Voltaren 75mg/3ml solution for injection

Country: Malta

Tungumál: enska

Heimild: Medicines Authority

Virkt innihaldsefni:

DICLOFENAC SODIUM

Fáanlegur frá:

Novartis Ireland Limited Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4,, Ireland

ATC númer:

M01AB05

INN (Alþjóðlegt nafn):

DICLOFENAC SODIUM 25 mg/ml

Lyfjaform:

SOLUTION FOR INJECTION CONCENTRATE FOR SOLUTION FOR INFUSION

Samsetning:

DICLOFENAC SODIUM 25 mg/ml

Gerð lyfseðils:

POM

Lækningarsvæði:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Leyfisstaða:

Authorised

Leyfisdagur:

2005-11-15

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VOLTAREN
®
75 MG/3 ML SOLUTION FOR INJECTION
DICLOFENAC SODIUM
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep the leaflet. You may need to read it again.
-
If you have any further questions ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them even if their signs of illness are the same as yours.
-
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 Voltaren is and what it is used for
2
What you need to know before you take Voltaren
3
How to take Voltaren
4
Possible side effects
5
How to store Voltaren
6
Contents of the pack and other information
1
WHAT VOLTAREN IS AND WHAT IT IS USED FOR
Voltaren solution for injection contains the active ingredient
diclofenac sodium. Voltaren
belongs
to
a
group
of
medicines
called
“non-steroidal
anti-inflammatory
drugs”
(NSAIDs). NSAIDs reduce pain and inflammation, by blocking the
synthesis of the
molecules (prostaglandins) responsible for inflammation, pain and
fever. It has no effect
on the causes of inflammation or fever.
The intramuscular injection is used to reduce fever and treat a number
of conditions
including:
•
Flare-ups of joint or back pain, frozen shoulder, tennis elbow, and
other types of
rheumatism.
•
Attacks of gout
•
Pain caused by gallstones or kidney stones.
•
Pain and swelling following surgery and injuries
•
Severe migraine attacks.
Voltaren can either be given as an injection into the muscle, or as a
slow infusion into a
vein. The intravenous infusion is used in hospitals to prevent or
treat pain following
surgery.
Voltaren is not suitable for children.
MONITORING DURING YOUR TREATMENT WITH VOLTAREN
If you have established heart disease or significant risks for heart
disease, your doctor will
periodically re-evaluate wh

Vara einkenni

VOLTAREN
®
(DICLOFENAC SODIUM)
75 mg/3 mL solution for injection
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2
1.
NAME OF THE MEDICINAL PRODUCT
VOLTAREN 75mg/3mL solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active substance is diclofenac sodium.
One Voltaren ampoule of 3 mL contains 75 mg of diclofenac sodium.
Excipient(s) with known effect
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection, concentrate for infusion.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Voltaren for Intramuscular injection use is indicated in
t
reatment of
•
Exacerbations of inflammatory and degenerative forms of rheumatism:
rheumatoid
arthritis, ankylosing spondylitis, osteoarthritis, spondyloarthritis,
painful syndromes of
the vertebral column, non-articular rheumatism.
•
Acute attacks of gout.
•
Renal colic and biliary colic.
•
Symptomatic short-term treatment of post-traumatic and post-operative
pain (POP),
inflammation and swelling.
•
Severe migraine attacks.
Voltaren
for
Intravenous
infusion
use
is
indicated
in
treatment
or
prevention
of
postoperative pain in a hospital setting.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
As a general recommendation, the dose should be individually adjusted.
Undesirable
effects may be minimised by using the lowest effective dose for the
shortest duration
necessary to control symptoms (see section 4.4 Special warnings and
precautions for use).
ADULTS
Voltaren solution for injection should not be given for more than 2
days; if necessary,
treatment
can
be
continued
with
Voltaren
tablets
or
suppositories
(see
Method
of
administration).
Page 3
SPECIAL POPULATIONS
PAEDIATRIC POPULATION
_ _
Voltaren solution for injection is not recommended for use in children
below 18 years of age.
ELDERLY
No adjustment of the starting dose is generally required for elderly
patients aged 65 years
or above (see section 4.4 Special warnings and precautions for use).
However, caution is
indicated on basic medical grounds, especially