Consumer medicine information

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about DEXMEDETOMIDINE EVER PHARMA. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking DEXMEDETOMIDINE EVER PHARMA against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet. You may need to read it again.

WHAT IS DEXMEDETOMIDINE EVER PHARMA USED FOR

Intensive Care Sedation

DEXMEDETOMIDINE EVER PHARMA can be used as a sedative (calming agent) if adults need to be calm or sleepy in the Intensive Care Unit whilst they are being ventilated (on a breathing machine). It may be given as an infusion up to 24 hours.

Procedural Sedation

DEXMEDETOMIDINE EVER PHARMA can be given to adults prior to an operation if they are not on a ventilator (breathing machine) if it is required for the procedure or surgery that they be sleepy and calm.

This medicine belongs to a group of medicines called alpha-2-receptor agonists. This medicine works by its actions on brain chemicals.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

DEXMEDETOMIDINE EVER PHARMA is only available with a doctor's prescription.

BEFORE YOU ARE GIVEN DEXMEDETOMIDINE EVER PHARMA

When you must not take it

Do not take DEXMEDETOMIDINE EVER PHARMA if you have an allergy to:

• any medicine containing dexmedetomidine hydrochloride
• any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

• shortness of breath
• wheezing or difficulty breathing
• swelling of the face, lips, tongue or other parts of the body
• rash, itching or hives on the skin

Do not take this medicine if you are pregnant. It may affect your developing baby if you take it during pregnancy.

Do not breast-feed if you are taking this medicine. The active ingredient in DEXMEDETOMIDINE EVER PHARMA passes into breast milk and there is a possibility that your baby may be affected.

Do not give this medicine to a child under the age of 18 years. Safety and effectiveness in children younger than 18 years have not been established.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

• cardiovascular disease
• diabetes

Elderly patients greater than 65 years old may be more prone to the blood pressure lowering effects of DEXMEDETOMIDINE EVER PHARMA.

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding. Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell him/her before you start taking DEXMEDETOMIDINE EVER PHARMA.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and DEXMEDETOMIDINE EVER PHARMA may interfere with each other. These include:

• medicines used to produce calmness or to help you sleep
• strong pain relievers

These medicines may be affected by DEXMEDETOMIDINE EVER PHARMA or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

HOW TO TAKE DEXMEDETOMIDINE EVER PHARMA

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

How much to take

Your doctor will decide what dose you will receive. This depends on your condition and other factors such as your weight. The dose will be adjusted to keep you at the right depth of sleep or sedation.

How to it is given

DEXMEDETOMIDINE EVER PHARMA is given by a slow injection (drip) into a vein. DEXMEDETOMIDINE EVER PHARMA should only be given by a doctor or nurse.

If you take too much (overdose)

As DEXMEDETOMIDINE EVER PHARMA is given to you under the supervision of your doctor, it is very unlikely that you will receive too much.

Symptoms of an overdose may include extreme drowsiness, confusion, dizziness, weakness or becoming unconscious.

WHILE YOU ARE TAKING DEXMEDETOMIDINE EVER PHARMA

Things you must do

Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. It may affect other medicines used during surgery.

If you become pregnant while taking this medicine, tell your doctor immediately.

If you are about to have any blood tests, tell your doctor that you are taking this medicine. It may interfere with the results of some tests.

Things you must not do

Do not take DEXMEDETOMIDINE EVER PHARMA to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Things to be careful of

Be careful driving or operating machinery until you know how DEXMEDETOMIDINE EVER PHARMA affects you.

This medicine may cause dizziness, light-headedness, tiredness, drowsiness, and therefore affect alertness in some people.

If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous. Ask your doctor when you can return to work involving driving or operating machinery or heavy equipment.

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly. Standing up slowly, especially when you get up from bed or chairs, will help your body get used to the change in position and blood pressure. If this problem continues or gets worse, talk to your doctor.

SIDE EFFECTS

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking DEXMEDETOMIDINE EVER PHARMA.

This medicine helps provide sedation for most people but it may have unwanted side effects in a few people. All medicines can have side effects.

Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

If you are over 65 years of age you may have an increased chance of getting side effects

Do not be alarmed by the following lists of side effects.

You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

• dizziness
• light-headedness
• nausea and/or vomiting
• high temperature
• dry mouth

The above list includes the more common side effects of your medicine. They are usually mild and short-lived.

Tell your doctor or nurse as soon as possible if you notice any of the following:

• changes in heart rate including slowing or quickening of heart beat

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

• overheating of your body that you can't control by normal cooling methods
• excessive thirst, extreme fatigue, lack of energy, confusion, muscle twitching or spasms, restlessness, seizures

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation, and your medicine may need to be stopped.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

AFTER USING DEXMEDETOMIDINE EVER PHARMA

Storage

DEXMEDETOMIDINE EVER PHARMA will be stored in the pharmacy or kept on the ward. The injection is kept in a cool dry place where the temperature stays below 25°C.

