DBL DIAZEPAM 10mg/2ml injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

diazepam, Quantity: 5 mg/mL

Available from:

Pfizer Australia Pty Ltd

INN (International Name):

Diazepam

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: ethanol; propylene glycol; sodium hydroxide; water for injections

Administration route:

Intravenous, Intramuscular

Units in package:

50x10mg/2mL, 5x10mg/2mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Management of anxiety disorders or for the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam is a useful adjunct for the relief of reflex muscle spasms due to local trauma (injury, inflammation) to muscles, bones and joints. It can also be used to combat spasticity due to upper motor neuron lesions such as cerebral palsy and paraplegia, as well as in athetosis and stiff man syndrome. Intravenous diazepam is useful in controlling status epilepticus and the spasms of tetatnus. Diazepam is also used as preoperative medication.

Product summary:

Visual Identification: Clear colourless solution; Container Type: Ampoule; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2005-03-23

Patient Information leaflet

DBL™ DIAZEPAM INJECTION
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I BEING TREATED WITH DBL DIAZEPAM INJECTION?
DBL Diazepam Injection contains the active ingredient diazepam. DBL
Diazepam Injection is used for a number of conditions
including: tension and anxiety, repeated or prolonged epileptic
seizures, to help relax you before an operation, muscle spasm, for
the relief of symptoms of alcohol withdrawal, and muscle stiffness due
to cerebral palsy or paraplegia.
For more information, see Section 1. Why am I being treated with DBL
Diazepam Injection? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE TREATMENT WITH DBL DIAZEPAM INJECTION?
Do not start treatment if you have ever had an allergic reaction to
DBL Diazepam Injection, or any medicine in the benzodiazepine
group, or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before
treatment with DBL Diazepam Injection? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with DBL Diazepam Injection and affect
how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW IS DBL DIAZEPAM INJECTION GIVEN?
Your doctor will decide how much DBL Diazepam Injection you will
receive. This depends on your condition. DBL Diazepam
Injection should only be given by a doctor, nurse, or other trained
person.
More instructions can be found in Section 4. How is DBL Diazepam
Injection given? in the full CMI.
5.
WHAT SHOULD I KNOW DURING TREATMENT WITH DBL DIAZEPAM INJECTION?
THINGS YOU
SHOULD DO
•
Remind any doctor, nurse, dentist, or pharmacist who is treating you
that you are using DBL Diazepam
Inject

Summary of Product characteristics

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AUSTRALIAN
PRODUCT
INFORMATION
–
DBL
™ DIAZEPAM (DIAZEPAM) INJECTION
1.
NAME OF THE MEDICINE
Diazepam
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 mL ampoule contains diazepam 10 mg and the following inactive
ingredients:
propylene glycol 53% v/v, ethanol absolute 31% v/v, in Water for
Injections; pH 6.2 to 7.0.
EXCIPIENT(S) WITH KNOWN EFFECT
Ethanol absolute
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Benzodiazepine derivative is a colourless crystalline compound,
insoluble in water. DBL Diazepam
Injection is a clear colourless to pale yellow solution for injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Management of anxiety disorders or for the short term relief of
symptoms of anxiety. Anxiety
or tension associated with the stress of everyday life usually does
not require treatment with an
anxiolytic.
In acute alcohol withdrawal, diazepam may be useful in the symptomatic
relief of acute
agitation, tremor, impending or acute delirium tremens and
hallucinosis.
Diazepam is a useful adjunct for the relief of reflex muscle spasms
due to local trauma (injury,
inflammation) to muscles, bones and joints. It can also be used to
combat spasticity due to
upper motor neuron lesions such as cerebral palsy and paraplegia, as
well as in athetosis and
stiff man syndrome.
Intravenous diazepam is useful in controlling status epilepticus and
the spasms of tetanus.
Diazepam is also used as pre-operative medication.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
_ADULTS _
The usual adult dose is 2 to 10 mg by intramuscular or intravenous
injection repeated every
three to four hours as required. In general, the maximum adult dose
should not exceed 30 mg
over an eight hour period.
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Supersedes: pfpdiap11019
Page 2 of 19
Intravenous injections should be given into a large vessel, such as an
antecubital vein, and the
solution should be administered slowly at a rate not exceeding 5
mg/mi