1 mg / ml and 5 mg / ml solution for injection / infusion
midazolam
What the Midazolam Accord is and what it is used for
Midazolam Accord 1 mg/ml and 5 mg/ml solution for injection/infusion contain midazolam which belongs to a group of medicines called benzodiazepines.
It is a short-acting drug used to induce sedation (a very relaxed state of calm, drowsiness, or sleep) and reduces anxiety and muscle tension.
This medicine is used for:
- for sedation (awake but relaxed state of calm or drowsiness during a medical examination or procedure) of adults and children.
- for sedation of adults and children in the intensive care unit.
- for anesthesia of adults, alone or in combination with other drugs.
- as a pre-medication to induce relaxation, calm and drowsiness before anesthesia in adults and children
Midazolam contained in the Midazolam Accord may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you are given Midazolam Accord
You should not be given Midazolam Accord
- if you are allergic (hypersensitive) to midazolam or any of the other ingredients of this medicine (listed in section 6).
- if you are allergic to other medicines with benzodiazepines , such as diazepam or nitrazepam.
- if you have severe breathing problems and you should receive Midazolam Accord for awake sedation .
You should not be given Midazolam Accord if any of the above apply to you. If you are not sure, talk to your doctor or nurse before taking this medicine.
Warnings and cautions
Talk to your doctor or nurse before using Midazolam Accord if:
- You are over 60 years old.
- You have a long-term illness (such as breathing problems or kidney, liver or heart problems).
- You are weakened (have a disease that makes you feel very weak, exhausted or lack energy).
- You have a condition called “sleep apnea syndrome” (which means that you stop breathing while you sleep), so you can be closely monitored.
- You have myasthenia gravis (a neuromuscular disease that causes muscle weakness).
- You regularly drink large amounts of alcohol or if you have previously had problems with alcohol use. Alcohol may increase the effects of Midazolam Accord and possibly lead to severe sedation which may lead to coma or death.
- You take drugs regularly or if you have had problems with drugs in the past.
- You are pregnant or think you may be pregnant (see ‘Pregnancy and breast-feeding’).
Children
If your child is to receive this medicine:
You must tell your doctor or nurse if your child has cardiovascular disease (heart problem). Your child will be closely monitored and the dose adjusted accordingly.
Children must be closely monitored. For infants under 6 months, this will include monitoring of respiration and oxygen levels.
Talk to your doctor or nurse if any of the above apply to your child.
Other medicines and Midazolam Accord
Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines. This also includes over-the-counter ones and herbal remedies.
This is extremely important as concomitant use of other medicines may intensify or weaken the effects of the medicines.
In particular, tell your doctor or nurse if you are taking any of the following medicines
- sedatives (medicines for anxiety or to help you sleep)
- sleeping pills (drugs that help you sleep)
- sedatives (medicines that make you calm or sleepy)
- antidepressants
- narcotic painkillers (very strong painkillers)
- antihistamines (medicines for allergies )
- antifungal drugs ( ketoconazole , voriconazole, fluconazole , itraconazole, posaconazole)
- macrolide antibiotics (eg erythromycin or clarithromycin)
- diltiazem (medicine for high blood pressure )
- drugs for the treatment of HIV , protease inhibitors (eg saquinavir)
- drugs for the treatment of hepatitis C ( protease inhibitors such as boceprevir and telaprevir)
- atorvastatin (drug for high cholesterol )
- rifampicin (medicines for mycobacterial infections , eg tuberculosis )
- tikagrelor (used to prevent heart attack)
- the natural remedy St. John ‘s wort
If any of the above apply to you, or if you are not sure, talk to your doctor or nurse before taking Midazolam Accord.
Operations
If you are going to receive an anesthetic before an operation or dental treatment (including anesthetics that you inhale), you must tell your doctor or dentist that you are using Midazolam Accord.
Midazolam Accord with alcohol
Do not drink alcohol if you have been given Midazolam Accord. This is because alcohol can increase the sedative effect of Midazolam Accord and can cause breathing problems.
Pregnancy and breastfeeding
- Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby. Your doctor will decide if this medicine is right for you.
- Do not breast-feed within 24 hours of receiving Midazolam Accord. This is because the drug can pass into breast milk.
