SERENACE haloperidol 20 mg/2 mL injection ampoule

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

haloperidol, Quantity: 10 mg/mL

Tersedia dari:

Aspen Pharmacare Australia Pty Ltd

Bentuk farmasi:

Injection, solution

Komposisi:

Excipient Ingredients: lactic acid; sodium hydroxide; water for injections

Rute administrasi :

Intramuscular, Intravenous

Unit dalam paket:

10 ampoules

Jenis Resep:

(S4) Prescription Only Medicine

Indikasi Terapi:

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

Ringkasan produk:

Visual Identification: Clear, colourless solution; Container Type: Ampoule; Container Material: Glass Type I Coloured; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Status otorisasi:

Registered

Tanggal Otorisasi:

1991-08-30

Karakteristik produk

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