Patient Medication Information: uses, side effects, how to take - Nubain Injection 20mg/mL
ABOUT THIS MEDICATION
What the medication is used for:
NUBAIN is indicated in adults:
- for the relief of moderate to severe pain.
- to aid anesthesia for surgery.
- to help manage pain before and after surgery.
- to help manage pain during child birth.
What it does:
NUBAIN is a pain medication belonging to the class of medicines known as opioids. It relieves pain by acting on specific nerve cells of the spinal cord and brain
When it should not be used:
- If you have a known history of allergic reactions or sensitivity to this drug or other agents in the same drug family
What the medicinal ingredient is:
Nalbuphine hydrochloride
What the nonmedicinal ingredients are:
Sodium chloride (only for 10 mg/mL), sodium citrate dihydrate, citric acid and water for injection. pH adjusted with hydrochloric acid.
What dosage forms it comes in:
Solution for injection: 10 mg/mL, 20 mg/mL
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
NUBAIN should only be administered by persons with the appropriate training and experience with this kind of drug.
Complete resuscitation (life-saving) equipment and an antidote to rapidly counteract the effects of the drug should always be available.
BEFORE being given NUBAIN, talk to your doctor if you:
- plan on operating a car or heavy machinery after receiving NUBAIN.
- have a condition with any part of your body, such as your heart, kidney, lung, or liver.
have heavy alcohol use.
- use any drugs not given to you by a doctor.
are pregnant or breast feeding.
- have a known allergic reaction to this drug or any other pain medications or any other general anesthetics.
- have had a head injury, or if you experience difficulties breathing.
- have a history of drug abuse or dependence.
- are less than 18 years of age.
Other warnings you should know about:
There are important differences between physical dependence and addiction, and each is a reason for close medical supervision and honest discussions with your doctor. If you have questions or concerns about abuse, addiction or physical dependence, please tell your doctor.
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with NUBAIN include: sleeping pills (barbiturates), phenothiazines or other tranquilizers, pain medication (opioids), general anesthetics, or other depressants of the central nervous system.
Alcohol may also change the effect of NUBAIN.
PROPER USE OF THIS MEDICATION
Usual adult dose:
NUBAIN will be given to you as an injection either under the skin, into a muscle or into your vein.
Your doctor will determine your dose based on how much you weigh.
Overdose:
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
During or after the use of NUBAIN, talk to your doctor or nurse if you feel anything unusual or bothering (see the following table).
These are not all the possible side affects you may feel when taking NUBAIN. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||||
|---|---|---|---|---|---|---|
| Symptom/effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediate medical help | ||||
| Only if severe | In all cases | |||||
| Common | ||||||
| Dizziness, light-headedness, sensation of spinning | ✓ | |||||
| Drowsiness | ✓ | |||||
| Nausea and/or vomiting | ✓ | |||||
| Sweating, clammy skin | ✓ | |||||
| sleepiness | ✓ | |||||
| Les common | ||||||
| Dry mouth | ✓ | |||||
| Headache | ✓ | |||||
| Rare | ||||||
| Skin: reactions at the injection site such as pain, swelling, redness, burning and hot sensations, itching, rash. | ✓ | |||||
| Difficulty breathing, shortness of breath, wheezing | ✓ | |||||
| Slow or fast, pounding irregular heartbeat or pulse, fainting | ✓ | |||||
| Confusing, restlessness, euphoria, hostility, floating, unusual dreams, numbness, changes in speech | ✓ | |||||
| Allergic reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing. | ✓ | |||||
This is not a complete list of side effects. For any unexpected effects following the administration of NUBAIN, contact your doctor or pharmacist.
HOW TO STORE IT
NUBAIN should be stored between 15°C and 30°C and protected from light. Store in carton until contents have been used.
Keep out of reach and sight of children.
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:
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- 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, Sandoz Canada Inc., at: 1-800-361-3062
or
by written request at:
145, Jules-Léger
Boucherville, (QC), Canada
J4B 7K8
or by e-mail at :
medinfo@sandoz.com