Ropivacaine Sandoz Solution for injection
Ropivacaine Sandoz Solution for injection is a brand of medicine containing the active ingredient ropivacaine hydrochloride.
Find out more about active ingredients.
Consumer medicine information (CMI) leaflet
Developed by the pharmaceutical company responsible for this medicine in Australia, according to TGA regulations.
Ropivacaine hydrochloride (as monohydrate) solution for injection and infusion
Consumer Medicine Information
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Ropivacaine Sandoz.
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 taking this medicine against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
WHAT ROPIVACAINE SANDOZ IS USED FOR
The name of your medicine is Ropivacaine Sandoz. It contains the active ingredient Ropivacaine hydrochloride (as monohydrate).
Ropivacaine Sandoz belongs to a group of medicines called local anaesthetic. It is injected into the body where it makes the nerves unable to pass messages to the brain. Depending on the amount used, Ropivacaine Sandoz will either totally stop pain or will cause a partial loss of feeling.
Ropivacaine Sandoz is used as an anaesthetic to stop the pain of surgery and/or to make childbirth less painful. Ropivacaine Sandoz is also used after surgery to treat post-operative pain.
Your doctor will have explained why you are being treated with Ropivacaine Sandoz and told you what 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.
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.
BEFORE YOU ARE GIVEN ROPIVACAINE SANDOZ
When you must not be given it
Do not have this medicine if you have an allergy to:
- Ropivacaine hydrochloride, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product Description
- any other local anaesthetics
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 not have this medicine if:
- you have problems controlling your low blood pressure
- you have inflammation and/or an infection at the site of injection.
If you are not sure whether you should be given this medicine, talk to your doctor.
Before you are given it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following 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 infections.
- muscle disease or weakness (e.g. myasthenia gravis).
Tell your doctor if you are pregnant, are breastfeeding, or plan to breast feed while you are receiving Ropivacaine Sandoz. Your doctor will discuss the possible risks and benefits of being treated with Ropivacaine Sandoz during pregnancy and breast-feeding.
If you have not told your doctor about any of these things, tell him/her before you start treatment with Ropivacaine Sandoz.
Ropivacaine Sandoz 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.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Ropivacaine Sandoz may interfere with each other. These include:
- medicines that control your heart beat
- 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.
These medicines may be affected by Ropivacaine Sandoz or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.
HOW ROPIVACAINE SANDOZ IS GIVEN
Ropivacaine Sandoz should only be administered by trained professionals, with appropriate handling, in a hospital or clinic environment.
Ropivacaine Sandoz will be injected by your doctor 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. This will result in an area of numbness at the site of injection, near the site of injection or in an area that may seem unrelated to the site of injection. The latter will be the case if you are given an epidural injection (an injection around the spinal cord).
Ropivacaine Sandoz should not be injected directly into the blood.
Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.
If you do not understand the instructions, ask your doctor or pharmacist for help.
How much is given
Your doctor will decide what dose of Ropivacaine Sandoz you will receive. The dosage you will be given will depend on your body size, age and the type of pain relief required. Your doctor will have had a lot of experience injecting or infusing Ropivacaine Sandoz or other local anaesthetics and will choose the best dose for you. Ask your doctor if you want to know more about the dose of Ropivacaine Sandoz you receive.
If you receive too much (overdose)
As Ropivacaine Sandoz is given to you under the supervision of your doctor, it is very unlikely that you will receive too much. However, if you experience any unexpected or worrying side effects after being given Ropivacaine Sandoz, telephone your doctor or the Poisons Information Centre (telephone Australia 13 11 26 or New Zealand 0800 POISON or 0800 764766) for advice, or go to Accident and Emergency at the nearest hospital.
You may need urgent medical attention.
If you are particularly sensitive to Ropivacaine Sandoz, 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.
WHILE YOU ARE BEING GIVEN ROPIVACAINE SANDOZ
Things to be careful of
Be careful driving or operating machinery after you have been given Ropivacaine Sandoz. You may be drowsy and your reflexes may be slow.
Do not drink alcohol while you are being given Ropivacaine Sandoz. If you drink alcohol while you are being given Ropivacaine Sandoz your blood pressure may drop making you feel dizzy and faint.
