MIDAZOLAM 5MG/ML SOLUTION FOR INJECTION
Active substance: MIDAZOLAM
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PACKAGE LEAFLET: INFORMATION FOR THE USER
D00522
Midazolam 5mg/ml Solution for injection or infusion Midazolam Hydrochloride
Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. 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 pharmacist.
Taking other medicines: Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes: Antifungal medicines such as Itraconazole, fluconazol, voriconazole, ketoconazole or posaconazole Medicines to reduce blood pressure such as verapamil or diltiazem Medicines to treat high cholesterol, such as Atorvastatin Medicines to treat mycobacteria infections such as tuberculosis (rifampicin) Antibiotics prescribed by your doctor such as erythromycin or clarithromycin HIV medications such as saquinavir ritonavir, indinavir, nelfinavir and amprenavir Drugs that depress the central nervous system (cause drowsiness) such as phenytoin or carbamazepine Alcohol or drugs containing alcohol General anaesthetics (given by inhalation) Strong painkillers The herbal medicine St. Johns Wort If you are in any doubt please tell your doctor about any medication you are taking. Pregnancy and breast-feeding: This medicine should not be used during pregnancy unless your doctor feels it is necessary. Midazolam passes in low amounts into breast milk. Nursing mothers are advised to stop breast-feeding for 24 hours following administration of midazolam Please speak to your doctor if you are pregnant, trying to become pregnant or are breast-feeding. Driving and using machinery: This medicine may adversely affect your ability to drive or use machines. You should not drive a vehicle or operate a machine until completely recovered. Your physician should decide when these activities may be resumed. It is recommended that you are accompanied when returning home after you are discharged from hospital. Important information about some of the ingredients of Midazolam Midazolam injection is essentially sodium free as it contains less than 1mmol sodium (23mg) per ampoule.
If you are given too much Midazolam: 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, nurse or pharmacist if you have any concerns. If you stop taking Midazolam During prolonged treatment with Midazolam, physical dependence may develop. Suddenly stopping the treatment may be accompanied by withdrawal symptoms. The following symptoms may occur: headaches, muscle pain, anxiety, tension, restlessness, confusion, irritability, rebound insomnia (unable to sleep), mood changes, hallucinations and convulsions. Since the risk of withdrawal symptoms is greater after suddenly stopping treatment, it is recommended to stop doses gradually. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Rush and itching Muscle tremor If any of the side effects get serious, or you notice any side effects not listed in the leaflet, please tell your doctor or pharmacist.
5. How to store Midazolam
Your doctor or pharmacist is responsible for storing Midazolam injection. They are also responsible for disposing of any unused Midazolam. You should not be given Midazolam injection after the expiry date which is stated on the carton and ampoule. The expiry date refers to the last date of the month Keep out of the reach and sight of children. This medicinal product does not require any special temperature storage conditions Keep the container in the outer carton in order to protect from light. Your doctor or nurse should not use this product if the solution is discoloured.
In this leaflet:
1. 2. 3. 4. 5. 6. What Midazolam is and what it is used for Before Midazolam is given How Midazolam will be given Possible side effects How to store Midazolam solution for injection or infusion Further information
4. Possible side effects
Like all medicines Midazolam can cause side effects, although not everybody gets them. If any of the following symptoms occur contact your doctor or nearest accident and emergency department immediately. These are symptoms of a serious allergic reaction. skin irritation or rash including redness, itchiness and swelling Other side effects drowsiness prolonged sedation (sleepiness), reduced alertness or confusion, euphoria (state of excitement), hallucinations, fatigue, headache, dizziness, ataxia (reduced control of limb movements), amnesia (memory loss) agitation, hyperactivity, hostility, rage, aggressiveness, convulsions (muscle tightening and relaxing) nausea, vomiting, hiccups, coughing, constipation, dry mouth chest pain or problems with your heart, heart failure, changes in heart rate breathing difficulties, such as spasm of the airway tract stopping breathing Swelling or pain on injection site Blood clots at the site of injection Addiction Low blood pressure
6. Further Information
What Midazolam contains The active ingredient is Midazolam (as hydrochloride). Each 2ml of solution for injection or infusion contains 10mg midazolam (as the hydrochloride). Each 3ml of solution for injection or infusion contains 15mg midazolam (as the hydrochloride). The other ingredients are water for injections, dilute hydrochloric acid, sodium chloride and sodium hydroxide Each ml of solution for injection contains 5mg of Midazolam (as the hydrochloride). What Midazolam looks like and contents of the pack: Midazolam solution for Injection is a clear colourless solution, filled in clear glass ampoules The medicine is supplied to your pharmacist or doctor in packs of 10 clear glass ampoules (2ml and 3ml). Marketing Authorisation Holder and Manufacturer: Martindale Pharmaceuticals, Bampton Road, Harold Hill, Romford, RM3 8UG, United Kingdom. Product Licence Number (s): PL 00156/0123 PA 361/21/1 For any information about this medicine, please contact the Marketing Authorisation Holder, details provided above. This leaflet was approved in: 10/2010
1. What Midazolam 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 to relax you and help you to sleep. Midazolam Injection is used to help you feel relaxed and to help you sleep before and during an operation. It can also calm you during an operation where you are not asleep. It may also be used to help patients in intensive care units to relax.
