Dexamethasone (base) 3.8mg/1ml solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Dexamethasone sodium phosphate

Available from:

base) 3.8mg/1ml solution for injection vials (Aspen Pharma Trading Ltd

ATC code:

H02AB02

INN (International Name):

Dexamethasone sodium phosphate

Dosage:

3.8mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intraarticular; Rectal; Intramuscular; Intravenous; Intrabursal; Subcutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06030200; GTIN: 5013945300529

Patient Information leaflet

B. PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DEXAMETHASONE 3.8 MG/ML SOLUTION FOR INJECTION
Dexamethasone
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)
•
IF YOU TAKE IT FOR MORE THAN 3 WEEKS, IN THE UK, YOU WILL GET A BLUE
‘STEROID CARD’: ALWAYS
KEEP IT WITH YOU AND SHOW IT TO ANY DOCTOR OR NURSE TREATING YOU
•
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.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 pharmacist.
-
If you get any side effects, talk to your doctor or pharmacist. 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 use Dexamethasone
3.
How you use Dexamethasone
4.
Possible side effects
5.
How to s

Summary of Product characteristics

OBJECT 1
DEXAMETHASONE 3.8 MG/ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 01-Feb-2018 | Aspen
1. Name of the medicinal product
Dexamethasone 3.8 mg/ml solution for injection
2. Qualitative and quantitative composition
Each one ml contains 3.8 mg dexamethasone (as sodium phosphate) which
is equivalent to 5.0 mg
dexamethasone sodium phosphate.
Excipient with known effect
Sodium: < 1 mmol sodium (23 mg) per dose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection
Colourless aqueous solution
4. Clinical particulars
4.1 Therapeutic indications
Dexamethasone solution for injection 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.
4.2 Posology and method of administration
Posology
NOTE: ALL DOSE RECOMMENDATIONS STATED IN THIS SECTION ARE EXPRESSED AS
MG DEXAMETHASONE BASE.
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
hours, until a satisfactory result has been obtained. In brain surgery
these dosages may be necessary until
several days after the operation. Thereafter, the dosage has to be
tapered off gradually.
Increase of intracranial pressure associated with brain tumours can be
counteracted by continuous
treatment.
For local treatment, the following dosages can be recommended