Midazolam Baxter

Leaflet accompanying the packaging: patient information

Midazolam Baxter, 5 mg/ml, solution for injection/infusion

Midazolam (as midazolam hydrochloride)
The full name of the medicine is "Midazolam Baxter 5 mg/ml solution for injection/infusion", but in the content of this leaflet, the shortened name "Midazolam Baxter" will be used.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not mentioned in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Midazolam Baxter and what is it used for
• 2. Important information before using Midazolam Baxter
• 3. How to use Midazolam Baxter
• 4. Possible side effects
• 5. How to store Midazolam Baxter
• 6. Package contents and other information

1. What is Midazolam Baxter and what is it used for

Midazolam Baxter belongs to a group of medicines called benzodiazepines. It is a short-acting medicine used to induce sedation (a deep state of calm, drowsiness, or sleep) and to relieve symptoms of anxiety and reduce muscle tension.
Midazolam Baxter acts quickly, causing drowsiness or sleep in the patient. It calms the patient and relaxes their muscles.

Midazolam Baxter is used in adults:

• as a general anesthetic to induce and maintain sleep.

Midazolam Baxter is also used in adults and children:

• in intensive care units to calm the patient and induce sleep. This is called "sedation";
• before and during a medical examination or procedure, during which the patient should remain conscious. The medicine makes the patient feel calm and sleepy. This is called "light sedation";
• to calm the patient and make them feel sleepy before receiving an anesthetic.

2. Important information before using Midazolam Baxter

When not to use Midazolam Baxter:

• if the patient is allergic to midazolam or any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergic (hypersensitive) to other medicines in the benzodiazepine group, such as diazepam or nitrazepam),
• if the patient has severe breathing difficulties, and Midazolam Baxter is to be used for light sedation. If any of the above situations apply to the patient, they should not be given Midazolam Baxter. If the patient is unsure, they should tell their doctor or nurse before taking the medicine.

Warnings and precautions

When using Midazolam Baxter, special caution should be exercised

Children and infants

In the case of a child receiving Midazolam Baxter:

• It is especially important for parents to inform the doctor, pharmacist, or nurse if the child has cardiovascular diseases (has heart problems). The child will be closely monitored, and the dose of the medicine will be adjusted in a special way.
• Children must be closely monitored. In the case of children under 6 months of age, this should include monitoring of breathing and blood oxygenation.

Adults

Before using Midazolam Baxter, the patient should discuss it with their doctor, pharmacist, or nurse if:

• the patient is over 60 years old,
• the patient has a chronic illness (chronic respiratory, kidney, liver, or heart disease),
• the patient is weakened (has a disease that makes them feel very weak, is exhausted, and lacks energy),
• the patient has myasthenia (a nerve-muscle disease characterized by muscle weakness),
• the patient regularly consumes large amounts of alcohol or has had problems with alcohol in the past
• the patient regularly takes psychoactive substances for recreational purposes or has had problems with drugs in the past,
• the patient is pregnant or thinks they may be pregnant.

If any of the above situations apply to the patient or they have doubts, they should inform their doctor, pharmacist, or nurse before using the medicine.

Midazolam Baxter and other medicines

The patient should tell their doctor or nurse about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This includes over-the-counter medicines and herbal medicines.
This is very important because taking more than one medicine at a time can increase or decrease the effect of the medicines being taken.
In particular, the patient should inform their doctor or nurse if they are taking any of the following medicines:

• antidepressants (medicines used to treat depression),
• sleeping pills (medicines that cause sleep),
• sedatives (medicines that induce a state of calm and sleepiness),
• calming medicines (used to treat anxiety and to facilitate sleep),
• carbamazepine or phenytoin (medicines used to treat epilepsy),
• rifampicin (used to treat mycobacterial infections, such as tuberculosis),
• medicines used to treat HIV infection, known as protease inhibitors (such as saquinavir),
• macrolide antibiotics (such as erythromycin or clarithromycin),
• medicines used to treat fungal infections (such as ketoconazole, voriconazole, fluconazole, itraconazole, posaconazole),
• strong painkillers,
• atorvastatin (used to lower high cholesterol levels),
• antihistamines (medicines used to treat allergies),
• St. John's Wort (Hypericum perforatum) (a herbal medicine for depression),
• medicines used to treat high blood pressure, known as calcium channel blockers (such as diltiazem).

If any of the above situations apply to the patient or they have doubts, they should inform their doctor, pharmacist, or nurse before using the medicine.
Taking Midazolam Baxter and opioid medicines (strong painkillers, medicines used for substitution therapy, and some cough medicines) at the same time increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. For this reason, their simultaneous use can only be considered if other treatment methods are not possible.
If, however, the doctor has prescribed Midazolam Baxter at the same time as opioid medicines, they should limit the dose and duration of concurrent treatment.
The patient should inform their doctor about all opioid medicines they are taking and strictly follow their doctor's instructions regarding dosing. It may be helpful to inform friends or relatives so that they are aware of the above symptoms. If such symptoms occur, the patient should contact their doctor.

