ULTIVA 5 MG

País: Israel

Língua: inglês

Origem: Ministry of Health

Ingredientes ativos:

REMIFENTANIL AS HYDROCHLORIDE

Disponível em:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

Código ATC:

N01AH06

Forma farmacêutica:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION / INFUSION

Composição:

REMIFENTANIL AS HYDROCHLORIDE 5 MG/VIAL

Via de administração:

I.V

Tipo de prescrição:

Required

Fabricado por:

GLAXO SMITHKLINE MANUFACTURING S.P.A., ITALY

Grupo terapêutico:

REMIFENTANIL

Área terapêutica:

REMIFENTANIL

Indicações terapêuticas:

Ultiva is indicated as an analgesic agent for use during induction and/or maintenance of general anaesthesia under close supervision . Ultiva is indicated for provision of analgesia and sedation in mechanically ventilated intensive care patients 18 years of age and over.

Data de autorização:

2022-12-31

Folheto informativo - Bula

1
_ _
ראורבפ
2019
,ה/דבכנ ת/חקור ה/אפור
ירבה דרשמ
ולעב םיאבה םינוכדעה תא רשיא תוא
ן
רישכתה
םי
:
ULTIVA 2MG ULTIVA 1MG ULTIVA 5MG הויטלוא
1
ג"מ הויטלוא
2
ג"מ
יטלוא
ו ה
5
ג"מ
ליעפ רמוח
:
Remifentanil ( as hydrochloride ) 1mg/vial, 2mg/vial, 5mg/vial
--------------------------------------------------------------------------------------
:םושירה תדועתב הרשואש יפכ היוותה
Ultiva is indicated as an analgesic agent for use during induction
and/or maintenance of general
anaesthesia under close supervision .
Ultiva is indicated for provision of analgesia and sedation in
mechanically ventilated intensive
care patients 18 years of age and over.
ולעש עידוהל וננוצרב
ן
רישכתה
םי
ודנה
םינ
כדוע
ן
.הטמ םיטרופמה םיפיעסב
וז העדוהב
םיניוצמ
.יתוהמ יוניש וא הרמחה םיווהמ רשא
םייוניש קר בוהצ עקרב םינמוסמו
הרמחה םיווהמ םניאש םיפסונ םייוניש
ועצוב ןולעב
.
ל ןולעה
אפור
רבעוה
רשמ לש טנרטניאה רתאבש תופורתה רגאמב
םוסרפל
תואירבה ד
http://www.health.gov.il
,לארשי וגירפ תרבחל הינפ י"ע ספדומ ולבקל
ןתינו
:ןופלטב
03-5773700
.
,הכרבב
מ"עב תויונכוס לארשי וגירפ
2
_ _
ה ןלהל םינוכדע םיירקיעה
ל ןולעב
אפור
:
3. PHARMACEUTICAL FORM
Lyophilised powder for reconstitution for solution for intravenousfor
intravenous (IV)
administration.
Ultiva is a sterile, non-pyrogenicendotoxin-free, preservative-free,
white to off white,
Lyophilised powder, to be reconstituted before use.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
……
RISK FROM CONCOMITANT USE OF SEDATIVE MEDICINES SUCH AS
BENZODIAZEPINES OR RELATED
DRUGS
Concomitant use of Ultiva and sedative medicines such as
benzodiazepines or related drugs
may result in sedation, r

Características técnicas

1
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
ULTIVA
5 MG
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
When reconstituted as directed, solutions of Ultiva are clear and
colourless and
contain 1 mg/ml of remifentanil base as remifentanil hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for injection/infusion.
Ultiva is a sterile, non-pyrogenic, preservative-free, white to off
white, lyophilised
powder, to be reconstituted before use.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ultiva is indicated as an analgesic agent for use during induction
and/or
maintenance of general anaesthesia under close supervision.
Ultiva is indicated for provision of analgesia and sedation in
mechanically
ventilated intensive care patients 18 years of age and over.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ULTIVA SHOULD BE ADMINISTERED ONLY IN A SETTING FULLY EQUIPPED FOR THE
MONITORING AND SUPPORT OF RESPIRATORY AND CARDIOVASCULAR FUNCTION AND
BY
PERSONS SPECIFICALLY TRAINED IN THE USE OF ANAESTHETIC DRUGS AND THE
RECOGNITION AND MANAGEMENT OF THE EXPECTED ADVERSE EFFECTS OF POTENT
OPIOIDS,
INCLUDING RESPIRATORY AND CARDIAC RESUSCITATION. SUCH TRAINING MUST
INCLUDE
THE ESTABLISHMENT AND MAINTENANCE OF A PATENT AIRWAY AND ASSISTED
VENTILATION.
Continuous infusions of Ultiva must be administered by a calibrated
infusion
device into a fast flowing IV line or via a dedicated IV line. This
infusion line
should be connected at, or close to, the venous cannula and primed, to
minimise
the potential dead space (
_see section 6.6_
for additional information, including
WARNING: RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES
OR OTHER CNS DEPRESSANTS
Concomitant use of opioids with benzodiazepines or other central
nervous
system (CNS) depressants, including alcohol, may result in profound
sedation, respiratory depression, coma, and death [see sections 4.4
and 4.5].
Reserve concomitant prescribing of these drugs for use in patients for
whom