CAMBIA diclofenac potassium 50 mg powder for oral liquid sachet

Երկիր: Ավստրալիա

Լեզու: անգլերեն

Աղբյուրը: Department of Health (Therapeutic Goods Administration)

Ակտիվ բաղադրիչ:

diclofenac potassium, Quantity: 50 mg

Հասանելի է:

Southern XP IP Pty Ltd

INN (Միջազգային անվանումը):

diclofenac potassium

Դեղագործական ձեւ:

Oral Liquid, powder for

Կազմը:

Excipient Ingredients: potassium bicarbonate; saccharin sodium; mannitol; aspartame; glyceryl behenate; Flavour

Կառավարման երթուղին:

Oral

Միավորները փաթեթում:

3 sachets, 9 sachets, 30 sachets, 21 sachets

Ռեկվիզորի տեսակը:

(S4) Prescription Only Medicine

Թերապեւտիկ ցուցումներ:

As short-term treatment (up to one week) for the relief of acute pain states in which there is an inflammatory component. Treatment of acute migraine attacks (with or without aura). Symptomatic treatment of primary dysmenorrhoea.

Ապրանքի ամփոփագիր:

Visual Identification: White to light yellow homogenous powder; Container Type: Sachet; Container Material: Al laminated with LDPE/paper; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius

Լիազորման կարգավիճակը:

Registered

Հաստատման ամսաթիվը:

2007-05-10

Տեղեկատվական թերթիկ

CAMBIA
1
CAMBIA
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING CAMBIA?
CAMBIA contains the active ingredient diclofenac potassium. CAMBIA is
used to relieve pain and reduce swelling and redness.
For more information, see Section 1. Why am I taking CAMBIA?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE CAMBIA?
Do not use if you have ever had an allergic reaction to diclofenac or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I take
CAMBIA?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with CAMBIA and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I TAKE CAMBIA?
•
Stir the sachet into a glass of water. Take CAMBIA immediately after
mixing and preferably before meals. Your doctor will
advise the correct dose for your condition.
•
Do not use CAMBIA for more than one week at a time.
More instructions can be found in Section 4. How do I take CAMBIA?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING CAMBIA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are taking
CAMBIA.
•
Elderly patients should be careful to only take the minimum dosage
required.
•
Remind your doctor if you have recently had surgery.
THINGS YOU
SHOULD NOT DO
•
Do not take CAMBIA during the first 6 months of pregnancy, except on
doctor's advice. Do not use
during the last three months of pregnancy.
•
Do not exceed the recommended dose or take CAMBIA for longer than your
doctor says.
DRIVING OR USING
MACHINES
•
Be careful driving, operating machinery or doing jobs that require you
to be alert until you know how
CAM

Ապրանքի հատկությունները

1
AUSTRALIAN PI – CAMBIA (DICLOFENAC POTASSIUM) ORAL POWDER
FOR LIQUID SACHETS
1
NAME OF THE MEDICINE
Diclofenac potassium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cambia sachets contain 50mg of diclofenac potassium.
LIST OF EXCIPIENTS WITH KNOWN EFFECTS: mannitol, aspartame, saccharin
sodium. Each diclofenac
potassium 50 mg sachet contains 14.4 mg of elemental potassium. The
recommended maximum
daily dose of this medicine contains 2.9 g of mannitol. Products
containing mannitol may have a
laxative effect or cause diarrhoea.
For the full list of excipients, see section 6.1 ‘LIST OF
EXCIPIENTS’.
3
PHARMACEUTICAL FORM
Powder for oral solution (white to light yellow homogenous powder).
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
•
As short-term treatment (up to one week) for the relief of acute pain
states in which there is
an inflammatory component.
•
Treatment of acute migraine attacks (with or without aura)
•
Symptomatic treatment of primary dysmenorrhoea.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The sachet formulation has not been studied beyond a single dose.
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 ‘SPECIAL
WARNINGS AND PRECAUTIONS’). Patients on long term treatment should
be reviewed regularly with
regards to efficacy, risk factors and ongoing need for treatment.
DOSE
Adults
ACUTE PAIN STATES WITH AN INFLAMMATORY COMPONENT
As a rule, the initial daily dosage for adults is 100 to 150 mg. In
milder cases, as well as for children
over 14 years of age, 75 to 100 mg daily is usually sufficient. The
total daily dosage should generally
be prescribed in 2 or 3 fractional doses. Treatment is to continue for
a maximum of 7 days. If the
2
pain has not resolved satisfactorily after 7 days’ treatment, the
patient should be instructed to
return for review by