TERIPARATIDE KAMADA

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

TERIPARATIDE

Available from:

KAMADA LTD, ISRAEL

ATC code:

H05AA02

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

TERIPARATIDE 0.250 MG / 1 ML

Administration route:

S.C

Prescription type:

Required

Manufactured by:

ALVOGEN INC., USA

Therapeutic area:

TERIPARATIDE

Therapeutic indications:

Treatment of Postmenopausal Women with Osteoporosis at High Risk for FractureTeriparatide Kamada is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, Teriparatide Kamada Increases BMD reduces the risk of vertebral and nonvertebral fractures.Increase of Bone Mass in Men with Primary or Hypogonadal Osteoporosis at High Risk for FractureTeriparatide Kamada is indicated to increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.Treatment of Men and Women with Glucocorticoid-Induced Osteoporosis at High Risk for FractureTeriparatide Kamada is indicated for the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy (daily dosage equivalent to 5 mg or greater of prednisone) at high risk for fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.

Authorization date:

2022-07-24

Patient Information leaflet

Kamada
Teriparatide
Solution for Injection
User manual
355.6 x 750 mm
7.5
7
7.5
1
Heb+Eng
08/12/22
Keren
2
Heb+Eng
21/12/22
Keren
3
Heb+Eng
5-1-23
Keren
4
Heb+Eng
30-1-23
Keren
5
Heb+Eng
06-2-23
Keren
6
Heb+Eng
13-2-23
Keren
7 Heb+Eng+Arabic
13/3/23
Rima
8 Heb+Eng+Arabic
21/3/23
Rima
Client
C M Y K
3200004076-01
הקידב אלל ינכט - תילגנאו תירבע
Lot: XXX XXXX
1
2
Lot: XXX XXXX
EXP: MM / YYYY
EXP: MM / YYYY
EXP: MM / YYYY
EXP: MM / YYYY
3
4
5
6
7
8
9
10
הקרזה טע רובע שמתשמל ןולע
עדהמק דייטארפירט הקרזהל הסימת
שומישל ןכומ טעב
עדהמק דייטארפירט
שומישל ןכומ טעב הקרזהל הסימת
עדהמק דייטארפירט
שומישל ןכומ טעב הקרזהל הסימת
TERIPARATIDE KAMADA
SOLUTION FOR INJECTION IN A PRE-FILLED PEN
TERIPARATIDE KAMADA
SOLUTION FOR INJECTION IN A PRE-FILLED PEN :ותומכו ליעפה רמוחה
ל"מ/םרגורקימ 250 דייטארפירט
:הליכמ תקרזומ הנמ לכ
)teriparatide 20 mcg( םרגורקימ 20 דייטארפירט .תולולכ ןניא םיטחמ*
שמתשהל ץלמומ הז טעב
תרבח לש 29-31G לדוגב םיטחמב
Becton, Dickinson and Company
.)המוד וא(
תא תוסכל שי .תע לכב )2°C-8°C( ררקמב ןסחא
קזנמ תינסחמה לע ןגהל ידכ ןבלה הסכמה םע
טעה
רישכתב שמתשהל ןיא .איפקהל ןיא .רואמו
יזיפ
.אפקוהש
:הנושארה החיתפה רחאל
ררקמב ןסחאל שי ןושארה שומישה רחאל
•
ךילשהל שי .םימי 28 ךות שמתשהלו )2°C-8°C(
.ןושארה שומישהמ םימי 28 רחאל טעה תא
ךשמ תא רעזמל שי שומישה תפוקת ךלהמב
םע דיימ הנמה קירזהל ןתינ ;ררקמל ץוחמ
ןמזה
.ררקמהמ האצוהה
.אפקוהש רישכתב שמתשהל ןיא .איפקהל ןיא
•
.תרבוחמ טחמ םע טעה תא ןסחאל ןיא
.שומישה ינפל םיידיה ת�

Summary of Product characteristics

Page 1 of 14
TERIPARATIDE KAMADA
TERIPARATIDE 250 MCG/ML
SOLUTION FOR SUBCUTANEOUS INJECTION
FULL PRESCRIBING INFORMATION
WARNING: POTENTIAL RISK OF OSTEOSARCOMA
IN MALE AND FEMALE RATS, TERIPARATIDE CAUSED AN INCREASE IN THE
INCIDENCE OF OSTEOSARCOMA (A MALIGNANT BONE TUMOR)
THAT WAS DEPENDENT ON DOSE AND TREATMENT DURATION. THE EFFECT WAS
OBSERVED AT SYSTEMIC EXPOSURES TO TERIPARATIDE
RANGING FROM 3 TO 60 TIMES THE EXPOSURE IN HUMANS GIVEN A 20-MCG DOSE.
BECAUSE OF THE UNCERTAIN RELEVANCE OF THE
RAT OSTEOSARCOMA FINDING TO HUMANS, PRESCRIBE TERIPARATIDE KAMADA ONLY
FOR PATIENTS FOR WHOM THE POTENTIAL
BENEFITS ARE CONSIDERED TO OUTWEIGH THE POTENTIAL RISK. TERIPARATIDE
KAMADA SHOULD NOT BE PRESCRIBED FOR PATIENTS
WHO ARE AT INCREASED BASELINE RISK FOR OSTEOSARCOMA (INCLUDING THOSE
WITH PAGET’S DISEASE OF BONE OR UNEXPLAINED
ELEVATIONS OF ALKALINE PHOSPHATASE, PEDIATRIC AND YOUNG ADULT PATIENTS
WITH OPEN EPIPHYSES, OR PRIOR EXTERNAL BEAM
OR IMPLANT RADIATION THERAPY INVOLVING THE SKELETON) _[SEE WARNINGS
AND PRECAUTIONS (5.1), ADVERSE REACTIONS (6.2), _
_AND NONCLINICAL TOXICOLOGY (13.1)]_.
TERIPARATIDE KAMADA IS A BIOSIMILAR MEDICINAL PRODUCT THAT HAS BEEN
DEMONSTRATED TO BE SIMILAR IN QUALITY,
SAFETY AND EFFICACY TO THE REFERENCE MEDICINAL PRODUCT FORTEO. PLEASE
BE AWARE OF ANY DIFFERENCES IN THE
INDICATIONS BETWEEN THE BIOSIMILAR MEDICINAL PRODUCT AND THE REFERENCE
MEDICINAL PRODUCT. THE BIOSIMILAR
IS NOT TO BE SWITCHED WITH THE REFERENCE MEDICINAL PRODUCT UNLESS
SPECIFICALLY STATED OTHERWISE. MORE
DETAILED INFORMATION REGARDING BIOSIMILAR MEDICINAL PRODUCTS IS
AVAILABLE ON THE WEBSITE OF THE MINISTRY OF
HEALTH:
HTTPS://WWW.HEALTH.GOV.IL/UNITSOFFICE/HD/MTI/DRUGS/REGISTRATION/PAGES/BIOSIMILARS.ASPX
1
INDICATIONS AND USAGE
1.1
TREATMENT OF POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS AT HIGH RISK FOR
FRACTURE
Teriparatide Kamada is indicated for the treatment of postmenopausal
women with osteoporosis at high risk for
fracture, defined as a history of osteoporotic fracture, multiple risk
factors for fracture, or pati