Wednesday 21 September 2016

Lidocaine Hydrochloride Injection 1%+2% (International Medication Systems)




6911901D


7-04


222



LIDOCAINE HYDROCHLORIDE INJECTION



BP MINIJET 1% & 2% w/v


SOLUTION FOR INJECTION



Please read this leaflet carefully. It contains important information about your medicine. If there is anything you do not understand, please ask your doctor.




What is this medicine?


This medicine is called Lidocaine hydrochloride Injection BP Minijet. There are two strengths available. One contains 10mg lidocaine hydrochloride per ml in vials of 10ml and the other 20mg lidocaine hydrochloride per ml in vials of 5ml, as the active ingredient.


The active ingredient in this medicine is Lidocaine hydrochloride. This is the new name for Lidocaine (Lignocaine) hydrochloride. The ingredient itself has not changed.


They also contain hydrochloric acid, sodium chloride, sodium hydroxide and water for injections.


Lidocaine is a local anaesthetic. It numbs the area of the body it is applied to.




Who makes it?



Marketing Authorisation Holder:



International Medication Systems (UK) Limited

208 Bath Road

Slough

Berkshire

SL1 3WE

UK




Manufacturer:



International Medication Systems (UK) Ltd.

Unit 14

Foster Avenue

Woodside Park

Dunstable

Beds
LU5 5TA

UK





What is it for?


Lidocaine numbs the area of the body it is applied to and is used to stop pain being felt during investigations, operations or delivery.


It can also be used to treat heartbeat disturbances, especially after heart attacks or heart surgery.




Before you are given Lidocaine


  • Are you allergic to any of the ingredients or other local anaesthetics?

  • Do you have porphyria, epilepsy, blood disorders, liver, heart or chest disease?

  • Do you have severe renal disease?

  • Are you taking propranolol (e.g. for high blood pressure), cimetidine (e.g. for stomach ulcer), or drugs for your heart?

  • Are you having clonidine or adrenaline as an epidural injection into the spine?

  • Are you pregnant, likely to become pregnant, or breast-feeding?

  • Are you about to have a general anaesthetic that will involve the use of suxamethonium?

If the answer to any of these questions is YES, please tell the doctor, even if you have already had the Lidocaine.




How much will I be given?


The lowest possible dose is used. The dose depends on the area to be numbed and the way it is being given and how you respond to it.



For local anaesthesia:


Lidocaine is injected into the area that is to be numbed.


In adults: the usual dose should not exceed 200mg.


In children: the usual dose should not exceed 3mg per kg they weigh.


For an epidural, a ‘test dose’ is given 5 minutes before the total dose. For continuous epidural, caudal or paracervical anaesthetic (often used in obstetrics), the maximal dose should not be repeated at intervals under 90 minutes.


So, if the maximal dose for you was 100mg, you should not get 100mg altogether more often than every 90 minutes.


For i.v. regional anaesthesia (Bier’s block), you will have a tourniquet applied around the affected limb. This keeps the lidocaine in the area it is needed. The tourniquet should not be released until at least 20 minutes after administration.




For heart problems:


Lidocaine is given by injection into a blood vessel.


In adults: the usual dose is 50-100mg given into a vein. This can be repeated after 5 minutes, but no more than 300mg should be given in any hour. Lidocaine can be given through a drip into the blood stream at a rate of 1- 4mg/minute.


In children: 0.8-1mg for every kg they weigh, repeated if necessary up to 3-5mg/kg followed by a drip of 10-50 micrograms/kg/minute.


Your doctor may monitor your heart whilst giving you lidocaine: do not worry, this is a normal safety precaution.


If you are elderly the dose may be smaller.


Usually, the lidocaine drip is not given for more than 24 hours.


Do talk to your doctor or nurse to find out what dose you have had or are having.


If you think you have had too much medicine, tell your doctor.





Are there any side effects?


Very rarely, a patient may have an allergic reaction including breathlessness and collapse.


Other side effects may include light headedness, drowsiness, dizziness, mood changes, ringing in your ears, fear, vision difficulties, sickness, or feeling sick, headache, pain or discomfort in the buttocks or legs, unusual blood readings ,sensations of heat, cold or numbness, twitching, fits, shaking, unconsciousness, stopping breathing, low blood pressure, changes in heartbeat, collapse including the heart stopping.


If you think it has upset you in ANY way, please tell your doctor.




How to store this medicine


Do not store above 25°C.


Do not use after expiry date printed on carton and vial label.


KEEP THIS AND ALL MEDICINES OUT OF REACH AND SIGHT OF CHILDREN


Leaflet revised: June 2004


This leaflet only applies to product Lidocaine Hydrochloride Injection BP Minijet 1% & 2% w/v.






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