2.5 mg / ml + 5 micrograms / ml and 5 mg / ml + 5 micrograms / ml injection solution
bupivacaine hydrochloride and adrenaline
What Marcain Adrenaline is and what it is used for
Marcain Adrenaline contains two different active substances. One is bupivacaine hydrochloride, which is a local anesthetic that temporarily blocks the nerve signals in the area where it is injected. The other is adrenaline which prolongs the effect of bupivacaine. Adrenaline also reduces the risk of side effects.
Marcain Adrenaline is used to temporarily reduce or remove the sensation in a part of the body.
Marcain Adrenaline 2.5 mg / ml + 5 micrograms / ml is given as:
- local anesthetic before surgery for adults and children over 12 years of age
- acute painkillers for adults and children over 1 year of age
Marcain Adrenaline 5 mg / ml + 5 micrograms / ml is given as:
- local anesthetic before surgery for adults and children over 12 years of age
- acute pain relief for adults and children over 12 years of age
What you need to know before using Marcain Adrenaline
Do not use Marcain Adrenaline
- if you are allergic to adrenaline , 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 (Biers blockade)
- to anesthetize an area with end arteries (such as the penis).
Warnings and cautions
Talk to your doctor or nurse before giving Marcain Adrenaline .
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
- have ischemic heart disease such as heart attack or angina
- have severe diabetes
- has impaired heart function and blood circulation
- have a serious liver disease
- has severe renal impairment
- have too much hormone production in the thyroid gland ( hyperthyroidism )
- have problems with blood circulation in the brain
- is pregnant (especially in later stages of pregnancy)
- have very high blood pressure or high blood pressure that is left untreated
- is older
- has a reduced general permit
- if you are being treated with antiarrhythmic drugs.
The doctor will be observant of any side effects that may occur in connection with the administration of the drug in the eye.
The doctor will also be careful when giving the medicine in peripheral parts of the body such as fingers (or parts of the body that otherwise have a low blood supply) and when giving large amounts.
Children and young people
Marcain Adrenaline should not be given to newborns and children under 1 year of age as available data is limited. For pain relief in children aged 1-12 years, the lower strength of Marcain Adrenaline should be used.
Other drugs and Marcain Adrenaline
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Be especially careful if you are taking the following medicines:
- other local anesthetics
- drugs for arrhythmias in the heart)
- medicines for high blood pressure , angina, heart failure , arrhythmias and glaucoma , for the prevention of migraines and after myocardial infarction (non-selective beta-blockers , eg propranolol)
- antidepressants and painkillers ( tricyclic antidepressants )
- medicines used to expel the placenta and reduce bleeding after childbirth (ergot-type medicines)
- inhaled anesthetics (eg halothane)
- medicines used to treat psychosis , such as sleeping pills and nausea (phenothiazines and butyrophenones).
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:
When Marcain Adrenaline is used for cervical anesthesia during childbirth, there is an increased risk of an increase or decrease in the baby’s heart rhythm. The baby’s heart rhythm will be checked. In addition, adrenaline can reduce uterine contractions and blood flow.
Breast-feeding:
Bupivacaine passes into breast milk, but it is unlikely to have any effects on the breast-fed baby. It is not known whether adrenaline passes into breast milk, but it is unlikely that breastfed babies can be affected.
Driving and using machines
Depending on the dose you receive, Marcain Adrenaline 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 Adrenaline contains sodium chloride and sodium metabisulfite
This medicine contains 67 mg of sodium (the main ingredient in table salt/table salt) per vial. This corresponds to 2.9% of the maximum recommended daily sodium intake for adults.
Marcain Adrenaline contains sodium metabisulfite (E 223) which in rare cases can cause severe hypersensitivity reactions and convulsions in the trachea. Tell your healthcare provider if you are allergic to sodium metabisulfite.
How to use Marcain Adrenaline
You will receive Marcain Adrenaline from a doctor or nurse, in the form of an injection. The dose of one of the medicines 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 and uses the lowest possible dose one that provides adequate anesthesia.
If you use more Marcain Adrenaline 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 Adrenaline is accidentally injected into a blood vessel, poisoning reactions can occur quickly (within seconds or minutes). 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 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 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 Adrenaline
Marcain Adrenaline 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. Keep the vial in the outer carton. Sensitive to light.
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 substances are bupivacaine hydrochloride and adrenaline . One ml contains 2.5 mg bupivacaine hydrochloride and 5 micrograms adrenaline or 5 mg bupivacaine hydrochloride and 5 micrograms adrenaline .
- The other ingredients are sodium chloride, sodium metabisulfite, sodium hydroxide and / or hydrochloric acid (for pH adjustment) and water for injections. See section 2 “Marcain Adrenaline contains sodium chloride and sodium metabisulfite” for further information.
What the medicine looks like and contents of the pack
Marcain Adrenaline 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
Aspen Pharma Trading Limited
3016 Lake Drive, Citywest Business Campus
Dublin 24, Ireland
Tel. 0046 856642572