Atracurium Besylate Injection USP 25mg/5ml
Atracurium Besylate Injection USP 50mg/5ml
Atracurium Besylate Injection USP 100mg/10ml
Atracurium besilate
Read all of this leaflet carefully before you start having this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions ask your doctor, pharmacist or nurse.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
- What Atracurium Besylate Injection USP 100mg/10ml / 50mg/5ml / 25mg/2.5ml is and what it is used for
- What you need to know before you have Atracurium Besylate Injection USP 100mg/10ml / 50mg/5ml / 25mg/2.5ml
- How to have Atracurium Besylate Injection USP 100mg/10ml / 50mg/5ml / 25mg/2.5ml
- Possible side effects
- How to store Atracurium Besylate Injection USP 100mg/10ml / 50mg/5ml / 25mg/2.5ml
- Contents of the pack and other information
1. WHAT ATRACURIUM BESYLATE INJECTION USP 100MG/10ML / 50MG/5ML / 25MG/2.5ML IS AND WHAT IT IS USED FOR
Atracurium Besylate Injection USP 100mg/10ml / 50mg/5ml / 25mg/2.5ml contains a medicine called atracurium besilate. This belongs to a group of medicines called muscle relaxants.
Atracurium Besylate Injection USP 100mg/10ml / 50mg/5ml / 25mg/2.5ml is used:
- to relax muscles during operations on adults and children over 1 month of age
- to help insert a tube into the windpipe (tracheal intubation), if a person needs help to breathe
- To relax the muscles of adults in intensive care.
Ask your doctor if you would like more explanation about this medicine.
2. WHAT YOU NEED TO KNOW BEFORE YOU HAVE ATRACURIUM BESYLATE INJECTION USP 100MG/10ML / 50MG/5ML / 25MG/2.5ML Do not have Atracurium Besylate Injection USP 100mg/10ml / 50mg/5ml / 25mg/2.5ml Taj Pharma if:
- you are allergic to atracurium besilate, any other muscle relaxant or any of the other ingredients in Atracurium Besylate Injection USP 100mg/10ml / 50mg/5ml / 25mg/2.5ml (listed in section 6)
- you have reacted badly to an anaesthetic before.
Do not have Atracurium Besylate Injection USP 100mg/10ml / 50mg/5ml / 25mg/2.5ml if any of the above apply to you. If you are not sure, talk to your doctor, nurse or pharmacist before you have Atracurium Besylate Injection USP 100mg/10ml / 50mg/5ml / 25mg/2.5ml.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before having Atracurium Besylate Injection USP 100mg/10ml / 50mg/5ml / 25mg/2.5ml if:
- you have muscle weakness, tiredness or difficulty in coordinating your movements (myasthenia gravis)
- you have a neuromuscular disease, such as a muscle-wasting disease, paralysis, motor neurone disease or cerebral palsy
- you have a severe electrolyte imbalance
- you have a lower than normal volume of blood (hypovolaemia)
- you have a burn which requires medical treatment
- you have ever had an allergic reaction to any muscle relaxant which was given as part of an operation
- you have a history of sensitivity to histamine. In particular, spasm of the airways may occur if you have a history of allergy or asthma.
If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before you are given Atracurium Besylate Injection USP 100mg/10ml / 50mg/5ml / 25mg/2.5ml.
Other medicines and Atracurium Besylate Injection USP 100mg/10ml / 50mg/5ml / 25mg/2.5ml
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because these medicines can affect how well Atracurium Besylate Injection USP 100mg/10ml / 50mg/5ml / 25mg/2.5ml works or can cause side effects.
In particular tell your doctor, nurse or pharmacist if you are taking any of the following:
- anaesthetics (used to reduce sensation and pain during surgical procedures)
- antibiotics (used to treat infections)
- medicines for heart conditions
- medicines for high blood pressure
- water tablets (diuretics), such as furosemide
- medicines for fits (epilepsy), such as phenytoin or carbamazepine
- medicines containing magnesium, such as those to treat indigestion and heartburn
- drugs for Alzheimer?s disease (anticholinesterases e.g. donepezil)
- medicines for mental illness, such as lithium
- medicines for inflammation of the joints, such as chloroquine or D-penicillamine
- steroids.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before having this medicine.
