Hypnovel

দেশ: নিউ জিলণ্ড

ভাষা: ইংরেজি

সূত্র: Medsafe (Medicines Safety Authority)

সক্রিয় উপাদান:

Midazolam 5 mg/mL (present as midazolam hydrochloride 5.5556mg/mL);  

থেকে পাওয়া:

Roche Products (NZ) Ltd

INN (আন্তর্জাতিক নাম):

Midazolam 5 mg/mL (present as midazolam hydrochloride 5.5556mg/mL)

ডোজ:

5 mg/mL

ফার্মাসিউটিকাল ফর্ম:

Solution for injection

রচনা:

Active: Midazolam 5 mg/mL (present as midazolam hydrochloride 5.5556mg/mL)   Excipient: Hydrochloric acid Sodium chloride Sodium hydroxide as 1N solution, for pH adjustment, pH 3.3±0.1 Water for injection

প্যাকেজ ইউনিট:

Ampoule, glass, 3 mL, 5 dose units

শ্রেণী:

Class C5 Controlled Drug

প্রেসক্রিপশন টাইপ:

Class C5 Controlled Drug

Manufactured by:

F.I.S. Fabbrica Italiana Sintetici SpA

থেরাপিউটিক ইঙ্গিত:

Hypnovel is indicated for Adults · Premedication before induction of anaesthesia · Conscious sedation before diagnostic or surgical interventions carried out under local anaesthesia · Long-term sedation in intensive care units · Induction and maintenance of anaesthesia. As an induction agent in inhalation anaesthesia or a sleep-inducing component in combined anaesthesia, including total intravenous anaesthesia. Children · Premedication before induction of anaesthesia · Conscious sedation before diagnosticc or surgical interventions carried out under local anaesthesia · Ataralgesia in combination with ketamine · Ataralgesia in combination with ketamine in children (i.m. administration).

পণ্য সারাংশ:

Package - Contents - Shelf Life: Ampoule, glass, 3 mL - 5 dose units - 60 months from date of manufacture stored at or below 30°C. (approved to 35°C)

অনুমোদন তারিখ:

1983-08-03

তথ্য লিফলেট

_ _
_ _

Hypnovel Ampoules 170918
1
NEW ZEALAND CONSUMER MEDICINE INFORMATION
HYPNOVEL
®
MIDAZOLAM SOLUTION FOR INJECTION 5MG/5ML AND 15MG/3ML IN AMPOULES
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Hypnovel solution for
injection.
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 your using Hypnovel
against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT IS HYPNOVEL USED FOR
Hypnovel may be given as a sedative during some short medical
procedures.
Hypnovel may be given before an operation to produce sleepiness or
drowsiness and to relieve anxiety. It
may also be used in combination with other anaesthetic agents to keep
you asleep during an operation.
If you are in an intensive care unit, you may receive Hypnovel as a
sedative.
Hypnovel belongs to a group of medicines called benzodiazepines. They
are thought to work by their
action on brain chemicals.
Hypnovel can cause sedation (sleepiness), short term amnesia (no
memory of events around the time
you are given Hypnovel, and/or anaesthesia (heavy sleep for surgery)
depending on the dose you are
given.
Your doctor, however, may have prescribed Hypnovel for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY HYPNOVEL HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only with a prescription.
BEFORE YOU RECEIVE HYPNOVEL
_WHEN YOU MUST NOT HAVE HYPNOVEL SOLUTION FOR INJECTION _
DO NOT HAVE HYPNOVEL IF:
_ _
_ _

Hypnovel Ampoules 170918
2
1. YOU HAVE HAD AN ALLERGIC REACTION TO HYPNOVEL SOLUTION FOR
INJECTION OR TABLETS, ANY OTHER
BENZODIAZEPINE MEDICINE, OR ANY OF THE INGREDIENTS LISTED AT THE END
OF THIS LEAFLET
IF YOU ARE NOT SURE WHETHER YOU SHOULD BE GIVEN HYPNOVEL, TALK TO YOUR
DOCTOR.
_BEFORE YOU RECEIVE IT _
TELL YOUR DOCTOR IF:
1. YOU

পণ্য বৈশিষ্ট্য

NEW ZEALAND DATA SHEET
Hypnovel 170717
1
1.
PRODUCT NAME
Hypnovel
®
5mg/5mL and 15mg/3mL solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: midazolam as hydrochloride
Ampoules 5mg/5 mL and 15mg/3 mL solution for intravenous (IV),
intramuscular (IM),
intranasal, oral and rectal administration.
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypnovel is indicated for
ADULTS
•
Premedication before induction of anaesthesia.
•
Conscious sedation before diagnostic or surgical interventions carried
out under local
anaesthesia.
•
Long-term sedation in intensive care units.
•
Induction and maintenance of anaesthesia. As an induction agent in
inhalation anaesthesia
or a sleep-inducing component in combined anaesthesia.
CHILDREN
•
Premedication before induction of anaesthesia.
•
Conscious sedation before diagnostic or surgical interventions carried
out under local
anaesthesia.
•
Ataralgesia in combination with ketamine.
4.2
DOSE AND METHOD OF ADMINISTRATION
In the case of elderly patients with organic cerebral changes or
impaired cardiac and
respiratory function, the dosage should be determined with caution.
Special factors relating to
each patient should be taken into consideration.
NEW ZEALAND DATA SHEET
Hypnovel 170717
2
Initial and subsequent intravenous injections must be given slowly
(see Section 4.2,
_ induction _
_of anaesthesia_
and
_conscious sedation_
for specific recommendations) The medicine takes
effect about two minutes after the injection is started.
PREMEDICATION BEFORE AN OPERATION
_ADULTS – PREMEDICATION BEFORE AN OPERATION _
_Intramuscular administration _
In patients suffering from pain before an intervention.
Administration alone or in combination with anticholinergics and
possibly analgesics.
These doses should be administered about 30 minutes before induction
of anaesthesia.
_ _
0.07-0.10 mg per kg bodyweight i.m. according to age and general
condition o