Consumer medicine information

Ropivacaine ReadyfusOR

Ropivacaine hydrochloride

BRAND INFORMATION

Brand name

Ropivacaine ReadyfusOR

Active ingredient

Ropivacaine hydrochloride

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Ropivacaine ReadyfusOR.

Ropivacaine ReadyfusOR

Ropivacaine ReadyfusOR

 Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

 1. Why am I using Ropivacaine ReadyfusOR?

Ropivacaine ReadyfusOR contains the active ingredient ropivacaine hydrochloride. Ropivacaine ReadyfusOR is used in adults after surgery to treat post-operative pain.

For more information, see Section 1. Why am I using Ropivacaine ReadyfusOR? in the full CMI.

 2. What should I know before I use Ropivacaine ReadyfusOR?

Do not use if you have ever had an allergic reaction to Ropivacaine ReadyfusOR 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 Ropivacaine ReadyfusOR? in the full CMI.

 3. What if I am taking other medicines?

Some medicines may interfere with Ropivacaine ReadyfusOR 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 Ropivacaine ReadyfusOR?

Your doctor will have had a lot of experience using ropivacaine hydrochloride or other local anaesthetics, and will choose the best dose for you.

Your doctor will inject the medicine in the Ropivacaine ReadyfusOR into the skin, near a single nerve, or into an area which contains a large number of nerves. It may also be directed into a surgical incision after surgery by a tube.

More instructions can be found in Section 4. How do I use Ropivacaine ReadyfusOR? in the full CMI.

 5. What should I know while using Ropivacaine ReadyfusOR?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using Ropivacaine ReadyfusOR.
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how Ropivacaine ReadyfusOR affects you.
Drinking alcohol
  • Do not drink alcohol while you are fitted with the Ropivacaine ReadyfusOR.

For more information, see Section 5. What should I know while using Ropivacaine ReadyfusOR? in the full CMI.

 6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary.

The most common side effects are nausea (feeling sick), dizziness, irregular or slow heartbeat, a tingling feeling ("pins and needles"), difficulty sleeping (insomnia), fever, back pain, headache, vomiting, difficulty passing urine, pain in the chest, shivering.

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.

Ropivacaine ReadyfusOR

Active ingredient: ropivacaine hydrochloride

 Consumer Medicine Information (CMI)

This leaflet provides important information about using Ropivacaine ReadyfusOR. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Ropivacaine ReadyfusOR.

Where to find information in this leaflet:

1. Why am I using Ropivacaine ReadyfusOR?
2. What should I know before I use Ropivacaine ReadyfusOR?
3. What if I am taking other medicines?
4. How do I use Ropivacaine ReadyfusOR?
5. What should I know while using Ropivacaine ReadyfusOR?
6. Are there any side effects?
7. Product details

 1. Why am I using Ropivacaine ReadyfusOR?

Ropivacaine ReadyfusOR contains a local anaesthetic called ropivacaine hydrochloride, which is already inside the dispenser. The local anaesthetic is injected into the body where it makes the nerves unable to pass messages to the brain.

Depending on the amount used, it will either totally stop pain or will cause a partial loss of feeling.

Ropivacaine ReadyfusOR is used in adults after surgery to treat post-operative pain.

Your doctor will have explained why you are being treated with ropivacaine hydrochloride and will have told you about the length of time you will be treated and the dose you will be given.

Follow all directions given to you by your doctor carefully.

They may differ from the information contained in this leaflet.

Your doctor may prescribe this medicine for another use. Ask your doctor if you want more information.

Ropivacaine hydrochloride, the medicine in Ropivacaine ReadyfusOR, is not addictive.

