Propofol 10mg/ml emulsion for i/v injection/infusion

Երկիր: Հայաստան

Լեզու: անգլերեն

Աղբյուրը: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ակտիվ բաղադրիչ:

propofol

Հասանելի է:

PharmaTech CJSC

ATC կոդը:

N01AX10

INN (Միջազգային անվանումը):

propofol

Դոզան:

10mg/ml

Դեղագործական ձեւ:

emulsion for i/v injection/infusion

Միավորները փաթեթում:

(5) ampoules 20ml

Ռեկվիզորի տեսակը:

Prescription

Լիազորման կարգավիճակը:

Registered

Հաստատման ամսաթիվը:

2022-10-11

Տեղեկատվական թերթիկ

PharmaTech CJSC 111 Raffi st. Yerevan, 0064 Republic of ArmeniaTel:
[phone]Fax: [phone]
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROPOFOL 10MG/ML
10MG/ML,
EMULSION FOR INJECTION OR INFUSION
Propofol
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 or pharmacist.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Propofol 10mg/ml is and what it is used for
2.
What you need to know before you use Propofol 10mg/ml
3.
How to use Propofol 10mg/ml
4.
Possible side effects
5.
How to store Propofol 10mg/ml
6.
Contents of the pack and other information
1.
WHAT PROPOFOL 10MG/ML IS AND WHAT IT IS USED FOR
Propofol 10mg/ml belongs to a group of medicines called ‘general
anaesthetics’. General anaesthetics are
used to cause unconsciousness (sleep) so that surgical operations or
other procedures can be performed.
They can also be used to sedate you (so that you are sleepy but not
completely asleep).
Propofol 10mg/ml will be given to you as an injection by a doctor.
Propofol 10mg/ml is used to:

Induce and maintain general anaesthesia in adults and children > 1
month

Sedate patients > 16 years of age receiving artificial respiration in
intensive care

Sedate adults and children > 1 month during diagnostic and surgical
procedures, alone or in
combination with local or regional anaesthesia.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PROPOFOL 10MG/ML
DO NOT USE PROPOFOL 10MG/ML:

if you are allergic to propofol or any of the other ingredients of
this medicine (listed in section 6).

in patients allergic to peanut or soya. This is because Propofol
10mg/ml contains soya-bean oil.

in patients of 16 years of age or younger for sedation in intensive
care
PharmaTech CJSC 111 Raffi st. Yerev

Ապրանքի հատկությունները

PharmaTech CJSC 111 Raffi st. Yerevan, 0064 Republic of ArmeniaTel:
[phone]Fax: [phone]
1
SUMMARY OF PRODUCT CHARACTERISTICS
PROPOFOL 10 MG/ML
10MG/ML,
EMULSION FOR INJECTION OR INFUSION
Propofol
1. NAME OF THE MEDICINAL PRODUCT
Propofol 10 mg/ml
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml emulsion for injection/infusion contains 10 mg propofol.
Each 20 ml vial contains 200 mg propofol.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Emulsion for injection/infusion.
Milky white colored emulsion.
pH: 6.0 - 8.5
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Propofol is a short-acting intravenous general anaesthetic for:
- Induction and maintenance of general anaesthesia in adults and
children > 1 month
- Sedation for diagnostic and surgical procedures, alone or in
combination with local or regional
anaesthesia in adults and children > 1 month
- Sedation of ventilated patients > 16 years of age in the intensive
care unit.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Propofol must only be administered in hospitals or adequately equipped
day therapy units by physicians
trained in anaesthesia or in the care of patients in intensive care.
Circulatory and respiratory functions should be constantly monitored
(e.g. ECG, pulse oxymetry) and
facilities for maintenance of a patient airways, artificial
ventilation, and other resuscitation facilities
should be immediately available at all times.
For sedation during surgical and diagnostic procedures Propofol should
not be administered by the same
person conducting the surgical or diagnostic procedure.
PharmaTech CJSC 111 Raffi st. Yerevan, 0064 Republic of ArmeniaTel:
[phone]Fax: [phone]
2
Propofol has no analgesic properties and therefore supplementary
analgesic agents are generally required
in addition to Propofol.
Posology
The dose of Propofol should be individually adapted according to the
patient's response.
Rapid bolus administration (single or repeated) should not be used in
older people as this may lead to
card