Midazolam
Shopper Drugs Info
What’s on this leaflet
This leaflet solutions some frequent questions on MIDAZOLAM VIATRIS.
It doesn’t include all of the accessible info.
It doesn’t take the place of speaking to your physician or pharmacist.
All medicines have advantages and dangers. Your physician has weighed the dangers of you taking
MIDAZOLAM VIATRIS towards the advantages anticipated for you.
When you have any issues about taking this drugs, speak to your physician or pharmacist.
Hold this leaflet along with your drugs.
You might must learn it once more.
What MIDAZOLAM VIATRIS is used for
MIDAZOLAM VIATRIS could also be injected as a sedative throughout some quick medical procedures.
MIDAZOLAM VIATRIS could also be given to you by injection earlier than an operation to supply
sleepiness or drowsiness and to alleviate nervousness.
In case you are in an intensive care unit, chances are you’ll obtain an infusion of MIDAZOLAM VIATRIS
over a number of hours or days as a sedative.
MIDAZOLAM VIATRIS belongs to a gaggle of medicines generally known as benzodiazepines.
They’re thought to work by their motion on mind chemical substances.
MIDAZOLAM VIATRIS could cause sedation, hypnosis, amnesia and/or anaesthesia, relying
on the dose.
Ask your physician in case you have any questions on why MIDAZOLAM VIATRIS has been prescribed
for you.
Your physician, nevertheless, might have prescribed MIDAZOLAM VIATRIS for one more function.
MIDAZOLAM VIATRIS is just given by a physician skilled to make use of this drugs. If you’ll
be receiving MIDAZOLAM VIATRIS throughout surgical procedure, your physician will provide you with the drugs
and intently observe your progress.
This drugs is on the market solely with a physician’s prescription.
Earlier than you’re given MIDAZOLAM VIATRIS
When you have to not obtain it
Don’t use MIDAZOLAM VIATRIS in case you have an allergy to:
any drugs containing midazolam
any of the elements listed on the finish of this leaflet
Among the signs of an allergic response might embrace
shortness of breath
wheezing or problem respiration
swelling of the face, lips, tongue or different components of the physique
rash, itching or hives on the pores and skin
Don’t use MIDAZOLAM VIATRIS if:
You may have extreme muscle weak spot, often known as myasthenia gravis
You may have a situation referred to as acute slim angle glaucoma
You might be affected by shock, coma or acute alcoholic intoxication
In case you are unsure whether or not you need to be given MIDAZOLAM VIATRIS, speak to your physician.
Don’t give MIDAZOLAM VIATRIS to kids.
The security or effectiveness of MIDAZOLAM VIATRIS in kids lower than eight years
of age haven’t been established.
Earlier than you obtain it
Inform your physician in case you have or have had any of the next earlier than you obtain MIDAZOLAM
VIATRIS:
1. in case you are pregnant or plan to turn into pregnant
MIDAZOLAM VIATRIS just isn’t advisable to be used in pregnant ladies, particularly within the
third (final) trimester or throughout labour. If there’s a want to make use of MIDAZOLAM VIATRIS
if you end up pregnant, your physician will focus on the dangers and advantages to you and
the unborn child.
2. in case you are breastfeeding or plan to breastfeed
MIDAZOLAM VIATRIS might cross into the breast milk and trigger drowsiness and/or feeding
difficulties within the child. MIDAZOLAM VIATRIS just isn’t advisable to be used whereas breastfeeding.
3. in case you have another well being issues together with:
liver, kidney, coronary heart or lung illness
excessive or low blood stress
psychological issues together with; melancholy, psychosis or
schizophrenia
epilepsy (suits or convulsions)
historical past of alcohol or drug abuse
4. should you drink alcohol usually or use illicit (unlawful) medicine usually
MIDAZOLAM VIATRIS could cause bodily dependency, particularly in case you have a historical past
of drug or alcohol abuse, when used long-term. Your dose perhaps diminished regularly to
overcome this impact.
