2.5 mg / ml and 5 mg / ml injection solution
bupivacaine hydrochloride
What Marcain is and what it is used for
Marcain contains the active substance bupivacaine hydrochloride, which is a local anesthetic. It temporarily blocks the nerve signals in the area where it is injected.
Marcain is used to temporarily reduce or remove the sensation in a part of the body.
Marcain is given as:
- local anesthetics in surgery in adults and children over 12 years of age
- acute painkillers for adults (including pain relief during childbirth), infants and children over 1 year of age.
What you need to know before using Marcain
Do not use Marcain
- 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 very low blood pressure
- intravenously (for example in the case of Bier’s blockade).
Warnings and cautions
Talk to your doctor or nurse before giving Marcain.
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
- has impaired cardiovascular function has a serious liver disease
- has a severe impaired renal function
- treated with antiarrhythmic drugs
- is older
- has generally impaired general condition
- is pregnant (especially in later stages of pregnancy).
The doctor will be observant of any side effects that may occur in connection with the administration of the drug in the eye.
Children and young people
Only a limited amount of data is available for the use of Marcain in newborns or children under 1 year of age.
Other drugs and Marcain
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Marcain 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:
With cervical anesthesia, there is an increased risk of an increase or decrease in the fetal heart rate.
Breast-feeding:
Marcain 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 and how it is given, Marcain 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 contains sodium chloride
This medicine contains 62 mg sodium (the main ingredient in table salt/table salt) per vial. This corresponds to 2.6% of the maximum recommended daily sodium intake for adults. This should be considered by patients on a low-salt diet.
How to use Marcain
You will receive the medicine from a doctor or nurse in the form of an injection. Dose one of Marcain is determined by the doctor and depends on the type of anesthesia you need, the area to be anesthetized, and the duration of the anesthesia. The doctor adjusts dose one to your age, weight, and general health, using the lowest possible dose one that provides adequate anesthesia.
If you use more Marcain than you should
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.
In case of overdose, poisoning reactions may occur, usually within 15-60 minutes after injection. If Marcain is accidentally injected into a blood vessel, poisoning reactions can quickly (within seconds or minutes) occur. The reactions mainly affect the central nervous system and the cardiovascular system, see section 4.
If you have any further questions on the use of this product, ask your doctor or nurse.
Possible side effect
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 cramps, tingling or numbness around the mouth, numbness in the tongue, increased sensitivity to sound, visual disturbances, loss of consciousness, tremors, intoxication, tinnitus , difficulty speaking clearly ( less common side effects may occur in up to 1 out of 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
Common (may affect up to 1 in 10 people):
- tingling sensation (tingling) in the skin
- dizziness
- slow heart rate ( bradycardia )
- high blood pressure
- vomiting
- urinary retention ( urinary retention )
Rare (may affect up to 1 in 1,000 people):
- double vision
- allergic reactions
- nerve damage
- inflammation of the cobweb (the middle meninges)
- paralysis
- irregular heartbeat
How to store Marcain
Marcain is kept in 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 2.5 mg and 5 mg of bupivacaine hydrochloride, respectively.
- The other ingredients are sodium chloride (see section 2 “Marcain 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 is a clear, colorless solution for injection provided in glass vials. One vial contains 20 ml.
One pack contains 5 vials.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Aspen Pharma Trading Limited
3016 Lake Drive, Citywest Business Campus
Dublin 24, Ireland
Manufacturer:
Recipharm Monts
Uses de Monts
18, Rue de Montbazon
F-37260 Monts
France