Patient Medication Information: uses, side effects, how to take - Ropivacaine Hydrochloride Injection
ABOUT THIS MEDICATION
What the medication is used for:
ROPIVACAINE HYDROCHLORIDE INJECTION is for pain relief, and can be used:
To provide pain relief in labour and after surgery or acute
injury.
What it does:
ROPIVACAINE HYDROCHLORIDE INJECTION acts by temporally preventing the nerves in the injected area from transmitting sensations of pain, heat or cold. However, you may still experience sensations such as pressure and touch. In many cases this means that the nerves to the muscles in the area will also be blocked, causing temporary weakness or paralysis.
When it should not be used:
ROPIVACAINE HYDROCHLORIDE INJECTION should not be used in patients who:
are allergic to ropivacaine, any other “-caine” type
anaesthetics, or any of the non-medicinal ingredients in the product (see What the non-medicinal ingredients are below).
Because of the potential for irreversible joint damage, pain following joint surgery should not be managed by infusing ROPIVACAINE HYDROCHLORIDE INJECTION into the joint (i.e. by use of a post-operative ‘pain pump’).
What the medicinal ingredient is:
The medicinal ingredient is ropivacaine hydrochloride.
What the important nonmedicinal ingredients are:
ROPIVACAINE HYDROCHLORIDE INJECTION also contains sodium chloride, hydrochloric acid and/or sodium hydroxide and water for injection.
What dosage forms it comes in:
ROPIVACAINE HYDROCHLORIDE INJECTION 2 mg/mL for infusion is available in 100 mL and 200 mL infusion bags.
WARNINGS AND PRECAUTIONS
You should talk to your doctor prior to surgery:
- about all health problems you have now or have had in the past;
- about other medications you take, including ones you can buy without a prescription;
- if you are taking other medicines such as drugs used to treat irregular heart activity (anti-arrhythmics);
- if you have ever had a bad, unusual allergic reaction to ropivacaine or any other medicines ending with “-caine”;
if you have a heart, liver or kidney disease, since the dose of
ROPIVACAINE HYDROCHLORIDE INJECTION may have to be adjusted;
if you are pregnant, plan to become pregnant or are breastfeeding;
if you are planning to drive or operate any tools or machinery on the day of surgery, because ROPIVACAINE HYDROCHLORIDE INJECTION may temporarily interfere with your reactions and muscular coordination;
- if you have been diagnosed with porphyria, a rare hereditary disorder.
INTERACTIONS WITH THIS MEDICATION
Many drugs interact with ROPIVACAINE HYDROCHLORIDE INJECTION. Tell your doctor about all prescription, over-the-counter and natural health products that you are using (see WARNINGS AND PRECAUTIONS above).
Usage of some medicines at the same time as ROPIVACAINE HYDROCHLORIDE INJECTION may increase the risk of serious side effects.
PROPER USE OF THIS MEDICATION
Usual dose:
ROPIVACAINE HYDROCHLORIDE INJECTION should be administered by a doctor, or occasionally by an anaesthesia professional under the supervision of a doctor. The dose to be given is decided by the doctor, based on the clinical need and your physical condition.
Overdose:
Serious side effects from getting too much ROPIVACAINE HYDROCHLORIDE INJECTION need special treatment and the doctor treating you is trained to deal with these situations. The first signs of being given too much ROPIVACAINE HYDROCHLORIDE INJECTION are usually as follows:
- felling dizzy or light-headed,
- numbness of the lips and around the mouth,
- numbness of the tongue,
- hearing problems,
- tingling in the ears,
- problems with your sight (vision).
More serious side effects from being given too much ROPIVACAINE HYDROCHLORIDE INJECTION include problems with your speech, twitching of your muscles, tremors,
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trembling, fits (seizures), and loss of consciousness.
To reduce the risk of serious side effects, your doctor will stop giving you ROPIVACAINE HYDROCHLORIDE INJECTION as soon as these signs appear. This means that if any of these happen to you, or you think you have received too much ROPIVACAINE HYDROCHLORIDE INJECTION, seek immediate emergency assistance.
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like any medication, ROPIVACAINE HYDROCHLORIDE INJECTION may cause side effects in some people.
Medicines affect different people in different ways. Just because side effects have occurred in some patients, does not mean that you will get them.
Tell your doctor as soon as possible if you do not feel well during treatment with ROPIVACAINE HYDROCHLORIDE INJECTION.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Sudden life-threatening allergic reactions (such as anaphylaxis) are rare, affecting less than 1 in 1,000 people. Possible symptoms include sudden onset of rash, itching or lumpy rash (hives); swelling of the face, lips, tongue or other parts of the body; and shortness of breath, wheezing or difficulty breathing. If you think that ROPIVACAINE HYDROCHLORIDE INJECTION is
causing an allergic reaction, seek immediate emergency assistance.
There are other possible side effects that have been reported for ROPIVACAINE HYDROCHLORIDE INJECTION. Tell your doctor or anaesthesia professional or seek immediate emergency assistance if you experience any of the following side effects:
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||
| Symptom / effect | Talk with your doctor | Seek immediate emergency assistance | |
| Only if severe | In all cases | ||
| Very Common | |||
Low blood pressure (hypotension). This might make you feel dizzy or light-headed. | X | ||
| Feeling sick (nausea) | X | ||
| Common | |||
| Pins and needles | X | ||
| Feeling dizzy | X | ||
| Headache | X | ||
| Slow or fast heartbeat (bradycardia, tachycardia) | X | ||
| High blood pressure (hypertension) | X | ||
| Being sick (vomiting) | X | ||
| Difficulty in passing urine | X | ||
| High temperature (fever) or stiffness (rigor) | X | ||
| Back pain | X | ||
| Uncommon | |||
| Anxiety | X | ||
| Decreased sensitivity or feeling in the skin | X | ||
| Fainting | X | ||
| Difficulty in breathing | X | ||
| Low body temperature (hypothermia) | X | ||
Some symptoms can happen if the injection was given into a blood vessel by mistake, or if you have been given too much ROPIVACAINE HYDROCHLORIDE INJECTION (see also “OVERDOSAGE” section above). These include fits (seizures), feeling dizzy or light-headed, numbness of the lips and around the mouth, numbness of the tongue, hearing problems, problems with your sight (vision), problems with your speech, stiff muscles and trembling. | X | ||
| Rare | |||
| Heart attack (cardiac arrest) | X | ||
| Uneven heart beat (arrhythmias) | X | ||
Other possible side effects include:
- Numbness, due to nerve irritation caused by the needle or the injection. This does not usually last for long.
Possible side effects seen with other local anaesthetics which might also be caused by ROPIVACAINE
HYDROCHLORIDE INJECTION include:
- Damaged nerves, rarely (affecting less than 1 in 1,000
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people), this may cause permanent problems.
If too much ROPIVACAINE HYDROCHLORIDE
INJECTION is given into the spinal fluid, the whole body may become numbed (anaesthetised).
This is not a complete list of side effects. For any unexpected effects while taking ROPIVACAINE HYDROCHLORIDE INJECTION, contact your doctor or pharmacist.
HOW TO STORE IT
ROPIVACAINE HYDROCHLORIDE INJECTION should be stored at 15°C to 30°C. Do not freeze.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
-------------------------------------------------------------------------- $ Report online at www.healthcanada.gc.ca/medeffect $ Call toll-free at 1-866-234-2345
$ Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
Mail to: Canada Vigilance Program Health Canada
Postal Locator 0701E
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Teva Canada Limited at:
1-800-268-4127 ext. 5005 (English);
1-877-777-9117 (French)
or druginfo@tevacanada.com
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9