5 mg / ml injection solution
bupivacaine hydrochloride
What Marcain spinal is and what it is used for
Marcain spinal contains the active substance bupivacaine hydrochloride, which is a local anesthetic and is injected into the lower back. It temporarily blocks the nerve signals in the area where it is injected.
Marcain spinal is used to temporarily reduce or remove the sensation in a part of the body.
Marcain spinal is used in adults and children of all ages before surgery to numb the lower body. It is used, for example, in bone or hip surgeries that last 3-4 hours.
What you need to know before using Marcain spinal
Do not use Marcain spinal
- if you are allergic to bupivacaine hydrochloride or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to other local anesthetics belonging to the same group (eg mepivacaine, lidocaine )
- if you have diseases of the brain, spinal cord or spine
- if you have blood poisoning
- if you have a malignant infection at or near the injection site
- if you have an injury to the spine
- if you are in a state of shock
- if your blood does not clot properly or if you are taking medicines to prevent blood clots
- if you have problems with the spinal cord due to anemia .
Warnings and cautions
Talk to your doctor or nurse before giving Marcain a spinal.
You may need to be monitored more closely or given a smaller dose if you:
- has a type of arrhythmia in the heart called AV ‑ block II or III
- treated with antiarrhythmic drugs
- have a serious liver disease
- has severe renal impairment
- is older
- has generally impaired general condition
- is pregnant (especially in later stages of pregnancy)
Neurological diseases are probably not aggravated by anesthesia, but caution should be exercised.
Other drugs and Marcain spinal
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Marcain spinal can affect or be affected by other drugs, such as:
- other local anesthetics
- drugs for arrhythmias in the heart.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Pregnancy:
There are no known risks when using this medicine for the fetus during pregnancy. In later stages of pregnancy, however, the dose should be reduced.
Breast-feeding:
Marcain spinal passes into breast milk, but it is unlikely to have any effects on the breast-fed baby.
Driving and using machines
Depending on the dose you receive, Marcain spinal can have a transient effect on your mobility and coordination.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Marcain spinal contains sodium chloride
This medicine contains less than 1 mmol sodium (23 mg) per milliliter, ie essentially ‘sodium-free’.
How to use Marcain spinal
You will receive the medicine from a doctor or nurse in the form of an injection in the lower back. Dose one of Marcain’s spinal is determined by the doctor and depends on the type of anesthesia you need, the area to be anesthetized, and how long the anesthesia should work. Your doctor will adjust dose one to your age, weight, and general health, using the lowest possible dose that provides adequate anesthesia.
If you use too much Marcain spinal
You will be given this medicine in a hospital and it is unlikely that you will be given too much. If you are worried that you have been given too high a dose or if you have any questions about the dose you have been given, talk to your doctor or nurse who will give you the medicine.
Dose one given in the spine with Marcain spinal is low which means that overdose is unlikely. If signs of overdose still occur, the physician should immediately discontinue the administration of the drug and begin appropriate treatment.
In case of an overdose of Marcain spinal, acute poisoning reactions may occur. The risk of poisoning reactions increases if the drug is accidentally injected into a blood vessel or if other local anesthetics are given at the same time. The reactions mainly affect the central nervous system and the cardiovascular system. For symptoms see section 4, Possible side effects.
If you have any further questions on the use of this product, ask your doctor or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience the following symptoms, stop treatment and contact a doctor immediately :
- signs of intoxication reactions in the central nervous system , such as numbness, tingling, loss of movement (paralysis), muscle weakness or dysesthesia (emotional disturbances) (less common side effects , may occur in up to 1 in 100 users).
- cardiac arrest (rare side effect , may affect up to 1 in 1,000 people )
- respiratory depression (rare side effect , may affect up to 1 in 1,000 people )
- severe allergic reaction that may be life-threatening, with symptoms such as difficulty breathing, swelling of the lips, throat and tongue and low blood pressure (anaphylactic shock ) (rare side effect , may affect up to 1 in 1,000 people)
Other side effects that may occur:
Very common: (may affect more than 1 user in 10)
- low blood pressure
- nausea
- slow heart rate ( bradycardia )
Common: (may affect up to 1 in 10 people)
- headache
- vomiting
- urinary retention ( urinary retention )
- Involuntary urination (urinary incontinence)
Uncommon: (may affect up to 1 in 100 people)
- back pain
Rare: (may affect up to 1 in 1000 people)
- nerve damage
- inflammation of the cobweb (the middle meninges)
- paralysis
- allergic reactions
How to store Marcain spinal
Marcain spinal is stored in a hospital by a doctor or nurse, out of sight and reach of children.
Do not store above 25 ° C. Do not freeze.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.
Contents of the pack and other information
Content declaration
- The active substance is bupivacaine hydrochloride. One ml contains 5 mg of bupivacaine hydrochloride.
- The other ingredients are sodium chloride (see section 2 “Marcain spinal contains sodium chloride” for further information), sodium hydroxide and / or hydrochloric acid (for pH adjustment) and water for injections.
What the medicine looks like and contents of the pack
Marcain spinal is a solution for injection in a glass ampoule. One glass ampoule contains 4 ml of solution.
Glass ampoule one is marked with two orange color markings around the neck of the ampoule.
One pack contains 5 glass ampoules. The glass ampoules are sterile packaged in blisters.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Aspen Pharma Trading Limited
3016 Lake Drive, Citywest Business Campus
Dublin 24, Ireland
Manufacturer:
Cenexi
52 Rue Marcel and Jacques Gaucher
94120 Fontenay sous Bois
France