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1 Ampoule of Dormicum (Midazolam) 5mg5ml

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Product Description

INFORMATION FOR THE USER

Dormicum ® V 5 mg / 5 ml solution for injection midazolam

Read this entire leaflet carefully before you starts using this medicine.
• Keep this leaflet. You might want to read it again.
• If you have any questions, please contact your physician or the nursing staff.
• 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.

In this leaflet:

1 what is V Dormicum 5 mg / 5 ml and what it is used?
2 What you need to consider 5 mg / 5 ml before the administration of midazolam V?
3 How is 5 mg / 5 ml Dormicum V?
4 What side effects are possible?
5 How is Dormicum V storing 5 mg / 5 ml?
6 more information

1:- What is V Dormicum 5 mg / 5 ml and what it are used?

Dormicum contains an active ingredient called midazolam. This drug belongs to a group of medicines called benzodiazepines.
Dormicum you can be or fall asleep quickly sleepy. It also soothes and loosens muscle tensions.
Dormicum is used in adults:
• as a general anesthetic for falling asleep or maintaining sleep.
Dormicum is also used in adults and children:
• to bring about a feeling of calm or sleepiness in intensive care units. This process is called “sedation”;
• before and during a medical examination or a procedure. Here, the patients remain awake, but feel calm and sleepy. This process is Called “conscious sedation”;
• to bring about a feeling of calm or sleepiness prior to the administration of an anesthetic.

2:- What you need to consider 5 mg / 5 ml before the administration of midazolam V?

V Dormicum 5 mg / 5 ml should not be used if you
• be hypersensitive (allergic) to midazolam or any of the other ingredients of V Dormicum 5 mg / 5 ml are described in the section 6 More information is called;
• are allergic to other benzodiazepines , such as Diazepam or nitrazepam ;
• suffer from severe breathing problems and Dormicum V should receive 5 mg / 5 ml for " conscious sedation " .
If any of these apply to you, Dormicum V must not exceed 5 mg / 5 ml at you not be applied. Ask your doctor or nurse for advice if you are unsure before using this drug.

Take special care with the use of midazolam V 5 mg / 5 ml:

Talk to your before you use Dormicum V 5 mg / 5 ml with your doctor or nurse if you:

• are over 60 years old,
• have persistent disorders of the respiratory , kidney, liver or heart ,
• have a condition where you feel very weak, knocked off and de-energized ,
• suffer from a so-called " myasthenia gravis " ( a disease that is characterized by muscle weakness),
• Been once dependent on alcohol ,
• Been once dependent on drugs .

If any of these apply to you or you are unsure of which to inform before use of Dormicum V 5 mg / 5 ml your doctor or nurse.

If your child is to be given this medicine:
• tell your doctor or nurse if any of the above apply to your child.
• This is especially true if your child has a heart disease or breathing problems.

With the use of midazolam V 5 mg / 5 ml with other medicaments

Please tell your doctor or nurse if you are taking any other medicines / taking or have recently taken / , even if it is obtained without a prescription and herbal medicines . This is important because V Dormicum 5 mg / 5 ml can affect the way some other medicines work. Also, some other medicines, the effect of V Dormicum 5 mg / 5 ml of influence.

Inform especially if you are taking with your doctor or nurse of the following medicines:

• medicines used to treat depression ,
• sleeping pills,
• sedatives,
• medicines for anxiety, tension and agitation ( tranquilizers ) ,
• carbamazepine or phenytoin ( used to treat seizures ) ,
• rifampicin (a medicine used to treat tuberculosis )
• medicines used to treat HIV infection, called " protease inhibitors " such as saquinavir,
 • antibiotics named " macrolide " , such as Erythromycin or clarithromycin,
• medicines used to treat fungal infections , such as Ketoconazole , voriconazole, fluconazole , itraconazole or posaconazole ,
• very strong painkillers ,
• atorvastatin (used to treat high cholesterol) ,
• medicines used to treat allergies ( antihistamines )
• St. John's wort ( a herbal medicine used to treat depression ) ,
• medicines used to treat high blood pressure with the name"Calcium channel blockers " , such as Diltiazem.

If you are taking any of the medicines listed above or which are uncertain, please contact before using Dormicum V 5 mg / 5 ml your doctor or nurse.

