APO-go 50mg/5ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Apomorphine hydrochloride

Available from:

Britannia Pharmaceuticals Ltd

ATC code:

N04BC07

INN (International Name):

Apomorphine hydrochloride

Dosage:

10mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Subcutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04090100; GTIN: 5055962500018

Patient Information leaflet

_* Abbreviated to _APO-go Ampoules_ in the text_
PACKAGE LEAFLET: INFORMATION FOR THE USER
For use in adults
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, pharmacist or
nurse.
−
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, pharmacist or nurse.
This includes
any side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What APO-go Ampoules is and what it is used for
2.
What you need to know before you use APO-go Ampoules
3.
How to use APO-go Ampoules
4.
Possible side effects
5.
How to store APO-go Ampoules
6.
Contents of the pack and other information
1. WHAT APO-GO AMPOULES IS AND WHAT IT IS USED FOR
APO-go Ampoules contains apomorphine solution for injection. It is
injected into the
area under the skin (subcutaneously). The active ingredient in APO-go
Ampoules
is apomorphine hydrochloride. There is 10 mg of apomorphine in each
millilitre of
solution.
Apomorphine hydrochloride belongs to a group of medicines known as
dopamine
agonists. APO-go Ampoules is used to treat Parkinson’s disease.
Apomorphine helps
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
(another treatment for
Parkinson’s disease) and/or other dopamine agonists. Your doctor or
nurse will help
you to recognise the signs of when to use your medicine.
Despite the name, apomorphine does not contain morphine.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE APO-GO AMPOULES
Before you use APO-go Ampoules, your doctor will obtain an ECG
(electrocardiogram)
and will ask for a list of all other medicines you take. This ECG will
be repeated
in the first days of your treatment and at any point if y

Summary of Product characteristics

OBJECT 1
APO-GO AMPOULES 10MG/ML SOLUTION FOR
INJECTION OR INFUSION
Summary of Product Characteristics Updated 16-Mar-2018 | Britannia
Pharmaceuticals Limited
1. Name of the medicinal product
APO-go
®
AMPOULES 10 mg/ml Solution for Injection or Infusion
_* ABBREVIATED TO _APO-GO _IN THE TEXT_
2. Qualitative and quantitative composition
1 ml contains 10 mg apomorphine hydrochloride
2 ml contains 20 mg apomorphine hydrochloride
5 ml contains 50 mg apomorphine hydrochloride
Excipient(s) with known effect
Sodium metabisulphite (E223) 1 mg per ml
For a full list of excipients, see Section 6.1
3. Pharmaceutical form
Solution for Injection or Infusion
Clear, colourless or almost colourless, practically free from visible
particles
pH 3.0-4.0
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
Selection of Patients suitable for APO-go injections:
Patients selected for treatment with APO-go should be able to
recognise the onset of their 'off' symptoms
and be capable of injecting themselves or else have a responsible
carer able to inject 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 should be initiated in the controlled environment of a
specialist clinic. The patient should
be supervised 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 s