HYPNOMIDATE INJECTION 2MG/ML
Active substance: ETOMIDATE
View full screen / Print PDF » Download PDF ⇩
Transcript
Package lea et: Information for the user
J-C 2013
GB - 10000000097654
Etomidate
Hypnomidate is a registered trademark
. . .
Keep this lea et. You may need to read it again If you have any further questions, ask your doctor or nurse This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours If you get side e ects and they become serious or if you notice any side e ects not listed in this lea et, please tell your doctor or nurse
Read all of this lea et carefully before you start using this medicine.
In this lea et
1 What Hypnomidate is and what it is used for 2 Before you are given Hypnomidate 3 How Hypnomidate is given 4 Possible side e ects 5 How Hypnomidate is stored 6 Further information
1 What Hypnomidate is and what it is used for
Hypnomidate contains a medicine called etomidate. It is a general anaesthetic and is used for short surgical procedures (such as in a day clinic) and for heart surgery.
2 Before you are given Hypnomidate
Do not have Hypnomidate if:
You are allergic to anything in Hypnomidate (listed in section 6 below) If you are not sure if this applies to you, talk to your doctor or nurse before having Hypnomidate. Check with your doctor or nurse before being given this medicine if you have ever had: Problems with your liver Low blood pressure Long-term treatment with strong painkillers Problems with your drinking (alcoholism) Problems with your adrenal glands not working properly Also tell your doctor if you are su ering from a serious infection in your blood (sepsis). Your doctor will carefully monitor the amount of Hypnomidate they give you or you may need other medication. If you are not sure if any of the above applies to you, talk to your doctor or nurse before having Hypnomidate. Before your anaesthetic, you will normally be given another medicine, known as a pre-med. This will probably make you feel drowsy and will also help stop any uncontrollable muscle twitches which can occur.
The e ect of Hypnomidate may be altered when it is received together with
Take special care with Hypnomidate
Strong medicines for pain called opioid analgesics such as morphine, codeine, fentanyl or alfentanil Medicines to calm you down (also called sedatives) Medicines to improve thoughts, feelings and/or behaviour (also called neuroleptics) Alcohol Talk to your doctor before having Hypnomidate if you are taking any of these medicines. They may have to change the amount of Hypnomidate you are given. You must tell your doctor before having Hypnomidate if you are pregnant, think you may be pregnant or might become pregnant. You may still be able to have Hypnomidate if your doctor thinks you need to. Hypnomidate may get into breast milk. Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breastfeeding.
Pregnancy and breast-feeding
Driving and using machines
Special monitoring
Hypnomidate may make you breathe more slowly. Your breathing will be carefully monitored until it returns to normal. Please tell your doctor or nurse if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription or herbal medicines.
Do not drive or use any tools or machines for 24 hours after having Hypnomidate. You may be less alert than usual. Ask your doctor or pharmacist for advice.
Important information about an ingredient of Hypnomidate
Hypnomidate contains propylene glycol that may cause alcohol-like symptoms
Taking other medicines
3 How Hypnomidate is given
Hypnomidate is given by a doctor experienced in using this type of medicine. Check with your doctor or nurse if you are not sure about anything. Hypnomidate is given into a vein by slow injection or as a drip (infusion). It may be diluted before use with a sodium chloride or a dextrose solution Hypnomidate does not stop pain so you may be given a painkiller at the same time Your doctor will decide how much Hypnomidate you need. This may depend on: Your body weight in kilograms Your general health Your age The type of operation you are having
Adults and children
The usual dose is 0.3 mg/kg. No more than 3 ampoules will be used.
How Hypnomidate is given
Elderly patients
Less Hypnomidate may be used in patients that are elderly or weak due to ill health. It is unlikely that you will be given too much Hypnomidate. This will be monitored during your operation.
If you have too much Hypnomidate
How much Hypnomidate is given
. . .
