MIDAZOLAM INJECTION 1MG/1ML
Active substance: MIDAZOLAM
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PACKAGE LEAFLET: INFORMATION FOR THE USER
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4. Possible side effects
Like all medicines, Midazolam Injection can cause side effects, although not everybody gets them. Repeated use of midazolam can result in tolerance and addiction. If any of the following symptoms occur tell your doctor immediately. These are symptoms of a serious allergic reaction. sudden wheeziness and tightness of chest swelling of eyelids, face or lips skin lumps or hives skin rash (red spots), itchiness, fever collapse Other possible side effects include: feeling or being sick slower breathing than usual or difficulty breathing a slow heartbeat low blood pressure, the symptoms of which include feeling dizzy or light-headed, feeling weak and fainting feeling restless or worried involuntary movements confusion slurred speech blurred vision a lack or energy dizziness seeing or hearing things that arent real (hallucinations). These hallucinations may be sexual. temporary loss of memory for a short time after being given this medicine Rarely you may experience pain at the site of injection blood clots, the symptoms of which include swelling, redness and pain in the area. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
6. Further Information
What Midazolam Injection contains The active substance is Midazolam 50mg in 50ml The other ingredients are hydrochloric acid 10%, sodium chloride, sodium hydroxide and water for injections What Midazolam Injection looks like and contents of the pack Midazolam Injection is a clear, colourless solution supplied in a clear glass vial containing 50ml of the solution. Marketing Authorisation Holder Aurum Pharmaceuticals Ltd. Bampton Road, Harold Hill, Romford, Essex, RM3 8UG Manufacturer Rotexmedica GMBH Arzneimittel Werk Bunsenstrasse 4, D-22946 Trittau Germany This leaflet was last approved in 08/2008. PL 12064/0038
Midazolam Injection 1mg/1ml Midazolam
Read all of this leaflet carefully before you are given this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or nurse. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse. rifampicin, a medicine used to treat tuberculosis antihistamines (medicines used to treat allergies) medicines used to treat serious mental disorders (antipsychotics) medicines used ot treat high blood pressure (alpha-blockers) lofexidine, a medicine used to treat withdrawal symptoms caused when stopping taking opioid drugs such as morphine baclofen, a medicine used relax the muscles disulfiram, a medicine used to help treat alcoholism nabilone, a medicine used to treat feeling or being sick cimetidine, a medicine used to treat stomach ulcers If you have any doubts about whether you should be given Midazolam Injection please discuss these with the doctor, anaesthetist or nurse before use. Pregnancy and breast-feeding If you are pregnant, trying for a baby or breast-feeding you should discuss with your doctor before being given Midazolam Injection. Your doctor will only give you Midazolam Injection if the benefits outweigh the potential risks. Driving and using machines Midazolam Injection will cause drowsiness. Do not drive or use machinery until you have checked with your doctor that it is safe to do so.
In this leaflet:
1. 2. 3. 4. 5. 6. What Midazolam Injection is and what it is used for Before you are given Midazolam Injection How Midazolam Injection will be given Possible side effects How to store Midazolam Injection Further information
1. What Midazolam Injection is and what it is used for
Midazolam is one of a group of medicines known as benzodiazepines. Benzodiazepines are sedatives, meaning that they are used relax you and help you to sleep. Midazolam Injection is used to relax and calm you during operations where you are awake. It may also be used to help patients in intensive care units to sleep.
2. Before you are given Midazolam Injection
You should not be given Midazolam Injection if: you know you are allergic to Midazolam or to medicines like Midazolam (benzodiazepines), or to any of the other ingredients of this medicine, listed in section 6 of this leaflet. you are pregnant unless the benefits outweigh the potential risks (see section Pregnancy and breast-feeding) you are suffering from difficulty breathing Take special care with Midazolam Injection if: you suffer from breathing difficulties you are suffering from shock, the symptoms of which are fainting, cold hands and feet, sweating and an irregular heartbeat you have a dangerously low body temperature (hypothermia) you are elderly you suffer from liver or kidney disease you suffer from heart problems you have a history of drug or alcohol abuse you suffer from a muscle disorder known as myasthenia gravis If any of the above apply to you or your child please tell your doctor before you are given Midazolam Injection Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Medicines which may interact with Midazolam Injection include: alcohol medicines that cause drowsiness (sedatives, barbiturates) anaesthetics e.g. ketamine painkillers (opioids) e.g. fentanyl medicines used to treat bacterial infections such as erythromycin and clarithromycin medicines used to treat fungal infections e.g itraconazole, ketoconazole and fluconazole medicines used to treat chest pains e.g. diltiazem and verapamil
3. How Midazolam Injection will be given
Your doctor will administer Midazolam Injection to you into a vein (intravenously) by slow infusion (drip) Adults and children over 12 years To help you to relax during an operation: The usual initial dose is 2mg followed after 2 minutes by 0.5 1mg if necessary until sedation is achieved. To help you to sleep: The usual initial dose is 30-300 micrograms per kilogram of body weight given over 5 minutes, then 30-200 micrograms per kilogram every hour. The doctor may adjust your dose depending on how much sedation you need. The elderly To help you to relax during an operation: The usual initial dose is 1 - 1.5mg followed after 2 minutes by 0.5 - 1mg if necessary until sedation is achieved. Children under 12 years Not recommended If you are given more Midazolam Injection than you should be As this medicine will be given to you whilst you are in hospital, it is unlikely that you will be given too little or too much, however, tell your doctor or nurse if you have any concerns. Continued overleaf
5. How to store Midazolam Injection
Keep out of the reach and sight of children. You should not be given Midazolam Injection after the expiry date which is printed on the carton and ampoule label. The doctor, nurse or anaesthetist will check that the expiry date on the label has not been passed before administering the injection to you. The expiry date refers to the last day of that month. Store below 25C. Protect from light.