Using Midazolam Baxter with alcohol

While using Midazolam Baxter, the patient should not consume alcohol. Alcohol can significantly increase the sedative effect of Midazolam Baxter and cause breathing difficulties.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
The doctor will decide whether this medicine is suitable for them.
The patient should not breastfeed for 24 hours after receiving Midazolam Baxter. This medicine may pass into breast milk.

Driving and using machines

• The patient should not drive or operate machinery until the effects of the medicine have worn off completely. The doctor should advise the patient when they can resume these activities.
• Midazolam Baxter can cause drowsiness, disrupt memory, concentration, and coordination. This affects the ability to perform complex tasks, such as driving or operating machinery.
• After receiving this medicine, the patient should be accompanied by an adult on their way home.

Midazolam Baxter contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per ampoule, which means the medicine is considered "sodium-free".

3. How to use Midazolam Baxter

This medicine should only be administered by experienced medical personnel (a doctor, pharmacist, or nurse). The administration of the medicine should take place in a healthcare facility (hospital, clinic, or office) equipped with equipment for monitoring the patient, supporting respiratory and circulatory functions, and recognizing and treating possible adverse events during anesthesia.

Dosage, method, and route of administration, frequency of administration, and duration of treatment

Midazolam Baxter will be administered to the patient by a doctor or nurse. This will be done in a facility equipped with the necessary equipment to monitor the patient and treat possible adverse events. In particular, this includes monitoring of breathing, heart function, and circulation.
Midazolam Baxter is not recommended for use in children under 6 months of age. However, if the doctor considers it necessary, the medicine can be administered to an infant or child under 6 months of age who is in an intensive care unit.

Midazolam may be administered in one of four different ways:

• by slow injection into a vein (intravenous administration),
• by intravenous drip (intravenous infusion),
• by intramuscular injection (intramuscular administration),
• rectally.

After receiving the medicine, the patient should be accompanied by an adult on their way home.

Recommended dose of Midazolam Baxter

The dose of Midazolam Baxter may be different for different patients. The doctor determines the dose individually, depending on the patient's age, weight, and overall health. Additionally, the dose depends on:

• the indication for treatment and the type of sedation required and its purpose,
• the patient's response to Midazolam Baxter,
• the need to use other medicines at the same time.

After administering the dose of Midazolam Baxter

After administering Midazolam Baxter, the patient should always be accompanied by another adult on their way home, who can take care of them. This is because Midazolam Baxter can cause drowsiness or disorientation. It can also affect concentration and coordination.
If the patient receives Midazolam Baxter for a long time, for example, in an intensive care unit, the body may get used to the medicine. This also means that it may not be as effective as before.

Using a higher dose of Midazolam Baxter than recommended

Midazolam Baxter is administered by a doctor or nurse. If the patient accidentally receives too much of the medicine, they may experience:

• drowsiness, loss of coordination (ataxia) and reflexes,
• speech problems (dysarthria) and involuntary eye movements (nystagmus).
• low blood pressure (hypotension), which can cause dizziness or fainting,
• breathing difficulties and cardiac arrest (slowdown or stoppage of breathing and heartbeat) and coma.

Using Midazolam Baxter for a longer period in intensive care units for sedation

If Midazolam Baxter is used for a longer period, the patient may:

• develop tolerance to the medicine, which will become less effective and stop working properly,
• develop dependence on the medicine and experience withdrawal symptoms (see: Stopping Midazolam Baxter).

Stopping Midazolam Baxter

Risk of withdrawal symptoms:
If the patient has been receiving Midazolam Baxter for a longer period, for example, in an intensive care unit, after stopping the medicine, they may experience withdrawal symptoms.
These include:

• mood changes
• seizures
• headache
• muscle pain
• difficulty sleeping
• anxiety, tension, restlessness, confusion, or bad mood (irritability),
• hallucinations (seeing and hearing things that do not exist).

The doctor will gradually reduce the dose of the medicine to avoid withdrawal symptoms.
If the patient has any doubts about using this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Midazolam Baxter can cause side effects, although not everybody gets them.
The following side effects may occur during treatment with this medicine. Their frequency is unknown and cannot be estimated from the available data.

If the patient experiences any of the following side effects, they should stop using Midazolam Baxter and immediately inform their doctor. These side effects can be life-threatening and require immediate treatment.

• Anaphylactic shock (a life-threatening allergic reaction). Symptoms include sudden rash, itching, or hives, swelling of the face, lips, tongue, or other parts of the body. Breathing difficulties, wheezing, or breathing problems may also occur.
• Heart attack. The symptom is chest pain.
• Breathing difficulties and breathing problems (sometimes leading to respiratory arrest).
• Laryngospasm causing choking. Life-threatening side effects occur more frequently in adults over 60 years of age and in people with breathing difficulties and heart disease, especially if the medicine is injected too quickly or in too high a dose.

