Marcain® Polyamp® Steripack 0.25% w/v and 0.5% w/v Solution for Injection
1. What Marcain Polyamp Steripack is and what it is used for
2. What you need to know before Marcain Polyamp Steripack is given to you
3. How Marcain Polyamp Steripack is given to you
4. Possible side effects
5. How to store Marcain Polyamp Steripack
6. Contents of the pack and other information
Marcain Polyamp Steripack contains a medicine called bupivacaine hydrochloride. It belongs to a group of medicines called local anaesthetics.
Marcain Polyamp Steripack is used to numb (anaesthetise) parts of the body. It is used to stop pain happening or to provide pain relief. It can be used to:
You must not be given this medicine if any of the above apply to you. If you are not sure, talk to your doctor or nurse before you are given this medicine.
Talk to your doctor or nurse before having Marcain Polyamp Steripack:
If you are not sure if any of the above apply to you, talk to your doctor or nurse before you are given this medicine.
Tell your doctor if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Marcain Polyamp Steripack can affect the way some medicines work and some medicines can have an effect on Marcain Polyamp Steripack.
In particular, tell your doctor if you are taking any of the following medicines:
If you are pregnant or breast-feeding, think that you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine
Marcain Polyamp Steripack may make you feel sleepy and affect the speed of your reactions. After you have been given Marcain Polyamp Steripack, you should not drive or use tools or machines until the next day.
Marcain Polyamp Steripack contains up to 3.2 milligrams (mg) of sodium in each millilitre (ml), equivalent to 31.5 mg per 10 ml ampoule. Your doctor will take this into account if you are on a sodium controlled diet.
Marcain Polyamp Steripack will be given to you by a doctor. Your doctor will know the correct way to give you this medicine.
The dose that your doctor gives you will depend on the type of pain relief that you need and the part of your body that the medicine will be injected into. It will also depend on your body size, age, and physical condition. Usually one dose will last long enough but more doses may be given if the surgery takes a long time.
Marcain Polyamp Steripack will be given to you as an injection or infusion. The part of the body where you are injected will depend on why you are being given Marcain Polyamp Steripack. Your doctor will give you Marcain Polyamp Steripack in one of the following places:
When Marcain Polyamp Steripack is injected into the body in one of these ways, it stops the nerves from being able to pass pain messages to the brain. It will slowly wear off when the medical procedure is over.
Depending on the type of required analgesia Marcain Polyamp Steripack is injected slowly either into the epidural space (part of the spine) or other parts of the body by a doctor experienced in paediatric anaesthetic techniques. Dosage depends on the age and weight of the patient and will be determined by the doctor.
Serious side effects from getting too much Marcain Polyamp Steripack are unlikely. They need special treatment and the doctor treating you is trained to deal with these situations. The first signs of being given too much Marcain Polyamp Steripack are usually as follows:
To reduce the risk of serious side effects, your doctor will stop giving you Marcain Polyamp Steripack as soon as these signs appear. This means that if any of these happen to you, or you think you have received too much Marcain Polyamp Steripack, tell your doctor immediately.
More serious side effects from being given too much Marcain Polyamp Steripack include twitching of your muscles, fits (seizures), being sick (vomiting) and loss of consciousness.
Like all medicines, this medicine can cause side effects although not everybody gets them.
Severe allergic reactions (rare, may affect up to 1 in 1,000 people)
If you have a severe allergic reaction, tell your doctor immediately. The signs may include sudden onset of:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Side effects in children are similar to those in adults.
Do not be concerned by this list of possible side effects. You may not get any of them.
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
The active ingredient is bupivacaine hydrochloride. Marcain Polyamp Steripack comes in two strengths. Each ml of the 0.25% w/v strength contains bupivacaine hydrochloride 2.64 mg equivalent to bupivacaine hydrochloride anhydrous 2.5 mg (25 mg per 10 ml Polyamp). Each ml of the 0.5% w/v strength contains bupivacaine hydrochloride 5.28 mg equivalent to bupivacaine hydrochloride anhydrous 5 mg (50 mg per 10 ml Polyamp).
The other ingredients are sodium chloride, sodium hydroxide/hydrochloric acid, and water for injections.
Marcain Polyamp Steripack is a solution for injection. It comes in 10 ml or 20 ml plastic ampoules. Not all pack sizes may be marketed.
The Marketing Authorisations for Marcain Polyamp Steripack 0.25% w/v and 0.5% w/v are held by
Marcain Polyamp Steripack 0.25% w/v and 0.5% w/v is manufactured by