Driving and using machines
This medicine may make you drowsy, dizzy, forgetful or affect your concentration and coordination. This may affect your ability to perform more difficult tasks, such as driving or using machines. Do not drive or use machines until you are fully recovered. Your doctor will tell you when you can do it again.
Do not drive while taking this medicine until you know how it affects you.
Talk to your doctor or pharmacist if you are not sure if it is safe to drive while you are taking this medicine.
Lack of sleep or alcohol consumption can further impair your wakefulness.
You should always be accompanied home by a responsible adult after the treatment.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Important information about some of the ingredients of Midazolam Accord
Midazolam Accord contains less than 1 mmol (23 mg) sodium per ampoule, ie essentially ‘sodium-free’.
How Midazolam Accord is given
Midazolam Accord should only be given by an experienced healthcare professional (doctor or nurse). It should be given in a place (hospital, clinic, or clinic) that has the equipment to monitor and support the patient’s breathing, heart, and circulation ( cardiovascular function) and can recognize signs and treat expected side effects of anesthesia.
How much Midazolam Accord is given
Your doctor will decide which dose is right for you. The dose you receive depends on why you are receiving treatment and what type of sedation you need. Your weight, your age, your state of health, how you respond to Midazolam Accord, and if other medicines are required at the same time will also affect the dose you receive.
If you need strong painkillers, you get them first and then you get Midazolam Accord. Your doctor will decide on the appropriate dose for you.
How Midazolam Accord is given
Midazolam Accord can be given to you in one of the following four different ways:
- as a slow injection into a vein ( intravenous injection )
- via a tube into one of the veins ( intravenous infusion )
- as an injection into a muscle ( intramuscular injection )
- in the rectum ( rectum )
You should always be accompanied home by a responsible adult after the treatment.
Children
- In children and infants under 6 months of age, Midazolam Accord is only recommended for sedation in intensive care units. Dose one will be given successively in a vein.
- Children 12 years and under usually receive Midazolam Accord in a vein. When Midazolam Accord is used as a pre-medication (to induce relaxation, calm and drowsiness before anesthesia) it can be given in the rectum .
If you are given too much Midazolam Accord
Your medicine will be given to you by a doctor or nurse.
If you are accidentally given too much Midazolam Accord, you may:
- feel sleepy
- have problems coordinating movements ( ataxia ) and loss of reflexes
- get speech problems ( dysarthria )
- have involuntary eye movements ( nystagmus )
- develop low blood pressure ( hypotension )
- stop breathing ( apnea ) and suffer from cardiorespiratory depression (breathing and heartbeat become slow or stop) and coma .
Stop treatment with Midazolam Accord
If you are receiving long-term treatment with Midazolam Accord (given for a long time), you can:
Be tolerant of Midazolam Accord. The drug becomes less effective and does not work so well for you.
Become addicted to this drug and get withdrawal symptoms (see below).
Your doctor will reduce the dose gradually to prevent these effects from affecting you.
The following effects have been seen with the use of Midazolam Accord, especially in children and the elderly: restlessness, agitation, irritability, involuntary movements, hyperactivity, hostility, delusion, anger, aggression, anxiety, nightmares, hallucinations (see and possibly hear things that are not there ), psychosis (losing touch with reality), inappropriate behavior, arousal and threats (these are also called paradoxical reactions, which are results that are contrary to the effects normally expected of the drug). If you experience these, your doctor will consider stopping treatment with Midazolam.
Withdrawal symptoms:
Medicines containing benzodiazepines such as Midazolam Accord may make you addicted if you use it for a long time (eg in intensive care). This means that if you stop treatment suddenly or lower the dose too quickly, you may get withdrawal symptoms. These symptoms may include:
- headache, diarrhea and muscle aches
- strong anxiety, tension, restlessness, confusion or bad mood (irritable) and sleep problems
- mood swings
- hallucinations (see and possibly hear things that are not there), seizures.
In severe cases of withdrawal symptoms, the following may occur: a feeling of losing touch with reality, numbness and tingling in the extremities (eg hands and feet), sensitivity to light, sound, and touch.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported with this medicine (no known frequency).
Stop taking midazolam and contact your doctor immediately if you notice any of the following side effects. They can be life-threatening and you may need urgent medical attention:
- Anaphylactic shock (a life-threatening allergic reaction ). Signs may include sudden rash, itching or raised rash (nose rash) and swelling of the face, lips, tongue or other parts of the body. You may also have shortness of breath, wheezing or difficulty breathing.
