CONTROLOC I.V.

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

PANTOPRAZOLE AS SODIUM

Disponible des:

TAKEDA ISRAEL LTD

Codi ATC:

A02BC02

formulario farmacéutico:

POWDER FOR SOLUTION FOR INJECTION

Composición:

PANTOPRAZOLE AS SODIUM 40 MG/VIAL

Vía de administración:

I.V

tipo de receta:

Required

Fabricat per:

TAKEDA GMBH, GERMANY

Grupo terapéutico:

PANTOPRAZOLE

Área terapéutica:

PANTOPRAZOLE

indicaciones terapéuticas:

For the treatment of duodenal ulcer, gastric ulcer, moderate and severe forms of reflux oesophagitis. Zollinger Ellison Syndrome.

Data d'autorització:

2023-10-31

Informació per a l'usuari

1 | P a g e
TAKEDA ISRAEL LTD. IL/PANV/0919/0004
25 Efal st., P.O.B 4140, Petach-Tikva 4951125
Tel:+972-
-
3- 33733140 Fax (local): + 972-3-3733150
וטקוא
רב
2019
אפור
/
ה
ה/דבכנ
,
חקור
/
ת
דבכנ
/
ה
,
:ןודנה
CONTROLOC
® I.V. 40 MG/VIAL
קולורטנוק
™
.
V
.
I
0
4
/ג"מ
) ןוקובקב
לאיו
(
ןכדעתה ,ןודנבש רישכתה לש אפורל ןולעה
יכ םכעידוהל תשקבמ מ"עב לארשי הדקט תרבח
ב
רבמטפס
2019
.
וכדעה
ן
הז בתכמב עיפומ
הטמ ,
.
עדימל
ףסונ
,
שי
ןייעל
רגאמב
תופורתה
רתאבש
דרשמ
תואירבה
.
,ןכ ומכ
לבקל ןתינ
קתעה
ספדומ
ןולעה לש
ינכדעה
ע
ל
-
ידי
:םושירה לעבל היינפ
לעפא 'חר ,מ"עב לארשי הדקט
25
חתפ ,
-
קת
ו
,הו
:'לט
03-3733140
.
:לארשיב רישכתל תרשואמה היוותהה
Controloc I.V. is indicated for the treatment of duodenal ulcer,
gastric ulcer, moderate and severe forms of
reflux oesophagitis, Zollinger Ellison Syndrome.
ביכרמ
ליעפ
:
Pantoprazole (as sodium) 40 mg/Vial
הכרבב
,
ידרו בהי
תחקור
הנוממ
הדקט
לארשי
עב
"
מ
2 | P a g e
TAKEDA ISRAEL LTD. IL/PANV/0919/0004
25 Efal st., P.O.B 4140, Petach-Tikva 4951125
Tel:+972-
-
3- 33733140 Fax (local): + 972-3-3733150
פורל ןולעב ןוכדעה
וניה א
)
טסקט
ףסונש
ןמוסמ
ב
לוחכ
טסקט ,
הרמחה הווהמה
בוהצב שגדומ
(
:
4.8
UNDESIRABLE EFFECTS
…
Table 1. Adverse reactions with pantoprazole in clinical trials and
post-marketing experience FREQUENCY
SYSTEM
ORGAN CLASS
COMMON
UNCOMMON
RARE
VERY RARE
NOT KNOWN
Gastrointestinal
disorders
Fundic gland
polyps
(benign)
Diarrhoea;
Nausea/
vomiting;
Abdominal
distension and
bloating;
Constipation;
Dry mouth;
abdominal pain
and discomfort
MICROSCOPIC COLITIS
…

Fitxa tècnica

PRESCRIBING INFORMATION
CONTROLOC
®
I.V.
1.
NAME OF THE MEDICINAL PRODUCT
Controloc
®
I.V.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains pantoprazole sodium
42.3 mg (corresponding to pantoprazole 40 mg)
For
a
full list of excipients, see section
6.1.
3.
PHARMACEUTICAL
FORM
Powder for solution for injection.
White to off-white powder.
4. CLINICAL PARTICULARS
4.1
Therapeutic indications
-
duodenal ulcer
-
gastric ulcer
- moderate and severe reflux oesophagitis
-
Zollinger-Ellison
-
Syndrome
4.2
Posology and method of administration
This medicine should be administered by a healthcare professional and
under appropriate medical
supervision.
Intravenous administration of
Controloc
®
I. V.
is recommended only if oral administration is not
appropriate. Data are available on intravenous use for up to 7
days.
_ _
Therefore, as soon as oral therapy is possible, treatment with
Controloc
®
I.V. should be
discontinued and 40 mg pantoprazole p.o.
should be administered instead.
Posology
Duodenal ulcer, gastric ulcer, moderate and severe reflux oesophagitis
_ _
The recommended intravenous dose is one vial of
Controloc
®
I.V.
(40
mg pantoprazole) per day.
Zollinger-Ellison- Syndrome
_ _
For the long-term management of Zollinger-Ellison
-
Syndrome patients should start their treatment
with a daily dose of 80
mg
Controloc I.V
. Thereafter, the dose can be titrated up or down as needed
using measurements of gastric acid secretion to guide. With doses
above 80
mg daily, the dose should
be divided and given twice daily. A temporary increase of the dose
above 160
mg pantoprazole is
possible but should not be applied longer than required for adequate
acid control.
In case a rapid acid control is required, a starting dose of 2
x
80
mg
Controloc
®
I.V.
is sufficient to
manage a decrease of acid output into the target range (
<
10
mEq/h) within one hour in the majority of
patients.
Special populations
:
_Patients with hepatic impairment _
_ _
A daily dose of 20
mg pantoprazole (half a vial of 40
mg pantoprazole) sho