HYCAMTIN IV

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

TOPOTECAN AS HYDROCHLORIDE

Disponible des:

NOVARTIS ISRAEL LTD

Codi ATC:

L01XX17

formulario farmacéutico:

POWDER FOR SOLUTION FOR INFUSION

Composición:

TOPOTECAN AS HYDROCHLORIDE 4 MG/VIAL

Vía de administración:

I.V

tipo de receta:

Required

Fabricat per:

GLAXO SMITH KLINE MANUFACTURING SPA,ITALY

Grupo terapéutico:

TOPOTECAN

Área terapéutica:

TOPOTECAN

indicaciones terapéuticas:

Topotecan monotherapy is indicated for the treatment of:• patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy.• patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate.Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease.Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination.

Data d'autorització:

2022-03-31

Informació per a l'usuari

אפורל ןולעב )תוחיטב עדימ ( הרמחה לע
העדוה אפורל ןולעב )תוחיטב עדימ ( הרמחה לע
העדוה
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
) ךיראת
02/2014 םושירה רפסמו תילגנאב רישכת םש
HYCAMTIN: 104-89-28936 םושירה לעב םש
GLAXOSMITHKLINE )ISRAEL( LTD :
! דבלב תורמחהה טורפל דעוימ הז ספוט
אפורל ןולעב
אפורל ןולעב
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
UNDESIRABLE EFFECTS
BLOOD AND LYMPHATIC SYSTEM
DISORDERS
Very Common: Anaemia, febrile
neutropenia, leucopenia,
neutropenia, thrombocytopenia
Not known: Severe bleeding
)associated with
thrombocytopenia(
BLOOD AND LYMPHATIC SYSTEM
DISORDERS
Very common: febrile
neutropenia,
neutropenia )see Gastrointestinal
disorders(,
thrombocytopenia,
anaemia, leucopenia
Common: pancytopenia
Not known: severe bleeding
)associated with thrombocytopenia(
SKIN AND SUBCUTANEOUS
DISORDERS
Very Common: Alopecia
SKIN AND SUBCUTANEOUS TISSUE
DISORDERS
Very common: alopecia
Common: pruritus
INFECTIONS AND INFESTATIONS
Common: Infection, sepsis )see
Warnings and Precautions(
INFECTIONS AND INFESTATIONS
Very common: infection
Common: sepsis
IMMUNE SYSTEM DISORDERS
Common: Hypersensitivity,
including rash
IMMUNE SYSTEM DISORDERS
Common: hypersensitivity reaction
including rash
Rare: anaphylactic reaction,
angioedema, urticaria
-
The incidence of adverse events
listed above have the potential to
occur with a higher frequency in
patients who have a poor
performance status )see section 4.4(.
OVERDOSAGE
SYMPTOMS AND SIGNS
The primary complications of
overdosage are anticipated to
be bone marrow suppression
and stomatitis.
TREATMENT
There is no known antidote
for topotecan overdosage.
Overdoses (up to 10-fold of the
prescribed dose) occurred in
patients treated with intravenous
topotecan. The primary
complication of overdosage is
bone marrow suppression. The
observed signs and symptoms of
overdose are consistent w

Fitxa tècnica

HYC IV API DEC20 V
3
1.
NAME OF THE MEDICINAL PRODUCT
HYCAMTIN
®
I.V.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 4 mg topotecan (as hydrochloride).
The total content of active substance in the vial provides 1 mg per ml
of active substance when
reconstituted as recommended.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for infusion.
Light yellow to greenish
cake.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Topotecan monotherapy is indicated for the treatment of:

patients with metastatic carcinoma of the ovary after failure of
first-line or subsequent therapy.

patients with relapsed small cell lung cancer (SCLC) for whom
re-treatment with the first-line
regimen is not considered appropriate (see section 5.1).
Topotecan in combination with cisplatin is indicated for patients with
carcinoma of the cervix
recurrent after radiotherapy and for patients with Stage IVB disease.
Patients with prior exposure to cisplatin require a sustained
treatment free interval to justify treatment
with the combination (see section 5.1).
4.2
Posology and method of administration
The use of topotecan should be confined to units specialised in the
administration of cytotoxic
chemotherapy. Topotecan should only be administered under the
supervision of a physician
experienced in the use of chemotherapy (see section 6.6).
Posology
When topotecan is used in combination with cisplatin, the full
prescribing information for cisplatin
should be consulted.
Prior to administration of the first course of topotecan, patients
must have a baseline neutrophil count
of
≥
1.5 x 10
9
/l, a platelet count of
≥
100 x 10
9
/l and a haemoglobin level of
≥
9 g/dl (after transfusion
if necessary).
Ovarian and small cell lung carcinoma
HYC IV API DEC20 V3
Initial dose
The recommended dose of topotecan is 1.5 mg/m
2
body surface area per day administered by
intravenous infusion over 30 minutes daily for five consecutive days
with a three-week interval
between the start of each