Doribax 500mg powder for solution for infusion

Doribax is an antibiotic. Doribax works by killing different types of bacteria (germs) that cause infections in various parts of the body.

Doribax is used for the following infections:

• Pneumonia (a serious type of chest or lung infection) that you catch in a hospital or similar setting. Thisincludes pneumonia that you catch when on a machine that helps you breathe.
• Complicatedinfections of the area around your stomach (abdominal infections).
• Complicated urinary tract infections, including kidney infections and cases that have spread to the bloodstream.

Do not use Doribax

• If you are allergic (hypersensitive) to doripenem.
• If you are allergic to other antibiotics such as penicillins, cephalosporins or carbapenems (which are used to treat various infections) as you may also be allergic to Doribax.

Do not use Doribax if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before being given Doribax.

Take special care with Doribax

If you have:

• Kidney problems. Your doctor may need to lower your dose of Doribax.
• Diarrhoea. It is important that you tell your doctor if you have bloody diarrhoea before, during or after your treatment with Doribax. This is because you may have a condition known as colitis (an inflammation of the bowel). Do not take any medicine to treat diarrhoea without first checking with your doctor.

Convulsions have infrequently been reported during treatment with closely related antibiotics.While antibiotics including Doribaxkill certain bacteria, other bacteria and fungi may continue to grow more than normal. This is called overgrowth. Your doctor will monitor you for overgrowth and treat you if necessary.

Tell your doctor if you are taking medicines called valproic acid or sodium valproate (see Taking other medicinesbelow).

Doribax should not be inhaled as it may cause inflammation of the lung (pneumonitis).

Doribax should not be given to children or adolescents (under 18years of age) as there is not enough information to be sure that Doribax can be used safely in children or adolescents.

Takingother medicines

Always tell your doctor or pharmacist if you are taking or have recently taken any other medicines, This includes medicines you get without a prescription or herbal medicines. Tell your doctor if you are taking medicines called valproic acid or sodium valproate (used to treat epilepsy, bipolar disorder, migraines or schizophrenia) or probenecid (used to treat gout or high levels of uric acid in the blood). Your doctor will decide whether you should use Doribax in combination with these other medicines.

Pregnancy and breast-feeding

Tell your doctor or pharmacist before using Doribax if:

• You are pregnant or think you may be pregnant. Your doctor will decide whether you should use Doribax.
• You are breast-feeding or if you plan to breast-feed. Small amounts of this medicine may pass into breast milk and it may affect the baby.Therefore, your doctor will decide whether you should use Doribax while breast-feeding.

Driving and using machines

Doribax is not likely to affect your ability to drive or operate machinery.

How Doribax is given

• Doribax will be prepared and given to you by a doctor or nurse over one or four hours as an intravenous infusion into one of your veins (this is sometimes known as a ?drip?).

How much Doribax is given

• Your doctor will decide how much Doribax you need and for how long.

Adults (including people over 65years of age)

• The usual dose is 500mg every eight hours. Each dose is given over a period of one or four hours.
• The course usually lasts 5 to 14days.
• If you have kidney problems, your doctor may lower your dose of Doribax to 250mg given over one or four hours every eight or 12hours.

If you use more Doribax than you should

If you are concerned that you may have been given too much Doribax, talk to your doctor or pharmacist straight away.

If a Doribax dose has been missed

If you are concerned that you may have missed a dose of Doribax, talk to your doctor or pharmacist straight away. It is important that you receive treatment with Doribax as long as your doctor feels it is necessary.

If you have any further questions on the use of Doribax, ask your doctor or pharmacist.

Like all medicines, Doribax can cause side effects, although not everybody gets them.

The frequency of possible side effects listed below is defined using the following convention:very common (affects more than 1user in 10)
common (affects 1 to 10users in 100)
uncommon (affects 1 to 10users in 1,000)
rare (affects 1 to 10users in10,000)
very rare (affects less than 1user in 10,000)
not known (frequency cannot be estimated from the available data).

Very common

• Headache

Common

• Rash, itching or hives
• Diarrhoea. Tell your doctor straight away if you get bloody diarrhoeabefore, during or after your treatment with Doribax.
• Feeling sick (nausea)
• Vein wall inflammation where the intravenous infusion (or ?drip?) goes into your vein (phlebitis)
• Fungal infections (thrush) in your mouth or vagina
• Increase in the level of some liver enzymes in your blood.

Uncommon

• Inflammation of the bowel with diarrhoea ( Clostridium difficilecolitis)
• Decrease of blood platelet count
• Decrease of white blood cells which may increase your risk of infections
• Sudden swelling of your lips, face, throat or tongue, a rash, swallowing or breathing problems. These may be signs of a severe allergic reaction (anaphylaxis) and may be life-threatening. Tell your doctor straight away if you get these as you may need urgent medical treatment.

The following side effects were also seen in a small number of patients

• Serious skin reactions, with a widespread rash with peeling skin and blisters in the mouth, eyes and genitals (toxic epidermal necrolysis or Stevens-Johnson syndrome).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date stated on the container. The first two numbers indicate the month. The next four numbers indicate the year. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Medicines should not be disposed of viawastewater or household waste. These measures will help to protect the environment.

What Doribax contains

• The active substance is doripenem. Each vial contains doripenem monohydrate equivalent to500mg 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 medicinal product, 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

Detailed information on this medicine is available on the European MedicinesAgency website: http://www.ema.europa.eu/

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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 500mg dose of solution for infusionusing the 500mg vial

1.Add 10ml of sterile water for injections or sodium chloride 9mg/ml (0.9%) solution for injectionto the 500mg 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 100ml of either sodium chloride 9mg/ml (0.9%) solution for injectionor dextrose 50mg/ml (5%) solution for injection and mix to complete dissolution. Infuse all of this solution to administer a 500mg dose of doripenem.

Preparation of 250mg dose of solution for infusion using the 500mg vial

1.Add10ml of sterile water for injections or sodium chloride 9mg/ml (0.9%) solution for injectionto the 500mg 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 100ml of either sodium chloride 9mg/ml (0.9%) solution for injectionor dextrose 50mg/ml (5%) solution for injection and mix to complete dissolution.

4.Remove 55ml of this solution from the infusion bag and discard. Infuse all of the remaining 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 for injection, 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.