Midazolam 100mg/50ml solution for infusion vials

Pajjiż: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Midazolam hydrochloride

Disponibbli minn:

hameln pharma Ltd

Kodiċi ATC:

N05CD08

INN (Isem Internazzjonali):

Midazolam hydrochloride

Dożaġġ:

2mg/1ml

Għamla farmaċewtika:

Solution for infusion

Rotta amministrattiva:

Intravenous; Rectal; Intramuscular

Klassi:

Schedule 3 (CD No Register Exempt Safe Custody)

Tip ta 'preskrizzjoni:

Valid as a prescribable product

Sommarju tal-prodott:

BNF: 15010401; GTIN: 5016386005510

Fuljett ta 'informazzjoni

Midazolam
WHAT IS IN THIS LEAFLET
1. What Midazolam is and what it is used for
2. What you need to know before you use 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
belongs
to
a
group
of
medicines
called
‘benzodiazepines’. Midazolam works quickly to make
you feel sleepy or to put you to sleep. It also makes you
calm and relaxes your muscles.
MIDAZOLAM IS USED IN ADULTS:
• as a general anaesthetic to put them to sleep or to keep
them asleep.
MIDAZOLAM IS ALSO USED IN ADULTS AND CHILDREN:
• to make them feel calm and sleepy if they are in
intensive care. This is called ‘sedation’.
• before and during a medical test or procedure where
they are going to stay awake. It makes them feel calm
and sleepy. This is called ‘conscious sedation’.
• to make them feel calm and sleepy before they are
given an anaesthetic.
2.
WHAT YOU NEED TO KNOW BEFORE YOU
USE MIDAZOLAM
DO NOT USE MIDAZOLAM:
• if you are allergic (hypersensitive) to midazolam or
any of the other ingredients of this medicine (listed in
section 6).
• if you are allergic to other benzodiazepine medicines,
such as diazepam or nitrazepam.
• if you have severe breathing problems and you are
going to have Midazolam for ‘conscious sedation’.
You must not use Midazolam if any of the above applies
to you. If you are not sure, talk to your doctor or nurse
before you use this medicine.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before using Midazolam:
• if you are over 60 years of age.
• if you have a long term illness, such as breathing
problems or kidney, liver or heart problems.
• if you have an illness that makes you feel very weak,
run down and short of energy.
• if you have something called ‘myasthenia gravis’ where
your muscles are weak.
• if you have ever had alcohol problems.
• if you have ever had drug problems.
If any of the above applies to you (or you are not sure),
t

Karatteristiċi tal-prodott

OBJECT 1
MIDAZOLAM 2MG/ML, SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 17-Nov-2014 | hameln
pharmaceuticals ltd
1. Name of the medicinal product
Midazolam 2 mg/ml, solution for injection
2. Qualitative and quantitative composition
1 ml Midazolam 2 mg/ml contains:
Midazolam hydrochloride 2.22 mg equivalent to 2 mg Midazolam.
Each 5 ml, 25 ml and 50 ml ampoule/vial contains 10 mg, 50, 100 mg
Midazolam.
Excipient with known effect:
Midazolam 2 mg/ml contains 3.39 mg sodium per ml.
This should be taken into consideration for patients on a controlled
sodium diet.
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Solution for injection/infusion or rectal solution
The medicinal product is a clear and colourless solution.
pH 2.9 – 3.7
Osmolality 275 – 305 mOsmol/kg
4. Clinical particulars
4.1 Therapeutic indications
Midazolam 2 mg/ml 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
Posology
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 ac count. Standard dosages are provided in the table
below. Additional det