APOWOK apomorphine hydrochloride hemihydrate 10 mg/mL solution for injection or infusion ampoule
국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
환자 정보 전단 유효 성분:
apomorphine hydrochloride hemihydrate, Quantity: 10 mg/mL
제공처:
Wockhardt Bio Pty Ltd
약제 형태:
Injection, solution
구성:
Excipient Ingredients: sodium metabisulfite; sodium hydroxide; hydrochloric acid; water for injections
관리 경로:
Subcutaneous
패키지 단위:
5 x 5mL ampoules, 10 x 5mL ampoules, 1 x 5 mL ampoules
처방전 유형:
(S4) Prescription Only Medicine
치료 징후:
APOWOK 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.
제품 요약:
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
승인 상태:
Registered
승인 날짜:
2018-03-14
환자 정보 전단
APOWOK (Apomorphine) CMI V1.2
Page 1
APOWOK
™
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
APOWOK
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 APOWOK
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 APOWOK
TM
SOLUTION FOR INJECTION
OR INFUSION IS USED
FOR
APOWOK
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
APOWOK
TM
SOLUTION FOR INJECTION
OR INFUSION
_WHEN YOU MUST NOT USE IT _
DO NOT USE APOWOK
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
difficulty breathing; swelling of the
face, lips, tongue or other parts of
the body; rash, itching or hives on
the skin.
DO
전체 문서 읽기
제품 특성 요약
Apowok Product Information - Australia
Version 1.4
Page 1
APOWOK
TM
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
APOWOK
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).
APOWOK
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.
Apowok 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
dopamine receptors, but stimulation of presynaptic D
2
dopamine
receptors and
전체 문서 읽기
