DROLEPTAN droperidol 2.5mg/1mL injection

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

droperidol, Quantity: 2.5 mg/mL

Tilgjengelig fra:

Phebra Pty Ltd

Legemiddelform:

Injection, solution

Sammensetning:

Excipient Ingredients: tartaric acid; mannitol; water for injections

Administreringsrute:

Intravenous

Enheter i pakken:

10 x 1mL

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

IN ANAESTHESIA - DROLEPTON is indicated to produce tranquillisation and to reduce the incidence of nausea and vomiting in surgical and diagnostic procedures; for premedication, induction, and as an adjunct in the maintenance of general and regional anaesthesia; in neuroleptanalgesia in which DROLEPTAN is given concurrently with a narcotic analgesic, to aid in producing tranquillity and decreasing anxiety and pain. IN PSYCHIATRY - the management of severe agitation, hyperactivity, or agressiveness in psychotic disorders, including schizophrenic reaction and the manic type of manic depressive illness, or in disturbed states, such as some types of acute brain syndrome and in nonpsychotic acute excitation states.

Produkt oppsummering:

Visual Identification: Clear, colourless solution.; Container Type: Ampoule; Container Material: Glass Type I Coloured; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Autorisasjon status:

Registered

Autorisasjon dato:

1993-11-01

Informasjon til brukeren

Droleptan
®
Injection
Page 1 of 3
_Version 08 _
DROLEPTAN
®
INJECTION
CONTAINS 2.5 MG/ML DROPERIDOL
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Droleptan Injection. It
does not contain all the available
information. It does not take the place
of talking to your doctor.
All medicines have risks and benefits
.
Your doctor has weighed the risks of
you being given Droleptan Injection
against the benefits they expect it will
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR.
KEEP THIS LEAFLET
.
You may need to read it again.
WHAT DROLEPTAN
INJECTION IS USED FOR
Droleptan Injection is a tranquilliser
used to:
_ _
•
calm patients before surgery
•
reduce nausea and vomiting which
may occur with anaesthesia
•
help produce or maintain
anaesthesia
•
help reduce anxiety and pain when
used with strong pain killers during
surgery
•
help manage severe agitation,
aggression and over-activity.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it for
another reason.
There is not enough information to
recommend the use of this medicine
for children under the age of 2 years.
_ _
BEFORE YOU ARE GIVEN
DROLEPTAN INJECTION
_WHEN YOU MUST NOT BE GIVEN _
_IT_
_ _
YOU SHOULD NOT BE GIVEN DROLEPTAN
INJECTION IF YOU HAVE AN ALLERGY TO:
•
any medicine containing droperidol
•
any of the ingredients listed at the
end of this leaflet
•
any other similar medicines such as
haloperidol.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue or
other parts of the body
•
rash, itching or hives on the skin.
_ _
DROLEPTAN INJECTION SHOULD NOT BE
GIVEN IF YOU HAVE:
•
severe drowsiness and slowness as
a result of brain disease or damage
•
Parkinson’s disease
•
pheochromocytoma, a type of
tumour, which causes high blood
pressure
•
a rare heart disorder k

Preparatomtale

PRODUCT INFORMATION
Australian Product Information – Droleptan Injection
Page 1 of 13
Version 10
DROLEPTAN
® INJECTION
(DROPERIDOL)
1
NAME OF THE MEDICINE
Droperidol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Droleptan injection contains 2.5 mg/mL droperidol as the active
ingredient.
Droperidol is a cream-coloured, light-sensitive, crystalline,
hygroscopic substance, slightly soluble in water and
alcohol, and soluble in aqueous solutions with pH < 4.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Droleptan injection is presented as a 1 mL solution in an ampoule.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
ANAESTHESIA
Droleptan injection is indicated to produce tranquillisation and to
reduce the incidence of nausea and vomiting in
surgical and diagnostic procedures; for premedication, induction, and
as an adjunct in the maintenance of general
and regional anaesthesia; in neuroleptanalgesia in which Droleptan
injection is given concurrently with a narcotic
analgesic, to aid in producing tranquillity and decreasing anxiety and
pain.
PSYCHIATRY
The
management
of
severe
agitation,
hyperactivity,
or
aggressiveness
in
psychotic
disorders,
including
schizophrenic reaction and the manic type of manic depressive illness,
or in disturbed states, such as some types
of acute brain syndrome and in nonpsychotic acute excitation states.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Dosage should be individualised. Some of the factors to be considered
in determining the dose are age,
bodyweight, physical status, underlying pathological condition, use of
other drugs, type of anaesthesia to be used
and the surgical procedure involved.
Vital signs should be monitored routinely. To minimise the risk of
ventricular arrhythmia, an electrocardiograph
(ECG) should be performed and examined for evidence of QT prolongation
before any operation commences.
ECG monitoring should continue during the surgical procedure and
subsequently for a period of time consistent
PRODUCT INFORMATION
DROLEPTAN