OZASED 2 mg /Ml Roztwór Doustny

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1. OZASED 2 mg/ml, oral solution in single-dose container
   1. What is OZASED and what is it used for
   2. What you need to know before your child is given OZASED
   3. How to use OZASED
   4. Possible side effects
   5. How to store OZASED
   6. Contents of the pack and other information

OZASED 2 mg/ml, oral solution in single-dose container

Midazolam

Read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If your child experiences any side effects, including those not listed in this leaflet, tell your child’s doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What OZASED is and what it is used for
• 2. What you need to know before giving OZASED to your child
• 3. How to use OZASED
• 4. Possible side effects
• 5. How to store OZASED
• 6. Contents of the pack and other information

1. What is OZASED and what is it used for

OZASED contains midazolam. It belongs to the class of medicines known as benzodiazepines.
OZASED is used in infants, children and adolescents from 6 months to 17 years for moderate sedation:

• before a therapeutic or diagnostic procedure to relieve anxiety, distress and agitation related to the procedure
• as premedication before anesthesia.

2. What you need to know before your child is given OZASED

Do not use OZASED:

• if your child is allergic to midazolam, to benzodiazepines or to any of the other ingredients of this medicine (listed in section 6)
• if your child suffers from neuromuscular diseases that cause severe muscle weakness (myasthenia gravis)
• if your child suffers from severe breathing difficulties
• if your child suffers from conditions that cause frequent interruption of breathing during sleep (sleep apnea syndrome)
• if your child suffers from severe liver problems.

Warnings and precautions
Talk to your doctor or pharmacist before giving OZASED to your child

• if your child suffers from a chronic illness (such as breathing problems or kidney, liver or heart problems)
• if your child is in poor health
• if your child has a history of alcoholism or drug addiction
• if your child is under 6 months of age

Other medicines and OZASED
Tell your doctor or pharmacist if your child is taking, has recently taken or might
take any other medicines, especially if your child is taking any of the following
medicines:

• medicines used to treat bacterial infections (antibiotics), for example erythromycin, clarithromycin, telithromycin, roxithromycin
• medicines used to treat fungal infections (antifungals), for example ketoconazole, voriconazole, fluconazole, itraconazole and posaconazole
• medicines used to treat stomach ulcers (antiulcer), for example cimetidine and ranitidine
• medicines used to treat epilepsy (antiepileptics), for example phenytoin and carbamazepine
• medicines used to treat high blood pressure (antihypertensive), for example diltiazem and verapamil
• medicines used to treat HIV and AIDS, for example saquinavir, including combinations containing ritonavir and efavirenz
• medicines used to prevent nausea and vomiting, for example aprepitant
• medicines used to reduce fat in the blood, for example atorvastatin
• medicines used to treat depression that causes drowsiness (sedative antidepressants)
• other medicines to treat depression (antidepressants), for example fluvoxamine
• medicines used to treat cystic fibrosis, for example ivacaftor
• medicines used to treat urinary incontinence, for example propiverine
• medicines used to treat mycobacterial infections such as tuberculosis, for example rifampicin
• medicines used as anesthetics, for example inhalation anesthetics, propofol, ketamine, etomidate
• sleeping pills (hypnotics)
• medicines used as strong painkillers (narcotic analgesics), for example fentanyl
• medicines used for cough relief (antitussive) or used to treat opioid dependence (substitution treatment) that contain opioids
• medicines used to treat specific mental disorders such as psychosis (antipsychotics)
• medicines containing benzodiazepines used for the treatment of anxiety or sleep disorders (benzodiazepines used as anxiolytics or hypnotics)
• medicines for the treatment of allergies (antihistamines)
• herbal remedies, for example St. John's wort, echinacea purpurea, turmeric rhizome

OZASED with food, drinks and alcohol
Before sedation, general guidelines on fasting must be followed.
Your child should not drink alcohol while taking OZASED, as alcohol can increase the
sedative effects of this medicine and therefore cause severe drowsiness.
Your child should not drink grapefruit juice while taking OZASED, as this may
increase the sedative effects of this medicine and therefore cause severe drowsiness.

Pregnancy and breastfeeding
Pregnancy
If your daughter is pregnant or if she suspects she is pregnant, ask your doctor for advice before
this medicine is given to your daughter.

Breastfeeding
If your daughter is a breastfeeding mother, she should be informed of the need to stop
breastfeeding for 24 hours after the administration of midazolam, as this passes in
small amounts into breast milk.

