Ozalin
OZALIN is a medicine that helps calm babies, children, and teenagers (6 months to 17 years old) before medical procedures or anesthesia to reduce fear and anxiety.
Form
oraaliliuos, kerta-annospakkaus
Strength
2 mg/ml
Active Ingredient
Midazolam
Manufacturer
Istituto Gentili S.r.l.
How to Use
Dosage
The dose is 0.25 mg per kilogram of body weight, given once to children from 6 months of age.
Method
This medicine is given by mouth by a healthcare professional using a special oral applicator before a procedure or anesthesia.
Important
The maximum dose is 20 mg of midazolam (which is two ampoules), even if the child or teenager weighs more than 80 kg.
Possible Side Effects
RARE
- •Feeling very calm or too calm for too long.
- •Feeling restless, upset, angry, aggressive, excited, confused, unusually happy, or seeing/hearing things that aren't there.
- •Feeling sleepy or less alert.
- •Feeling dizzy.
- •Trouble coordinating movements.
- •Feeling like everything is spinning (vertigo).
- •Problems with speech.
- •Dry mouth.
- •Increased saliva (drooling).
- •Leaking urine without meaning to.
- •Headache.
- •Forgetting things for a short time.
RARE
- •Allergic reactions like swelling (angioedema).
- •Chest pain, which can be a sign of a severe allergic reaction called Kounis syndrome.
RARE
- •Heartbeat changing (slower or faster).
RARE
- •Difficulty breathing, noisy breathing, wheezing (whistling sound when breathing).
- •Loud breathing.
- •Hiccups.
RARE
- •Vomiting.
- •Feeling sick to your stomach.
RARE
- •Blurred vision.
- •Seeing double.
RARE
- •Itching, red, bumpy rash (like hives).
- •Rash.
RARE
- •Feeling unusually tired.
- •Feeling weak.
Important Warnings
- Do not use if your child is allergic to midazolam, benzodiazepines, or any other ingredients in this medicine.
- Do not use if your child has a nerve-muscle disease causing severe muscle weakness (myasthenia gravis).
- Do not use if your child has severe breathing problems.
- Do not use if your child has a condition that causes frequent pauses in breathing during sleep (sleep apnea).
- Do not use if your child has severe liver problems.
Show 6 more warnings
- Tell your doctor if your child has a long-term illness, such as breathing, kidney, liver, or heart problems.
- Tell your doctor if your child is in poor general health.
- Tell your doctor if there is a history of alcohol or drug abuse.
- Do not use this medicine if your child is under 6 months old.
- Do not give your child grapefruit juice with OZALIN, as it can increase the medicine's calming effects and make your child very sleepy.
- Your child must not consume alcohol while taking OZALIN, as alcohol can increase the calming effects and make them very sleepy.