 2. What should I know before I use Ropivacaine ReadyfusOR?

Warnings

Do not use Ropivacaine ReadyfusOR if:

  • you are allergic to:
    - ropivacaine hydrochloride
    - any of the ingredients listed at the end of this leaflet
    - any other local anaesthetics
    Always check the ingredients to make sure you can use this medicine.
  • you have problems controlling your low blood pressure
  • you have inflammation and/or an infection at the site of the injection

Check with your doctor if you:

  • have any allergies to other substances
  • have any of these medical conditions:
    - problems with your blood pressure or circulation
    - blood poisoning
    - problems with the clotting of your blood
    - acidosis, or too much acid in the blood
    - nerve problems
    - liver, kidney or heart problems
    - disease of the brain or spine, including meningitis, polio, cancer or infection
    - muscle disease or weakness (e.g. myasthenia gravis)
    It may not be safe for you to use Ropivacaine ReadyfusOR if you have any of these conditions.
  • have any other medical condition
  • take any medicines for any other condition

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Your doctor will discuss the possible risks and benefits of using Ropivacaine ReadyfusOR during pregnancy and breastfeeding.

 3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Ropivacaine ReadyfusOR and affect how it works. These include:

  • medicines that control your heartbeat
  • medicines used to thin the blood, including aspirin
  • low molecular weight heparin or other medicines used to prevent blood clots
  • fluvoxamine, a medicine used to treat depression
  • enoxacin, a medicine used to treat bacterial infections
  • ketoconazole, a medicine used to treat fungal infections
  • cimetidine, a medicine used to treat stomach ulcers or heartburn
  • medicines for depression

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Ropivacaine ReadyfusOR.

 4. How do I use Ropivacaine ReadyfusOR?

How much to use

  • Your doctor will have had a lot of experience using ropivacaine hydrochloride or other local anaesthetics, and will choose the best dose for you. They will be willing to discuss this decision with you.

How it will be used

  • Ropivacaine ReadyfusOR should only be used by or under the supervision of doctors experienced in regional anaesthesia.
  • Refer to the Package Insert for detailed instructions for use of the Ropivacaine ReadyfusOR product.
  • The Ropivacaine ReadyfusOR is intended for single use only, and the dispenser should be discarded after single use.
  • The medicine in the Ropivacaine ReadyfusOR will be injected by your doctor into the skin, near a single nerve, or into the skin, near a single nerve, or into an area which contains a large number of nerves. It may also be directed into the surgical incision after surgery by a tube.
  • This will result in an area of numbness at or near the site of administration.
  • The medicine in Ropivacaine ReadyfusOR is ropivacaine hydrochloride and it should not be injected directly into the blood.

If you use too much Ropivacaine ReadyfusOR

The doctor giving you ropivacaine hydrochloride will be experienced in the use of local anaesthetics, so it is unlikely that you will be given too much.

However, if you are particularly sensitive to ropivacaine hydrochloride, or the dose is accidentally injected directly into your blood, you may develop problems with your sight, hearing, and get a numb feeling in or around the mouth, feel dizzy or stiff, or have twitchy muscles.

In rare cases, these effects may be followed by drowsiness and fits. In extreme cases you may have problems with your breathing or your heart and you may become unconscious.

If you think that you have been given too much Ropivacaine ReadyfusOR, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

 5. What should I know while using Ropivacaine ReadyfusOR?

Things you should do

Remind any doctor, dentist, nurse or pharmacist you visit that you are using Ropivacaine ReadyfusOR.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Ropivacaine ReadyfusOR affects you.

Ropivacaine ReadyfusOR may cause dizziness in some people.

Drinking alcohol

Do not drink alcohol while you are fitted with the Ropivacaine ReadyfusOR.

If you drink alcohol while you are being given ropivacaine hydrochloride your blood pressure may drop making you feel dizzy and faint.

Getting rid of any unwanted medicine

Ropivacaine ReadyfusOR is for single use only.

The Ropivacaine ReadyfusOR will be disposed of in a safe manner by your doctor or nurse after you have used it, even if there is some ropivacaine hydrochloride solution left in the dispenser.

