Voltaren

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Diclofenac sodium 25 mg/mL;  

Available from:

Novartis New Zealand Ltd

INN (International Name):

Diclofenac sodium 25 mg/mL

Dosage:

75mg/3mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Diclofenac sodium 25 mg/mL   Excipient: Benzyl alcohol Mannitol Propylene glycol Sodium hydroxide Sodium metabisulfite Water for injection

Units in package:

Ampoule, glass, Type I, 5 dose units

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Unique Chemicals (A Division of JB Chemicals & Pharmaceuticals Ltd)

Therapeutic indications:

Treatment of biliary colic.

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, Type I - 5 dose units - 24 months from date of manufacture stored at or below 30°C protect from light

Authorization date:

1980-05-21

Patient Information leaflet

__________________________________________________________________________________________________
VOLTAREN

Page
1
of
5
VOLTAREN

_75mg/3ml solution for injection _
_diclofenac sodium_
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Voltaren 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 you having it
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT HAVING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT VOLTAREN SOLUTION FOR INJECTION IS USED FOR
Voltaren relieves pain and reduces inflammation (swelling and
redness). It has no effect on the causes of inflammation.
Injections of Voltaren into a muscle are used to treat the following
conditions:

Pain due to gallstones or kidney stones.

Severe migraine attacks
Infusions of Voltaren into a vein are used to:

treat or prevent pain following surgery
Voltaren belongs to a family of medicines called non-steroidal
anti-inflammatory drugs (NSAIDs). These medicines can
relieve the symptoms of pain and inflammation but they will not cure
your condition.
Your doctor may prescribe Voltaren for another purpose.
Ask your doctor if you have any questions about why it has been
prescribed for you.
Voltaren is only available with a doctor's prescription. It is not
addictive.
BEFORE YOU HAVE VOLTAREN SOLUTION FOR INJECTION
_WHEN YOU MUST NOT HAVE IT_
DO NOT HAVE VOLTAREN SOLUTION FOR INJECTION IF YOU HAVE AN ALLERGY TO:

diclofenac (the active ingredient in Voltaren) or any of the other
ingredients listed at the end of this leaflet

other medicines containing diclofenac (eg.Voltaren Emulgel)

aspirin/ acetylsalicylic acid

any other NSAID medicine
Many medicines used to treat headache, period pain and other aches and
pains contain aspirin or NSAID medic

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Page 1 of 16
1
PRODUCT NAME
VOLTAREN®
75 mg/3 mL Solution for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule of 3 mL contains 75 mg of diclofenac sodium.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_INTRAMUSCULAR INJECTION _
Treatment of:

Renal colic and biliary colic.

Severe migraine attacks when other forms of Voltaren are considered
unsuitable.
_INTRAMUSCULAR INJECTION _
Treatment or prevention of post‐operative pain in a hospital
setting.
4.2
DOSE AND METHOD OF ADMINISTRATION
Voltaren should only be prescribed when the benefits are considered to
outweigh the potential risks.
After assessing the risk/benefit ratio in each individual patient, the
lowest effective dose for the
shortest possible duration should be used. Adverse effects may be
minimized by using the lowest
effective dose for the shortest duration necessary to control symptoms
(see section 4.4).
Dosage
GENERAL POPULATION
Voltaren solution for injection should not be given for more than 2
days; if necessary, treatment can
be continued with Voltaren tablets or suppositories.
SPECIAL POPULATIONS
_PAEDIATRIC POPULATION _
Because of their dosage strength, the ampoules of Voltaren solution
for injection are not suitable for
children and adolescents.
_GERIATRIC POPULATION (PATIENTS AGED 65 OR ABOVE) _
No adjustment of the starting dose is generally required for elderly
patients However, caution is
indicated on basic medical grounds, especially for frail elderly
patients or those with a low body weight
(see section 4.4).
_PATIENTS WITH ESTABLISHED CARDIOVASCULAR DISEASE OR SIGNIFICANT
CARDIOVASCULAR RISK FACTORS _
Treatment with Voltaren solution for injection is generally not
recommended in patients with
established cardiovascular disease or uncontrolled hypertension. If
needed, patients with established
cardiovascular disease, uncontrolled hypertension or significant risk
factors for cardiovascular dis