2. Before Midazolam is given
You should not be given Midazolam: If you are allergic or hypersensitive to Midazolam or other or to any of the ingredients in the product. If you have severe breathing difficulties or problems with your lungs Take special care with Midazolam if: you have severe or moderate breathing difficulties you are over 60 years of age it is to be given to children, especially those suffering heart or blood vessel problems (cardiovascular) you have severe kidney problems you have problems with your heart or have a heart condition you have a history of alcohol or drug abuse or have liver disease you have a condition called myasthesia gravis You are debilitated (have an illness that makes you feel very weak, run down and short of energy). You are pregnant or think you may be pregnant (see Pregnancy and breast-feeding). If any of the above applies to you, please tell your doctor.
3. How Midazolam is given
Adults and the elderly. Midazolam Injection will be given to you by a doctor or nurse slowly in a vein (intravenous) either as a continuous infusion or intermittent bolus injection or into a muscle. Your doctor will decide the correct dosage for you as this would be dependent on your general physical condition, age, weight and your response to treatment and whether other medicines are needed at the same time. Children The precise dose and route of administration must be decided by a doctor qualified in the treatment of children. Continued overleaf
TECHNICAL INFORMATION
D00522
Midazolam 5mg/ml Solution for injection or infusion Midazolam Hydrochloride
The following information is intended for medical or healthcare professionals only: Standard Dosage Indication Conscious sedation Adults<60 years IV Initial dose: 2-2.5mg Titration doses: 1mg Total dose: 3.5-7.5mg Incompatibilities The product should not be mixed with other medicinal products apart from 5% Glucose Intravenous Infusion BP, Sodium Chloride Intravenous Infusion BP or 0.18% Sodium Chloride and 4% Glucose Intravenous Infusion BP Adults 60 years+/debilitated or seriously ill IV Initial dose: 0.5-1mg Titration doses: 0.5-1mg Total dose: <3.5mg Children IV in patients 6 months-5 years Initial dose: 0.05-0.1mg/kg Total dose: <6mg IV in patients 6-12 years Initial dose: 0.025-0.05mg/kg Total dose: < 10mg Rectal>6 months 0.3-0.5mg/kg IM 1-15 years 0.05-0.15mg/kg Rectal> 6 months 0.3-0.5mg/kg IM 1-15 years 0.08-0.2mg/kg Sedative component in combined anaesthesiA IV Intermittent doses of 0.03-0.1 mg/kg or continuous infusion of 0.03-0.1 mg/kg/hr IV Lower doses than recommended for adults<60 years IV in neonates<32 weeks gestational age 0.03 mg/kg/hr IV in neonates>32 weeks and children up to 6 months 0.06 mg/kg/hr IV in patients>6 months Loading dose: 0.05-0.2mg/kg Maintenance dose: 0.06-0.12mg/kg/h
Sedation in ICU
IV Loading dose: 0.03-0.3 mg/kg in increments of 1-2.5mg Maintenance dose: 0.03-0.2mg/kg/hr
Anaesthesia premedication
IV 1-2mg repeated IM 0.07-0.1mg/kg IV 0.15-0.2mg/kg (0.3-0.35 mg/kg without premedication)
IV Initial dose 0.5mg Slow uptitration as needed IM 0.025-0.05mg/kg IV 0.1-0.2mg/kg (0.15-0.3 mg/kg without premedication)
Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product Midazolam Injection is for single use only. Discard any unused contents. The product should be used immediately after opening. Midazolam Injection is stable, both physically and chemically, for up to 24 hours at 2C-8C when mixed aseptically with 500 ml infusion fluids containing Dextrose 4% with Sodium Chloride 0.18%, Dextrose 5% or Sodium Chloride 0.9%.
