RENAGEL sevelamer hydrochloride 800 mg tablet bottle

দেশ: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: Department of Health (Therapeutic Goods Administration)

সক্রিয় উপাদান:

sevelamer hydrochloride, Quantity: 800 mg

থেকে পাওয়া:

Sanofi-Aventis Australia Pty Ltd

INN (আন্তর্জাতিক নাম):

Sevelamer hydrochloride

ফার্মাসিউটিকাল ফর্ম:

Tablet, film coated

রচনা:

Excipient Ingredients: colloidal anhydrous silica; stearic acid; hypromellose; acetylated monoglycerides; propylene glycol; isopropyl alcohol; purified water; iron oxide black

প্রশাসন রুট:

Oral

প্যাকেজ ইউনিট:

180, 30

প্রেসক্রিপশন টাইপ:

(S4) Prescription Only Medicine

থেরাপিউটিক ইঙ্গিত:

Renagel is indicated for the management of hyperphosphataemia in adult patients with stage 4 and 5 chronic kidney disease.

পণ্য সারাংশ:

Visual Identification: Off-white film-coated tablet imprinted with 'RENAGEL 800' on one side and blank on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

অনুমোদন অবস্থা:

Registered

অনুমোদন তারিখ:

2005-06-30

তথ্য লিফলেট

RENAGEL
®
_Sevelamer hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Renagel. It does not
contain all the available information.
It does not take the place of talking to
your treating doctor or a trained
health care professional.
All medicines have risks and
benefits. Your treating doctor has
weighed the risks of you taking
Renagel against the benefits this
medicine is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
TREATING DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT RENAGEL IS USED
FOR
The name of your medicine is
Renagel. It contains the active
ingredient called sevelamer
hydrochloride.
Renagel is used to treat
hyperphosphataemia, a condition
caused by too much dietary
phosphorus being retained in your
body due to a diseased kidney.
ASK YOUR TREATING DOCTOR IF YOU
HAVE ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
_HOW IT WORKS_
Renagel belongs to a class of
medicines that are called ion
exchange resins.
Renagel helps to remove excess
phosphorus that has built up in your
body by binding the phosphorus that
is in the food that you eat.
BEFORE YOU USE
RENAGEL
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE RENAGEL IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
sevelamer hydrochloride
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath, wheezing or
difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
skin rash, itching or hives
DO NOT TAKE RENAGEL IF YOU HAVE:
•
hypophosphatemia, a condition
where you do not have enough
phosphorus in your body
•
a bowel obstruction
DO NOT TAKE RENAGEL IF THE
PACKAGING IS TORN OR SHOWS SIGNS OF
TAMPERING.
DO NOT TAKE RENAGEL AFTER THE
EXPIRY DATE (EXP) PRINTED ON THE
PACK HAS PASSED.
IF YOU TAKE THIS MEDICINE AFTER THE
EXPIRY DATE IT MAY HAVE NO EFFECT AT
ALL, OR WORSE,

পণ্য বৈশিষ্ট্য

Property of the Sanofi group - strictly confidential
Renagel-ccdsv6-piv6-25feb20
Page 1
AUSTRALIAN PRODUCT INFORMATION - RENAGEL (SEVELAMER
HYDROCHLORIDE)
1
NAME OF MEDICINE
sevelamer hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Renagel 800 mg tablets contain 800 mg sevelamer hydrochloride on an
anhydrous basis.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Film coated tablets.
Renagel tablets are oval off-white film coated tablets imprinted with
"Renagel 800" on one side
and blank on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Renagel is indicated for the management of hyperphosphataemia in adult
patients with stage 4 and
5 chronic kidney disease.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
_STARTING DOSE _
The recommended starting dose for patients not taking a phosphate
binder is 800 to 1600 mg
(Table 1), which can be administered as one to two Renagel 800 mg
tablets with each meal based
on serum phosphorus level.
Property of the Sanofi group - strictly confidential
Renagel-ccdsv6-piv6-25feb20
Page 2
TABLE 1 - STARTING DOSE FOR PATIENTS NOT TAKING A PHOSPHATE BINDER
SERUM PHOSPHORUS
RENAGEL 800 MG TABLETS
> 1.78 and < 2.42 mmol/L
1 tablet, three times daily with meals

2.42 and <2.91 mmol/L
2 tablets, three times daily with meals

2.91 mmol/L
2 tablets, three times daily with meals
When patients are converting from a calcium based phosphate binder,
Renagel should be given in
equivalent doses on a (mg to mg) weight basis compared to the
patient’s previous calcium based
phosphate binder (Table 2). Serum phosphorus levels should be closely
monitored and the dose
of Renagel adjusted accordingly with the goal of lowering serum
phosphorus. Serum phosphorus
should be tested every 2 to 3 weeks until a stable serum phosphorus
level is reached, and on a
regular basis thereafter.
TABLE 2 - STARTING DOSE FOR PATIENTS SWITCHING FROM CALCIUM ACETATE TO
RENAGEL
CALCIUM ACETATE 667 MG
(TABLETS PER MEAL)
RENAGEL 800 MG
(TABLETS PER MEAL)
1 t