Midazolam B. Braun 1mg/ml solution for injection/infusion (5ml amp)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MIDAZOLAM

Available from:

B Braun Melsungen AG Carl-Braun-Strasse 1, D34212 Melsungen, Germany

ATC code:

N05CD08

INN (International Name):

MIDAZOLAM 1 mg/ml

Pharmaceutical form:

SOLUTION FOR INJECTION/INFUSION

Composition:

MIDAZOLAM 1 mg/ml

Prescription type:

POM

Therapeutic area:

PSYCHOLEPTICS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2020-11-02

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MIDAZOLAM B. BRAUN 1 MG/ML SOLUTION FOR INJECTION/INFUSION
MIDAZOLAM
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 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.
WHAT IS IN THIS LEAFLET
1.
What Midazolam B. Braun is and what it is used for
2.
What you need to know before you use Midazolam B. Braun
3.
How to use Midazolam B. Braun
4.
Possible side effects
5
How to store Midazolam B. Braun
6.
Contents of the pack and other information
1.
WHAT MIDAZOLAM B. BRAUN IS AND WHAT IT IS USED FOR
Midazolam B. Braun 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.
Its active substance midazolam
belongs to a group of substances called benzodiazepines.
This medicine is used in adults:
•
as a general anaesthesia, to put you to sleep or keep you asleep
This medicine is also used in adults and children:
•
to induce a feeling of relaxation or sleepiness in intensive care.
This is known as “sedation”;
•
before and during a medical procedure or surgery. In this case,
patients stay awake but feel very
calm and sleepy. This is known as “conscious sedation”,
•
to induce a feeling of relaxation or sleepiness before an anaesthetic
is given.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MIDAZOLAM B. BRAUN
DO NOT USE MIDAZOLAM B. BRAUN:
•
if you are hypersensitive (allergic) to midazolam or to any of the
other ingredients of this
medicine (listed in section 6),
•
if you are allergic to benzodiazepine medicines, such as diazepam or
nitrazepam,
•
if you have severe breathing problems and you need midazolam for
conscious sedation.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharma

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Midazolam B. Braun 1 mg/ml solution for injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains
1 mg midazolam
(as midazolam hydrochloride, 1.112 mg)
Each ampoule of 5 ml contains
5 mg midazolam
(as midazolam hydrochloride, 5.56 mg)
Each bottle of 50 ml contains
50 mg midazolam
(as midazolam hydrochloride, 55.6 mg)
Each bottle of 100 ml contains
100 mg midazolam
(as midazolam hydrochloride, 111.2 mg)
Excipient with known effect: sodium 3.5 mg/ml
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection/infusion
Clear, colourless aqueous solution
pH: 2.9 to 3.7
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Midazolam B. Braun is a short-acting sleep-inducing medicinal product
that is indicated:
In adults:
_ _
●
CONSCIOUS SEDATION
before and during diagnostic or therapeutic procedures with or without
local anaesthesia
●
GENERAL ANAESTHESIA
–
premedication before induction of general anaesthesia
–
induction of general 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
●
GENERAL ANAESTHESIA
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premedication before induction of general anaesthesia
●
SEDATION IN INTENSIVE CARE UNITS
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Standard posology
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 th