HYPNOVEL midazolam 5mg/1mL (as hydrochloride) injection ampoule

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

midazolam, Quantity: 5 mg/mL

Доступна с:

Pharmaco Australia Ltd

Фармацевтическая форма:

Injection, solution

состав:

Excipient Ingredients: hydrochloric acid; sodium chloride; water for injections; sodium hydroxide

Администрация маршрут:

Intravenous, Intramuscular

Штук в упаковке:

1mL x 10

Тип рецепта:

(S4) Prescription Only Medicine

Терапевтические показания :

1. Intravenously as an agent for conscious sedation prior to short surgical, diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography and cardiac cathetherization, either alone or in conjunction with a narcotic; 2. Intravenously for induction of anaesthesia, preliminary to administration of other anaesthetic agents. With the use of a narcotic premedicant, induction of anaesthesia can be attained with narrower dose range and in a shorter period of time; 3. Sedation in intensive care units by intravenous intermittent administration or continuous infusion; 4. Intramuscularly for preoperative sedation (induction of sleepiness or drowsiness and relief of apprehension) and to impair memory of perioperative events.

Обзор продуктов:

Visual Identification: clear, colourless liquid; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius

Статус Авторизация:

Registered

Дата Авторизация:

1991-08-23

тонкая брошюра

Hypnovel
®
1
HYPNOVEL®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING HYPNOVEL?
Hypnovel contains the active ingredient Midazolam. Hypnovel is used as
a sedative during some short medical procedures.
For more information, see Section 1. Why am I using Hypnovel? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE HYPNOVEL?
Do not use if you have ever had an allergic reaction to Hypnovel or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Hypnovel? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Hypnovel and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE HYPNOVEL?
•
Hypnovel may be given to you as an injection into a vein or muscle. It
may also be given through an infusion set in an
intensive care unit. Other medications may also be given at the same
time.
•
Your doctor will adjust the dose necessary for you. This depends on
which medical procedure you will be having, your age,
weight and your general health. Elderly patients may need to receive
less.
More instructions can be found in Section 4. How do I use Hypnovel? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING HYPNOVEL?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Hypnovel.
•
Tell your doctor if you are taking any other medicines or have any
conditions listed in section 2 of
the full CMI prior to taking Hypnovel.
THINGS YOU
SHOULD NOT DO
•
Do not take any other medicines whether they require a prescription or
not without first telling
your doctor.
DRIVING OR USING
MACHINES
•
Do not drive or operate machin

Характеристики продукта

AUSTRALIAN PRODUCT INFORMATION – HYPNOVEL
® (MIDAZOLAM)
SOLUTION FOR INJECTION
2020-04 v1.0
1
1.
NAME OF THE MEDICINE
Midazolam
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hypnovel 5mg/5mL
Each mL contains 1mg of midazolam (as hydrochloride)
One 5mL ampoule contains 5mg midazolam
Hypnovel 5mg/1mL
Each mL contains 5 mg midazolam (as hydrochloride)
One 1 mL ampoule contains 5 mg midazolam
One 3 mL ampoule contains 15 mg midazolam
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
IV as an agent for conscious sedation prior to short surgical,
diagnostic, therapeutic or
endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy,
coronary
angiography and cardiac catheterisation, either alone or in
conjunction with a narcotic;
-
IV for induction of anaesthesia, preliminary to administration of
other anaesthetic agents.
With the use of a narcotic premedicant, induction of anaesthesia can
be attained with a
narrower dose range and in a shorter period of time.
-
IV for sedation in intensive care units; intermittent administration
or continuous infusion.
-
IM for preoperative sedation (induction of sleepiness or drowsiness
and relief of
apprehension) and to impair memory of perioperative events.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
Dosage should be individualised and drug should be administered
slowly. Lower doses may be
required in elderly or debilitated patients or in patients with
hepatic or renal insufficiency.
Because serious and life-threatening cardio-respiratory adverse events
have been reported,
provision for monitoring, detection and correction of these reactions
must be made for every
patient to whom Hypnovel injection is administered, regardless of age
or health status. The
dosage of Hypnovel administered should be adjusted according to the
type and amount of
premedication used.
Intravenously (IV)
Hypnovel should be administered slowly.
2020-04 v1.