5. in case you have allergy symptoms to another medicines, meals, preservatives or dyes.
When you have not instructed your physician about any of the above, inform him/her earlier than you begin
taking MIDAZOLAM VIATRIS.
Taking different medicines
Inform your physician or pharmacist in case you are taking another medicines, together with any
that you just get and not using a prescription from a pharmacy, grocery store or well being meals store.
Some medicines and MIDAZOLAM VIATRIS might intrude with one another. These medicines
embrace:
different sleeping tablets, sedatives or tranquillisers
anaesthetics
medicines for melancholy akin to fluvoxamine and nefazodone
medicines to manage suits akin to sodium valproate
medicines for allergy symptoms or colds akin to antihistamines
ache relievers
muscle relaxants
cimetidine (Tagamet®, Magicul®), a drugs used to deal with ulcers
disulfiram (Antabuse®), a drugs utilized in alcohol abuse
erythromycin and clarithromycin, frequent antibiotic
diltiazem (Cardizem®), verapamil (Isoptin®, Anpec®, Cordilox®, Veracaps®), medicines used to deal with hypertension
atorvastatin
ketoconazole, fluconazole and itraconazole or different medicines used to deal with fungal
infections
ritonavir and saquinavir and different HIV protease inhibitors
Bicalutamide, drugs used within the remedy of prostate most cancers and extreme hair
loss significantly in ladies
Aprepitant, a drugs used for remedy of nausea (feeling sick) and vomiting related
with chemotherapy
Goldenseal, a complementary drugs
These medicines could also be affected by MIDAZOLAM VIATRIS or might have an effect on how effectively MIDAZOLAM
VIATRIS works. You might want completely different quantities of your medicines, or chances are you’ll must
take completely different medicines.
Your physician and pharmacist have extra info on medicines to watch out with or
keep away from whereas taking this drugs.
How MIDAZOLAM VIATRIS is given
MIDAZOLAM VIATRIS could also be given to you as an injection right into a vein or muscle, or by
an intravenous infusion in an intensive care unit, by a physician or a nurse.
Different medicines might also be given on the similar time.
How a lot is given
Your physician will modify the dose essential for you. This is dependent upon which medical
process you’ll be having, your age, weight and your basic well being. Aged sufferers
might must obtain much less.
How lengthy is MIDAZOLAM VIATRIS given for
MIDAZOLAM VIATRIS could also be given as soon as earlier than a medical process, or repeatedly by
infusion for sufferers in an intensive care unit.
MIDAZOLAM VIATRIS shall be stopped as soon as there is no such thing as a additional want for sedation.
When you have been given an excessive amount of (overdose)
Inform the physician or nurse on responsibility should you suppose you might have been given an overdose of MIDAZOLAM
VIATRIS.
Nonetheless, in case you are given an excessive amount of MIDAZOLAM VIATRIS, chances are you’ll expertise negative effects
akin to drowsiness, tiredness, confusion, dizziness, weak spot or unconsciousness.
Ask your physician in case you have any issues.
Your physician has info on tips on how to recognise and deal with an overdose.
When you are given MIDAZOLAM VIATRIS
Issues you have to do
Don’t take another medicines whether or not they require a prescription or not with out
first telling your physician.
Inform your physician should you really feel MIDAZOLAM VIATRIS not serving to you.
Issues you have to not do
Don’t drive or function equipment till you understand how MIDAZOLAM VIATRIS impacts you.
MIDAZOLAM VIATRIS might trigger drowsiness or dizziness, fatigue, confusion and forgetfulness
in some individuals and subsequently might have an effect on alertness.
Be sure you know the way you react to MIDAZOLAM VIATRIS earlier than you drive a automotive or
function equipment, or do something
else that may very well be harmful should you
are drowsy, dizzy or not alert.
Wouldn’t have any alcohol for at the very least 12 hours after you might have been given MIDAZOLAM
VIATRIS.
Issues to watch out of
Watch out in case you are aged, ingesting alcohol, unwell or taking different medicines.
