Colistilab 1 million international UNITS

Country: Jordan

Language: English

Source: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

Active ingredient:

Colistimethate Sodium 1 million international UNITS

Available from:

مستودع أدوية الشرق شخشير - ORIENT DRUG STORE CO

ATC code:

J01XB01

INN (International Name):

Colistimethate Sodium 1 million international UNITS

Dosage:

1 million international UNITS

Units in package:

10 VIAL

Manufactured by:

Hikma Italia S.P.A (ايطاليا)

Patient Information leaflet

NOT33166-A
XXXXX/XX
COLISTILAB
®
Colistimethate Sodium
Labatec Art. code
Supplier Art. code
170
250
LABATEC PHARMA
_Document:_
_Department:_
_Creation date:_
_Cutting Dimension:_
_Country:_
_Laetus Code:_
Labatec Pharma, 31, rue du Cardinal Journet CP12 CH-1217 Meyrin 1
(Genève), Switzerland
Packaging Development Dpt: Tel: + 41 22 593 78 28
Pantone Black C
_Colors_
_Colors_
_Modification made_
_N° Modification - Date_
1 - 20.07.2017
Text modification (RB e-mail 20.07.2017)
2 - 09.08.2017
Text modification (RB e-mail 22.07.2017)
4 - 15.11.2018
Text modification
3 - 10.08.2017
Text modification (RB e-mail 09.08.2017)
Cutting Die
NOT33166-A COLISTILAB 170X250 JO
_File name: Packaging code-Version _
_Description:_
_User plant:_
Hikma IT
Artwork
dd-mm-2017
Packaging Dvlpt
170X250
Jordan
TBC by supplier
Item N° (Position + N°)
Dimensions, Die cut
Variable data position
Laetus code : Position, Number, Direction
Datamatrix: (Dim + Position + content)
"PRODUCER" CHECKS
(TECHNICAL DATA)
General presentation
APPROVAL area (Please sign electronically this doc using Adobe
Acrobat)
Requestor checks
FOR ORALS + DIVERS PRODUCTS
Product code
Dosage
Quantity + galenic form + logo
Therapeutic indication on box
Colours
Composition (on box)
Storage conditions (on box)
Language DE+FR±IT, other
Logos: Customer, Swissmedic, (on Box) Labatec (on Box+Label)
Datamatrix and GTIN number (on Box + Label)
Datamatrix and GTIN printed on line (on Box + Label)
Barre code EAN13 (on Box)
Barre code Laetus (on Box + Leaflet)
Variable data format
General presentation
Product name
APPROVAL area (Please sign electronically this doc using Adobe
Acrobat)
!
Date approbation des autorités locales:
Local autorities approval date:
NOT33166-A
XXXXX/XX
PEDIATRIC POPULATION
patients with Colistin, is not different from that observed in adult
patients.
STORAGE
Do not store above 30 ° C, keep in the original packaging from light
Keep out of reach of children.
Do not freeze.
Reconstituted solutions
Reconstituted solutions should be used immediately after p