Midazolam Sandoz 1 mg/ml, oplossing voor injectie of infusie

País: Països Baixos

Idioma: neerlandès

Font: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

ingredients actius:

MIDAZOLAMHYDROCHLORIDE SAMENSTELLING overeenkomend met ; ; MIDAZOLAM 1 mg/ml

Disponible des:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

Codi ATC:

N05CD08

Designació comuna internacional (DCI):

MIDAZOLAMHYDROCHLORIDE SAMENSTELLING overeenkomend met ; ; MIDAZOLAM 1 mg/ml

formulario farmacéutico:

Oplossing voor injectie of infusie

Composición:

NATRIUMCHLORIDE ; STIKSTOF (HEAD SPACE) (E 941) ; WATER VOOR INJECTIE ; ZOUTZUUR (E 507),

Vía de administración:

Intraveneus gebruik, Intramusculair gebruik, Rectaal gebruik

Área terapéutica:

Midazolam

Resumen del producto:

Hulpstoffen: NATRIUMCHLORIDE; STIKSTOF (HEAD SPACE) (E 941); WATER VOOR INJECTIE; ZOUTZUUR (E 507);

Data d'autorització:

2012-11-12

Informació per a l'usuari

Sandoz B.V.
Page 1/11
Midazolam Sandoz 1 mg/ml en 5 mg/ml – oplossing voor injectie of
infusie
RVG 110832-110837
1311-V7a
1.3.1.3 Bijsluiter
Oktober 2023
PACKAGE LEAFLET: INFORMATION FOR THE USER
MIDAZOLAM SANDOZ 1 MG/ML, OPLOSSING VOOR INJECTIE OF INFUSIE
MIDAZOLAM SANDOZ 5 MG/ML, OPLOSSING VOOR INJECTIE OF INFUSIE
midazolam
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What [nationally completed name] is and what it is used for
2.
What you need to know before you use [nationally completed name]
3.
How to use [nationally completed name]
4.
Possible side effects
5.
How to store [nationally completed name]
6.
Contents of the pack and other information
1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed name] contains the active substance midazolam
and belongs to a group
of medicines known as benzodiazepines. It is a short-acting medicine
that induces sedation –
a state of calm, drowsiness or sleep - and relieves anxiety and muscle
tension. It has
anticonvulsant effects and causes loss of memory for recent events.
[NATIONALLY COMPLETED NAME] IS USED FOR:
•
conscious
SEDATION
during a medical test or procedure, in adults and children
•
sedation in intensive care units, in adults and children
•
ANAESTHESIA
in adults, used alone or with other anaesthetic medicines
•
sedation before induction of anaesthesia, in adults and children
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN [NATIONALLY COMPLETED
NAME]
YOU MUST NOT BE GIVEN [NATIONALLY CO

Fitxa tècnica

Sandoz B.V.
Page 1/22
Midazolam Sandoz 1 mg/ml en 5 mg/ml – oplossing voor injectie of
infusie
RVG 110832-37
1311-V5
1.3.1.1 Samenvatting van de Productkenmerken
juli 2023
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Midazolam Sandoz 1 mg/ml, oplossing voor injectie of infusie
Midazolam Sandoz 5 mg/ml, oplossing voor injectie of infusie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for injection or infusion contains 1 mg of
midazolam (as hydrochloride).
Each ampoule of 5 ml solution for injection or infusion contains 5 mg
of midazolam (as
hydrochloride).
_ _
Each ml of solution for injection or infusion contains 5 mg of
midazolam (as hydrochloride).
Each ampoule of 1 ml solution for injection or infusion contains 5 mg
of midazolam (as
hydrochloride).
Each ampoule of 3 ml solution for injection or infusion contains 15 mg
of midazolam (as
hydrochloride).
Each ampoule of 10 ml solution for injection or infusion contains 50
mg of midazolam (as
hydrochloride).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection or infusion.
Clear, slightly yellow solution.
pH 2.9 – 3.7.
Osmolality 280 – 330 mOsmol/kg
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is indicated for i.v. use, i.m. use and rectal
use only.
Midazolam is a short-acting sleep-inducing medicinal product that is
indicated for:
IN ADULTS:
•
CONSCIOUS SEDATION before and during diagnostic or therapeutic
procedures with or
without local anaesthesia
•
ANAESTHESIA
-
Premedication before induction of anaesthesia
-
Induction of anaesthesia
-
As a sedative component in combined anaesthesia
Sandoz B.V.
Page 2/22
Midazolam Sandoz 1 mg/ml en 5 mg/ml – oplossing voor injectie of
infusie
RVG 110832-37
1311-V5
1.3.1.1 Samenvatting van de Productkenmerken
juli 2023
•
SEDATION IN INTENSIVE CARE UNITS
IN CHILDREN:
•
CONSCIOUS SEDATION before and during diagnostic or therapeutic
procedures with or
without local anaesthesia
•
ANAESTHESIA
-
Premedicat