 60 GSM
QUALITY OF GUM :
BARCODE INFORMATION:
BARCODE SCAN REPORT:
PACKING: 5ML AMP
PLANT LOCATION : INJECTABLE
LANGUAGE : ENGLISH
COUNTRY: UNITED KINGDOM, IRELAND
ARTWORK REQ. NO: 25857
ARTWORK CONTROL KEY NO.:
COLOUR CODE :
BLACK
PANTONE
PANTONE
PANTONE
PANTONE
PANTONE
PANTONE
PANTONE
BAXTER PHARMACEUTICALS INDIA PRIVATE LIMITED
DATE: 28/08/19
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MIDAZOLAM 1 MG/ML SOLUTION FOR INJECTION/INFUSION
MIDAZOLAM (AS MIDAZOLAM HYDROCHLORIDE)
·
You are debilitated (have an illness that makes you feel very
weak, run down and short of energy).
If any of the above apply to you, or if you are not sure, talk to
your doctor or pharmacist or nurse before you are given
Midazolam.
·
Carbamazepine or phenytoin (these may be used for fits or
seizures)
OTHER MEDICINES AND MIDAZOLAM
Please tell your doctor or pharmacist or nurse if you are taking or
have recently taken any other medicines, including medicines
obtained without a prescription and herbal medicines.
ADULTS
·
You are pregnant or think you may be pregnant (see
'Pregnancy and breast-feeding').
·
Hypnotics (medicines to make you sleep)
In particular, tell your doctor or pharmacist or nurse if you are
taking any of the following medicines:
INTERACTIONS WITH OTHER MEDICINES
·
Children must be carefully monitored. For infants and babies
under 6 months this will include monitoring of breathing and
oxygen levels
Before Midazolam is given, let your doctor or pharmacist or
nurse know if:
·
You are over 60 years of age.
·
You regularly drink large amounts of alcohol or you have
had problems with alcohol use in the past.
·
It is particularly important to tell your doctor or pharmacist
or nurse if your child has cardiovascular disease (heart
problems). Your child will be carefully monitored and the
dose will be adjusted specially.
·

Summary of Product characteristics

Health Products Regulatory Authority
17 September 2019
CRN008LLK
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Midazolam 1 mg/ml solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains midazolam (as hydrochloride) 1 mg.
This medicine contains sodium. The sodium content is less than 1 mmol
(23 mg) per ampoule i.e sodium-free.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection/infusion
A clear, colourless to pale yellow solution, practically free from any
visible particles.
pH of the solution is between 2.90 and 3.70 and osmolality of the
solution should be 270 mOsmol/kg to 320 mOsmol/kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Midazolam is a short-acting sleep-inducing drug 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 component 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
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
STANDARD DOSAGE
Midazolam is a potent sedative agent that requires titration and slow
administration. Titration is strongly recommended to
safely obtain 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, dose should be determined with caution and
risk factors related to each patient should be taken into account.
Standard dosages are provided in the table below. Additional
details are provided in the text following the table.
INDICATION
ADULTS
<60
YEARS
ADULTS
≥
60
YEARS
/
DEBILITATED OR
CHRONICALLY ILL
CHILDREN