Please talk to your doctor or pharmacist about these possibilities if you think they may bother you.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are being given Ropivacaine Sandoz. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
- nausea (feeling sick)
- irregular or slow heart beat
- a tingling feeling ("pins and needles")
- difficulty passing urine.
These are mild side effects of the medicine.
Tell your doctor as soon as possible if you notice any of the following:
- stiff or twitching muscles
- painful joints
- difficulty breathing
- extreme dizziness
- slow heart beat
- pain in the chest
On rare occasions you may lose consciousness.
The above list includes serious side effects that may require medical attention. Serious side effects are rare.
Tell your doctor or pharmacist if you notice anything else that is making you feel unwell. Other side effects not listed above may also occur in some people.
AFTER BEING GIVEN ROPIVACAINE SANDOZ
Ropivacaine Sandoz will be stored by your doctor or pharmacist under the recommended storage conditions.
The ampoules or infusion bag are kept in a cool dry place where the temperature stays below 30ºC, out of the reach of children.
Do not freeze. Do not re-autoclave.
Any Ropivacaine Sandoz which is not used, and which is left in the container, will be disposed of in a safe manner by your doctor, nurse or pharmacist.
What it looks like
Ropivacaine Sandoz is a clear colourless solution for injection or infusion.
Available in packs of 5 bags for infusion and 5 ampoules for injection.
- Ropivacaine Sandoz 400mg/200mL infusion bag - 400mg ropivacaine hydrochloride (as monohydrate)
- Ropivacaine Sandoz 200mg/100mL infusion bag - 200mg ropivacaine hydrochloride (as monohydrate)
- Ropivacaine Sandoz 200mg/20mL injection ampoule - 200mg ropivacaine hydrochloride (as monohydrate)
- Ropivacaine Sandoz 150mg/20mL injection ampoule - 150mg ropivacaine hydrochloride (as monohydrate)
- Ropivacaine Sandoz 100mg/20mL injection ampoule - 100mg ropivacaine hydrochloride (as monohydrate)
- Ropivacaine Sandoz 40mg/20mL injection ampoule - 40mg ropivacaine hydrochloride (as monohydrate)
- Ropivacaine Sandoz 100mg/10mL injection ampoule - 100mg ropivacaine hydrochloride (as monohydrate)
- Ropivacaine Sandoz 75mg/10mL injection ampoule - 75mg ropivacaine hydrochloride (as monohydrate)
- Ropivacaine Sandoz 50mg/10mL injection ampoule - 50mg ropivacaine hydrochloride (as monohydrate)
- Ropivacaine Sandoz 20mg/10mL injection ampoule - 20mg ropivacaine hydrochloride (as monohydrate)
Each Ropivacaine Sandoz infusion bag and ampoule also contains:
- sodium chloride
- hydrochloric acid or sodium hydroxide for pH adjustment
- water for injections.
This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes. The infusion bags and ampoules are latex free.
Sandoz Pty Ltd
ABN 60 075 449 553
Level 2, 19 Harris St
Pyrmont NSW 2009
Tel: 1800 634 500
Novartis New Zealand Ltd
Private Bag 65904 Mairangi Bay
Tel: 0800 354 335
This leaflet was prepared in August 2011.
Australian Register Numbers
- Ropivacaine Sandoz 400mg/200mL infusion bag: AUST R 162857
- Ropivacaine Sandoz 200mg/100mL infusion bag: AUST R 162869
- Ropivacaine Sandoz 200mg/20mL ampoule: AUST R 162851
- Ropivacaine Sandoz 150mg/20mL ampoule: AUST R 162859
- Ropivacaine Sandoz 100mg/20mL ampoule: AUST R 162865
- Ropivacaine Sandoz 40mg/20mL ampoule: AUST R 162853
- Ropivacaine Sandoz 100mg/10mL ampoule: AUST R 162856
- Ropivacaine Sandoz 75mg/10mL ampoule: AUST R 162852
- Ropivacaine Sandoz 50mg/10mL ampoule: AUST R 162860
- Ropivacaine Sandoz 20mg/10mL ampoule: AUST R 162866
CMI provided by MIMS Australia, June 2013