)‫בטיחות‬
)‫מידע בטיחות‬
‫החמרה (( מידע‬
‫על החמרה‬
‫הודעה על‬
‫הודעה‬
___February 3, 2008____________________ ‫תאריך‬
_EXTRANEAL_ Solution for peritoneal dialysis_‫שם תכשיר באנגלית‬
_____116 27 29763 00___________‫מספר רישום‬
Teva Medical Marketing Ltd, Haorgim St. 2, Ashdod 77100_‫שם בעל הרישום‬
‫השינויים בעלון מסומנים על רקע צהוב‬
‫רופא‬
‫בעלון ללרופא‬
‫בעלון‬
‫ים‬/‫ים המבוקש‬/‫פרטים על השינוי‬
‫טקסט חדש‬
‫טקסט נוכחי‬
Blood glucose measurement must be done with a glucose
specific method to prevent maltose interference. Glucose
dehydrogenase pyrroloquinolinequinone (GDH PQQ) or
glucose-dye-oxidoreductase-based methods should not be
used. If GDH-PQQ or glucose-dye-oxidoreductase-based
methods are used, using Extraneal may cause a falsely
high glucose reading, which could result in the
administration of more insulin than needed. This can cause
hypoglycaemia, which can result in loss of consciousness,
coma, neurological damage and death. Additionally,
falsely elevated blood glucose measurements due to
maltose interference may mask true hypoglycaemia and
allow it to go untreated with similar consequences. It is
recommended that reference is made to the relevant
section of the glucose test kit product leaflet to ascertain
that interference while using Icodextrin-based dialysis
therapy or maltose / medicines metabolised to maltose is
not described
Blood glucose measurement must be done
with a glucose specific method to prevent
maltose interference. Glucose
dehydrogenase pyrroloquinolinequinone
(GDH PQQ) or glucose-dyeoxidoreductase-based methods should not
be used. If GDH-PQQ or glucose-dyeoxidoreductase-based methods are used,
using Extraneal may cause a falsely high
glucose reading, which could result in the
administration of more insulin than
needed. This can cause hypoglycaemia,
which can result in loss of consciousness,
coma, neurological damage and death.
Additionally, falsely elevated blood
glucose measurements due to maltose
interference may mask true hypoglycaemia
and allow it to go untreated with similar
consequences. It is recommended that
reference is made to the relevant section of
the glucose test kit product leaflet to
ascertain that interference while using
Icodextrin-based dialysis therapy is not
described
Adverse Drug Reaction
Body General
Abdominal Pain: frequency: Common
Asthenia frequency :Common
Headache frequency:: Common
Abnormal laboratory tests
(increased alkaline phosphatases
SGOT/SGPT (<1%), decreased serum
amylase and decreased sodium and
chloride levels) frequency: Common
Undesirable Effects
Undesirable effects which occurred in patients treated with
Extraneal from the clinical trials are listed below. The
adverse drug reactions listed in this section are given
following the recommended frequency convention: very
common: 10%; common: 1% and <10%; uncommon:
0.1% and <1%; very rare: <0.01%..
MedRA Standard System Organ Class (SOC)
Metabolism and nutrition disorders
Undesirable effects
Preferred term/High Level Term (PT)
Dehydration, frequency: common
Cardio-Vascular System
Hypertension: frequency: common
Hypotension frequency: common
‫פרק בעלון‬
Warnings and
Precautions
Adverse
events
Hypochloraemia, frequency: common.
Hyponatraemia: frequency: common.
Hypovolaemia, frequency: common.
MedRA Standard System Organ Class (SOC)
Nervous system disorders:
Dizziness:: common.
Headache: common.
MedRA Standard System Organ Class (SOC)
Vascular disorders
Hypertension: common
Hypotension: common
MedRA Standard System Organ Class (SOC)
Gastrointestinal disorders
Abdominal pain: common
MedRA Standard System Organ Class (SOC)
Skin and subcutaneous disorders
Pruritus: common
Rash: common
Skin exfoliation: common
MedRA Standard System Organ Class (SOC)
General disorders and administration site conditions
Asthenia: common
Oedema: common.
MedRA Standard System Organ Class (SOC)
Investigations
Alanine aminotransferase increased: uncommon
Aspartate aminotransferase increased: uncommon
Blood alkaline phosphate increased: common
Blood amylase decreased.: common
Adverse Drug Reaction
Body General
Abdominal Pain: frequency*: Common
Asthenia frequency* :Common
Headache frequency*:: Common
Abnormal laboratory* tests
(increased alkaline phosphatases SGOT/SGPT (<1%),
decreased serum amylase and decreased sodium and
chloride levels) frequency* Common
Cardio-Vascular System
Hypertension: frequency*: common
Hypotension frequency*: common
Metabolic and Nutrition
Hypovolaemia and dehydration frequency:
common
Oedema Frequency: c
Nervous System
Dizziness frequency: common
Skin
Rash frequency: common
Pruritus frequency common
Exfoliation
Common
(*) The term common means a frequency
between 1 and 10 %.
Metabolic and Nutrition
Hypovolaemia and dehydration frequency*: common
Oedema Frequency*: cpmmon
Nervous System
Dizziness frequency*: common
Skin
Rash frequency*: common
Pruritus frequency* common
Exfoliation frequency*
Common
(*) The term common means a frequency between 1 and
10 %.
Interaction with other Medicinal Products and other
forms of Interaction
None known - however, the blood
teractions Interaction with other Medicinal Products and other
concentrations of dialysable drugs may be
forms of Interaction
reduced by dialysis. Corrective therapy
None known - however, the blood concentrations of
should be instituted if necessary. In
dialysable drugs may be reduced by dialysis. Corrective
patients using cardiac glycosides, plasma
therapy should be instituted if necessary. In patients using
levels of potassium and calcium must be
cardiac glycosides, plasma levels of potassium and
carefully checked. In the event of
calcium must be carefully checked. In the event of
abnormal levels, appropriate actions
abnormal levels, appropriate actions should be taken.
should be taken.
Blood glucose measurement must be done with a glucose
specific method to prevent maltose interference. Glucose
dehydrogenase pyrroloquinolinequinone (GDH PQQ) or
glucose-dye-oxidoreductase-based methods to measure
glucose should not be used while using Extraneal (see
section 4.4). It is recommended that reference is made to
the relevant section of the glucose test kit product leaflet to
ascertain that interference while using Icodextrin-based
dialysis therapy is not described.
Blood glucose measurement must be done
with a glucose specific method to prevent
maltose
interference.
Glucose
dehydrogenase pyrroloquinolinequinone
(GDH
PQQ)
or
glucose-dyeoxidoreductase-based methodse should not
be used. It is recommended that reference
is made to the relevant section of the
glucose test kit product leaflet to ascertain
that interference while using Icodextrinbased dialysis therapy is not described.
Drug
Interactions
Special Precautions for Storage
Do not store above 30°C. Do not use unless the solution is
clear and the container undamaged.
The product, once removed from its overpouch should be
used immediately.
Detailed instructions on the PD exchange procedure is
given to patients by means of training, in a specialised
training centre, prior to home use.
Special Precautions for Storage
Do not store above 30°C. Do not use
unless the solution is clear and the
container undamaged.
Others
Detailed instructions on the PD exchange
procedure is given to patients by means of
training, in a specialised training centre,
prior to home use
Precautions)
(Storage