Dexamethasone phosphate 4mg/ml Solution for Injection or Infusion

Држава: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Dexamethasone sodium phosphate

Доступно од:

Pinewood Laboratories Ltd

АТЦ код:

H02AB; H02AB02

INN (Међународно име):

Dexamethasone sodium phosphate

Дозирање:

4 milligram(s)/millilitre

Фармацеутски облик:

Solution for injection/infusion

Терапеутска област:

Glucocorticoids; dexamethasone

Статус ауторизације:

Not marketed

Датум одобрења:

2015-01-09

Информативни летак

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER
DEXAMETHASONE PHOSPHATE 4 MG/ML SOLUTION FOR INJECTION OR INFUSION
IMPORTANT INFORMATION ABOUT THIS MEDICINE
•
DEXAMETHASONE IS A STEROID MEDICINE
, prescribed for many different conditions including
serious illnesses.
•
YOU NEED TO TAKE IT REGULARLY
to get the maximum benefit.
•
DON’T STOP TAKING THIS MEDICINE
without talking to your doctor. You may need to reduce
the dose gradually.
•
DEXAMETHASONE CAN CAUSE SIDE EFFECTS IN SOME PEOPLE
(read Section 4: Possible side
effects). Some problems such as mood changes (feeling depressed, or
‘high’), or stomach
problems can happen straight away. If you feel unwell, in any way,
keep taking your
medicine,
BUT SEE YOUR DOCTOR STRAIGHT AWAY.
•
SOME SIDE EFFECTS ONLY HAPPEN AFTER WEEKS OR MONTHS
. These include weakness of arms
and legs, or developing a rounder face (read Section 4 for more
information).
•
KEEP AWAY FROM PEOPLE WHO HAVE CHICKEN POX OR SHINGLES
if you have never had them.
They could affect you severely. If you do come into contact with
chicken pox or shingles,
SEE
YOUR DOCTOR STRAIGHT AWAY.
NOW READ THE REST OF THIS LEAFLET.
It includes other important information on the safe and
effective use of this medicine that might be especially important for
you.
THIS LEAFLET WAS
LAST UPDATED IN MARCH 2022.
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, pharmacist or
nurse
• If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Dexamethasone is and what it is used for
2. What you need to know before you are given Dexamethasone
3. How you are given Dexamethasone
4. Possible side effects
5. How to store Dexamethasone
6.
Contents of the pack and other
information
1. WHAT DEXAMETHASONE IS A

Карактеристике производа

Health Products Regulatory Authority
01 April 2022
CRN00CPNK
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dexamethasone phosphate 4mg/ml Solution for Injection or Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 3.3 mg dexamethasone (as sodium
phosphate) which is equivalent to 4 mg dexamethasone
phosphate or 4.37 mg dexamethasone sodium phosphate.
Each 2 ml contains 6.6 mg dexamethasone (as sodium phosphate) which is
equivalent to 8 mg dexamethasone phosphate or
8.74 mg dexamethasone sodium phosphate.
For the full list of excipients, see 6.1.
3 PHARMACEUTICAL FORM
Solution for injection or infusion.
Clear, colourless to slightly yellowish solution, having pH ranging
from 7.0 to 8.5.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dexamethasone can be used for all forms of general and local
glucocorticoid injection therapy and all acute conditions in
which intravenous glucocorticoids may be life-saving.
Dexamethasone is indicated in the treatment of coronavirus disease
2019 (COVID-19) in adult and adolescent patients (aged
12 years and older with body weight at least 40 kg) who require
supplemental oxygen therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
DOSAGE
N.B. FOR THIS SECTION OF DOCUMENT ALL DOSES ARE EXPRESSED AS MG
DEXAMETHASONE
In general, glucocorticoid dosage depends on the severity of the
condition and response of the patient. Under certain
circumstances, for instance in stress, extra dosage adjustments may be
necessary. If no favourable response is noted within a
couple of days, glucocorticoid therapy should be discontinued.
_Adults and Elderly_
Once the disease is under control the dosage should be reduced or
tapered off to the lowest suitable level under continuous
monitoring and observation of the patient (See Section 4.4).
For acute life-threatening situations (e.g. anaphylaxis, acute severe
asthma) substantially higher dosages may be needed.
Cerebral oedema (adults): initial dose 8-16 mg iv followed by 5 mg iv
or im every 6 ho