Dexmedetomidine Hydrochloride Injection 80mcg/1ml
Dexmedetomidine Hydrochloride Injection 100mcg/1ml
Dexmedetomidine Hydrochloride Injection 200mcg/2ml
Dexmedetomidine Hydrochloride Injection 400mcg/4ml
Dexmedetomidine Hydrochloride Injection 1000mcg/10ml
Package leaflet: Information for the user
Dexmedetomidine
Read all of this leaflet carefully before you are given 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 or nurse.
- If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Dexmedetomidine
Hydrochloride is and what it is used for
2. What you need to know before you are given Dexmedetomidine Hydrochloride
3. How to use Dexmedetomidine Hydrochloride
4. Possible side effects
5. How to store Dexmedetomidine Hydrochloride
6. Contents of the pack and other information
1. WHAT DEXMEDETOMIDINE HYDROCHLORIDE IS AND WHAT IT IS USED FOR
Dexmedetomidine Hydrochloride contains an active substance called dexmedetomidine which belongs to a medicine group called sedatives. It is used to provide sedation (a state of calm, drowsiness or sleep) for adult patients in hospital intensive care settings or awake sedation during different diagnostic or surgical procedures.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DEXMEDETOMIDINE HYDROCHLORIDE
You must not be given Dexmedetomidine Hydrochloride
- if you are allergic to dexmedetomidine or any of the other ingredients of this medicine (listed in section 6).
- if you have some disorders of heart rhythm (heart block grade 2 or 3).
- if you have very low blood pressure which does not respond to treatment.
- if you have recently had a stroke or other serious condition affecting the blood supply to the brain.
Warnings and precautions
Before you have this medicine, tell your doctor or nurse if any of the following apply as Dexmedetomidine Hydrochloride should be used cautiously:
- if you have an abnormally slow heart rate (either due to illness or high levels of physical fitness)
- if you have low blood pressure
- if you have low blood volume, for example after bleeding
- if you have certain heart disorders
- if you are elderly
- if you have a neurological disorder (for instance head or spinal cord injury or stroke)
- if you have severe liver problems
- if you have ever developed a serious fever after some medicines, especially anaesthetics
Other medicines and Dexmedetomidine Hydrochloride
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
The following medicines may enhance the effect of Dexmedetomidine Hydrochloride :
- medicines that help you sleep or cause sedation (e.g. midazolam, propofol)
- strong pain medicines (e.g. opioids such as morphine, codeine)
- anaesthetic medicines (e.g. sevoflurane, isoflurane)
If you are using medicines which lower your blood pressure and heart rate, co-administration with Dexmedetomidine Hydrochloride may enhance this effect. Dexmedetomidine Hydrochloride should not be used with medicines that cause temporary paralysis.
Pregnancy and breast-feeding
Dexmedetomidine Hydrochloride should not be used during pregnancy or breast-feeding unless clearly necessary.
Ask your doctor for advice before having this medicine
Driving and using machines
Dexmedetomidine Hydrochloride has a major impact on the ability to drive and use machines. After you have been given Dexmedetomidine Hydrochloride you must not drive, operate machinery, or work in dangerous situations until the effects are completely gone. Ask your doctor when you can start doing these activities again and when you can go back to this kind of work.
Excipients
Dexmedetomidine Hydrochloride contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ?sodium-free?.
3. HOW TO USE DEXMEDETOMIDINE HYDROCHLORIDE
Hospital intensive care
Dexmedetomidine Hydrochloride is administered to you by a doctor or nurse in hospital intensive care.
Procedural sedation/awake sedation
Dexmedetomidine Hydrochloride is administered to you by a doctor or a nurse prior to and/or during diagnostic or surgical procedures requiring sedation, i.e. procedural/awake sedation.
Your doctor will decide on a suitable dose for you. The amount of Dexmedetomidine Hydrochloride depends on your age, size, the general condition of health, the level of sedation needed and how you respond to the medicine. Your doctor may change your dose if needed and will monitor your heart and blood pressure during the treatment.
Dexmedetomidine Hydrochloride is diluted and it is given to you as an infusion (drip) into your veins.
After sedation/wake-up
- The doctor will keep you under medical supervision for some hours after the sedation to make sure that you feel well.
- You should not go home unaccompanied.
- Medicines to help you sleep, cause sedation or strong painkillers may not be appropriate for some time after you have been given Dexmedetomidine Hydrochloride. Talk to your doctor about the use of these medicines and about the use of alcohol.
If you have been given more Dexmedetomidine Hydrochloride than you should
If you are given too much Dexmedetomidine Hydrochloride, your blood pressure may go up or down, your heartbeat may slow down, you may breathe more slowly and you may feel more drowsy. Your doctor will know how to treat you based on your condition.
If you have any further questions on the use of this medicine, ask your doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (affects more than 1 user in 10)
- slow heart rate
- low or high blood pressure
- change in breathing pattern or stopping breathing.
Common (affects 1 to 10 users in 100)
- chest pain or heart attack
- fast heart rate
- low or high blood sugar
- nausea, vomiting or dry mouth
- restlessness
- high temperature
- symptoms after stopping the medicine
Uncommon (affects 1 to 10 users in 1,000)
- reduced heart function
- swelling of the stomach
- thirst
- a condition where there is too much acid in the body
- low albumin level in the blood
- shortness of breath
- hallucinations
- the medicine is not effective enough.
Not known (frequency cannot be estimated from the available data)
- increased need to pass urine
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE DEXMEDETOMIDINE HYDROCHLORIDE
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
This medicine does not require any special temperature storage conditions. Keep the ampoules or vials in the outer carton in order to protect from light.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Dexmedetomidine Hydrochloride contains
Dexmedetomidine Hydrochloride Injection 100mcg/1ml
Each ml contains:
Dexmedetomidine Hydrochloride USP
Equivalent to Dexmedetomidine 100mg
Water for Injection q.s
What Dexmedetomidine Hydrochloride looks like and contents of the pack
Dexmedetomidine Hydrochloride is supplied in packs containing 1, 4 or 5 vials.
Not all pack sizes may be marketed.
7. Manufactured in India by:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
Mumbai-400001
at: Ahmedabad- Gujarat, INDIA.
Ho.NO.+91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)