Dexdor 1mg10ml concentrate for solution for infusion vials

দেশ: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)

সক্রিয় উপাদান:

Dexmedetomidine hydrochloride

থেকে পাওয়া:

Orion Pharma (UK

INN (আন্তর্জাতিক নাম):

Dexmedetomidine hydrochloride

ডোজ:

100microgram/1ml

ফার্মাসিউটিকাল ফর্ম:

Solution for infusion

প্রশাসন রুট:

Intravenous

শ্রেণী:

No Controlled Drug Status

প্রেসক্রিপশন টাইপ:

Valid as a prescribable product

পণ্য সারাংশ:

BNF: ; GTIN: 6432100020857

তথ্য লিফলেট

PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
DEXDOR 100 MICROGRAMS/ML CONCENTRATE FOR SOLUTION FOR INFUSION
Dexmedetomidine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed in
this leaflet. See section 4.
_ _
WHAT IS IN THIS LEAFLET
:
1.
What Dexdor is and what it is used for
2.
What you need to know before you are given Dexdor
3.
How to use Dexdor
4.
Possible side effects
5.
How to store Dexdor
6.
Contents of the pack and other information
1.
WHAT DEXDOR IS AND WHAT IT IS USED FOR
Dexdor contains an active substance called dexmedetomidine which
belongs to a medicine group called
sedatives. It is used to provide sedation (a state of calm, drowsiness
or sleep) for adult patients in hospital
intensive care settings.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DEXDOR
_ _
YOU MUST NOT BE GIVEN DEXDOR
-
if you are allergic to dexmedetomidine or any of the other ingredients
of this medicine (listed in
section 6).
-
if you have some disorders of heart rhythm (heart block grade 2 or 3).
-
if you have very low blood pressure which does not respond to
treatment.
-
if you have recently had a stroke or other serious condition affecting
blood supply to the brain.
WARNINGS AND PRECAUTIONS
Before you have this medicine, tell your doctor or nurse if any of the
following apply as Dexdor should be
used cautiously:
-
if you have an abnormally slow heart rate (either due to illness or
high levels of physical fitness)
-
if you have low blood pressure
-
if you have low blood volume, for example after bleeding
-
if you have certain heart disorders
-
if you are elderly
-
if you have a neurological disorder (for instance head or spinal cord
injury or stroke)
-
if you have severe liver problems
-
if you have ever developed a serious fever after some m

পণ্য বৈশিষ্ট্য

OBJECT 1
DEXDOR 100 MICROGRAMS/ML CONCENTRATE FOR
SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 16-Sep-2016 | Orion Pharma
(UK) Limited
1. Name of the medicinal product
Dexdor 100 micrograms/ml concentrate for solution for infusion
2. Qualitative and quantitative composition
Each 1 ml of concentrate contains dexmedetomidine hydrochloride
equivalent to 100 micrograms
dexmedetomidine.
Each 2 ml ampoule contains 200 micrograms of dexmedetomidine.
Each 2 ml vial contains 200 micrograms of dexmedetomidine.
Each 4 ml vial contains 400 micrograms of dexmedetomidine.
Each 10 ml vial contains 1000 micrograms of dexmedetomidine.
The concentration of the final solution after dilution should be
either 4 micrograms/ml or 8
micrograms/ml.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Concentrate for solution for infusion (sterile concentrate).
The concentrate is a clear, colourless solution, pH 4.5 – 7.0
4. Clinical particulars
4.1 Therapeutic indications
For sedation of adult ICU (Intensive Care Unit) patients requiring a
sedation level not deeper than arousal
in response to verbal stimulation (corresponding to Richmond
Agitation-Sedation Scale (RASS) 0 to -3).
4.2 Posology and method of administration
For hospital use only. Dexdor should be administered by healthcare
professionals skilled in the
management of patients requiring intensive care.
Posology
Patients already intubated and sedated may switch to dexmedetomidine
with an initial infusion rate of 0.7
micrograms/kg/h which may then be adjusted stepwise within the dose
range 0.2 to 1.4 micrograms/kg/h
in order to achieve the desired level of sedation, depending on the
patient's response. A lower starting
infusion rate should be considered for frail patients. Dexmedetomidine
is very potent and the infusion rate
is given per HOUR. After dose adjustment, a new steady state sedation
level may not be reached for up to
one hour.
_Maximum dose_
The maximum dose of 1.4 micrograms/kg/h should not be exceeded.
Patients failing to achi