)‫בטיחות‬
)‫מידע בטיחות‬
‫החמרה (( מידע‬
‫על החמרה‬
‫הודעה על‬
‫הודעה‬
7/05/07 ‫תאריך‬
: ‫שם תכשיר באנגלית‬
Zomera®4 mg/5 ml (zoledronic acid)
Concentrate for Solution for Intravenous Infusion
129 53 30791 00 : ‫מספר רישום‬
‫ פתח תקווה‬, 23 ‫ רח' הסיבים‬,‫ פרמהאקסל בע"מ‬: ‫שם בעל הרישום‬
‫השינויים בעלון מסומנים על רקע צהוב‬
‫רופא‬
‫בעלון ללרופא‬
‫בעלון‬
‫ים‬/‫ים המבוקש‬/‫פרטים על השינוי‬
‫טקסט חדש‬

WARNINGS
Due to the risk of clinically significant
deterioration in renal function, which
may progress to renal failure, single
doses of Zomera® (zoledronic acid)
should not exceed 4 mg and the
duration of infusion should be no less
than 15 minutes. In the trials and in
post-marketing experience, renal
deterioration, progression to renal
failure and dialysis, have occurred in
patients, including those treated with
the approved dose of 4 mg infused
over 15 minutes. There have been
instances of this occurring after the
initial or single Zomera dose.
‫טקסט נוכחי‬
WARNINGS
‫פרק בעלון‬
Precautions
Due to the risk of clinically significant
deterioration in renal function, which may
progress to renal failure, single doses of
Zomera® (zoledronic acid) should not exceed
4 mg and the duration of infusion should be no
less than 15 minutes. In the trials and in postmarketing experience, renal deterioration,
progression to renal failure and dialysis, have
occurred in patients, including those treated
with the approved dose of 4 mg infused over 15
minutes. There have been instances of this
occurring after the initial Zomera dose.
…
Patients must be assessed prior to
administration of Zomera to assure
that they are adequately hydrated.
Overhydration should be avoided in
patients at risk of cardiac failure.

Genaral
Zomera contains the same active
ingredient as found in Aclasta
(zoledronic acid). Patients being
treated with Zomera should not be
treated with Aclasta concomitantly.
Adverse events
Hypercalcemia of Malignancy
Hypercalcemia of Malignancy
‫ים‬/‫ים המבוקש‬/‫פרטים על השינוי‬
‫טקסט חדש‬
‫טקסט נוכחי‬
Adverse reactions to Zomera®
(zoledronic acid) are usually mild and
transient and similar to those reported
for other bisphosphonates. Intravenous
administration has been most commonly
associated with fever. Occasionally,
patients experience a flu-like syndrome
consisting of fever, chills, flushing, bone
pain and/or arthralgias, and myalgias.
Gastrointestinal reactions such as nausea
and vomiting have been reported
following intravenous infusion of
Zomera. Local reactions at the infusion
site, such as redness or swelling, were
observed infrequently. In most cases, no
specific treatment is required and the
symptoms subside after 24-48 hours.
Adverse reactions to Zomera® (zoledronic acid)
are usually mild and transient and similar to
those reported for other bisphosphonates.
Intravenous administration has been most
commonly associated with fever. Occasionally,
patients experience a flu-like syndrome
consisting of fever, chills, bone pain and/or
arthralgias, and myalgias. Gastrointestinal
reactions such as nausea and vomiting have
been reported following intravenous infusion of
Zomera. Local reactions at the infusion site,
such as redness or swelling, were observed
infrequently. In most cases, no specific
treatment is required and the symptoms subside
after 24-48 hours.
…
Post-Marketing Experience
Cases of osteonecrosis (primarily
involving the jaws) have been reported
in patients treated with bisphosphonates.
The majority of the reported cases are in
cancer patients attendant to a dental
procedure. Osteonecrosis of the jaws has
multiple well-documented risk factors
including a diagnosis of cancer,
concomitant therapies (e.g.,
chemotherapy, radiotherapy,
corticosteroids) and co-morbid
conditions (e.g., anemia, coagulopathies,
infection, pre-existing oral disease).
Although causality cannot be
determined, it is prudent to avoid dental
surgery as recovery may be prolonged.
(See PRECAUTIONS.)
The following adverse reactions have
been reported in post-marketing use:
CNS: taste disturbance, hyperesthesia,
tremor, somnolence;
Special Senses: blurred vision;
Gastrointestinal: dry mouth;
Skin: increased sweating;
Musculoskeletal: muscle cramps;
Cardiovascular: hypertension,
bradycardia, hypotension (ssociated with
syncope or circulatory collapse primarily
in patients with underlying risk factors),
atrial fibrilation;
Renal: hematuria, proteinuria;
Allergic Reactions: hypersensitivity
reaction, angioneurotic edema;
Respiratory: Bronchoconstriction
…
Post-Marketing Experience
Cases of osteonecrosis (primarily involving the
jaws) have been reported in patients treated
with bisphosphonates. The majority of the
reported cases are in cancer patients attendant
to a dental procedure. Osteonecrosis of the jaws
has multiple well-documented risk factors
including a diagnosis of cancer, concomitant
therapies (e.g., chemotherapy, radiotherapy,
corticosteroids) and co-morbid conditions (e.g.,
anemia, coagulopathies, infection, pre-existing
oral disease). Although causality cannot be
determined, it is prudent to avoid dental
surgery as recovery may be prolonged. (See
PRECAUTIONS.)
Cases of uveitis and episcleritis have been
reported during post-approval use.
‫פרק בעלון‬
‫ים‬/‫ים המבוקש‬/‫פרטים על השינוי‬
‫טקסט חדש‬
‫טקסט נוכחי‬
‫פרק בעלון‬
General Disorders and
Administration Site: weight increase,;
Laboratory Abnormalities:
hyperkalemia, hypernatremia.
Cases of uveitis and episcleritis have
been reported during post-marketing use.
OVERDOSAGE
Clinical
experience with acute
overdosage of Zomera® (zoledronic
acid) is limited. Two patients received
Zomera 32 mg over 5 minutes in clinical
trials. Neither patient experienced any
clinical or laboratory toxicity. Patients
who have received doses higher than
those recommended should be carefully
monitored,
since
renal
function
impairment (including renal failure) and
serum electrolyte (including calcium,
phosphorus
and
magnesium)
abnormalities have been observed.
Overdosage may cause clinically
significant
hypocalcemia,
hypophosphatemia,
and
hypomagnesemia. Clinically relevant
reductions in serum levels of calcium,
phosphorus, and magnesium should be
corrected by intravenous administration
of calcium gluconate, potassium or
sodium phosphate, and magnesium
sulfate, respectively.
OVERDOSAGE
There is no experience of acute overdose with
Zomera® (zoledronic acid). Two patients
received Zomera 32 mg over 5 minutes in
clinical trials. Neither patient experienced any
clinical or laboratory toxicity. Overdosage may
cause clinically significant hypocalcemia,
hypophosphatemia, and hypomagnesemia.
Clinically relevant reductions in serum levels
of calcium, phosphorus, and magnesium should
be corrected by intravenous administration of
calcium gluconate, potassium or sodium
phosphate,
and
magnesium
sulfate,
respectively.
Others