Doribax
doripenem
doripenem
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
What Doribax is and what it is used for
What you need to know before you use Doribax
How to use Doribax
Possible side effects
How to store Doribax
Contents of the pack and other information
Doribax contains the active substance doripenem. This medicine is an antibiotic which works by killing different types of bacteria (germs) that cause infections in various parts of the body.
Doribax is used to treat adults for the following infections:
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Pneumonia (a serious type of chest or lung infection) that you catch in a hospital or similar setting. This includes pneumonia that you catch when on a machine that helps you breathe.
Complicated infections of the area around your stomach (abdominal infections).
Complicated urinary tract infections, including kidney infections and cases that have spread to the bloodstream.
If you are allergic 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 this medicine if any of the above applies to you. If you are not sure, talk to your doctor, pharmacist or nurse before being given Doribax.
Talk to your doctor, pharmacist or nurse before being given Doribax, and 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.
reported during treatment with Doribax and antibiotics that work in a similar way to Doribax. While antibiotics including Doribax kill 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.
Doribax should not be inhaled as it may cause inflammation of the lung (pneumonitis).
Doribax should not be given to children or adolescents (under 18 years of age) as there is not enough information to be sure that Doribax can be used safely in children or adolescents.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. This includes medicines you get without a prescription or herbal medicines. Tell your doctor if you are taking:
Your doctor will decide whether you should use Doribax in combination with these other medicines.
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.
Doribax is not likely to affect your ability to drive or operate machinery.
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Your doctor will decide how much Doribax you need and for how long.
The usual dose is 500 mg every eight hours. Each dose is given over a period of one or four
hours.
The treatment course usually lasts 5 to 14 days.
If you have kidney problems, your doctor may lower your dose of Doribax to 250 mg given over one or four hours every eight or 12 hours.
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”).
Symptoms of overdose may include rash. If you are concerned that you may have been given too
much Doribax, talk to your doctor, pharmacist or nurse straight away.
If you are concerned that you may have missed a dose of Doribax, talk to your doctor, pharmacist or
nurse 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 this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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.
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 you get bloody diarrhoea before, during or after your treatment with Doribax (Clostridium
difficile colitis)
Headache
Rash, itching or hives
Diarrhoea
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.
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Decrease of blood platelet count which may increase your risk of bruising and bleeding
Decrease of white blood cells which may increase your risk of infections
Seizures.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and vial. 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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is doripenem. Each vial contains doripenem monohydrate equivalent to
250 mg doripenem.
Doribax is a white to slightly yellowish off-white crystalline powder in a glass vial. Doribax is supplied in packs of 10 vials.
Janssen-Cilag International NV Janssen Pharmaceutica NV
Turnhoutseweg 30 Turnhoutseweg 30
B-2340 Beerse B-2340 Beerse
Belgium Belgium
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
JANSSEN-CILAG NV/SA
Belgique/Belgien Tél/Tel: +32 14 64 94 11
Johnson & Johnson D. O. O.
Teл.: +359 2 489 94 00
AM MANGION LTD Tel: +356 2397 6000
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JANSSEN-CILAG A/S
Tlf: +45 45 94 82 82
JANSSEN-CILAG B.V.
Tel: +31 13 583 73 73
JANSSEN-CILAG GmbH
Tel: +49 2137 955 955
JANSSEN-CILAG AS
Tlf: + 47 24 12 65 00
Janssen-Cilag Polska Sp. z o.o. Eesti filiaal Tel: + 372 617 7410
JANSSEN-CILAG Pharma GmbH Tel: +43 1 610 300
JANSSEN-CILAG Φαρμακευτική Α.Ε.Β.Ε.
Tηλ: +30 210 809 0000
JANSSEN–CILAG Polska Sp. z o.o.
Tel.: + 48 22 237 60 00
JANSSEN-CILAG, S.A. Tel: +34 91 722 81 00
JANSSEN-CILAG FARMACEUTICA, LDA Tel: +351 21 4368835
JANSSEN-CILAG
Tél: 0800 25 50 75/+ 33 1 55 00 44 44
Johnson&Johnson România SRL Tel: +40 21 2071800
JANSSEN-CILAG Ltd.
Tel: +44 1494 567 444
Johnson & Johnson d.o.o.
Tel: + 386 1 401 18 30
JANSSEN-CILAG, c/o Vistor Hf Sími: +354 535 7000
Janssen, Johnson & Johnson, s.r.o. Tel: +421 232 408 400
JANSSEN-CILAG SpA Tel: +39 02 2510 1
JANSSEN-CILAG OY Puh/Tel: +358 207 531 300
Βαρνάβας Χατζηπαναγής Λτδ
Tηλ: +357 22 755 214
JANSSEN-CILAG AB
Tel: +46 8 626 50 00
Janssen-Cilag Polska Sp. z o.o. filiāle Latvijā Tel: +371 678 93561
UAB „Johnson & Johnson“
Tel: +370 5 278 68 88
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Thefollowinginformationisintendedforhealthcareprofessionalsonly
Each vial is for single use only.
Doribax is reconstituted and then further diluted prior to infusion.
Add 10 ml of sterile water for injections or sodium chloride 9 mg/ml (0.9%) solution for injection to the 250 mg vial and shake it to form a suspension.
Inspect the suspension visually for foreign matter. Note: the suspension is not for direct infusion.
Withdraw the suspension using a syringe and needle and add it to an infusion bag containing
50 ml or 100 ml of either sodium chloride 9 mg/ml (0.9%) solution for injection or dextrose
50 mg/ml (5%) solution for injection and mix to complete dissolution. Infuse all of this solution to administer a 250 mg 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.
Upon reconstitution with sterile water for injections or sodium chloride 9 mg/ml (0.9%) solution for
injection, Doribax suspension in the vial may be held for up to 1 hour below 30C prior to transfer and dilution in the infusion bag.
Following dilution in the infusion bag, Doribax infusions stored at room temperature or under refrigeration should be completed according to the times in the following table:
Infusion solution | Solution stored at room temperature | Solution stored in a refrigerator (2C-8C) |
sodium chloride 9 mg/ml (0.9%) solution for injection | 12 hours | 72 hours* |
+ dextrose 50 mg/ml (5%) solution for injection | 4 hours | 24 hours* |
* Once 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 mg/ml (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 24 hours at 2C-8C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Medicinal product no longer authorised
Any unused product or waste material should be disposed of in accordance with local requirements.