Haldol Conc

Kraj: Nowa Zelandia

Język: angielski

Źródło: Medsafe (Medicines Safety Authority)

Składnik aktywny:

Haloperidol decanoate 100 mg/mL

Dostępny od:

Janssen-Cilag (New Zealand) Ltd

INN (International Nazwa):

Haloperidol decanoate 100 mg/mL

Dawkowanie:

100 mg/mL

Forma farmaceutyczna:

Injection (depot)

Skład:

Active: Haloperidol decanoate 100 mg/mL

Sztuk w opakowaniu:

Ampoule, glass, 1mL, 5 dose units

Klasa:

Prescription

Typ recepty:

Prescription

Wyprodukowano przez:

Janssen Pharmaceutica NV

Wskazania:

The maintenance therapy of psychoses, particularly for patients requiring prolonged parenteral neuroleptic therapy.

Podsumowanie produktu:

Package - Contents - Shelf Life: Ampoule, glass, 1mL - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light

Data autoryzacji:

1991-06-19

Ulotka dla pacjenta

1
Haldol (211029) ACMI
HALDOL
 INJECTION
_Haloperidol decanoate _
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 is used to control the symptoms of mental
illnesses
in
adults
with
disturbances
in
thinking,
feelings and behaviour.
Haldol is a long-acting antipsychotic. It works by
correcting the chemical imbalances in the brain, which
may cause mental illness.
Your doctor may have prescribed Haldol for another
use. Ask your doctor 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
•
suffer from severe depression
•
have or have ever had muscle stiffness, restricted
or
uncontrollable
movement
due
to
certain
medical conditions, such as spastic diseases or
Parkinson’s disease
•
have senility with pre-existing Parkinson like
symptoms
•
suffer from Lewy body dementia
•
suffer from progressive supranuclear palsy
•
have an allergy to Haldol or any of the ingredients.
See
PRODUCT DESCRIPTION
at the end of this leaflet
for a list of ingredients.
Signs
of
allergy
may
include
skin
rash,
itching,
shortness of breath, and/or swollen face that may lead
to difficulty breathing or swallowing.
If you think you are having an allergic reaction, tell
your
doctor
immediately
or
go
to
accid

Charakterystyka produktu

CCDS(180302)
Page 1 of 15
HALDOL(211029)ADS
HALDOL
®
HALOPERIDOL DECANOATE
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
HALDOL haloperidol decanoate 50 mg/mL Injection
HALDOL CONCENTRATE haloperidol decanoate 100 mg/mL Injection
2.
QUANTITATIVE AND QUALITATIVE COMPOSITION
HALDOL 50 mg/ml
Haloperidol decanoate 70.52 mg, equivalent to 50 mg haloperidol base,
per millilitre.
HALDOL CONCENTRATE 100 mg/ml
Haloperidol decanoate 141.04 mg, equivalent to 100 mg haloperidol
base, per millilitre.
Excipient(s) of known effect: Contains sesame seed products.
For a full list of excipients, see SECTION 6.1.
3.
PHARMACEUTICAL FORM
Injection (depot)
HALDOL Injection (long acting) is a slightly amber, slightly viscous
solution, free from visible foreign
matter, filled in 1 mL amber glass ampoules.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HALDOL 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 should be administered by deep intramuscular injection into the
gluteal region. It is
recommended to alternate between the two gluteal muscles for
subsequent injections. 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.
DO NOT ADMINISTER INTRAVENOUSLY.
Patients must be previously stabilised on oral haloperidol before
converting to HALDOL.
Treatment initiation and dose titration must be carried out under
close clinical supervision. The
starting dose of HALDOL should be based on the patient's clinical
history, severity of symptoms,
physical condition and response to the current oral haloperidol dose.
Patients must always be
maintained on the lowest effective dose.
CCDS(180302)
Page 2 of 15
HALDOL(211029)ADS
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