Celebrex (Aspen)

Država: Novi Zeland

Jezik: engleski

Izvor: Medsafe (Medicines Safety Authority)

Aktivni sastojci:

Celecoxib 200mg;  ;  

Dostupno od:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International ime):

Celecoxib 200 mg

Doziranje:

200 mg

Farmaceutski oblik:

Capsule

Sastav:

Active: Celecoxib 200mg     Excipient: Croscarmellose sodium Gelatin Lactose monohydrate Magnesium stearate Povidone Sodium laurilsulfate

Jedinice u paketu:

Blister pack, physican sample pack, 2 capsules

Razred:

Prescription

Tip recepta:

Prescription

Proizveden od:

Pfizer Pharmaceuticals LLC

Terapijske indikacije:

Symptomatic treatment of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. For the management of acute pain and treatment of primary dysmenorrhoea in adults. The decision to prescribe a selective COX-2 inhibitor should only be made: · if non-pharmacological interventions and simple analgesic therapies have been tried and found to lack analgesic efficacy or to have unacceptable adverse effects in the individual patient, and · after assessment of the individual patient's overall risks. As the cardiovascular risks of the selective COX-2 inhibitors may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. Patients on long-term treatment should be reviewed regularly, such as every three months, with regards to efficacy, risk factors and ongoing need for treatment.

Proizvod sažetak:

Package - Contents - Shelf Life: Blister pack, physican sample pack - 2 capsules - 36 months from date of manufacture stored at or below 30°C - Blister pack, physican sample pack - 10 capsules - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/Aluminium foil or PVC/Aclar-Aluminium foil - 30 capsules - 36 months from date of manufacture stored at or below 30°C

Datum autorizacije:

1998-09-03

Uputa o lijeku

CELEBREX
®
Page 1 of 4
CELEBREX

_CELECOXIB _
_(SELL-E-COX-IB)_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Celebrex. 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 taking Celebrex
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
READ THIS LEAFLET CAREFULLY BEFORE
YOU START CELEBREX AND KEEP IT WITH
THE MEDICINE.
You may need to read it again.
WHAT CELEBREX IS USED
FOR
Celebrex is used to treat joint pain,
tenderness, swelling and stiffness in:
•
osteoarthritis,
•
rheumatoid arthritis and
•
ankylosing spondylitis, a chronic
inflammatory rheumatic disorder
that primarily affects, but is not
limited to, the spine.
Celebrex is also used to relieve short-
term pain, in cases such as:
•
menstrual cramps (period pain)
•
following surgery
•
dental pain.
Celebrex contains celecoxib and
belongs to a group of medicines
called Coxibs which are used to
relieve pain and inflammation in a
number of conditions.
Although Celebrex can relieve the
symptoms of pain and inflammation,
it will not cure your condition.
Your doctor, however, may have
prescribed Celebrex for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY CELEBREX HAS
BEEN PRESCRIBED FOR YOU.
Celebrex is not approved for use in
children or adolescents under 18
years of age.
This medicine is only available with
a doctor's prescription.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE CELEBREX IF:
•
YOUR DOCTOR HAS TOLD YOU THAT
YOU HAVE SEVERE HEART OR BLOOD
VESSEL DISEASE AFFECTING THE
CIRCULATION IN YOUR BRAIN OR
LIMBS
•
YOU HAVE SEVERE LIVER PROBLEMS
Your doctor will decide if your
condition is too severe to take this
medicine.
•
YOU HAVE PROBLEMS WITH YOUR
KIDNEY FUNCTION
•
YOU HAVE HAD AN ATTACK OF
ASTHMA, HIVES, I

Svojstava lijeka

CELEBREX – data sheet
Page 1 of 35
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
Celebrex
®
100 mg and 200 mg capsules.
2. QUALITATIVE AND QUANTITATIVE COMPOISTION
Celebrex 100 mg contains 100 mg celecoxib.
Celebrex 200 mg contains 200 mg celecoxib.
EXCIPIENT(S) WITH KNOWN EFFECT
Each 100 mg and 200 mg capsule contains 149.7 mg and 49.8 mg lactose
monohydrate,
respectively. For the full list of excipients, see section 6.1 List of
Excipients.
3. PHARMACEUTICAL FORM
100 mg capsules: Opaque, white capsules with 2 blue bands marked 7767
and 100.
200 mg capsules: Opaque, white capsules with 2 gold bands marked 7767
and 200.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of pain and inflammation in osteoarthritis,
rheumatoid arthritis and
ankylosing spondylitis.
For the management of acute pain and treatment of primary
dysmenorrhoea in adults.
The decision to prescribe a selective cyclooxygenase 2 (COX-2)
inhibitor should only be made:
•
if non-pharmacological interventions and simple analgesic therapies
have been tried and
found to lack analgesic efficacy or to have unacceptable adverse
effects in the individual
patient, and
•
after assessment of the individual patient’s overall risks.
As the cardiovascular (CV) risks of the selective COX-2 inhibitors may
increase with dose and
duration of exposure, the shortest duration possible and the lowest
effective daily dose should
be used. Patients on long-term treatment should be reviewed regularly,
such as every three
months, with regards to efficacy, risk factors and ongoing need for
treatment.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
All patients taking celecoxib should commence therapy at the lowest
recommended dose, and
be titrated to the lowest dose compatible with effective control of
symptoms for the shortest
possible period.
CELEBREX – data sheet
Page 2 of 35
Patients on long-term treatment should be reviewed regularly with
regards to efficacy, risk
factors and ongoing need for treatment.
The following doses can be given without regar