Driving and operating machinery
OZASED can cause drowsiness, distraction or affect concentration and coordination
of your child. Your child should not drive vehicles, bicycles or operate machinery before
full recovery. Ask your doctor if you need further guidance.

OZASED contains sodium, ethanol and gammadex
This medicine contains less than 1 mmol (23 mg) of sodium per vial, which means
it is essentially sodium-free.
This medicine contains 17.4 mg of alcohol (ethanol) in each dosage unit, vial of 5 ml, which is
equivalent to 3.5 mg/ml (ethanol/solution) or 0.32% w/v.
The amount of ethanol in 1 vial of 5 ml of this medicine (17.4 mg) is equivalent to 0.2 ml of wine.
The amount of ethanol in 2 vials of 5 ml of this medicine (34.8 mg) is equivalent to 0.4 ml of wine,
at the maximum dosage of 20 mg of midazolam.
The small amount of alcohol in this medicine will not produce significant effects.
This medicine contains 400 mg of gammadex in each vial, equivalent, at the recommended dose, to
10 mg/kg/day and is less than the permitted daily exposure. Therefore, even if OZASED
is inadvertently used with a dose of 0.5 mg/kg, the amount of gammadex will not exceed
the permitted daily exposure.

3. How to use OZASED

Instructions for use
OZASED must be administered orally.
OZASED will be administered to your child by a healthcare professional. It will be administered in a
location equipped with the necessary equipment to monitor the child and to treat any potential
side effects.
OZASED is not intended for self-administration.
Upon discharge, your child must be accompanied by an adult and must only leave the room
with the doctor's authorization.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During the administration of midazolam, the following side effects may occur, the frequency of which has not been determined and is impossible to estimate based on currently
available data.
Nervous system disorders

• Prolonged sedation/oversedation
• Agitation, restlessness, hostility, anger or aggression, excitement, confusion, euphoria (an excessive feeling of happiness or excitement) or hallucinations (seeing and possibly hearing things that are not real)
• Numbness, drowsiness
• Dizziness
• Difficulty coordinating muscles
• Vertigo
• Speech disorders
• Dry mouth
• Salivation
• Urinary incontinence
• Headache
• Temporary memory loss. Immune system disorders
• Hypersensitivity reactions and angioedema may occur in sensitive individuals.
• Chest pain has been observed as a sign of a serious allergic reaction calledKounis syndrome.Cardiac disorders
• Modified heart rate (slow or accelerated). Respiratory disorders
• Laryngospasm (narrowing of the vocal cords causing difficulty breathing and noisy breathing), difficulty breathing (slow breathing), wheezing
• Noisy breathing
• Hiccups Gastrointestinal disorders
• Vomiting
• Nausea Eye disorders
• Blurred vision
• Double vision Skin disorders
• Itching, rash with raised, red, itchy blisters (urticarial reaction)
• Rash Systemic disorders and conditions related to the site of administration
• Unusual fatigue
• Feeling of weakness

Reporting of side effects
If your child experiences any side effect, including those not listed in this
leaflet, please inform your child’s doctor or pharmacist.
You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store OZASED

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 label, on the blister or on the
vial box after EXP. The expiry date refers to the last day of that month.
To protect it from light, store this medicine in the original package. Do not store at
temperatures above 25 °C. Do not refrigerate or freeze.

6. Contents of the pack and other information

What OZASED contains

• The active ingredient is midazolam.
• The other ingredients are: citric acid monohydrate, gammadex, sucralose, orange flavour (contains a particular percentage of 70-80% ethanol), sodium hydroxide (for pH adjustment), water for injections

Description of OZASED and contents of the pack
OZASED consists of an amber glass vial of 5 ml, a straw and an oral applicator,
packaged together inside a single blister.
OZASED is marketed in 3 different packs:

• pack of one blister
• pack of five blisters
• pack of ten blisters

Not all packs may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Istituto Gentili S.r.l.
Via San Giuseppe Cottolengo 15
20143 Milano (MI)
Manufacturer