C*****
4. Possible side effects
Like all medicines, Midazolam Injection can cause side effects, although not everybody gets them. Repeated use of midazolam can result in tolerance and addiction. If any of the following symptoms occur tell your doctor immediately. These are symptoms of a serious allergic reaction. sudden wheeziness and tightness of chest swelling of eyelids, face or lips skin lumps or hives skin rash (red spots), itchiness, fever collapse Other possible side effects include: feeling or being sick slower breathing than usual or difficulty breathing a slow heartbeat low blood pressure, the symptoms of which include feeling dizzy or light-headed, feeling weak and fainting feeling restless or worried involuntary movements confusion slurred speech blurred vision a lack or energy dizziness seeing or hearing things that arent real (hallucinations). These hallucinations may be sexual. temporary loss of memory for a short time after being given this medicine Rarely you may experience pain at the site of injection blood clots, the symptoms of which include swelling, redness and pain in the area. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
6. Further Information
What Midazolam Injection contains The active substance is Midazolam 50mg in 50ml The other ingredients are hydrochloric acid 10%, sodium chloride, sodium hydroxide and water for injections What Midazolam Injection looks like and contents of the pack Midazolam Injection is a clear, colourless solution supplied in a clear glass vial containing 50ml of the solution. Marketing Authorisation Holder Aurum Pharmaceuticals Ltd. Bampton Road, Harold Hill, Romford, Essex, RM3 8UG Manufacturer Rotexmedica GMBH Arzneimittel Werk Bunsenstrasse 4, D-22946 Trittau Germany This leaflet was last approved in 08/2008. PL 12064/0038
Midazolam Injection 1mg/1ml Midazolam
Read all of this leaflet carefully before you are given this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or nurse. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse. rifampicin, a medicine used to treat tuberculosis antihistamines (medicines used to treat allergies) medicines used to treat serious mental disorders (antipsychotics) medicines used ot treat high blood pressure (alpha-blockers) lofexidine, a medicine used to treat withdrawal symptoms caused when stopping taking opioid drugs such as morphine baclofen, a medicine used relax the muscles disulfiram, a medicine used to help treat alcoholism nabilone, a medicine used to treat feeling or being sick cimetidine, a medicine used to treat stomach ulcers If you have any doubts about whether you should be given Midazolam Injection please discuss these with the doctor, anaesthetist or nurse before use. Pregnancy and breast-feeding If you are pregnant, trying for a baby or breast-feeding you should discuss with your doctor before being given Midazolam Injection. Your doctor will only give you Midazolam Injection if the benefits outweigh the potential risks. Driving and using machines Midazolam Injection will cause drowsiness. Do not drive or use machinery until you have checked with your doctor that it is safe to do so.
In this leaflet:
1. 2. 3. 4. 5. 6. What Midazolam Injection is and what it is used for Before you are given Midazolam Injection How Midazolam Injection will be given Possible side effects How to store Midazolam Injection Further information
1. What Midazolam Injection is and what it is used for
Midazolam is one of a group of medicines known as benzodiazepines. Benzodiazepines are sedatives, meaning that they are used relax you and help you to sleep. Midazolam Injection is used to relax and calm you during operations where you are awake. It may also be used to help patients in intensive care units to sleep.
2. Before you are given Midazolam Injection
You should not be given Midazolam Injection if: you know you are allergic to Midazolam or to medicines like Midazolam (benzodiazepines), or to any of the other ingredients of this medicine, listed in section 6 of this leaflet. you are pregnant unless the benefits outweigh the potential risks (see section Pregnancy and breast-feeding) you are suffering from difficulty breathing Take special care with Midazolam Injection if: you suffer from breathing difficulties you are suffering from shock, the symptoms of which are fainting, cold hands and feet, sweating and an irregular heartbeat you have a dangerously low body temperature (hypothermia) you are elderly you suffer from liver or kidney disease you suffer from heart problems you have a history of drug or alcohol abuse you suffer from a muscle disorder known as myasthenia gravis If any of the above apply to you or your child please tell your doctor before you are given Midazolam Injection Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Medicines which may interact with Midazolam Injection include: alcohol medicines that cause drowsiness (sedatives, barbiturates) anaesthetics e.g. ketamine painkillers (opioids) e.g. fentanyl medicines used to treat bacterial infections such as erythromycin and clarithromycin medicines used to treat fungal infections e.g itraconazole, ketoconazole and fluconazole medicines used to treat chest pains e.g. diltiazem and verapamil
3. How Midazolam Injection will be given
Your doctor will administer Midazolam Injection to you into a vein (intravenously) by slow infusion (drip) Adults and children over 12 years To help you to relax during an operation: The usual initial dose is 2mg followed after 2 minutes by 0.5 1mg if necessary until sedation is achieved. To help you to sleep: The usual initial dose is 30-300 micrograms per kilogram of body weight given over 5 minutes, then 30-200 micrograms per kilogram every hour. The doctor may adjust your dose depending on how much sedation you need. The elderly To help you to relax during an operation: The usual initial dose is 1 - 1.5mg followed after 2 minutes by 0.5 - 1mg if necessary until sedation is achieved. Children under 12 years Not recommended If you are given more Midazolam Injection than you should be As this medicine will be given to you whilst you are in hospital, it is unlikely that you will be given too little or too much, however, tell your doctor or nurse if you have any concerns. Continued overleaf
5. How to store Midazolam Injection
Keep out of the reach and sight of children. You should not be given Midazolam Injection after the expiry date which is printed on the carton and ampoule label. The doctor, nurse or anaesthetist will check that the expiry date on the label has not been passed before administering the injection to you. The expiry date refers to the last day of that month. Store below 25C. Protect from light.
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.
