CARBOPLATIN TEVA

Država: Izrael

Jezik: engleski

Izvor: Ministry of Health

Aktivni sastojci:

CARBOPLATIN

Dostupno od:

ABIC MARKETING LTD, ISRAEL

ATC koda:

L01XA02

Farmaceutski oblik:

CONCENTRATE FOR SOLUTION FOR INFUSION

Sastav:

CARBOPLATIN 10 MG/ML

Administracija rute:

I.V

Tip recepta:

Required

Proizveden od:

PHARMACHEMIE BV, HOLLAND (TEVA GROUP)

Terapijska grupa:

CARBOPLATIN

Područje terapije:

CARBOPLATIN

Terapijske indikacije:

Advanced ovarian carcinoma in initial treatment and secondary treatment.Metastatic small cell carcinoma of the lung.

Datum autorizacije:

2015-01-31

Uputa o lijeku

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
)
ךיראת
_______
DECEMBER 31, 2014
__
םש
רישכת
תילגנאב
רפסמו
םושירה
CARBOPLATIN 10 MG.ML CONCENTRATE FOR SOLUTION FOR INFUSION
042
05
25540
05
םש
לעב
םושירה
SALOMON, LEVIN & ELSTEIN LTD. POBOX 3696 PETACH
TIKVA
_
ספוט
הז
דעוימ
טורפל
תורמחהה
דבלב
!
תורמחהה
תושקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
INDICATION
CONTRAINDICATIONS
POSOLOGY, DOSAGE & ADMINISTRATION
Therapy should not be repeated until
four
weeks
after
the
previous
carboplatin course
Paediatrics
Sufficient usage of carboplatin in
paediatrics has not occurred to allow
specific dosage recommendations to
be made.
Therapy should not be repeated until four weeks after
the previous carboplatin course . and/or until the
neutrophil count is at least 2000 cells/mm
3
and the
platelet count is at least 100.000 cells/ mm
3.
Therapy with carboplatin should be discontinued in the
case of an unresponsive tumour, progressive disease
and/or occurrence of not tolerable side effects.
Paediatric population
As no sufficient experience of carboplatin use in
children
is
available,
no
specific
dosage
recommendations can be given.
Paediatrics
Sufficient usage of carboplatin in paediatrics has not
occurred to allow specific dosage recommendations to
be made.
SPECIAL WARNINGS AND SPECIAL
PRECAUTIONS FOR USE
Renal function impairment may be
encountered
with
carboplatin.
Although no clinical evidence on
compounding nephrotoxicity has been
accumulated, it is recommended not to
combine
carboplatin
with
aminoglycosides or other nephrotoxic
compounds.
As for other platinum co-ordination
compounds,
allergic
reactions
to
carboplatin have been reported. They
may
occur
within
minutes
of
administration and should be managed
with appropriate supportive therapy..
Anaphylactic-like reactions may also

Svojstava lijeka

Carboplatin Teva MF 05/2020 Notification CLEAN
SUMMARY OF PRODUCT CHARACTERISTICS
Carboplatin Teva
Concentrate for Solution for Infusion
For I.V. Infusion
1.
NAME OF THE MEDICINAL PRODUCT
Carboplatin Teva
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vials containing 50 mg, 150 mg, 450 mg and 600 mg of carboplatin
(cis-diammine
(1,1-cyclobutanedicarboxylato)platinum) as a 10 mg/ml solution.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Carboplatin Teva is a clear, colourless to faintly yellow solution,
practically free from particles.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Advanced ovarian carcinoma:
-
_Initial treatment_: Carboplatin is indicated for the treatment of
advanced ovarian carcinoma in
established combination with other approved chemotherapeutic agents.
-
_Secondary treatment_: Carboplatin is indicated for the palliative
treatment of patients with
advanced ovarian carcinoma recurrent after prior chemotherapy,
including patients who have
been previously treated with cisplatin.
Metastatic small cell carcinoma of the lung.
4.2
Posology and method of administration
Carboplatin Teva Injection does not contain any antimicrobial
preservative; it is intended for single-
dose administration only.
_Parenteral drug products should be inspected visually for particulate
matter and discoloration prior _
_to administration, whenever solution and container permit. _
Administration
This preparation is intended for intravenous use only, usually by an
infusion lasting 15 minutes or
longer. It may be given to outpatients since hydration is not
required.
Aluminium reacts with carboplatin causing precipitate formation and
loss of potency; therefore,
needles or intravenous sets containing aluminium parts that may come
in contact with the drug must
not be used for the preparation or administration of carboplatin.
Therapy should not be repeated until four weeks after the previous
carboplatin course and/or until the
neutrophil count is at least 2,000