DIAZEPAM 5 Mg/Ml Solution for Injection
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
12-03-2016
Summary of Product characteristics
(SPC)
12-03-2016
Active ingredient:
DIAZEPAM
Available from:
Wockhardt UK Limited
ATC code:
N05BA01
INN (International Name):
DIAZEPAM
Dosage:
5 Mg/Ml
Pharmaceutical form:
Solution for Injection
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Benzodiazepine derivatives
Authorization status:
Authorised
Authorization date:
2009-05-22
Patient Information leaflet
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DIAZEPAM 5MG/ML SOLUTION FOR INJECTION
DIAZEPAM 5MG/ML
(Refer to as Diazepam Injection in this leaflet)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE THIS MEDICINE.
-
Keep this leaflet. You may need to read it again while you are receiving your treatment.
-
If you have any further questions, please ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
-
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Diazepam Injection is and what it is used for
2.
Before you take Diazepam Injection
3.
How to take Diazepam Injection
4.
Possible side effects
5.
How to store Diazepam Injection
6.
Further information
1.
WHAT DIAZEPAM INJECTION IS AND WHAT IT IS USED FOR
The name of your medicine is Diazepam Injection; the active ingredient is diazepam. This medicine
belongs to a group of medicines called benzodiazepines. Diazepam Injection is used:
to treat anxiety and agitation
as a sedative on minor surgical ad dental procedures
as an anticonvulsant (medicine to control fits)
as a muscle relaxant
2. BEFORE YOU TAKE DIAZEPAM INJECTION
YOU SHOULD NOT BE GIVEN DIAZEPAM INJECTION IF YOU:
are allergic (hypersensitivity) to diazepam, any other benzodiazepines or to any of the other
ingredients in Diazepam Injection (see section 6, Further information)
are suffering from phobias (irrational fears) or obsessions
have breathing problems
suffer from obstructive sleep apnoea ( a condition where you stop breathing during sleep)
have severe liver disease
hav
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diazepam 5 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Diazepam 5 mg/ml
Excipients - Contains Benzoic acid (E210) 1mg/ml, Ethanol 96% 100mg/ml, Sodium benzoate (E211) 49mg/ml,
Propylene Glycol 400mg/ml, Benzyl Alcohol 15mg/ml and sodium content 0.34mmol/ml
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to pale yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Diazepam injection may be used in severe or disabling anxiety and agitation; for the control of status epilepticus,
epileptic and febrile convulsions; to relieve muscle spasm; as a sedative in minor surgical and dental procedures; or
other circumstances in which a rapid effect is required.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dosage depends on individual response, age and weight.
_ADULTS:_
IN SEVERE ANXIETY OR ACUTE MUSCLE SPASM, diazepam 10mg may be given intravenously or intramuscularly and
repeated after 4 hours.
IN TETANUS, 0.1 to 0.3mg per kg bodyweight may be given intravenously and repeated every 1-4 hours; alternatively, a
continuous infusion of 3 to 10mg per kg every 24 hours may be used or similar doses may be given by nasoduodenal
tube.
IN STATUS EPILEPTICUS OR EPILEPTIC CONVULSIONS, 0.15 – 0.25mg per kg (usually 10-20mg) is given by intravenous
injection. The dose can be repeated if necessary after 30 to 60 minutes. Once the patient is controlled, recurrence of
seizures may be prevented by a slow infusion (maximum total dose 3mg per kg over 24 hours).
IN MINOR SURGICAL PROCEDURES AND DENTISTRY, 0.1-0.2mg per kg by injection (usually 10-20mg) adjusted to the
patient’s requirements.
_ELDERLY:_
Elderly or debilitated patients s
Read the complete document
