Apomorphine hydrochloride 5mg/ml solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Apomorphine hydrochloride hemihydrate

Available from:

Pharmaceuticals Sales & Development Sweden AB (PharmSwed)

ATC code:

N04BC; N04BC07

INN (International Name):

Apomorphine hydrochloride hemihydrate

Dosage:

5 milligram(s)/millilitre

Pharmaceutical form:

Solution for infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Dopamine agonists; apomorphine

Authorization status:

Not marketed

Authorization date:

2012-10-26

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
APOMORPHINE HYDROCHLORIDE 5 MG/ML, SOLUTION FOR INFUSION
apomorphine hydrochloride hemihydrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Apomorphine hydrochloride is and what it is used for
2.
What you need to know before you use Apomorphine hydrochloride
3.
How to use Apomorphine hydrochloride
4.
Possible side effects
5.
How to store Apomorphine hydrochloride
6.
Contents of the pack and other information
1.
WHAT APOMORPHINE HYDROCHLORIDE IS AND WHAT IT IS USED FOR
Apomorphine hydrochloride belongs to a group of medicines known as
dopamine agonists which are
used to treat Parkinson’s disease. It helps to reduce the amount of
time spent in an “off” or immobile
state in people who have previously been treated for Parkinson’s
disease with levodopa and/or other
dopamine agonists.
Your doctor or nurse will help you to recognise the signs of when to
use your medicine.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE APOMORPHINE HYDROCHLORIDE
DO NOT USE APOMORPHINE HYDROCHLORIDE:
-
if you are allergic to apomorphine or any of the other ingredients of
this medicine (listed in
section 6)
-
if you are under 18 years of age
-
if you have breathing difficulties or suffer from asthma
-
if you have dementia or Alzheimer’s disease
- if you suffer from confusion, hallucinations or any other similar
problems
-
if you have liver problems
-
if you have severe overmobility, so called dyskinesia (involuntary
movements), or abnormal
muscle tension (so called dystonia)

Summary of Product characteristics

Health Products Regulatory Authority
13 March 2020
CRN009DYX
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Apomorphine hydrochloride 5mg/ml solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 5 mg apomorphine hydrochloride hemihydrate.
One 20 ml vial contains 100 mg apomorphine hydrochloride hemihydrate.
Excipient with known effect: Sodium metabisulfite 1 mg per ml.
Contains sodium 3.3mg per ml.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
Clear and practically colourless solution
pH 2.6 – 4.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of motor fluctuations ('on-off' phenomena) in patients with
Parkinson’s disease which are not sufficiently controlled
by oral anti-Parkinson medication.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Patients Suitable for Apomorfin PharmSwed
Patients selected for treatment with Apomorfin PharmSwed be capable of
inserting the needle s.c. themselves or else have a
responsible carer able to insert the needle s.c. for them when
required.
Patients treated with apomorphine will usually need to start
domperidone at least two days prior to initiation of therapy. The
domperidone dose should be titrated to the lowest effective dose and
discontinued as soon as possible. Before the decision to
initiate domperidone and apomorphine treatment, risk factors for QT
interval prolongation in the individual patient should be
carefully assessed to ensure that the benefit outweighs the risk (see
section 4.4).
Apomorphine treatment should be initiated in a controlled environment
of a specialist clinic. The treatment should be
managed by a physician experienced in the treatment of Parkinson’s
disease (e.g. neurologist). The patient’s treatment with
levodopa, with or without dopamine agonists, should be optimised
before starting Apomorfin PharmSwed treatment.
_Establishment of treatment_
Alterations in dosage may be made according to the patient’s
response.
The optima