ALPRIM trimethoprim 300mg tablet blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

trimethoprim, Quantity: 300 mg

제공처:

Alphapharm Pty Ltd

약제 형태:

Tablet, uncoated

구성:

Excipient Ingredients: lactose monohydrate; povidone; sodium starch glycollate; purified talc; magnesium stearate

관리 경로:

Oral

패키지 단위:

7 tablets

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

This product approved for registration as a variation of a product accepted for inclusion in the ARTG as 'currently supplied' at the commencement of the Act. Indications are held in ARTG paper records. Previous Product Number AUST R 17577 and 43120. Product Information not reviewed. INDICATIONS AS AT 5 DECEMBER 1984 : Treatment of acute urinary tract infections caused by sensitive organisms.

제품 요약:

Visual Identification: 9.5mm white normal convex tablet marked TM/300 on on side, G on reverse.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

승인 상태:

Registered

승인 날짜:

1998-04-05

환자 정보 전단

ALPRIM
_trimethoprim_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ALPRIM.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking ALPRIM against
the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT ALPRIM IS USED
FOR
ALPRIM is used to treat infections of
the urinary tract caused by bacteria.
ALPRIM belongs to a group of
medicines called antibiotics. It works
by stopping the growth of the
bacteria that is causing your
infection.
USE ALPRIM ONLY AS DIRECTED AND
CONSULT A HEALTH CARE PROFESSIONAL IF
PAIN OR SYMPTOMS PERSIST.
ALPRIM will not work against
infections caused by viruses, such as
colds or flu.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ALPRIM HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
ALPRIM for another reason.
ALPRIM is available only with a
doctor's prescription.
ALPRIM is not recommended for
use in children under 6 years of age,
as the safety and effectiveness of
ALPRIM in this age group has not
been established.
BEFORE YOU TAKE
ALPRIM
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ALPRIM IF YOU ARE
ALLERGIC TO ANY OTHER MEDICINES
CONTAINING TRIMETHOPRIM OR ANY OF
THE INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
Some of the symptoms of an allergic
reaction may include red, itchy skin
rashes, itching or hives; swelling of
the face, lips or tongue which may
cause difficulty in swallowing or
breathing; wheezing or shortness of
breath.
DO NOT TAKE ALPRIM IF YOU HAVE:
•
a severe blood disorder or
anaemia
•
severe kidney problems.
DO NOT TAKE ALPRIM AFTER THE
EXPIRY DATE (EXP) PRINTED ON THE
PACK.
If you take this medicine after the
expiry date, it may not work as well.
DO NOT TAKE ALPRIM IF THE
PACKAGING IS TORN OR SHOWS SIGNS OF
TAMPERING

제품 특성 요약

AUSTRALIAN PRODUCT INFORMATION
ALPRIM
_Trimethoprim tablets _
1
NAME OF THE MEDICINE
Trimethoprim
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ALPRIM tablet contains trimethoprim 300 mg as the active
ingredient.
Excipients with known effect: lactose and traces of sulfites and
galactose.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ALPRIM (trimethoprim) 300 mg: 9.5mm white normal convex tablet marked
TM/300 on one side, G on reverse
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of acute urinary tract infections caused by sensitive
organisms.
4.2
DOSE AND METHOD OF ADMINISTRATION
_ADULTS AND CHILDREN OVER 12 YEARS _
One tablet daily for 7 days.
_CHILDREN OVER 6 YEARS _
Half a table daily for 7 days.
_CHILDREN UNDER 6 YEARS _
There is no information available at present concerning the
appropriate dose of ALPRIM in children under the
age of 6 years.
_RENAL FAILURE _
The use of trimethoprim in patients with creatinine clearance of less
than 15 mL/minute is not recommended. If
the creatinine clearance is between 15 and 30 mL/minute, a reduced
dose should be considered.
In the treatment of acute urinary tract infection due to susceptible
organisms it is not necessary to use ALPRIM
for longer than 7 days.
To ensure maximal urinary concentration it may be advantageous to take
the dose before bedtime. The dose may
be taken with some food to minimise the possibility of
gastrointestinal disturbance.
4.3
CONTRAINDICATIONS
ALPRIM should not be given to patients with a history of trimethoprim
hypersensitivity.
Patients with severely impaired renal function (creatinine clearance
less than 10 mL/min) should not be prescribed
ALPRIM unless the plasma concentration of trimethoprim is monitored
repeatedly during treatment.
ALPRIM should not be given to patients with severe haematological
disorders or documented megaloblastic
anaemia due to folate deficiency.
ALPRIM – PRODUCT INFORMATION
2
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
POSSIBLE FOLATE DEFICIENCY
Care sho