APOMORPHINE WOCKHARDT apomorphine hydrochloride hemihydrate 10 mg/mL solution for injection or infusion ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

apomorphine hydrochloride hemihydrate, Quantity: 10 mg/mL

Available from:

Wockhardt Bio Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium metabisulfite; sodium hydroxide; hydrochloric acid; water for injections

Administration route:

Subcutaneous

Units in package:

5 x 5mL ampoules, 1 x 5 mL ampoules, 10 x 5mL ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

APOMORPHINE WOCKHARDT Solution for Injection or Infusion is indicated to reduce the number and severity of ?off? phases in patients with Parkinson?s disease severely disabled by motor fluctuations refractory to conventional therapy. Initiation of therapy with apomorphine should be undertaken in a specialist unit in a hospital setting. Conventional therapy should be continued during ?on? phases.

Product summary:

Visual Identification: The solution is clear and colourless to slightly yellow, sterile, free from visible particles; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2018-03-14

Patient Information leaflet

APOMORPHINE WOCKHARDT (Apomorphine) CMI V1.2
Page 1
APOMORPHINE WOCKHARDT
™
SOLUTION FOR
INJECTION OR INFUSION
Apomorphine _(a-poe-MOR-feen) _hydrochloride hemihydrate
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
APOMORPHINE WOCKHARDT
TM
Solution for Injection or Infusion.
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
APOMORPHINE WOCKHARDT
TM
Solution for Injection or Infusion
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 IN A SAFE PLACE.
You may need to read it again.
WHAT APOMORPHINE
WOCKHARDT
TM
SOLUTION FOR INJECTION
OR INFUSION IS USED
FOR
APOMORPHINE
WOCKHARDT
TM
Solution for
Injection or Infusion contains
apomorphine which belongs to
a group of medicines called
dopaminergic compounds.
Apomorphine is used in the
treatment of Parkinson’s disease to
reduce the number and severity of
bouts of freezing and stiffness (or
“off” periods).
This medicine works by acting on
dopamine receptors. These
receptors help control movement
by the body.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is available only with
a doctor’s prescription.
There is not enough information to
recommend the use of this medicine
in children under 18 years.
BEFORE YOU USE
APOMORPHINE
WOCKHARDT
TM
SOLUTION FOR INJECTION OR
INFUSION
_WHEN YOU MUST NOT USE IT _
DO NOT USE APOMORPHINE
WOCKHARDT
TM
SOLUTION FOR
INJECTION OR INFUSION IF YOU HAVE
AN ALLERGY TO:
•
apomorphine
•
sodium metabisulfite
•
certain types of pain killers
such as morphine or other
opioid analgesics.
Some of the symptoms of an
allergic reaction may include
shortness of breath, wheezing or
dif

Summary of Product characteristics

Apomorphine Wockhardt Product Information - Australia
Version 1.4
Page 1
TM
APOMORPHINE WOCKHARDT
SOLUTION FOR INJECTION OR INFUSION
NAME OF THE MEDICINE
Apomorphine hydrochloride hemihydrate
The CAS registry number of apomorphine hydrochloride, hemihydrate is
41372-20-7
and the chemical structure is shown below:
DESCRIPTION
APOMORPHINE WOCKHARDT
TM
Solution for Injection or Infusion is a clear and
colourless to slightly yellow sterile solution, free from visible
particles and
containing apomorphine hydrochloride hemihydrate in Water for
Injections.
Sodium metabisulfite 1 mg/ mL is included in the formulation as an
antioxidant. Sodium
hydroxide and hydrochloric acid are also included in the formulation.
The pH of the
injection is 3.0 to 4.0.
Each 5 mL ampoule contains 50 mg apomorphine hydrochloride
hemihydrate, hence
1mL of solution contains 10 mg apomorphine hydrochloride hemihydrate
(10 mg/mL).
APOMORPHINE WOCKHARDT
TM
Solution for Injection or Infusion is for subcutaneous use
only and must not be administered via intravenous infusion. This
product may be diluted prior to
administration with sodium chloride 0.9% for use as a continuous
subcutaneous infusion with
suitable pumps/syringe drivers. See DOSAGE AND ADMINISTRATION for
Dilution
Instructions”
PHARMACOLOGY
Apomorphine is a directly acting dopamine receptor agonist,
structurally related to dopamine.
Apomorphine has high
_in vitro _
binding affinity for the dopamine D
4
and D
5
receptor (
_K_
_i_
: 4
and 14 nM respectively), moderate affinity (
_K_
_i_
: 26 to 130 nM) for the dopamine D
2
and D
3
,
adrenergic α
1D
, α
2B,
α
2C
receptors, serotonin 5HT
1A
, 5HT
2A
, 5HT
2B
, and 5HT
2C
receptors
and low affinity for the dopamine D
1
receptor (
_K_
_i_
: 370 nM). Apomorphine exhibits no affinity
for the adrenergic ß
1
and ß
2
or histamine H
1
receptors.
Apomorphine Wockhardt Product Information - Australia
Version 1.4
Page 2
The effect of apomorphine as an antiparkinsonian agent is believed to
be the result of direct
stimulation of postsynaptic D
2
do