Serenace

Quốc gia: New Zealand

Ngôn ngữ: Tiếng Anh

Nguồn: Medsafe (Medicines Safety Authority)

Thành phần hoạt chất:

Haloperidol 5 mg/mL

Sẵn có từ:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (Tên quốc tế):

Haloperidol 5 mg/mL

Liều dùng:

5 mg/mL

Dạng dược phẩm:

Solution for injection

Thành phần:

Active: Haloperidol 5 mg/mL Excipient: Lactic acid Sodium hydroxide Water for injection

Các đơn vị trong gói:

Ampoule, glass, 10 dose units

Lớp học:

Prescription

Loại thuốc theo toa:

Prescription

Sản xuất bởi:

Excella GmbH & Co KG

Chỉ dẫn điều trị:

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.

Tóm tắt sản phẩm:

Package - Contents - Shelf Life: Ampoule, glass, - 10 dose units - 36 months from date of manufacture stored at or below 30°C protect from light - Ampoule, glass, - 25 dose units - 36 months from date of manufacture stored at or below 30°C protect from light

Ngày ủy quyền:

1969-12-31

Tờ rơi thông tin

 
SERENACE INJECTION 
1
NEW ZEALAND CONSUMER MEDICINE INFORMATION 
SERENACE  
INJECTION 
_Haloperidol (Hal oh PER I doll) _

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 taking 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 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) 

Your doctor may have prescribed 
SERENACE for another reason.  
Ask your doctor if you have any 
questions about why SERENACE 
has been prescribed for you. 

SERENACE belongs to a group of 
medicines called antipsychotics. It 
helps to correct chemical 
imbalances in the brain, which may 
cause mental illness. _These _
_chemicals may also affect the parts _
_of the brain, which control nausea _
_and vomiting._ 

There is no evidence that 
SERENACE is addictive or habit 
forming. 

SERENACE is only available with

Đặc tính sản phẩm

1
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
SERENACE
Haloperidol tablets - 0.5mg; 1.5mg; 5mg
Haloperidol liquid – 2mg/mL
Haloperidol injection – 5mg/mL
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Serenace tablets contains 0.5mg, 1.5mg and 5mg haloperidol
respectively.
Serenace liquid contains 2mg/mL haloperidol
Serenace injection contains 5mg/mL haloperidol
For full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
SERENACE 0.5mg tablet: (1/4" diameter), green, biconvex, scored,
uncoated,
plain on one side, each containing haloperidol BP 0.5mg.
SERENACE 1.5mg tablet: (9/32" diameter), white, biconvex, scored,
uncoated,
plain on one side, each containing haloperidol BP 1.5mg.
SERENACE 5mg tablet: (5/16" diameter), red, biconvex, scored,
uncoated,
plain on one side, each containing haloperidol BP 5mg.
Liquid
Clear, colourless liquid containing 2mg haloperidol BP per ml, in a
bottle.
Injection Ampoule
1ml amber coloured ampoule containing 5mg haloperidol BP per ml.
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.
2
4.2
DOSAGE AND METHOD OF ADMINISTRATION
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 REACTIONS). 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