Ropivacaine ReadyfusOR will only be used if the solution is clear, the package is undamaged and the use by (expiry) date marked on the pack has not been passed.

 6. Are there any side effects?

Ropivacaine ReadyfusOR will help relieve pain in most people, but it may have some unwanted side effects.

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Tell your doctor or a nurse as soon as possible if you do not feel well while you are fitted with Ropivacaine ReadyfusOR.

Less serious side effects

Less serious side effectsWhat to do
Gut related
  • Nausea (feeling sick)
  • Vomiting
Brain and nervous system related
  • Headache
  • Dizziness
  • A tingling feeling ("pins and needles")
  • Shivering
  • Difficulty sleeping
  • Nervousness
  • Decreased feeling or sensitivity, especially in the skin
Heart related
  • Irregular or slow heartbeat
Urine related
  • Difficulty passing urine
Other
  • Fever
  • Back pain
Tell your doctor or a nurse if you notice any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
Heart related
  • Slow heartbeat
Brain and nervous system related
  • Extreme dizziness
Lung and upper airways
  • Difficulty breathing
General
  • Stiff or twitching muscles
  • Painful joints
  • Pain in the chest
  • Fits
  • Loss of consciousness
Tel your doctor or a nurse immediately if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

 7. Product details

This medicine is only available with a doctor's prescription.

What Ropivacaine ReadyfusOR contains

Active ingredient
(main ingredient)		Ropivacaine hydrochloride
Other ingredients
(inactive ingredients)

Sodium chloride

Hydrochloric acid or sodium hydroxide for pH adjustment

Water for injections

Potential allergensN/A

Do not take this medicine if you are allergic to any of these ingredients.

What Ropivacaine ReadyfusOR looks like

Ropivacaine ReadyfusOR containing 250 mL of the 0.2% ropivacaine hydrochloride solution is presented in the pre-filled dispenser. The ropivacaine hydrochloride solution is clear and colourless. (AUST R 267572).

Who distributes Ropivacaine ReadyfusOR

Sponsor:

BioQ Pharma Pty Ltd
225 George Street
Sydney, NSW 2000
Australia

Distributor:

STADA Pharmaceuticals Australia Pty Ltd
40-42 Scott Street
Dandenong, VIC 3175
Australia

This leaflet was prepared in November 2022.

Published by MIMS February 2023

BRAND INFORMATION

Brand name

Ropivacaine ReadyfusOR

Active ingredient

Ropivacaine hydrochloride

Schedule

S4

 

Notes

Distributed by STADA Pharmaceuticals Australia Pty Ltd

1 Name of Medicine

Ropivacaine hydrochloride.

2 Qualitative and Quantitative Composition

Ropivacaine ReadyfusOR 0.2% solution for injection is a sterile, isotonic, isobaric, aqueous solution of ropivacaine HCl.
The pH of the solution is adjusted with sodium hydroxide or hydrochloric acid to remain between 4.0-6.0 during the approved shelf-life and the nominal osmolality of the injection is 288 mOsm/kg.
The solution is preservative free.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

The solution for injection is a clear and colourless liquid, practically free from particles.