VALDEPHARM
Parc Industriel d’Incarville, 27106 Val-De-Reuil – France

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Austria OZASED 2 mg/ml Lösung zum Einnehmen im Einzeldosisbehältnis
Belgium Ozalin 2 mg/ml solution buvable en récipient unidose /
drank in verpakking voor éénmalig gebruik /
Lösung zum Einnehmen im Einzeldosisbehältnis
Denmark Ozalin 2 mg/ml oral opløsning i enkeltdosisbeholder
Finland Ozalin 2 mg/ml oraaliliuos kerta-annospakkaus
France Ozalin 2 mg/ml solution buvable en récipient unidose
Germany Ozalin 2 mg/ml Lösung zum Einnehmen im Einzeldosisbehältnis
Greece Ozalin 2 mg/ml πόσιµο διάλυµα σε περιέκτη µίας δόσης
Ireland Ozalin 2 mg/ml oral solution in single-dose container
Italy Ozased 2 mg/ml soluzione orale in contenitore monodose
Netherlands Ozalin 2 mg/ml drank in verpakking voor eenmalig gebruik
Norway Ozalin 2 mg/ml mikstur, oppløsning i endosebeholder
Poland OZASED, 2 mg/ml, roztwór doustny w pojemniku jednodawkowym
Portugal Ozalin 2 mg/ml solução oral em recipiente unidose
Spain Ozalin 2 mg/ml solución oral en envase unidosis

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The following information is intended for healthcare professionals only:
The solution must be visually inspected before use. Do not use this medicine if you notice
any visible signs of deterioration in the solution or in the pack. OZASED must be
administered only with the specific dedicated graduated in kgoral applicator

How to open the vial

• (1) The medicine must be administered to the patient using the vial, straw and oral applicator.
• (2) Connect the straw to the end of the oral applicator.

• (3) Tap the top of the vial to ensure that all the liquid has flowed to the bottom. Cover the top of the vial with a cloth and place your thumb on the white spot.
• (4) Hold the vial firmly with the white spot facing upwards in your direction. Push the neck of the vial to easily open it.

Preparation and administration of the solution

• (5) Insert the straw into the vial. Before adjusting the dosage and in order to eliminate any air present in the filter, it is recommended to perform a brief pumping (filling and emptying) of the solution into the vial with the applicator inside the vial.
• (6) Keeping the vial in a vertical position, fill the oral applicator up to the graduation line corresponding to the patient's weight in kilograms (kg). Align the reference line to the top of the flap to take the correct dose.
• (7) Remove the straw from the end of the oral applicator.

• (8) Empty the contents of the oral applicator into the patient's mouth. The solution must be ingested immediately.

• (9) After use, dispose of the vial, straw, oral applicator and any unused contents in a container intended for this purpose according to local requirements for controlled pharmaceutical substances and accessories.

Dosage
The dose must be adjusted to the patient's weight.
OZASED must be administered orally with a single dose of 0.25 mg/kg in children with
an age of six months or older.
The maximum dose should not exceed 20 mg of midazolam (corresponding to 2 vials) even for children
and adolescents weighing more than 80 kg.
In obese children and adolescents, the dose must be administered based on actual body weight,
up to the limit of 20 mg.
The oral applicator is graduated in kilograms, from 3 kg to 40 kg of body weight, with three types of graduation lines:

• A small graduation line corresponding to 1 kg, i.e.0.25 mg of midazolam.
• An intermediate graduation line corresponding to 5 kg, i.e.1.25 mg of midazolam.
• A large graduation line corresponding to 10 kg, i.e.2.50 mg of midazolam.

For patients weighing more than 40 kg, 2 vials are required. The minimum dose to be taken from a
vial must correspond to a dose of 3 kg. For patients weighing 41 and 42 kg and who
need more than one vial, take a dose of less than 40 kg in the first vial and supplement the
dose in the second vial; see examples below:

• For a patient weighing 41 kg, it is recommended to take 30 kg in the first vial and 11 kg in the second vial.
• For a patient weighing 42 kg, take a dose corresponding to 30 kg in the first vial and 12 kg in the second vial.

The oral applicator and straw are single-use withdrawal and administration devices.
OZASED must be administered 30 minutes (on average) before the procedure or anaesthesia.
OZASED is not recommended in newborns (born at term and premature) and in children under
6 months of age.
In case of overdose, it is necessary to induce vomiting (as soon as possible and, in any case,
within one hour of oral administration of midazolam) if the patient is conscious, or
perform gastric lavage while protecting the airways if the patient is unconscious. If
gastric lavage is not effective, administer activated charcoal to reduce absorption.
Flumazenil, a benzodiazepine antagonist, is indicated in the case of severe poisoning
accompanied by respiratory depression or coma. This treatment must be administered
exclusively under strict supervision and in accordance with local guidelines.