Alendroninezuur/Cholecalciferol Sandoz 70 mg/5600 IE, tabletten

Country: নেদারল্যান্ডস

ভাষা: ডাচ

সূত্র: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

সক্রিয় উপাদান:

CHOLECALCIFEROL CONCENTRAAT, POEDERVORM 56 mg/stuk SAMENSTELLING overeenkomend met ; CHOLECALCIFEROL 140 µg/stuk ; NATRIUMALENDRONAAT 3-WATER 91,4 mg/stuk SAMENSTELLING overeenkomend met ; ALENDRONINEZUUR 70 mg/stuk ; SAMENSTELLING overeenkomend met CHOLECALCIFEROL 5600 IE/stuk

থেকে পাওয়া:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

এটিসি কোড:

M05BB03

INN (International Name):

CHOLECALCIFEROL CONCENTRAAT, POEDERVORM 56 mg/stuk SAMENSTELLING overeenkomend met ; CHOLECALCIFEROL 140 µg/stuk ; NATRIUMALENDRONAAT 3-WATER 91,4 mg/stuk SAMENSTELLING overeenkomend met ; ALENDRONINEZUUR 70 mg/stuk ; SAMENSTELLING overeenkomend met CHOLECALCIFEROL 5600 IE/stuk

ফার্মাসিউটিকাল ফর্ম:

Tablet

রচনা:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEMODIFICEERD (MODIFICATIE ONBEKEND ; NATRIUMASCORBAAT (E 301) ; SACCHAROSE ; SILICIUMDIOXIDE (E 551) ; TOCOFEROL, DL-ALFA (E 307) ; TRIGLYCERIDEN MIDDELLANGE KETEN, CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEMODIFICEERD (MODIFICATIE ONBEKEND, (E 1450) ; NATRIUMASCORBAAT (E 301) ; SACCHAROSE ; SILICIUMDIOXIDE (E 551) ; TOCOFEROL, DL-ALFA (E 307) ; TRIGLYCERIDEN MIDDELLANGE KETEN,

প্রশাসন রুট:

Oraal gebruik

Therapeutic area:

Alendronic Acid And Colecalciferol

পণ্য সারাংশ:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEMODIFICEERD (MODIFICATIE ONBEKEND, (E 1450); NATRIUMASCORBAAT (E 301); SACCHAROSE; SILICIUMDIOXIDE (E 551); TOCOFEROL, DL-ALFA (E 307); TRIGLYCERIDEN MIDDELLANGE KETEN;

অনুমোদন তারিখ:

1900-01-01

তথ্য লিফলেট

Sandoz B.V.
Page 1/9
Alendroninezuur/Cholecalciferol Sandoz
®
70 mg/5600
IE, tabletten
RVG 117969
1313-v4
1.3.1.3 Bijsluiter
December 2020
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ALENDRONINEZUUR/CHOLECALCIFEROL SANDOZ
® 70 MG/5600 IE, TABLETTEN
alendronic acid/colecalciferol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
It is particularly important to understand the information in section
“3. How to take [Nationally
completed name]”, before taking this medicine.
WHAT IS IN THIS LEAFLET
1.
What [Nationally completed name] is and what it is used for
2.
What you need to know before you take [Nationally completed name]
3.
How to take [Nationally completed name]
4.
Possible side effects
5
How to store [Nationally completed name]
6.
Contents of the pack and other information
1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
WHAT IS [NATIONALLY COMPLETED NAME]?
[Nationally completed name] is a tablet containing the two active
substances, alendronic acid
(commonly called alendronate) and colecalciferol known as vitamin D
3
.
WHAT IS ALENDRONATE?
Alendronate belongs to a group of non-hormonal medicines called
bisphosphonates. Alendronate
prevents the loss of bone that occurs in women after they have been
through the menopause, and helps
to rebuild bone. It reduces the risk of spine and hip fractures.
WHAT IS VITAMIN D?
Vitamin D is an essential nutrient, required for calcium absorption
and healthy bones. The body can
only absorb calcium properly from our food if it has enough vitamin D.
Very few foods c

পণ্য বৈশিষ্ট্য

Sandoz B.V.
Page 1/14
Alendroninezuur/Cholecalciferol Sandoz 70 mg/5600
IE, tabletten
RVG 117969
1311-V4
1.3.1.1 Samenvatting van de Productkenmerken
December 2020
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Alendroninezuur/Cholecalciferol Sandoz 70 mg/5600 IE, tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
tablet
contains
70
mg
of
alendronic
acid
(as
sodium
alendronate
trihydrate)
and
140 micrograms colecalciferol (equivalent to 5600 IU vitamin D3).
Excipient with known effect:
Each tablet contains 9.8 mg of sucrose.
For the full list of excipients, see section 6.1.
_ _
3.
PHARMACEUTICAL FORM
Tablet
_ _
White to almost white, oval, debossed with 714 on one side.
Approximately 12.6mm x 6.6mm x 5.2mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Nationally completed name] is indicated for the treatment of
postmenopausal osteoporosis in women
at risk of vitamin D insufficiency. It reduces the risk of vertebral
and hip fractures.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is one tablet once weekly.
Patients should be instructed that if they miss a dose of [Nationally
completed name] they should take
one tablet on the morning after they remember. They should not take
two tablets on the same day but
should return to taking one tablet once a week, as originally
scheduled on their chosen day.
Due to the nature of the disease process in osteoporosis, [Nationally
completed name] is intended for
long-term use.
Sandoz B.V.
Page 2/14
Alendroninezuur/Cholecalciferol Sandoz 70 mg/5600
IE, tabletten
RVG 117969
1311-V4
1.3.1.1 Samenvatting van de Productkenmerken
December 2020
The optimal duration of bisphosphonate treatment for osteoporosis has
not been established. The need
for continued treatment should be re-evaluated periodically based on
the benefits and potential risks of
[Nationally completed name] on an individual patient basis,
particularly after 5 or more years of use.
Patients should receive supplemental calcium, if intake from diet is
inadequat