4 Clinical Particulars

4.9 Overdose

Acute emergencies associated with the use of local anaesthetics are generally related to high plasma levels or to unintended subarachnoid injection of the local anaesthetic solution (see Section 4.8 Adverse Effects (Undesirable Effects); Section 4.4 Special Warnings and Precautions for Use).
Accidental intravascular injections of local anaesthetics may cause immediate toxic effects. Toxic effects may also arise from exceptionally rapid absorption from highly vascularised areas. In the event of overdose, peak plasma concentrations may not be reached for one to two hours, depending on the site of the injection and signs of toxicity may thus be delayed.
Systemic toxic reactions may involve the central nervous system and the cardiovascular system.
Early signs of local anaesthetic toxicity may be difficult to detect in cases where the block is given during deep sedation or general anaesthesia.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).
Symptoms. Central nervous system toxicity is a graded response with symptoms and signs of escalating severity. Initially symptoms such as visual or hearing disturbances, perioral numbness, dizziness, light headedness, tingling and paraesthesia are seen. Dysarthria, muscular rigidity and muscular twitching are more serious and may precede the onset of generalised convulsions.
Unconsciousness and grand mal convulsions may follow, which can last from a few seconds to several minutes. Hypoxia and hypercapnia occur rapidly during convulsions due to the increased muscular activity, together with disruption to respiration and possible loss of functional airways. In severe cases apnoea may occur. Respiratory and metabolic acidosis, hyperkalaemia, hypocalcaemia and hypoxia increase and extend the toxic effects of local anaesthetics.
Recovery follows the redistribution of the local anaesthetic drug from the central nervous system and subsequent metabolism and excretion. Recovery should be rapid unless large amounts of the drug have been injected.
Cardiovascular toxicity indicates a more severe situation. Hypotension, bradycardia, arrhythmia and even cardiac arrest may occur as a result of high systemic concentrations of local anaesthetics. In volunteers the intravenous infusion of ropivacaine resulted in signs of depression of conductivity and contractility.
Cardiovascular toxic effects are generally preceded by signs of toxicity in the central nervous system, unless the patient is receiving a general anaesthetic or is heavily sedated with drugs such as benzodiazepines or barbiturates. However in rare cases, cardiac arrest has occurred without prodromal CNS effects.
Treatment. If signs of acute systemic toxicity occur, injection of the local anaesthetic should be stopped immediately.
Treatment consists of ensuring adequate ventilation and arresting convulsions. Assisted or controlled ventilation should be maintained with oxygen, if required.
If convulsions occur and do not spontaneously stop within 15-20 seconds, an anticonvulsant should be given intravenously e.g. diazepam 5-10 mg IV or where indicated, sodium thiopentone (5 mg/kg). If convulsions interfere with breathing and/or are not rapidly controlled by specific anticonvulsant medication, suxamethonium (1-2 mg/kg) may be used to paralyse the patient. Artificial ventilation must then be instituted.
If cardiovascular depression is evident (hypotension, bradycardia), appropriate treatment with intravenous fluids, vasopressor and or inotropic agents should be considered.
If ventricular fibrillation, cardiac arrest or circulatory arrest occur, cardiopulmonary resuscitation must be instituted and maintained. Optimal oxygenation and ventilation and circulatory support as well as treatment of acidosis are of vital importance.
Should cardiac arrest occur, prolonged resuscitative efforts may be required to improve the possibility of a successful outcome.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Ropivacaine hydrochloride was negative in the Ames salmonella/mammalian microsome mutagenicity test, human lymphocyte chromosome aberration test, mouse micronucleus test, E. coli differential DNA repair test, E. coli host-mediated DNA repair test in mice, and the somatic mutation and recombination test in Drosophila melanogaster (fruit fly), and weakly mutagenic in the mouse lymphoma test. The clinical use of ropivacaine is unlikely to pose any risk of genotoxicity.
Carcinogenicity. Long term animal assays of carcinogenic potential have not been performed.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

The chemical name for ropivacaine hydrochloride is (-)-(2S)-N-(2,6-dimethylphenyl)-1-propylpiperidine-2-carboxamide hydrochloride.
Ropivacaine hydrochloride was developed as the pure (S)-(-)-isomer and has an enantiomeric purity of > 99% and is a white crystalline powder with a water solubility of about 50 mg/mL. It has a pKa of 8.1 (at 25°C) and a molecular weight of 310.86. The pH of a saturated solution of ropivacaine hydrochloride is 4.5 and that of a 1% (w/v) aqueous solution is 5.0.
Chemical structure. The chemical formula of ropivacaine hydrochloride is C17H26N2O.HCl.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSROPHYD.gif CAS number. 98717-15-8.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription only medicine.

Summary Table of Changes

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