Other possible side effects Psychiatric and nervous system disorders

• reduced alertness
• confusion
• excessive feeling of happiness or excitement (euphoria)
• fatigue, drowsiness, and prolonged sedation
• seeing and hearing things that do not exist (hallucinations)
• disorders of consciousness (delirium)
• headache
• dizziness
• coordination disorders
• seizures in premature infants and newborns
• temporary memory loss. The duration of memory loss depends on the duration of treatment and the dose of the medicine. It may persist after the end of treatment, in individual cases, for a long time.
• agitation, restlessness, anger, or aggression. Uncontrolled muscle spasms or muscle tremors may also occur. The likelihood of their occurrence is higher if the patient received a high dose of Midazolam Baxter or if the medicine was administered too quickly. These symptoms occur more frequently in children and elderly patients.

Cardiovascular and circulatory disorders:

• fainting
• slow heart rate
• flushing of the face and neck (flushing)
• low blood pressure. It may cause dizziness or fainting.

Respiratory disorders:

• hiccups
• shortness of breath

Gastrointestinal disorders:

• dry mouth
• constipation
• nausea, vomiting

Skin disorders:

• itching
• rash, hives
• redness, pain, swelling, or thrombophlebitis at the injection site

General disorders and administration site conditions:

• allergic reactions, including rash and wheezing
• withdrawal symptoms (see "Stopping Midazolam Baxter" in section 3 above)
• falls and bone fractures. The risk of their occurrence is higher if the patient is taking other medicines that cause drowsiness (e.g., sedatives or sleeping pills) or if the patient is drinking alcohol.

Elderly

• Using Midazolam Baxter increases the risk of falls and bone fractures.
• In people over 60 years of age, the likelihood of life-threatening side effects is higher.

Reporting side effects

If side effects occur, including any side effects not mentioned in the leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw
tel.: +48 22 49 21 301,
fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Midazolam Baxter

The storage of Midazolam Baxter is the responsibility of the doctor, pharmacist, or nurse. These individuals are also responsible for the proper disposal of unused remnants of the medicine.
The medicine should be stored in a place that is not visible and inaccessible to children.
Ampoules should be stored in the original outer packaging to protect them from light.
Do not use this medicine after the expiry date stated on the ampoule label and carton after: EXP. The expiry date refers to the last day of the month stated.
Do not use this medicine if you notice any visible solid particles.Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Midazolam Baxter contains

The active substance of the medicine is midazolam, 5 mg (as midazolam hydrochloride)
Each ml contains 5 mg of midazolam (as hydrochloride).
Each 1 ml ampoule contains 5 mg of midazolam (as hydrochloride).
Each 3 ml ampoule contains 15 mg of midazolam (as hydrochloride).
Each 10 ml ampoule contains 50 mg of midazolam (as hydrochloride).
The other ingredients are:
sodium chloride, sodium hydroxide, hydrochloric acid, and water for injections.

What Midazolam Baxter looks like and what the package contains

Midazolam Baxter is supplied in a colorless glass ampoule. The medicine is a clear, colorless, or light yellow solution.
It is available in the following packages:
1 ml glass ampoule in packs of 5, 10, and 25 ampoules.
3 ml glass ampoule in packs of 5, 10, and 25 ampoules.
10 ml glass ampoule in packs of 5 and 10 ampoules.
Not all pack sizes may be marketed.

Marketing authorization holder and importer

Baxter Holding B.V.
Kobaltweg 49
3542CE Utrecht, Netherlands

Importer

UAB Norameda

Meistru g. 8a, 02189 Vilnius, Lithuania

Bieffe Medital S.P.A

Via Nuova Provinciale, 23034 Grosotto (SO), Italy

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Czech Republic
Midazolam Baxter
Estonia
Midazolam Baxter
France
Midazolam Baxter 5 mg/ml Solution pour Injection/Perfusion
Hungary
Midazolam Baxter 5 mg/ml oldatos injekció/infúzió
Ireland
Midazolam Baxter 5 mg/ml solution for injection/infusion
Latvia
Midazolam Baxter 5 mg/mL šķīdums injekcijām/infūzijām
Lithuania
Midazolam Baxter 5 mg/ml injekcinis ar infuzinis tirpalas
Poland
Midazolam Baxter
Portugal
Midazolam Baxter
Romania
Midazolam Baxter 5 mg/ml soluție injectabilă/perfuzabilă
Slovakia
Midazolam Baxter 5 mg/ml
Netherlands
Midazolam Baxter 5 mg/ml oplossing voor injectie/infusie
United Kingdom
Midazolam 5 mg/ml solution for injection/infusion

