Calamine Lotion Oily

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Kupi sada

Preuzimanje Uputa o lijeku (PIL)
28-09-2021
Preuzimanje Svojstava lijeka (SPC)
28-09-2021

Aktivni sastojci:

calamine, Quantity: 50 mg/g

Dostupno od:

JMAC (WA) Pty Ltd trading as PharmAust Manufacturing

Farmaceutski oblik:

Lotion

Sastav:

Excipient Ingredients: Arachis Oil; quaternium-15; calcium hydroxide; Wool fat; purified water; oleic acid

Administracija rute:

Topical

Jedinice u paketu:

100mL, 2 Litres

Razred:

Medicine Registered

Tip recepta:

Not scheduled. Not considered by committee

Terapijske indikacije:

This product accepted for registration/listing as 'currently supplied' at the time of commencement of the Act. Indications held in ARTG paper records. (Old code) For the temporary relief of insect bites and stings

Proizvod sažetak:

Visual Identification: Oily opaque pink lotion; Container Type: Bottle; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Status autorizacije:

Registered

Datum autorizacije:

1991-10-25

Uputa o lijeku

                                HALDOL
®
Injection (210920) ACMI
1
HALDOL
® DECANOATE
_Haloperidol decanoate solution for injection (IM OILY INJECTION) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Haldol injection. 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 treating you with Haldol
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING TREATED WITH HALDOL, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE. YOU MAY NEED TO READ IT
AGAIN.
WHAT HALDOL IS USED
FOR
Haldol contains the active substance
haloperidol (as haloperidol
decanoate). This belongs to a group
of medicines called ‘antipsychotics’.
Haldol is a long-acting antipsychotic.
It works by correcting the chemical
imbalances in the brain, which may
cause mental illness.
Haldol is used in adults whose
condition has previously been treated
with haloperidol taken by mouth. It is
used for illnesses affecting the way
you think, feel or behave. These
include mental health problems (such
as schizophrenia).
These illnesses may make you:
•
Feel confused (delirium)
•
See, hear, feel or smell things that
are not there (hallucinations)
•
Believe things that are not true
(delusions)
•
Feel unusually suspicious
(paranoia)
•
Feel very excited, agitated,
enthusiastic, impulsive or
hyperactive
•
Feel very aggressive, hostile or
violent.
Your doctor may have prescribed
Haldol for another use.
ASK YOUR DOCTOR OR HEALTHCARE
PROFESSIONAL IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Haldol is not addictive.
BEFORE YOU ARE GIVEN
HALDOL
_WHEN YOU MUST NOT BE GIVEN _
_IT: _
DO NOT GIVE HALDOL TO ANYONE WHO
IS UNCONSCIOUS OR IN A COMA.
YOU MUST NOT BE GIVEN HALDOL IF
YOU:
•
have severe drowsiness and
slowness due to illness or the use
of alcohol or medicine
•
feel unusually confused, dizz
                                
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Svojstava lijeka

                                CCDS180302
Page 1 of 17
HALDOL(210920)API
AUSTRALIAN PRODUCT INFORMATION
HALDOL
® DECANOATE
HALOPERIDOL DECANOATE
SOLUTION FOR INJECTION (IM OILY INJECTION)
1. NAME OF THE MEDICINE
Haloperidol decanoate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL injection contains 50 mg haloperidol (present as haloperidol
decanoate 70.52 mg) and
each 3 mL injection contains 150 mg haloperidol (present as
haloperidol decanoate 211.56 mg).
Excipient(s) of known effect: Contains sesame seed products.
For the full list of excipients, see Section 6.1 List of Excipients.
3. PHARMACEUTICAL FORM
The oily injection for intramuscular injection (IM) is a slightly
amber, slightly viscous solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
HALDOL DECANOATE is indicated for the maintenance therapy of psychoses
in adults; particularly
for patients requiring prolonged parenteral neuroleptic therapy.
4.2 DOSE AND METHOD OF ADMINISTRATION
ADMINISTRATION
HALDOL DECANOATE should be administered by deep intramuscular
injection into the gluteal
region. A 2-inch-long, 21-gauge needle is recommended. The maximum
volume per injection site
should not exceed 3 mL. The recommended interval between doses is 4
weeks. It is recommended
to alternate between the two gluteal muscles for subsequent
injections.
DO NOT ADMINISTER INTRAVENOUSLY
Patients
must
be
previously
stabilised
on
oral
haloperidol
before
converting
to
HALDOL
DECANOATE.
Treatment initiation and dose titration must be carried out under
close clinical supervision. The
starting dose of HALDOL DECANOATE should be based on the patient's
clinical history, physical
condition and response to the current oral haloperidol dose. Patients
must always be maintained on
the lowest effective dose.
CCDS180302
Page 2 of 17
HALDOL(210920)API
DOSAGE - ADULTS
Table 1.
Haloperidol decanoate dose recommendations for adults aged 18 years
and above
TRANSITION FROM ORAL HALOPERIDOL
•
A haloperidol decanoate dose of 10 to 15 times the previous daily dose
of oral haloperidol is
recommended.
•
Based
                                
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