Some individuals might expertise negative effects akin to drowsiness, confusion, dizziness and
unsteadiness, which can enhance the danger of a fall.
Unwanted side effects
Inform your physician or pharmacist as quickly as doable if you don’t really feel effectively after you
have acquired MIDAZOLAM VIATRIS.
Along with the helpful results of MIDAZOLAM VIATRIS, it’s doable that undesirable
results will happen throughout remedy, even when it’s used as supposed. All medicines
can have negative effects. Typically they’re severe, more often than not they don’t seem to be.
You might want medical remedy should you get a few of the negative effects.
All medical procedures which contain the usage of an anaesthetic have a really small threat
which your physician will focus on with you.
In aged, or excessive threat sufferers, dying has resulted hardly ever as a result of a slowdown of
the center and lungs.
Ask your physician or pharmacist to reply any questions you’ll have.
Inform your physician should you discover any of the next and so they fear you:
dizziness, unsteadiness
drowsiness, tiredness
lack of reminiscence, inattentiveness, confusion, lack of focus
muscle stiffness or irritation of the vein
slurred speech
disagreeable goals
blurred imaginative and prescient
ache, redness or hardness on the injection web site
constipation
coughing, hiccups
nausea with or with out vomiting
If any of the next occur, inform your physician instantly or go to Accident and
Emergency at your nearest hospital:
problem respiration
modifications in pulse price and blood stress
sudden nervousness or excitation
hallucinations, uncommon temper or delusions
extreme sleep disturbances
allergic response – sudden indicators akin to rash, itching or hives on the pores and skin, swelling
of the face, lips, tongue which can trigger problem in swallowing or respiration and
different components of the physique
The above listing contains severe negative effects. You might want pressing medical consideration
or hospitalisation. These negative effects are uncommon.
Inform your physician should you discover something that’s making you are feeling unwell, even when it
just isn’t on this listing.
Different negative effects not listed above might also happen in some individuals.
Ask your physician or pharmacist if you don’t perceive something on this listing.
Don’t be alarmed by this listing of negative effects.
You might not expertise any of them
After utilizing MIDAZOLAM VIATRIS
Storage
MIDAZOLAM VIATRIS shall be saved within the pharmacy or on the ward. The ampoule is stored
in a cool, dry place away from daylight, the place the temperature stays under 25°C. The
ampoule shouldn’t be saved within the fridge.
When you have any additional questions on MIDAZOLAM VIATRIS, or are uncertain of the data
given above, please see your physician or nurse, who will be capable of help you.
Product description
What it seems like
MIDAZOLAM VIATRIS is a transparent colourless answer containing MIDAZOLAM within the following
strengths:
5 mg/ 5 mL ampoule
5 mg/mL ampoule
15 mg/ 3 mL ampoule
50 mg/ 10 mL ampoule
Substances
Energetic Substances
MIDAZOLAM VIATRIS 5 mg/ 5 mL
MIDAZOLAM VIATRIS 5 mg/mL
MIDAZOLAM VIATRIS 15 mg/ 3 mL
MIDAZOLAM VIATRIS 50 mg/ 10mL
Inactive elements
sodium chloride
glucose
water for injection
small quantities of hydrochloric acid and sodium hydroxide to regulate the acidity of the
answer.
Provider
MIDAZOLAM VIATRIS is equipped in Australia by:
Alphapharm Pty Ltd buying and selling as Viatris
Degree 1, 30 The Bond
30 – 34 Hickson Highway
Millers Level NSW 2000
www.viatris.com.au
Telephone: 1800 274 276
Australian registration quantity
MIDAZOLAM VIATRIS 5 mg/ 5 mL – AUST R 160206
MIDAZOLAM VIATRIS 5 mg/mL – AUST R 160207
MIDAZOLAM VIATRIS 15 mg/ 3 mL – AUST R 160205
MIDAZOLAM VIATRIS 50 mg/ 10mL – AUST R 160208
This leaflet was ready on
July 2022.
Midazolam Viatris_cmiJul22/00