Date of last revision of the leaflet:

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Information intended for healthcare professionals only.
The content of the leaflet above the tear line is intended for patients.
INFORMATION FOR HEALTHCARE PROFESSIONALS
The full description of the medicinal product is contained in the Summary of Product Characteristics

Product characteristics

Each 1 ml of the product contains 5 mg of midazolam (as hydrochloride).
Each 1 ml ampoule contains 5 mg of midazolam (as hydrochloride).
Ampoules are made of colorless glass (type I) and have a capacity of 1 ml, packaged in packs of 5, 10, or 25 ampoules. Not all pack sizes may be marketed.
Each 3 ml ampoule contains 15 mg of midazolam (as hydrochloride).
Ampoules are made of colorless glass (type I) and have a capacity of 3 ml, packaged in packs of 5, 10, or 25 ampoules. Not all pack sizes may be marketed.
Each 10 ml ampoule contains 50 mg of midazolam (as hydrochloride).
Ampoules are made of colorless glass (type I) and have a capacity of 10 ml, packaged in packs of 5 or 10 ampoules.
Not all pack sizes may be marketed.
This medicinal product contains less than 1 mmol (23 mg) of sodium per ampoule, which means the medicinal product is considered "sodium-free".

Dosage and administration

Midazolam Baxter is a highly potent sedative that requires gradual dose increase and slow administration. It is absolutely recommended to gradually increase the dose to achieve the level of sedation corresponding to clinical needs, physical condition, age, and other medicines used by the patient. In adults over 60 years of age, weakened or chronically ill patients, and children and adolescents, the dose should be carefully determined, taking into account individual risk factors. Standard doses are listed in the table below.
Additional information can be found in the text below the table

Children over 6 months of age

In order to achieve the desired clinical effect, in intubated and mechanically ventilated children, an intravenous loading dose of 0.05-0.20 mg/kg body weight should be administered slowly over at least 2-3 minutes. Midazolam should not be administered as a rapid intravenous injection. After the loading dose, a continuous intravenous infusion should be started at a dose of 0.06-0.12 mg/kg body weight/hour (1-2 micrograms/kg body weight/minute). If necessary, the infusion rate can be increased or decreased (usually by 25% of the initial or subsequent rate) or additional intravenous doses of midazolam can be administered to increase or maintain the desired effect. When initiating midazolam infusion in hemodynamically unstable patients, the loading dose should usually be gradually increased in small increments, and the patient should be monitored for signs of hemodynamic instability, such as hypotension. These patients are also prone to midazolam-induced respiratory depression and require careful monitoring of respiratory rate and saturation. In preterm infants, full-term newborns, and children with a body weight of less than 15 kg, it is not recommended to use midazolam solutions with a concentration greater than 1 mg/ml. Solutions with a higher concentration should be diluted to 1 mg/ml.

Special patient groups

Patients with renal impairment
In patients with renal impairment (creatinine clearance below 10 ml/min), the pharmacokinetics of unbound midazolam after a single intravenous dose are similar to those in healthy individuals. However, in the case of prolonged intravenous infusion in patients in the intensive care unit (ICU), the mean duration of sedative action in patients with renal impairment (demonstrated after prolonged infusion in intensive care units) was significantly longer, probably due to the accumulation of α-hydroxymidazolam glucuronide. There are no data available on patients with severe renal impairment (creatinine clearance below 30 ml/min) receiving midazolam for induction of anesthesia.
Patients with hepatic impairment
Impaired hepatic function reduces the clearance of intravenous midazolam, prolonging the terminal elimination half-life. This may result in intensified and prolonged clinical effects of the drug. The required dose of midazolam may need to be reduced, and vital signs should be monitored accordingly (see section 4.4 of the SmPC).
Children and adolescents
See above and section 4.4 of the SmPC.

Incompatibilities

Midazolam Baxter should not be diluted with 6% dextran in glucose solution. Midazolam Baxter should not be mixed with alkaline injection solutions. Midazolam Baxter precipitates in a solution containing sodium bicarbonate. Midazolam Baxter should not be mixed with other medicinal products except those mentioned in section 6.6 of the SmPC.

Shelf life

3 years
Chemical and physical stability of diluted solutions has been demonstrated for 24 hours at room temperature or for 3 days at +5°C.
From a microbiological point of view, the product should be used immediately after dilution. If the product is not used immediately, the responsibility for the storage time and conditions before use lies with the user, but this time should not exceed 24 hours at a storage temperature of +2°C to +8°C, unless dilution has been carried out under controlled and validated aseptic conditions (information on dilution of the product, see section 6.6 of the SmPC)

Special precautions for storage

Store in the original outer packaging to protect from light.
Storage conditions for the diluted medicinal product - see section 6.3 of the SmPC
Date of approval of the package leaflet for healthcare professionals: