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Ampicillin / Sulbactam 2 G/1 G Powder For Solution For Injection Or Infusion

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Ampicillin / Sulbactam 2 g/1 g

Powder for solution for injection or infusion Active substances: 1 g sulbactam and 2 g ampicillin

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor or pharmacist.

-    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.


In this leaflet:

1.    What Ampicillin / Sulbactam 2 g/1 g is and what it is used for

2.    What you need to know before you are given Ampicillin / Sulbactam 2 g/1 g

3.    How Ampicillin / Sulbactam 2 g/1 g is given

4.    Possible side effects

5.    How to store Ampicillin / Sulbactam 2 g/1 g

6.    Contents of the pack and other information

1. WHAT AMPICILLIN / SULBACTAM 2 G/1 G IS AND WHAT IT IS USED FOR

Ampicillin / Sulbactam 2 g/1 g is an antibiotic and works by killing bacteria that cause infections. It contains two different medicines called ampicillin and sulbactam. Ampicillin belongs to a group of medicines called ‘penicillins’ and sulbactam belongs to a group of medicines called beta-lactam inhibitor. Ampicillin / Sulbactam is used in adults and children to treat the following

-    pneumonia

-    kidney infections

-    intra-abdominal infections

-    genital organ infection in women

-    skin and soft tissues infections

Ampicillin / Sulbactam is used to prevent infections associated with abdominal infections.

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN AMPICILLIN / SULBACTAM 2 G/1 G

Do not use Ampicillin / Sulbactam 2 g/1 g

•    If you are allergic (hypersensitive) to ampicillin, sulbactam, penicillin or any of the ingredients of Ampicillin / Sulbactam

•    If you have ever had a severe allergic (hypersensitive) reaction to any other antibiotic. This can include a skin rash or swelling of the face or neck

Do not take Ampicillin / Sulbactam if any of the above applies to you. If you are not sure, talk to your doctor, pharmacist or nurse before having Ampicillin / Sulbactam.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking this medicine if you:

•    Have glandular fever

•    Are being treated for kidney problems

•    Are not passing water well

Talk to your doctor, pharmacist or nurse before taking Ampicillin / Sulbactam.

Conditions to look out for

Ampicillin / Sulbactam can make some existing conditions worse or cause serious side effects. These include allergic reactions, convulsions (fits) and inflammation of the intestine. You must look out for certain symptoms while taking Ampicillin / Sulbactam , to reduce the risk of any problems (see section 4).

Blood and urine test

If you are having blood test or urine tests for glucose let your doctor or nurse know that you are taking Ampicillin / Sulbactam. This is because Ampicillin / Sulbactam can affect the results of these types of tests.

Other medicines and Ampicillin / Sulbactam

Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines.

If medicines to help you stop blood clots (such as warfarin); are taken with Ampicillin / Sulbactam then extra blood tests may be needed.

Ampicillin / Sulbactam can affect how methotrexate (a medicine used to treat cancer or rheumatic diseases) works.

If you are taking allopurinol (used for gout), it may be more likely that you will have an allergic skin reaction.

If you are taking probenecid (used for gout); your doctor may decide to adjust your dose of Ampicillin / Sulbactam.

If you are taking oral contraceptives (the pill), the contraceptive effect may be reduced. You should use barrier contraceptives (such as a condom) additionally.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

No studies on the ability to drive and use machines under influence of ampicillin and sulbactam have been carried out.

However, due to side effects (see section 4) your reactivity may be decreased. Do not drive if you feel affected.

Ampicillin / Sulbactam 2 g/1 g contains sodium

This medicinal product contains 230 mg sodium per vial.

To be taken into consideration by patients on a controlled sodium diet.

3. HOW AMPICILLIN / SULBACTAM 2 G/1 G IS GIVEN

You will never give yourself this medicine. A qualified person, like a doctor or nurse, will give you this medicine.

The recommended dose for adults is 3 to 12 g Ampicillin / Sulbactam depending on the severity of the infection divided into equal single doses every 6 to 8 hours.

Newborns above the second living week, infants and children up to 2 years old:

The usual dose is 150 mg/kg/day (ampicillin 100 mg/kg/ day + sulbactam 50 mg/kg/day) Therapeutic dosage should be given in three or four equal dosages.

Newborns up to first week of life:

Recommended dosage is 75 mg/kg/day (ampicillin 50 mg/kg/day + sulbactam 25 mg/kg/day). Therapeutic dosage should be given in two equal dosages.

Use in the Elderly:

Ampicillin / Sulbactam injection may be administered in the elderly in the usual dosages with no special precautions.

More or less frequent administration of Ampicillin / Sulbactam 2 g/1 g may be indicated depending on the severity of disease.

Patients with kidney problems

If you have kidney problems you may be given a different dose. A different strength or a different medicine may be chosen by your doctor.

The recommended dose to stop infections during and after surgery is 1.5 to 3g Ampicillin / Sulbactam given just before surgery when you are given your anaesthetic.

How Ampicillin / Sulbactam will be given to you

• It will be given as an injection into a vein or muscle or by intravenous infusion Duration of use

The duration of treatment depends on the course of the illness. The duration of treatment is generally 5 to 14 days depending on the severity of infection. In severe cases, treatment may be continued for a prolonged period.

