What Doribax contains
- The active substance is doripenem. Each vial contains doripenem monohydrate equivalent to250mg doripenem.
What Doribax looks like and contents of the pack
Doribax is a white to slightly yellowish off-white crystalline powder in a glass vial. Doribax is supplied in packs of 10vials.
Marketing Authorisation HolderJanssen-Cilag International NVTurnhoutseweg 30B-2340 BeerseBelgium ManufacturerJanssen PharmaceuticaTurnhoutseweg 30B-2340 BeerseBelgiu
For any information about this medicinalproduct, please contact the local representative of the Marketing Authorisation Holder:
BelgiëBelgiqueBelgienJANSSEN-CILAG N.V.S.A.TélTel 32 3 280 54 11LuxembourgLuxemburgJANSSEN-CILAG N.V.S.A.BelgiëBelgiqueBelgienTélTel 32 3 280 54 1
Johnson Johnson D. O. O.Te. 359 2 489 94 00 MagyarországJANSSEN-CILAG Kft.Tel. 36 23 513-80
eská republikaJANSSEN-CILAG s.r.o.Tel 420 227 012 222 MaltaAM MANGION LTDTel 356 2397 600
DanmarkJANSSEN-CILAG ASTlf 45 45 94 82 82 NederlandJANSSEN-CILAG B.V.Tel 31 13 583 73 7
DeutschlandJANSSEN-CILAG GmbHTel 49 2137-955-955 NorgeJANSSEN-CILAG ASTlf 47 24 12 65 0
EestiJanssen-Cilag Polska Sp. z o.o. Eesti filiaalTel 372 617 7410 ÖsterreichJANSSEN-CILAGTel 43 1 610 30
JANSSEN-CILAG ....T 30 210 809 0000 PolskaJANSSENCILAG Polska Sp. z o.o.Tel. 48 22 237 60 0
EspañaJANSSEN-CILAG, S.A.Tel 34 91 722 81 00 PortugalJANSSEN-CILAG FARMACEUTICA, LDATel 351 21-436883
FranceJANSSEN-CILAGTel 0800 25 50 75 33 1 55 00 44 44RomâniaJohnsonJohnson d.o.o.Rep.Office Janssen-Cilag.Tel 4 021 207180
IrelandJANSSEN-CILAG Ltd.Tel 44 01494 567567 SlovenijaJohnson Johnson d.o.o.Tel 386 1 401 18 3
ÍslandJANSSEN-CILAG, co Vistor HfSími 354 535 7000ItaliaJANSSEN-CILAG SpATel 39 022510.1 Slovenská republikaJANSSEN-CILAG, a JohnsonJohnson companyTel 421 233 552 600SuomiFinlandJANSSEN-CILAG OYPuhTel 358 207 531 30
T 357 22 755 214 SverigeJANSSEN-CILAG ABTel 46 8 626 50 0
LatvijaJanssen-Cilag Polska Sp. z o.o. filile LatvijTel 371 678 93561 United KingdomJANSSEN-CILAG Ltd.Tel 44 01494 56756
Lietuva
UAB ?Johnson & Johnson?
Tel: +370 5 278 68 88
This leaflet was last approved in MM/YYYY
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The following information is intended for medical or healthcare professionals only
Each vial is for single use only.
Doribax is reconstituted and then further diluted prior to infusion.
Preparation of 250mg dose of solution for infusion using the 250mg vial
1.Add 10ml of sterile water for injections or sodium chloride 9mg/ml (0.9%) solution for injection to the 250mg vial and shake it to form a suspension.
2.Inspect the suspension visually for foreign matter. Note: the suspension is not for direct infusion.
3.Withdraw the suspension using a syringe and needle and add it to an infusion bag containing 50ml or 100ml of either sodium chloride 9mg/ml (0.9%) solution for injection or dextrose 50mg/ml (5%) solution for injection and mix to complete dissolution. Infuse all of this solution to administer a 250mg dose of doripenem.
Doribax solutions for infusion range from clear, colourless solutions to solutions that are clear and slightly yellow. Variations in colour within this range do not affect the potency of the product.
Storage of reconstituted solutions
Upon reconstitution with sterile water for injections or sodium chloride 9mg/ml (0.9%) solution forinjection, Doribax suspension in the vial may be held for up to 1hour below 30-C prior to transfer and dilution in the infusion bag.
Following dilution in the infusion bag with sodium chloride 9mg/ml (0.9%) solution for injection or dextrose 50mg/ml (5%) solution for injection, Doribax infusions stored at room temperature or under refrigeration should be completed according to the times in the following table:
Time by which reconstitution, dilution and infusion must be completed for Doribax infusions solutionsInfusion solutionSolution stored at room temperatureSolution stored in a refrigerator 2C-8Csodium chloride 9 mgml 0.9 solution for injection 12 hours 72 hoursdextrose 50 mgml 5 solution for injection4 hours 24 hoursOnce removed from the refrigerator, infusions should be completed within the room temperature stability time, provided the total refrigeration time, time to reach room temperature and infusion time does not exceed refrigeration stability time.Dextrose 50 mgml 5 solution for injection should not be used for infusion durations greater than 1 hour
Chemical and physical in-use stability has been demonstrated for the times and solutions shown in the above table.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24hours at 2-C-8-C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Any unused product or waste material should be disposed of in accordance with local requirements.