10000000097654.pdf - Page 1 of 3 - February 11, 2013 - 11:47:26
J-C 2013
GB - 10000000097654
4 Possible side e ects
Like all medicines, Hypnomidate can cause side e ects, although not everybody gets them. If side e ects occur, they usually do so while you are asleep. Your doctor will monitor these e ects during your operation. The following side e ects have been reported: Very common (a ects more than 1 in 10 people) Muscle twitching or jerking, with di culty moving your body Common (a ects less than 1 in 10 people) Pain or discomfort along the vein where the injection was given Dizziness and fainting. These are signs of lowered blood pressure but are mild and do not usually last long Breathing stops for a short period of time. If necessary, your breathing will be helped by a machine (ventilator) Breathing faster and/or deeper than normal Noisy breathing Being sick Feeling sick Rash Uncommon (a ects less than 1 in 100 people) Unusual muscle sti ness causing poor control of movement Vision problems Heart beats more slowly Extra heartbeats Unusual fast heartbeat Swelling, redness and clotting in a vein, which is extremely tender when touched High blood pressure Breathing more slowly or weakly than usual Hiccups Cough Too much saliva Redness of the skin Pain where the injection was given. To prevent this happening, your doctor or nurse may inject a small amount of painkiller just before giving you Hypnomidate Complications with the anaesthetic Delayed recovery from the anaesthetic Not enough painkiller Other side e ects Allergic reactions including rare cases of serious allergic reaction which may cause di culty in breathing, wheezing or coughing, and hives or nettle rash (urticaria) Adrenal glands not working properly you may feel weak, more tired than usual and lose weight Fits or convulsions Heart attack Heart problems A dangerous decrease of blood pressure which, if untreated, may lead to collapse, coma and death In ammation of the blood vessels Shallow, slow or weak breathing Di culty in breathing or wheezing, which could be fatal Rare skin condition, with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals Pinkish, itchy swellings on the skin Problems using your jaw muscles You may still have some of these e ects when you wake up. If you think you have a side e ect, or if you notice any other side e ects after your operation and they are not listed in this lea et, please tell your doctor or nurse.
. . .
5 How Hypnomidate is stored
Hypnomidate is kept out of the reach and sight of children. It is stored in the hospital pharmacy. Do not store above 25C. Hypnomidate will not be used after the expiry date stated on the label. The expiry date refers to the last day of that month.
6 Further information
The active substance in Hypnomidate is etomidate. Each millilitre (ml) contains 2 milligrams (mg) of etomidate. The other ingredients are propylene glycol and water. It may also contain very small amounts of sodium hydroxide and hydrochloric acid.
For information in large print, tape, CD or Braille, telephone 0800 7318450.
This lea et was last revised in January 2013. March 2013.
What Hypnomidate looks like and contents of the pack
Hypnomidate is supplied in a clear glass ampoule containing 10 ml of liquid in packs of 5 ampoules.
The product licence is held by:
JANSSEN-CILAG LTD, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire HP12 4EG, UK GlaxoSmithKline Manufacturing S.p.A., Strada Provinciale Asolana N. 90 (loc San Polo), 43056 Torrile (PR), Italy OR McGregor Cory Ltd, Middleton Close, Banbury, Oxfordshire OX16 4RS, UK
Hypnomidate is made by:
. . .
10000000097654.pdf - Page 2 of 3 - February 11, 2013 - 11:47:26
J-C 2013
GB - 10000000097654
Etomidate
Hypnomidate is a registered trademark
. . .
Keep this lea et. You may need to read it again If you have any further questions, ask your doctor or nurse This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours If you get side e ects and they become serious or if you notice any side e ects not listed in this lea et, please tell your doctor or nurse
Read all of this lea et carefully before you start using this medicine.
In this lea et
1 What Hypnomidate is and what it is used for 2 Before you are given Hypnomidate 3 How Hypnomidate is given 4 Possible side e ects 5 How Hypnomidate is stored 6 Further information
1 What Hypnomidate is and what it is used for
Hypnomidate contains a medicine called etomidate. It is a general anaesthetic and is used for short surgical procedures (such as in a day clinic) and for heart surgery.
2 Before you are given Hypnomidate
Do not have Hypnomidate if:
You are allergic to anything in Hypnomidate (listed in section 6 below) If you are not sure if this applies to you, talk to your doctor or nurse before having Hypnomidate. Check with your doctor or nurse before being given this medicine if you have ever had: Problems with your liver Low blood pressure Long-term treatment with strong painkillers Problems with your drinking (alcoholism) Problems with your adrenal glands not working properly Also tell your doctor if you are su ering from a serious infection in your blood (sepsis). Your doctor will carefully monitor the amount of Hypnomidate they give you or you may need other medication. If you are not sure if any of the above applies to you, talk to your doctor or nurse before having Hypnomidate. Before your anaesthetic, you will normally be given another medicine, known as a pre-med. This will probably make you feel drowsy and will also help stop any uncontrollable muscle twitches which can occur.
The e ect of Hypnomidate may be altered when it is received together with
Take special care with Hypnomidate
Strong medicines for pain called opioid analgesics such as morphine, codeine, fentanyl or alfentanil Medicines to calm you down (also called sedatives) Medicines to improve thoughts, feelings and/or behaviour (also called neuroleptics) Alcohol Talk to your doctor before having Hypnomidate if you are taking any of these medicines. They may have to change the amount of Hypnomidate you are given. You must tell your doctor before having Hypnomidate if you are pregnant, think you may be pregnant or might become pregnant. You may still be able to have Hypnomidate if your doctor thinks you need to. Hypnomidate may get into breast milk. Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breastfeeding.