Diluted product should be discarded if not used within 24 hours. Do not use the product if the solution is discoloured
Anaesthesia induction
Continued overleaf
D00522
D00522
D00522
Midazolam 5mg/ml Solution for injection or infusion Midazolam Hydrochloride
Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. 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 pharmacist.
Taking other medicines: Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes: Antifungal medicines such as Itraconazole, fluconazol, voriconazole, ketoconazole or posaconazole Medicines to reduce blood pressure such as verapamil or diltiazem Medicines to treat high cholesterol, such as Atorvastatin Medicines to treat mycobacteria infections such as tuberculosis (rifampicin) Antibiotics prescribed by your doctor such as erythromycin or clarithromycin HIV medications such as saquinavir ritonavir, indinavir, nelfinavir and amprenavir Drugs that depress the central nervous system (cause drowsiness) such as phenytoin or carbamazepine Alcohol or drugs containing alcohol General anaesthetics (given by inhalation) Strong painkillers The herbal medicine St. Johns Wort If you are in any doubt please tell your doctor about any medication you are taking. Pregnancy and breast-feeding: This medicine should not be used during pregnancy unless your doctor feels it is necessary. Midazolam passes in low amounts into breast milk. Nursing mothers are advised to stop breast-feeding for 24 hours following administration of midazolam Please speak to your doctor if you are pregnant, trying to become pregnant or are breast-feeding. Driving and using machinery: This medicine may adversely affect your ability to drive or use machines. You should not drive a vehicle or operate a machine until completely recovered. Your physician should decide when these activities may be resumed. It is recommended that you are accompanied when returning home after you are discharged from hospital. Important information about some of the ingredients of Midazolam Midazolam injection is essentially sodium free as it contains less than 1mmol sodium (23mg) per ampoule.
If you are given too much Midazolam: 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, nurse or pharmacist if you have any concerns. If you stop taking Midazolam During prolonged treatment with Midazolam, physical dependence may develop. Suddenly stopping the treatment may be accompanied by withdrawal symptoms. The following symptoms may occur: headaches, muscle pain, anxiety, tension, restlessness, confusion, irritability, rebound insomnia (unable to sleep), mood changes, hallucinations and convulsions. Since the risk of withdrawal symptoms is greater after suddenly stopping treatment, it is recommended to stop doses gradually. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Rush and itching Muscle tremor If any of the side effects get serious, or you notice any side effects not listed in the leaflet, please tell your doctor or pharmacist.
5. How to store Midazolam
Your doctor or pharmacist is responsible for storing Midazolam injection. They are also responsible for disposing of any unused Midazolam. You should not be given Midazolam injection after the expiry date which is stated on the carton and ampoule. The expiry date refers to the last date of the month Keep out of the reach and sight of children. This medicinal product does not require any special temperature storage conditions Keep the container in the outer carton in order to protect from light. Your doctor or nurse should not use this product if the solution is discoloured.
In this leaflet:
1. 2. 3. 4. 5. 6. What Midazolam is and what it is used for Before Midazolam is given How Midazolam will be given Possible side effects How to store Midazolam solution for injection or infusion Further information
4. Possible side effects
Like all medicines Midazolam can cause side effects, although not everybody gets them. If any of the following symptoms occur contact your doctor or nearest accident and emergency department immediately. These are symptoms of a serious allergic reaction. skin irritation or rash including redness, itchiness and swelling Other side effects drowsiness prolonged sedation (sleepiness), reduced alertness or confusion, euphoria (state of excitement), hallucinations, fatigue, headache, dizziness, ataxia (reduced control of limb movements), amnesia (memory loss) agitation, hyperactivity, hostility, rage, aggressiveness, convulsions (muscle tightening and relaxing) nausea, vomiting, hiccups, coughing, constipation, dry mouth chest pain or problems with your heart, heart failure, changes in heart rate breathing difficulties, such as spasm of the airway tract stopping breathing Swelling or pain on injection site Blood clots at the site of injection Addiction Low blood pressure
6. Further Information
What Midazolam contains The active ingredient is Midazolam (as hydrochloride). Each 2ml of solution for injection or infusion contains 10mg midazolam (as the hydrochloride). Each 3ml of solution for injection or infusion contains 15mg midazolam (as the hydrochloride). The other ingredients are water for injections, dilute hydrochloric acid, sodium chloride and sodium hydroxide Each ml of solution for injection contains 5mg of Midazolam (as the hydrochloride). What Midazolam looks like and contents of the pack: Midazolam solution for Injection is a clear colourless solution, filled in clear glass ampoules The medicine is supplied to your pharmacist or doctor in packs of 10 clear glass ampoules (2ml and 3ml). Marketing Authorisation Holder and Manufacturer: Martindale Pharmaceuticals, Bampton Road, Harold Hill, Romford, RM3 8UG, United Kingdom. Product Licence Number (s): PL 00156/0123 PA 361/21/1 For any information about this medicine, please contact the Marketing Authorisation Holder, details provided above. This leaflet was approved in: 10/2010
1. What Midazolam 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 to relax you and help you to sleep. Midazolam Injection is used to help you feel relaxed and to help you sleep before and during an operation. It can also calm you during an operation where you are not asleep. It may also be used to help patients in intensive care units to relax.
