Bonviva tablets film-coated

מדינה: ארמניה

שפה: אנגלית

מקור: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

מרכיב פעיל:

ibandronic acid (ibandronic acid monosodium monohydrate)

זמין מ:

F. Hoffmann-La Roche Ltd.

קוד ATC:

M05BA06

INN (שם בינלאומי):

ibandronic acid (ibandronic acid monosodium monohydrate)

כמות:

150mg

טופס פרצבטיות:

tablets film-coated

יחידות באריזה:

(1), (3), in blister

סוג מרשם:

Prescription

מצב אישור:

Registered

תאריך אישור:

2019-07-30

עלון מידע

TABLE 2: CUMULATIVE COMMON ADVERSE DRUG REACTIONS (>1/100, ≤ 1/10)
IN PHASE III
OSTEOPOROSIS STUDIES THAT WERE CONSIDERED BY THE INVESTIGATOR TO BE
POSSIBLY
OR PROBABLY RELATED TO TREATMENT - TWO-YEAR DATA FROM STUDY BM16549
AND THREE-
YEAR DATA FROM PLACEBO-CONTROLLED FRACTURE STUDY MF4411
TWO-YEAR CUMULATIVE DATA
IN STUDY BM16549
THREE-YEAR DATA
IN STUDY MF4411
SYSTEM ORGAN CLASS/ ADVERSE
DRUG REACTION
BONVIVA 150 MG
ONCE MONTHLY
(N=396) (%)
BONVIVA
2.5 MG DAILY
(N=395) (%)
BONVIVA
2.5 MG DAILY
(N=977) (%)
PLACEBO
(N=975) (%)
GASTROINTESTINAL SYSTEM
Gastritis
1.0
0.3
0.7
0.5
Gastroesophageal reflux disease
0.8
1.0
0.5
0.1
Esophagitis
0
1.0
0.5
0.4
Diarrhea
2.5
2.0
1.4
1.0
Abdominal pain
4.0
3.0
2.1
2.9
Dyspepsia
4.0
6.3
4.0
2.7
Nausea
3.0
3.5
1.8
2.3
NERVOUS SYSTEM
Headache
0.8
1.5
0.8
0.6
GENERAL DISORDERS
Influenza-like illness*
3.3
0.3
0.3
0.2
MUSCULOSKELETAL SYSTEM
Muscle cramp
0.5
1.0
0.1
0.4
Musculoskeletal pain
1.0
0.5
0
0
Arthralgia
1.0
0.5
0.4
0.4
Myalgia
1.5
0.3
1.8
0.8
Musculoskeletal stiffness
1.0
0
0
0
SKIN DISORDERS
Rash
0.8
1.0
1.2
0.7
GENERAL DISORDERS
Influenza-like illness*
3.3
0.3
0.3
0.2
Fatigue
1.0
0.3
0.3
0.4
MUSCULOSKELETAL SYSTEM
Arthralgia
1.0
0.3
0.4
0.4
Myalgia
1.5
0.3
1.8
0.8
SKIN DISORDERS
Rash
0.8
1.0
1.2
0.7
Table 1: Common adverse drug reactions (>1/100, ≤ 1/10) in phase III
osteoporosis studies
that were considered by the investigator to be possibly or probably
related to
treatment - One-year data from study BM16549 and three-year data from
placebo-
controlled fracture study MF4411
One-year data in study BM16549
Three-year data in study MF4411
SYSTEM ORGAN CLASS/
ADVERSE DRUG REACTION
BONVIVA 150 MG
ONCE MONTHLY
(N=396) (%)
BONVIVA
2.5 MG DAILY
(N=395) (%)
2.5 MG DAILY
(N=977) (%)
PLACEBO
(N=975) (%)
GASTROINTESTINAL SYSTEM
Gastroesophageal
reflux disease
0.5
1.0
0.4
0.1
Diarrhea
2.5
1.8
1.4
1.0
BONVIVA
Abdominal pain
3.5
2.8
2.1
2.9
Dyspepsia
3.3
5.8
4.3
2.9
Nausea
3.3
3.5
1.8
2.3
Flatulence
0.5
1.0
0.4
0.7
NERVOUS SYSTEM
Headache
0.8
1.5
0.8
0.6
Technical approval
Date

מאפייני מוצר

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Bonviva 150 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg ibandronic acid (as sodium
monohydrate).
Excipients with known effect:
Contains 154.6 mg anhydrous lactose (equivalent to 162.75 mg lactose
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
White to off white film-coated tablets, of oblong shape marked
“BNVA” on one side, and “150” on
the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of osteoporosis in postmenopausal women at increased risk of
fracture (see section 5.1).
A reduction in the risk of vertebral fractures has been demonstrated,
efficacy on femoral neck fractures
has not been established.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is one 150 mg film-coated tablet once a month.
The tablet should preferably
be taken on the same date each month.
Bonviva should be taken after an overnight fast (at least 6 hours) and
1 hour before the first food or
drink (other than water) of the day (see section 4.5) or any other
oral medicinal products or
supplementation (including calcium).
In case a dose is missed, patients should be instructed to take one
Bonviva 150 mg tablet the morning
after the tablet is remembered, unless the time to the next scheduled
dose is within 7 days.
Patients should then return to taking their dose once a month on their
originally scheduled date.
If the next scheduled dose is within 7 days, patients should wait
until their next dose and then continue
taking one tablet once a month as originally scheduled.
Patients should not take two tablets within the same week.
Patients should receive supplemental calcium and / or vitamin D if
dietary intake is inadequate (see
section 4.4 and section 4.5).
The optimal duration of bisphosphonate treatment for osteoporosis has
not been established. The need
for continued treatment should be r