If you are given more Ampicillin / Sulbactam 2 g/1 g than you should

It is unlikely you will be given too much, but if you think you have been given too much Ampicillin / Sulbactam tell your doctor, pharmacist or nurse immediately. Signs may be an upset stomach (feeling sick, being sick or diarrhoea) or convulsions.

If you have any further questions about how this product is given, ask your doctor, pharmacist or nurse.

4. POSSIBLE SIDE EFFECTS

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

Conditions you need to look out for

Allergic reactions:

•    skin rash

•    inflammation of blood vessels (vasculitis) which may be visible as red or purple raised spots on the skin, but can affect other parts of the body

•    fever, joint pain, swollen glands in the neck, armpit or groin

•    swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing

•    collapse.

Contact a doctor immediately if you get any of these symptoms. Stop taking Ampicillin / Sulbactam .

Inflammation of large intestine

Inflammation of the large intestine, causing watery diarrhoea usually with blood and mucus, stomach pain and/or fever.

Contact your doctor as soon as possible for advice if you get these symptoms.

The possible side effects are listed according to the following categories:

”Very common” means "Common” means ”Uncommon” means "Rare” means "Very rare" means ”Not known" means


that the side effect occurs in 1 or more users in a group of 10 users.

that the side effect occurs in 1 to 10 of 100 users.

that the side effect occurs in 1 to 10 of 1,000 users.

that the side effect occurs in fewer than 1 of 1,000 users.

that the side effect occurs in fewer than 1 of 10,000 users.

that the frequency cannot be estimated from the available data.

Very common side effects:

• Pain at the injection site with the intramuscular route of administration.

Common side effects:

•    Pain at the injection site with the intravenous route of administration

•    inflammation of a vein after intravenous administration

•    Nausea

•    vomiting

•    mouth pain

•    dark tongue

•    abdominal pain

•    meteorism (presence of gas in the abdomen)

•    diarrhoea.

Uncommon side effects:

•    Skin

•    Rashes

•    itch

•    dermatitis and other non-specific skin reactions

•    weakness

•    sleepiness

•    dizziness

•    headache

•    cramps

Rare side effects:

•    Kidney inflammation (interstitial nephritis)

•    presence of crystals in the urine

Very rare side effects:

•    Alteration of red blood cells (anaemia)

•    alteration of the number of white blood cells

•    lowering of blood platelets with alteration of coagulation mechanism

•    increasing of the creatinphosphokinase (CPK)

•    liver disorders

•    abnormal liver function tests (transaminasis, azotaemie and creatinine increase)

•    jaundice

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet.

5. HOW TO STORE AMPICILLIN / SULBACTAM 2 G/1 G

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 the label after “EXP”. The expiry date refers to the last day of the month.

Storage conditions

Unopened vial:

Do not store above 25°C.

Reconstituted /Diluted solution:

The solution for intramuscular or intravenous injection must be used immediately after reconstitution.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION What Ampicillin / Sulbactam 2 g/1 g contains

- The active substances are sulbactam sodium and ampicillin sodium.

Each vial with 3220 mg powder contains 1094 mg sulbactam sodium, equivalent to 1 g sulbactam, and 2126 mg ampicillin sodium, equivalent to 2 g ampicillin.

There are no other ingredients.

What Ampicillin / Sulbactam 2 g/1 g looks like and contents of the pack

Ampicillin / Sulbactam 2 g/1 g is a white to off-white powder for solution for injection or infusion in a vial of clear, colourless glass.

Hospital pack with 1 vial with 3220 mg powder.

Marketing Authorization Holder

Mylan Potters Bar Hertfordshire EN6 1TL United Kingdom

Manufacturer

Agila Specialties Polska Sp. z o.o.

10, Daniszewska Str,

03-230 Warsaw,

Poland

This leaflet was last revised in 02/2015

The following information is intended for healthcare professionals only.

Shelf life

Unopened vial 2 years.

After opening

The content of the vial should be used immediately after the first breakage of vial. Reconstituted/Diluted solution

The solution for intramuscular or intravenous injection/infusion should be used immediately.

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.

Instructions for reconstitution and dilution

If an injection or infusion solution is to be prepared, this should be performed by trained healthcare personnel under aseptic conditions in a designated aseptic area.

Intramuscular injection

Dissolve the contents of one vial of Ampicillin / Sulbactam 2 g/1 g in 6.4 ml water for injections. To prevent pain during the injection, the solution can be prepared using 5 mg/ml (0.5%) lidocaine hydrochloride solution.

Intravenous injection

For intravenous injection, the contents of one vial of Ampicillin / Sulbactam 2 g/1 g can be prepared with at least 6.4 ml of water for injections and injected intravenously over at least 3 minutes after the substance has completely dissolved.

Short intravenous infusion

As for the intravenous injection, dissolve the contents of one vial of Ampicillin / Sulbactam 2 g/1 g in water for injections and then dilute further with 100 ml of one of the following infusion solutions: 9mg/ml (0,9%) Sodium Chloride Injection, 50mg/ml (5%) Glucose Injection, Lactated Ringer’s Solution, 50mg/ml (5%) Glucose in 0.45% NaCl, 100mg/ml (10%) Invert Sugar. Infuse the finished solution intravenously over 15 to 30 minutes.

The reconstitution/dilution is to be made under aseptic conditions. The solution is to be inspected visually for particulate matter and discoloration prior to administration. The solution should only be used if the solution is clear and free form particles.

For single use only. Discard any unused solution.