Pregnancy and breast-feeding
Driving and using machines
Special monitoring
Hypnomidate may make you breathe more slowly. Your breathing will be carefully monitored until it returns to normal. Please tell your doctor or nurse if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription or herbal medicines.
Do not drive or use any tools or machines for 24 hours after having Hypnomidate. You may be less alert than usual. Ask your doctor or pharmacist for advice.
Important information about an ingredient of Hypnomidate
Hypnomidate contains propylene glycol that may cause alcohol-like symptoms
Taking other medicines
3 How Hypnomidate is given
Hypnomidate is given by a doctor experienced in using this type of medicine. Check with your doctor or nurse if you are not sure about anything. Hypnomidate is given into a vein by slow injection or as a drip (infusion). It may be diluted before use with a sodium chloride or a dextrose solution Hypnomidate does not stop pain so you may be given a painkiller at the same time Your doctor will decide how much Hypnomidate you need. This may depend on: Your body weight in kilograms Your general health Your age The type of operation you are having
Adults and children
The usual dose is 0.3 mg/kg. No more than 3 ampoules will be used.
How Hypnomidate is given
Elderly patients
Less Hypnomidate may be used in patients that are elderly or weak due to ill health. It is unlikely that you will be given too much Hypnomidate. This will be monitored during your operation.
If you have too much Hypnomidate
How much Hypnomidate is given
. . .
10000000097654.pdf - Page 1 of 3 - February 11, 2013 - 11:47:26
J-C 2013
GB - 10000000097654
4 Possible side e ects
Like all medicines, Hypnomidate can cause side e ects, although not everybody gets them. If side e ects occur, they usually do so while you are asleep. Your doctor will monitor these e ects during your operation. The following side e ects have been reported: Very common (a ects more than 1 in 10 people) Muscle twitching or jerking, with di culty moving your body Common (a ects less than 1 in 10 people) Pain or discomfort along the vein where the injection was given Dizziness and fainting. These are signs of lowered blood pressure but are mild and do not usually last long Breathing stops for a short period of time. If necessary, your breathing will be helped by a machine (ventilator) Breathing faster and/or deeper than normal Noisy breathing Being sick Feeling sick Rash Uncommon (a ects less than 1 in 100 people) Unusual muscle sti ness causing poor control of movement Vision problems Heart beats more slowly Extra heartbeats Unusual fast heartbeat Swelling, redness and clotting in a vein, which is extremely tender when touched High blood pressure Breathing more slowly or weakly than usual Hiccups Cough Too much saliva Redness of the skin Pain where the injection was given. To prevent this happening, your doctor or nurse may inject a small amount of painkiller just before giving you Hypnomidate Complications with the anaesthetic Delayed recovery from the anaesthetic Not enough painkiller Other side e ects Allergic reactions including rare cases of serious allergic reaction which may cause di culty in breathing, wheezing or coughing, and hives or nettle rash (urticaria) Adrenal glands not working properly you may feel weak, more tired than usual and lose weight Fits or convulsions Heart attack Heart problems A dangerous decrease of blood pressure which, if untreated, may lead to collapse, coma and death In ammation of the blood vessels Shallow, slow or weak breathing Di culty in breathing or wheezing, which could be fatal Rare skin condition, with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals Pinkish, itchy swellings on the skin Problems using your jaw muscles You may still have some of these e ects when you wake up. If you think you have a side e ect, or if you notice any other side e ects after your operation and they are not listed in this lea et, please tell your doctor or nurse.
. . .
5 How Hypnomidate is stored
Hypnomidate is kept out of the reach and sight of children. It is stored in the hospital pharmacy. Do not store above 25C. Hypnomidate will not be used after the expiry date stated on the label. The expiry date refers to the last day of that month.
6 Further information
The active substance in Hypnomidate is etomidate. Each millilitre (ml) contains 2 milligrams (mg) of etomidate. The other ingredients are propylene glycol and water. It may also contain very small amounts of sodium hydroxide and hydrochloric acid.
For information in large print, tape, CD or Braille, telephone 0800 7318450.
This lea et was last revised in January 2013. March 2013.
What Hypnomidate looks like and contents of the pack
Hypnomidate is supplied in a clear glass ampoule containing 10 ml of liquid in packs of 5 ampoules.
The product licence is held by:
JANSSEN-CILAG LTD, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire HP12 4EG, UK GlaxoSmithKline Manufacturing S.p.A., Strada Provinciale Asolana N. 90 (loc San Polo), 43056 Torrile (PR), Italy OR McGregor Cory Ltd, Middleton Close, Banbury, Oxfordshire OX16 4RS, UK
Hypnomidate is made by:
. . .
10000000097654.pdf - Page 2 of 3 - February 11, 2013 - 11:47:26
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
