SERENACE INJECTION haloperidol 5 mg/mL ampoule 1mL

البلد: أستراليا

اللغة: الإنجليزية

المصدر: Department of Health (Therapeutic Goods Administration)

العنصر النشط:

haloperidol, Quantity: 5 mg/mL

متاح من:

Aspen Pharmacare Australia Pty Ltd

INN (الاسم الدولي):

Haloperidol

الشكل الصيدلاني:

Injection, solution

تركيب:

Excipient Ingredients: water for injections; sodium hydroxide; (S)-lactic acid

طريقة التعاطي:

Intravenous, Intramuscular

الوحدات في الحزمة:

10 ampoules

الفئة:

Medicine Registered

نوع الوصفة الطبية :

(S4) Prescription Only Medicine

الخصائص العلاجية:

Chronic Therapy: The management of manifestations of psychotic disorders such as schizophrenia, psychosis due to organic brain damage or mental deficiency, the manic phase of manic depressive illness, Gilles de la Tourette syndrome. Short Term Therapy: The treatment of acute alcoholism for the relief of delusions, hallucinations and confused states, and for the control of accompanying tremulousness and aggressive behaviour. In the treatment of intractable nausea and vomiting associated with radiation or malignancy and not responding to other therapy. Neuroleptanalgesia

ملخص المنتج:

Visual Identification: A clear, colourless liquid practically free of visible contamination.; Container Type: Ampoule; Container Material: Glass Type I Coloured; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

الوضع إذن:

Licence status A

تاريخ الترخيص:

2011-10-31

نشرة المعلومات

SERENACE injection – Consumer Medicine Information
Page 1 of 5
SERENACE INJECTION
_haloperidol _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SERENACE. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits
.
Your doctor has weighed
the risks of you using SERENACE
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT SERENACE IS
USED FOR
SERENACE contains haloperidol
as the active ingredient and
belongs to a group of medicines
called antipsychotics.
SERENACE helps to correct
chemical imbalances in the brain
and is used to treat mental illnesses
such as:
•
schizophrenia, an illness with
disturbances in thinking, feelings
and behaviour
•
mania, an illness where the
patient experiences episodes of
overactivity, elation or irritability
•
severe anxiety, tension or
excitement and severe agitation,
hyperactivity or aggression in
patients with mental or
emotional illness.
It is also used to treat:
•
behavioural problems in children
with mental retardation or
mental illness
•
nausea and vomiting (caused by
cancer treatment)
•
anxiety and pain during surgery
_(neurolept anaesthesia) _
•
Tourette’s Syndrome, a
condition with uncontrolled vocal
outbursts and body movements
(tics).
•
Before you receive SERENACE,
your doctor may recommend
that you have an
electrocardiogram or ECG.
•
Your doctor may also
recommend that you have an
ECG on a regular basis while
taking SERENACE.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY SERENACE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
There is no evidence that this
medicine is addictive.
SERENACE is only available with a
doctor’s prescription.
SERENACE is not recommended
for use in children under the ag

خصائص المنتج

Serenace ampoules – Product information
Page 1 of 18
AUSTRALIAN PRODUCT INFORMATION
SERENACE INJECTION (HALOPERIDOL)
1.
NAME OF THE MEDICINE
Haloperidol
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
SERENACE injections contain haloperidol as the active ingredient –
present as
haloperidol 5 mg/1 mL, haloperidol 10 mg/1 mL and haloperidol 20 mg/2
mL.
Excipients include (S)-lactic acid (5 mg/1 mL injection only), lactic
acid (10 mg/1 mL &
20 mg/2 mL injection only), sodium hydroxide and water for injections.
3.
PHARMACEUTICAL FORM
A clear, colourless solution practically free of visible particles in
amber coloured glass
ampoules
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
CHRONIC THERAPY
The management of manifestations of psychotic disorders such as
schizophrenia,
psychosis due to organic brain damage or mental deficiency, the manic
phase of
manic depressive illness, Gilles de la Tourette syndrome.
SHORT TERM THERAPY
The treatment of acute alcoholism for the relief of delusions,
hallucinations and
confused
states,
and
for
the
control
of
accompanying
tremulousness
and
aggressive behaviour.
In the treatment of intractable nausea and vomiting associated with
radiation or
malignancy and not responding to other therapy. Neuroleptanalgesia.
4.2 DOSE AND METHOD OF ADMINISTRATION
WARNING
Higher doses and intravenous administration of haloperidol appear to
be associated
with a higher risk of QT prolongation and Torsades de Pointes (see
PRECAUTIONS
and ADVERSE EFFECTS). Haloperidol solution for injection is
recommended for
intramuscular administration only. However, if administered
intravenously, continuous
ECG monitoring must be performed for QTc interval prolongation and for
ventricular
arrhythmias.
Where rapid control of an acutely disturbed patient is required, or
where heavier than
usual dosages are envisaged, or when parenteral administration,
particularly repeated
parenteral administration, is required, then the patient should be
transferred as soon as
possible to a situation where, ECG monitoring, parentera