Alcohol:-

Do not drink alcohol if you have received midazolam V 5 mg / 5 ml, because you feel otherwise very sleepy or difficulty breathing can occur.

Pregnancy and lactation:-

Inform. Before the administration of midazolam V 5 mg / 5 ml with your doctor if you are pregnant or think you may be pregnant your doctor will advise you and then decide whether this medicine is suitable for you.
Midazolam passes into breast milk. Therefore, you may after the last application of V Dormicum 5 mg / 5 ml your child for 24 hours not breastfeed.

Driving and using machines:-

• after administration of midazolam V 5 mg / 5 ml you may as long as do not drive or operate machinery until your doctor allows it.
• This is necessary because V Dormicum 5 mg / 5 ml may make you drowsy or forgetful. Likewise Dormicum V 5 mg / 5 ml impair your concentration and coordination skills, which will make your ability is limited, to drive a motor vehicle or operate machinery.
• After your treatment your need can be brought by an adult at home who can care for you.

Important information about some of the ingredients of midazolam:-

This medicinal product contains less than 1 mmol (23 mg) of sodium per vial, ie it is essentially ' sodium-free'.

3 How is 5 mg / 5 ml Dormicum V?

V Dormicum 5 mg / 5 ml is given to you by a doctor or by the nursing staff. The application is made ​​in a facility that has the necessary equipment to your monitoring and treatment of possible side effects. This may be a hospital or a surgical outpatient clinic. In particular, your breathing, your heart function and your circulation will be monitored.

V Dormicum 5 mg / 5 ml is not recommended for use in infants and young children less than 6 months. In intensive care, however, use in infants and young children under 6 months can be done if the doctor deems it necessary.

V as midazolam 5 mg / 5 ml, is applied

V Dormicum 5 mg / 5 ml is given to you on one of the following ways :

• by slow injection into a vein ( intravenous injection) ,
• via a drip into one of your veins ( intravenous infusion) ,
• by injection into a muscle ( intramuscular injection) ,
• by injection into your rectum ( rectal injection).

How much Dormicum V 5 mg / 5 ml are given to you:-

The midazolam dose varies from patient to patient. Your doctor will decide the right dose for you. This depends on your age, weight and general health. It also depends on the intended treatment, how you respond to the medicine and whether you should be given other medicines at the same time.

V after midazolam 5 mg / 5 ml was added:-

After your treatment you need can be brought by an adult at home who can care for you. This is necessary, since V Dormicum 5 mg / 5 ml may make you drowsy or forgetful. Also, can affect your concentration and coordination skills Dormicum V 5 mg / 5 ml.

Dormicum if V 5 mg / 5 ml, is applied over a longer period, such as in intensive care, your body can get used to the drug policy. This means that the effect may decrease.

If you have received 5 mg / 5 ml of a larger amount of midazolam V than you should

V Dormicum 5 mg / 5 ml is given to you by a doctor or nurse. It is therefore unlikely that you will receive an overdose. However, if you accidentally get an overdose, you might notice the following:

• drowsiness , and loss of the natural interplay of the muscles (coordination) , and reflexes ,
• slurred speech, and unusual eye movements ,
• low blood pressure. This allows you to feel drowsy or dizzy;
• slowing or cessation of breathing or heartbeat and loss of consciousness (coma) .

With long- term use of Dormicum V 5 mg / 5 ml for sedation in the intensive care

If you Dormicum V 5 mg / 5 ml over a long period of sedation (sedative drug - a state of calm, drowsiness or sleep) obtained the following may occur:

• the effect may decrease ,
• You can become addicted to this drug and withdrawal symptoms may occur if treatment is stopped (see " If treatment withTerminates Dormicum V 5 mg / 5 ml ").

If the treatment with Dormicum V 5 mg / 5 ml is terminated

Dormicum if V 5 mg / 5 ml, is applied over a longer period , for example, in intensive care, withdrawal symptoms may occur when stopping the treatment. These include:

• mood swings,
• convulsions,
• headache,
• muscle pain,
• sleep disturbances,
• Strong anxiety (fear ) , tension, restlessness , confusion or irritability ,
• seeing or hearing things that are not there (hallucinations ) .