2. Before Midazolam is given
You should not be given Midazolam: If you are allergic or hypersensitive to Midazolam or other or to any of the ingredients in the product. If you have severe breathing difficulties or problems with your lungs Take special care with Midazolam if: you have severe or moderate breathing difficulties you are over 60 years of age it is to be given to children, especially those suffering heart or blood vessel problems (cardiovascular) you have severe kidney problems you have problems with your heart or have a heart condition you have a history of alcohol or drug abuse or have liver disease you have a condition called myasthesia gravis You are debilitated (have an illness that makes you feel very weak, run down and short of energy). You are pregnant or think you may be pregnant (see Pregnancy and breast-feeding). If any of the above applies to you, please tell your doctor.
3. How Midazolam is given
Adults and the elderly. Midazolam Injection will be given to you by a doctor or nurse slowly in a vein (intravenous) either as a continuous infusion or intermittent bolus injection or into a muscle. Your doctor will decide the correct dosage for you as this would be dependent on your general physical condition, age, weight and your response to treatment and whether other medicines are needed at the same time. Children The precise dose and route of administration must be decided by a doctor qualified in the treatment of children. Continued overleaf
TECHNICAL INFORMATION
D00522
Midazolam 5mg/ml Solution for injection or infusion Midazolam Hydrochloride
The following information is intended for medical or healthcare professionals only: Standard Dosage Indication Conscious sedation Adults<60 years IV Initial dose: 2-2.5mg Titration doses: 1mg Total dose: 3.5-7.5mg Incompatibilities The product should not be mixed with other medicinal products apart from 5% Glucose Intravenous Infusion BP, Sodium Chloride Intravenous Infusion BP or 0.18% Sodium Chloride and 4% Glucose Intravenous Infusion BP Adults 60 years+/debilitated or seriously ill IV Initial dose: 0.5-1mg Titration doses: 0.5-1mg Total dose: <3.5mg Children IV in patients 6 months-5 years Initial dose: 0.05-0.1mg/kg Total dose: <6mg IV in patients 6-12 years Initial dose: 0.025-0.05mg/kg Total dose: < 10mg Rectal>6 months 0.3-0.5mg/kg IM 1-15 years 0.05-0.15mg/kg Rectal> 6 months 0.3-0.5mg/kg IM 1-15 years 0.08-0.2mg/kg Sedative component in combined anaesthesiA IV Intermittent doses of 0.03-0.1 mg/kg or continuous infusion of 0.03-0.1 mg/kg/hr IV Lower doses than recommended for adults<60 years IV in neonates<32 weeks gestational age 0.03 mg/kg/hr IV in neonates>32 weeks and children up to 6 months 0.06 mg/kg/hr IV in patients>6 months Loading dose: 0.05-0.2mg/kg Maintenance dose: 0.06-0.12mg/kg/h
Sedation in ICU
IV Loading dose: 0.03-0.3 mg/kg in increments of 1-2.5mg Maintenance dose: 0.03-0.2mg/kg/hr
Anaesthesia premedication
IV 1-2mg repeated IM 0.07-0.1mg/kg IV 0.15-0.2mg/kg (0.3-0.35 mg/kg without premedication)
IV Initial dose 0.5mg Slow uptitration as needed IM 0.025-0.05mg/kg IV 0.1-0.2mg/kg (0.15-0.3 mg/kg without premedication)
Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product Midazolam Injection is for single use only. Discard any unused contents. The product should be used immediately after opening. Midazolam Injection is stable, both physically and chemically, for up to 24 hours at 2C-8C when mixed aseptically with 500 ml infusion fluids containing Dextrose 4% with Sodium Chloride 0.18%, Dextrose 5% or Sodium Chloride 0.9%.
Diluted product should be discarded if not used within 24 hours. Do not use the product if the solution is discoloured
Anaesthesia induction
Continued overleaf
D00522
D00522
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.
