DROPERIDOL 2.5 mg/1 mL MEDSURGE droperidol 2.5 mg/1 mL solution for injection ampoule

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

droperidol, Quantity: 2.5 mg/mL

Disponível em:

Medsurge Pharma Pty Ltd

Forma farmacêutica:

Injection, solution

Composição:

Excipient Ingredients: tartaric acid; water for injections; sodium hydroxide; mannitol

Via de administração:

Intravenous, Intramuscular

Unidades em pacote:

10 x 2.5 mg/1 mL, 5 x 2.5 mg/1 mL, 50 x 2.5 mg/1 mL

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

ANAESTHESIA Droperidol solution for 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 droperidol solution for 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.

Resumo do produto:

Visual Identification: Clear, colourless solution; Container Type: Ampoule; Container Material: Glass Type I Coloured; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status de autorização:

Registered

Data de autorização:

2021-12-08

Folheto informativo - Bula

DROPERIDOL
DROPERIDOL SOLUTION FOR INJECTION
Droperidol Medsurge, Edition 01, Dec 2021
1
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 USING DROPERIDOL MEDSURGE?
Droperidol Medsurge contains the active ingredient droperidol.
Droperidol Medsurge is used for the following:
ANAESTHESIA
Droperidol solution for 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 droperidol solution for
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
For more information, see Section 1. Why am I using Droperidol
Medsurge? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE DROPERIDOL MEDSURGE?
Do not use if you have ever had an allergic reaction to droperidol 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 I use
Droperidol Medsurge? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Droperidol Medsurge 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 DO I USE DROPERIDOL MEDSURGE?
•
Your doctor will decide how much Droperidol solution for injection you
will need. This will d

Características técnicas

DROPERIDOL
_ _
PRODUCT INFORMATION
Droperidol Medsurge Edition 0.3 Dec 2021
PAGE 1 OF 13
AUSTRALIAN PRODUCT INFORMATION
DROPERIDOL 1.25 MG/1 ML MEDSURGE AND
DROPERIDOL 2.5 MG/1 ML MEDSURGE
(DROPERIDOL)
SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Droperidol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Droperidol solution for injection contains the active ingredient
droperidol.
Droperidol comes in two strengths and contains either 1.25 mg/1 mL or
2.5 mg/1 mL of droperidol.
For the full list of excipients, see section
6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Injection, solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
ANAESTHESIA
Droperidol solution for 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 droperidol solution for
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.
DROPERIDOL
_ _
PRODUCT INFORMATION
Droperidol Medsurge Edition 0.3 Dec 2021
PAGE 2 OF 13
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