Consumer medicine information

Movapo PFS 50 mg/10 mL Solution for infusion (prefilled syringe)

Apomorphine hydrochloride hemihydrate

BRAND INFORMATION

Brand name

Movapo PFS

Active ingredient

Apomorphine hydrochloride hemihydrate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Movapo PFS 50 mg/10 mL Solution for infusion (prefilled syringe).

1. Why am I using MOVAPO or MOVAPO PFS?


MOVAPO or MOVAPO PFS contains the active ingredient apomorphine hydrochloride hemihydrate. MOVAPO and MOVAPO PFS are used in the treatment of Parkinson's disease to reduce the number and severity of bouts of freezing and stiffness (or “off” periods).
For more information, see Section 1. Why am I using MOVAPO or MOVAPO PFS? in the full CMI.

2. What should I know before I use MOVAPO or MOVAPO PFS?


Do not use if you have ever had an allergic reaction to apomorphine hydrochloride hemihydrate, sodium metabisulfite or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use MOVAPO or MOVAPO PFS? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with MOVAPO or MOVAPO PFS and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use MOVAPO or MOVAPO PFS?

  • Your doctor will tell you how much to use.
  • MOVAPO and MOVAPO PFS are designed for injection under the skin (subcutaneous).
  • You will be trained to recognise when and how to inject. Follow the instructions given by your doctor or pharmacist.

More instructions can be found in Section 4. How do I use MOVAPO and MOVAPO PFS? in the full CMI.

5. What should I know while using MOVAPO or MOVAPO PFS?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using MOVAPO or MOVAPO PFS.
  • If you become pregnant while you are using this medicine, tell your doctor immediately.
Things you should not do
  • Do not use MOVAPO or MOVAPO PFS to treat any other complaints unless your doctor tells you to.
  • Do not give this medicine to anyone else, even if they have the same condition as you.
  • Do not stop MOVAPO or MOVAPO PFS abruptly or change the dose, without speaking to your doctor to discuss a taper treatment plan.
Driving or using machines
  • MOVAPO or MOVAPO PFS may cause drowsiness, sudden onset of sleepiness, dizziness or light-headedness in some people.
  • If you have any of these symptoms do not drive, operate machinery or do anything else that could be dangerous.
Looking after your medicine
  • Store below 25°C. Store in the medicine in its original carton to protect from light. Do not freeze.
  • Once opened, the solution should be used immediately. Discard any unused solution.

For more information, see Section 5. What should I know while using MOVAPO or MOVAPO PFS? in the full CMI.

6. Are there any side effects?


Like all medicines, this medicine can cause side effects, although not everybody gets them. Some side effects can be serious and you need to know what symptoms to look out for. MOVAPO and MOVAPO PFS can cause allergic reactions which may be very serious. If you develop symptoms of allergic reaction, you may need urgent medical attention or hospitalisation.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

BRAND INFORMATION

Brand name

Movapo PFS

Active ingredient

Apomorphine hydrochloride hemihydrate

Schedule

S4

 

1 Name of Medicine

Apomorphine hydrochloride hemihydrate.

2 Qualitative and Quantitative Composition

Each 10 mL prefilled syringe contains 50 mg apomorphine hydrochloride hemihydrate.
Sodium metabisulfite is included in the formulation as an antioxidant.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for injection in prefilled syringe.
Movapo Pre-Filled Syringe (PFS) is a clear solution, practically colourless, odourless and practically free from visible particles.

4 Clinical Particulars

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
Symptoms. The clinical features of overdose of Movapo PFS are an extension of the pharmacological effects of the drug. They include nausea and persistent vomiting, dyskinesias, hypotension and acute circulatory failure, cardiac arrest, respiratory depression, drowsiness and central nervous system depression or stimulation, euphoria, restlessness and hallucinations and possibly coma and death. Concomitant use of domperidone may exacerbate the clinical features of overdose.
Treatment. An opioid antagonist such as naloxone may be given to treat excessive vomiting, central nervous system depression and respiratory depression due to Movapo PFS overdose. Excessive vomiting may also be treated with domperidone. Atropine may be also used to treat bradycardia. To treat hypotension, appropriate measures should be taken e.g. raising the foot of the bed.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. In vitro genotoxicity studies demonstrated mutagenic and clastogenic effects, most likely due to products formed by oxidation of apomorphine. Apomorphine was not genotoxic in vivo in a mouse micronucleus test or in a rat unscheduled DNA synthesis test.
Carcinogenicity. No carcinogenicity studies have been performed.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSAPHYHE.gif CAS number. The CAS registry number of apomorphine hydrochloride hemihydrate is 41372-20-7.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/MOVPFSST.gif