Doribax (Doripenem)

Doribax 500 mg powder for solution for infusion. Doripenem

WHAT DORIBAX IS AND WHAT IT IS USED FOR

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.

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.

BEFORE YOU USE DORIBAX

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 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.

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

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.

Taking other 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) as these medicines may affect Doribax.

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 breastfeeding.

Driving and using machines

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

HOW TO USE DORIBAX

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 65 years of age)

The usual dose is 500 mg every eight hours. Each dose is given over a period of one or four hours The 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

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.

POSSIBLE SIDE EFFECTS

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 1 user in 10)
• common (affects 1 to 10 users in 100)
• uncommon (affects 1 to 10 users in 1,000)
• rare (affects 1 to 10 users in 10,000)
• very rare (affects less than 1 user 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 diarrhoea before, 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 difficile colitis)
• 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 we res also seen in a small number of patients:

Serious skin reactions, with a widespread rash with peeling skin and blistering 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.

HOW TO STORE DORIBAX

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 via wastewater or household waste. These measures will help to protect the environment.

FURTHER INFORMATION

What Doribax contains

The active substance is doripenem. Each vial contains doripenem monohydrate equivalent to 500 mg 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 10 vials.

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

1. Add 10 ml of sterile water for injections or sodium chloride 9 mg/ml (0.9%) solution for injection to 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 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 500 mg dose of doripenem.

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

1. Add 10 ml of sterile water for injections or sodium chloride 9 mg/ml (0.9%) solution for injection to 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 100 ml 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.
4. Remove 55 ml of this solution from the infusion bag and discard. Infuse all of the remaining 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.

Storage of reconstituted solutions

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 30°C prior to transfer and dilution in the infusion bag.

Following dilution in the infusion bag with sodium chloride 9 mg/ml (0.9%) solution for injection or dextrose 50 mg/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 solutions

Infusion solution	Solution stored at room temperature	Solution stored in a refrigerator (2°C-8°C)
sodium chloride 9 mg/ml (0.9%) solution for injection +dextrose 50 mg/ml (5%) solution for injection	12 hours 4 hours	72 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 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.