- Myocardial infarction (cardiac arrest). Signs may include chest pain that may spread to the neck and shoulders and down the left arm.
- Respiratory problems or respiratory complications (sometimes leading to respiratory arrest)
- Choking and sudden airway obstruction ( laryngospasm ).
Life-threatening side effects are more likely in adults over 60 years of age and in patients who already have difficulty breathing or heart problems, especially if the injection is given too quickly or at too high a dose.
Other possible side effects:
Problems with the immune system:
- general allergic reactions (skin reactions, cardiovascular reactions, wheezing).
Effects on behavior:
- restlessness, agitation, irritability, nervousness, anxiety
- hostility, anger or aggression, agitation
- overactive, change in libido
- inappropriate behavior.
Mental and nervous system problems:
- confusion, disorientation, emotional and mood disorders, involuntary movements, nightmares, abnormal dreams
- hallucinations (seeing and possibly hearing things that do not exist), psychosis (losing touch with reality)
- drowsiness and prolonged sedation , impaired alertness
- headache, dizziness
- problems coordinating muscles
- seizures in premature infants and newborns
- temporary memory loss; how long this lasts depends on how much Midazolam Accord you have received. You may experience this after the treatment. In some cases, this has persisted for a long time.
- drug addiction, addiction.
Problems with the heart and blood circulation:
- low blood pressure
- slow pulse
- redness of the face and neck, fainting or headache.
Respiratory problems:
- shortness of breath
- hiccup.
Stomach, intestine, and mouth problems:
- nausea or vomiting
- constipation
- dry mouth .
Skin problems:
- rash
- hives (increased rash)
- itching .
Muscle problem:
- muscle spasms and muscle tremors (muscle tremors that you can not control).
Injection site problems:
- redness
- skin swelling
- blood clots or pain at the injection site.
Injuries:
- patients taking benzodiazepines are at risk of falling and breaking bones; this risk is increased in the elderly and in people taking other sedatives (including alcohol).
Generally:
- fatigue (exhaustion)
Older:
- Life-threatening side effects are more likely to occur in adult patients over 60 years of age and those who already have difficulty breathing or heart problems, especially when injected too quickly or at a high dose .
Patients with severe renal impairment:
- Patients with severe kidney disease are more likely to experience side effects .
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
How to store Midazolam Accord
Doctors or pharmacists should be responsible for storing the Midazolam Accord. The following applies to storage:
- 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 ampoule label and the outer carton after EXP. The expiration date is the last day of the specified month.
- Store the ampoules (small glass bottles) in the outer carton. Sensitive to light.
Medicines should not be disposed of via wastewater or household waste. The medical staff will throw away any leftover medicine. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is midazolam (as midazolam hydrochloride).
Midazolam Accord 1 mg / ml:
Each ml of solution contains 1 mg of midazolam (as midazolam hydrochloride).
| Pack size | 5 ml |
|---|---|
| Amount of midazolam | 5 mg |
Midazolam Accord 5 mg / ml:
Each ml of solution contains 5 mg of midazolam (as midazolam hydrochloride).
| Pack size | 1 ml | 3 ml | 10 ml |
|---|---|---|---|
| Amount of midazolam | 5 mg | 15 mg | 50 mg |
The other ingredients are water for injections, sodium chloride, sodium hydroxide (for pH adjustment), concentrated hydrochloric acid (for pH adjustment).
What the medicine looks like and contents of the pack
Midazolam Accord is a clear, colorless to light yellow solution for injection into a clear glass ampoule.
Midazolam Accord 1 mg/ml is supplied in packs of 10 x 5 ml ampoules.
Midazolam Accord 5 mg / ml is supplied in packs of 10 x 1 ml, 10 x 3 ml, 1 x 10 ml and 10 x 10 ml ampoules .
Ampoule one is supplied in a blister/tray package.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare BV
Winthontlaan 200
3526 kV Utrecht
Netherlands
Manufacturer
Accord Healthcare Limited
Sage House, 319, Pinner Road, North Harrow, Middlesex, HA1 4HF, UK
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50,95-200 Pabianice, Poland
Accord Healthcare BV
Winthontlaan 200
3526 kV Utrecht
Netherlands