PRODUCT DESCRIPTION

What it looks like

DEXMEDETOMIDINE EVER PHARMA is a clear, colourless solution.

DEXMEDETOMIDINE EVER PHARMA is available as:

• 200 microgram/2 mL glass ampoules (packs of 1 x 2 mL and 25 x 2 mL)
• 200 microgram/2 mL glass vials (packs of 1 x 2 mL, 5 x 2 mL)
• 400 microgram/4 mL glass vials (packs of 1 x 4 mL, 4 x 4 mL and 5 x 4 mL)
• 400 microgram/4 mL glass ampoule (packs of 4 x 4 mL and 5 x 4 mL)
• 1000 microgram/10 mL glass vials (packs of 1 x 10 mL, 4 x 10 mL and 5 x 10 mL).
• 1000 microgram/10 mL glass ampoule (packs of 4 x 10 mL and 5 x 10 mL).

Ingredients

DEXMEDETOMIDINE EVER PHARMA contains 118 microgram/mL of dexmedetomidine hydrochloride (equivalent to 100 microgram/mL dexmedetomidine base) as the active ingredient.

It also contains:

• sodium chloride
• water for injections

This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Supplier

DEXMEDETOMIDINE EVER PHARMA is supplied by:

InterPharma Pty Ltd
Suite 103
39 East Esplanade
Manly, NSW, 2095
Australia

Australian Register Number(s)

200 microgram/2 mL AUST R 279345 (glass vial)

200 microgram/2 mL AUST R 279343 (glass ampoule)

400 microgram/4 mL AUST R 279346 (glass vial)

400 microgram/4 mL AUST R 331140 (glass ampoule)

1000 microgram/10 mL AUST R 279347 (glass vial)

1000 microgram/10 mL AUST R 331141(glass ampoule)

This leaflet was updated in - July 2020.

Published by MIMS September 2020

1 Name of Medicine

Dexmedetomidine hydrochloride.

2 Qualitative and Quantitative Composition

Dexmedetomidine hydrochloride is a white or almost white powder, freely soluble in water and its pKa is 7.1. The partition coefficient in octanol:water at pH 7.84 is 2.89.
Dexmedetomidine Ever Pharma is a clear, colourless, sterile and isotonic concentrated solution with a pH of 4.5 to 7.0. Dexmedetomidine Ever Pharma is a concentrated sterile, non-pyrogenic solution suitable for intravenous infusion after dilution. Each 1 mL of Dexmedetomidine Ever Pharma contains 118 microgram of dexmedetomidine hydrochloride (equivalent to 100 microgram dexmedetomidine base). The solution is preservative-free and contains no additives or chemical stabilisers.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Dexmedetomidine Ever Pharma is presented in a 2 mL, 4 mL and 10 mL vials or 2 mL, 4 mL and 10 mL ampoules, and must be diluted prior to use.

4 Clinical Particulars

4.9 Overdose

The tolerability of dexmedetomidine was noted in one study in which healthy subjects achieved plasma concentrations from 1.8 up to 13 times the upper boundary of the therapeutic range. The most notable effects observed in two subjects who achieved the highest plasma concentrations were 1st degree AV block and 2nd degree heart block. No haemodynamic compromise was noted with the AV block and the heart block resolved spontaneously within one minute.
Of five patients reported with overdose of dexmedetomidine in the Phase II/III ICU sedation studies, two had no symptoms reported; one patient received a 2 microgram/kg loading dose over 10 minutes (twice the recommended loading dose) and one patient received a maintenance infusion of 0.8 microgram/kg/hr. Two other patients who received a 2 microgram/kg loading dose over 10 minutes experienced bradycardia with or without hypotension. One patient, who received a loading bolus dose of undiluted (100 microgram/mL) dexmedetomidine (as hydrochloride; 19.4 microgram/kg), had a cardiac arrest from which he was successfully resuscitated.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Carcinogenicity. Animal carcinogenicity studies have not been performed with dexmedetomidine.
Genotoxicity. Dexmedetomidine was not mutagenic in vitro, in either the bacterial reverse mutation assay (E. coli and Salmonella typhimurium) or the mammalian cell forward mutation assay (mouse lymphoma). In a mouse micronucleus study, dexmedetomidine was not cytotoxic to bone marrow and did not increase the numbers of micronucleated PCEs at any dose tested, both in animals maintained at room temperature and in those kept warm. In addition, dexmedetomidine did not induce chromosomal aberrations in cultured human peripheral blood lymphocytes in the absence or presence of an exogenous metabolic activation system comprised of a human S9 homogenate.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Dexmedetomidine hydrochloride is chemically described as (+)-4-(S)-[1-(2, 3-dimethylphenyl) ethyl]-1H-imidazole monohydrochloride and has a molecular weight of 236.7 and the empirical formula is C₁₃H₁₆N₂.HCl. The structural formula is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSDEXHYD.gif CAS number. The CAS registry number for dexmedetomidine hydrochloride is CAS-145108-58-3.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/DEEVPHST.gif