Your doctor will reduce the dose gradually to prevent withdrawal symptoms in you.

4:- What side effects are possible?

Like all medicines, Dormicum V 5 mg / 5 ml have side effects, although not everybody gets them. The following side effects may happen with this medicine (frequency not known, this cannot be estimated based on the available data):

The use of midazolam V 5 mg / 5 ml must be terminated and you must immediately contact a doctor if you notice any of the following side effects. These can be life-threatening and require emergency measures:

• a severe allergic reaction (anaphylactic shock). The signs may include a sudden rash, itching or hives, and swelling of the face, lips, tongue or other parts of the body. It can also shortness of breath, wheezing or shortness of breath;
• heartbeat (cardiac arrest). The signs may be chest pain;
• Shortness of breath with occasional respiratory arrest ;
• Muscle spasm in the larynx , which causes choking .

Life-threatening side effects are more likely to affect adults over 60 years and in patients who already have respiratory or heart problems. The probability of the occurrence of these adverse reactions is also increased if the injection is carried out too rapidly or in a high dose.

Other possible side effects:-

Nervous system and mind
• Decreased attention,
• confusion,
• excessive well-being ( euphoria ) ,

• tiredness , drowsiness , prolonged sedation ,
• seeing or hearing things that are not there (hallucinations )
• headache,
• dizziness,
• Disorders of the natural interplay of the muscles ( in coordination ) ,
• seizures in premature and newborn infants ,
• temporary memory lapses . The duration of this memory impairment is dependent on the amount of the administered dose midazolam V 5 mg / 5 ml occasionally during longer-lasting memory impairment on.

• Agitation, restlessness, outbursts of anger or aggression. You may also experience muscle spasms or uncontrollable muscle twitching (tremor) . The probability for the occurrence of these side effects is higher if you a high dose of midazolam V 5 mg / 5 ml were added or when midazolam was administered too quickly. Children and the elderly are also more susceptible to these reactions.

Heart and Circulation:-

• fainting,
• slowed heartbeat sequence ,
• Face and Nackenröte ( hot flashes ) ,
• low blood pressure, you may feel dizzy or light-headed by the .

Breathing:-

• hiccups,
• Shortness of breath .

Mouth, stomach and intestines:-

• dry mouth,
• constipation,
• nausea and vomiting.

Skin:-

• itching,
• rash, including hives ,
• redness, skin swelling , blood clots and pain at the injection site.

Generally:-

• Allergic reactions including rash and shortness of breath,
• withdrawal symptoms (see " If treatment with midazolam V 5 mg / 5 ml is terminated " in section 3 above).

• Falls and fractures. The risk is increased in patients taking concomitant drug that increases known to lead to drowsiness (eg, sedative drugs or sleeping pills) , or alcohol.

Older people:-

• Older people have after the use of benzodiazepine drugs such as Dormicum an increased risk of falls and fractures.
• The probability of the occurrence of life-threatening adverse reactions is increased in patients older than 60 years.

Please tell your doctor or nurse if any of the side effects gets you serious or if you notice any side effects not listed in this leaflet.

5:- How is Dormicum V storing 5 mg / 5 ml?

• Your doctor or pharmacist is responsible for the safekeeping of V Dormicum 5 mg / 5 ml and for the proper disposal of unused V Dormicum 5 mg / 5 ml.
• Medicines reach of children.
• Medicines should after on the carton and on the vial label after “EXP to “expiry date no longer is applied. The expiry date refers to the last day of the month.
• V Dormicum 5 mg / 5 ml must not be used if you notice that the vial or carton is damaged.
• Keep the ampoules in the outer carton to protect from light.

6:- More information:-

Dormicum which V contains 5 mg / 5 ml

• The active substance is midazolam (as Midazolamhydrochlorid). Each ampoule V Dormicum 5 mg / 5 ml contains 5 mg midazolam (as Midazolamhydrochlorid ) in 5 ml solution for injection.
• The other ingredients are: sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.

As V Dormicum 5 mg / 5 ml looks like and contents of the pack
V Dormicum 5 mg / 5 mL is a clear, colorless liquid ( solution for injection ) , which is filled into colorless glass vials.
V Dormicum 5 mg / 5 mL comes in packs of 5 ampoules (N1 ) available .

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