Driving and using machines
It can be dangerous to drive or operate machinery too soon after having had an operation. Your doctor will tell you how long to wait before you can drive and use machinery.
3. HOW TO HAVE ATRACURIUM BESYLATE INJECTION USP 100MG/10ML / 50MG/5ML / 25MG/2.5ML
How your injection is given
You will never be expected to give yourself this medicine. It will always be given to you by a person who is qualified to do so.
Atracurium Besylate Injection USP 100mg/10ml / 50mg/5ml / 25mg/2.5ml can be given:
- as a single injection into your vein (intravenous bolus injection)
- as a continuous infusion into your vein. This is where the drug is slowly given to you over a long period of time.
Your doctor will decide the way you are given the drug and the dose you will receive. It will depend on:
- your body weight
- the amount and duration of muscle relaxation required
- your expected response to the medicine.
Children less than 1-month-old should not have this medicine.
If you receive more Atracurium Besylate Injection USP 100mg/10ml / 50mg/5ml / 25mg/2.5ml than you should
Atracurium Besylate Injection USP 100mg/10ml / 50mg/5ml / 25mg/2.5ml will always be given under carefully controlled conditions. However, if you think that you have been given more than you should tell your doctor or nurse immediately.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Atracurium Besylate Injection USP 100mg/10ml / 50mg/5ml / 25mg/2.5ml can cause side effects, although not everybody gets them. The following effects may happen with this medicine:
Allergic reactions
If you have an allergic reaction, tell your doctor or nurse straight away. The signs may include:
Common side effects (may affect up to 1 in 10 people)
- a decrease in blood pressure
- reddening of your skin
Uncommon side effects (may affect up to 1 in 100 people)
- wheezing or coughing
Rare side effects (may affect up to 1 in 1,000 people)
- a lumpy skin rash or ?hives? anywhere on your body
Very Rare side effects (may affect up to 1 in 10,000 people)
- sudden wheeziness, chest pain or chest tightness
- swelling of your eyelids, face, lips, mouth or tongue
- a decrease in heart rate
- shock, circulatory failure, cardiac arrest
Very rarely a severe allergic reaction can occur when given one or more anaesthetic agent.
Other side effects (unknown frequency) that you may experience are:
- seizures
- muscle disease (myopathy) or muscle weakness
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
5. HOW TO STORE ATRACURIUM BESYLATE INJECTION USP 100MG/10ML / 50MG/5ML / 25MG/2.5ML
- Keep out of the sight and reach of children
- Do not use Atracurium Besylate Injection USP 100mg/10ml / 50mg/5ml / 25mg/2.5ml after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of that month
- Store between 2 and 8?C. Do not freeze
- Keep in the outer carton in order to protect from light
- When Atracurium Besylate Injection USP 100mg/10ml / 50mg/5ml / 25mg/2.5ml is made up it should be used straight away. Any unused solution should be thrown away
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Atracurium Besylate Injection USP 100mg/10ml contains
Each ml of Injection contains:
Atracurium Besylate equivalent to
Atracurium USP???????……..10mg
The other ingredients are benzene sulfonic acid and Water for Injections.
What Atracurium Besylate Injection USP 100mg/10ml / 50mg/5ml / 25mg/2.5ml looks like and contents of the pack
Atracurium Besylate Injection USP 100mg/10ml / 50mg/5ml / 25mg/2.5ml injection comes in boxes of 5 by 2.5 ml and 5 ml glass ampoules or 2 by 25 ml glass vials.
Each vial/ampoule contains 10 mg/ml of the active ingredient atracurium besilate.
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at: Ahmedabad- Gujarat, INDIA.
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Toll Free Phone: (1800-222-434 / 1800- 222-825)