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Ampicillin 2 G Powder For Solution For Injection/Infusion

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Package Leaflet: Information for the user

Ampicillin 250 mg powder for solution for injection/infusion Ampicillin 500 mg powder for solution for injection/infusion Ampicillin 1 g powder for solution for injection/infusion Ampicillin 2 g powder for solution for injection/infusion

Ampicillin sodium

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, pharmacist or nurse.

- 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._

What is in this leaflet:

1. What Ampicillin powder for solution for injection/infusion is and what it is used for

2. What you need to know before you take Ampicillin powder for solution for inj ection/infusion

3. How to take Ampicillin powder for solution for inj ection/infusion

4. Possible side effects

5. How to store Ampicillin powder for solution for injection/infusion

6. Contents of the pack and other information

1. WHAT AMPICILLIN POWDER FOR SOLUTION FOR INJECTION/INFUSION IS AND WHAT IT IS USED FOR

Ampicillin powder for solution for injection/infusion is a medicine for the treatment of bacterial infections (antibiotic), and works by killing bacteria that cause infections. It contains ampicillin.

Ampicillin belongs to a group of medicines called ‘penicillins’.

Ampicillin powder for solution for injection/infusion is used to treat the following:

• complicated acute bacterial sinusitis

• meningitis caused by listeria

• infection of the heart

• kidney infections

• genital organ infections

• intra-abdominal infections

• urinary bladder infection

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMPICILLIN POWDER FOR SOLUTION FOR INJECTION/INFUSION

Do not take Ampicillin powder for solution for injection/infusion

- if you are allergic to ampicillin or other penicillins, or any of the other ingredients of this medicine (listed in section 6), because of the risk of allergic shock.

- 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.

- If you have ever had j aundice or liver failure due to ampicillin.

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Ampicillin powder for solution for injection/infusion if you:

- Have glandular fever, cytomegalovirus infection or Lymphoid leukaemia

- Are being treated for kidney problems

- Are not passing water well

If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before taking Ampicillin

Conditions to look out for

Ampicillin powder for solution for injection/infusion 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 powder for solution for injection/infusion, 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 powder for solution for injection/infusion. This is because Ampicillin powder for solution for injection/infusion can affect the results of these types of tests.

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 effects on the ability to drive and use machines have been performed. However, undesirable effects may occur (e.g. allergic reactions, dizziness, convulsions), which may influence the ability to drive and use machines.

Ampicillin powder for solution for injection/infusion contains sodium

10 ml of the reconstituted 10 % solution contains 2.86 mmol (65.8 mg) sodium. Please remember this fact if you have to maintain a low salt diet.

3. HOW TO TAKE AMPICILLIN POWDER FOR SOLUTION FOR INJECTION/INFUSION

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

Adults and adolescents

500mg every 4 to 6 hours (the daily dose can be rised up to 6 g in case of severe infection)

Intravenous injection or infusion Child 1 month - 12 years

25-50mg/kg (max 1g) every 6 hours (the dose can be doubled in case of severe infection)

Neonate 21 - 28days

30mg/kg every 6 hours (the dose can be doubled in case of severe infection)

Neonate 7 - 21 days

30mg/kg every 8 hours (the dose can be doubled in case of severe infection)

Neonate under 7 days

30mg/kg every 12 hours (the dose can be doubled in case of severe infection)

Dosage for impaired kidney function

No dose adjustment is required in patients with creatinine clearance (CrCl) greater than 30 ml/min.

For severely impaired renal function with a glomerular filtration rate of 30 ml/min and less, a reduction in the dose (administered amount) is recommended, since an accumulation of ampicillin is to be expected:

- at a creatinine clearance of 20 to 30 ml/min, the normal dose should be reduced to %,

- at a creatinine clearance below 20 ml/min, the normal dose should be reduced to A

As a general rule, a dose of 1 g ampicillin in 8 hours should not be exceeded in patients with severe renal insufficiency.

How Ampicillin powder for solution for injection/infusion will be given to you

It will be given as an injection into a vein, or by intravenous infusion, or into your muscle.

Duration of use

The duration of use depends on the course of the disease. As a general rule, ampicillin is used for 7 to 10 days, but for at least another 2 to 3 days after the signs of disease have subsided.

If you take more Ampicillin powder for solution for injection/infusion than you should,

It is unlikely you will be given too much, but if you think you have been given too much Ampicillin powder for solution for injection/infusion 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 on the use of this medicine, ask your doctor, pharmacist or nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them. Possible side effects are listed in the order of their frequency below:

very common	Affects more than 1 user in 10
common	Affects 1 to 10 users in 100
uncommon	Affects 1 to 10 users in 1000
rare	Affects 1 to 10 users in 10000
very rare	Affects less than 1 user in 10000

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 powder for solution for injection/infusion

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.

Very common side effects

- Skin reactions: itching, rash, skin rash (exanthema)

- Abdominal pain

- Feeling sick (nausea)

- Vomiting

- Flatulence (meteorism)

- Soft stools

- Diarrhoea

Common side effects

- Measles-like rash (develops several days (5 to 11) after the start of the treatment).

- Skin rash (exanthema) and mucous surface eruptions (enanthema) in the region of the mouth.

- Swelling and pain at the inj ection site after intramuscular injection.

- Swelling and redness along a vein which is extremely tender when touched (localised phlebitis - after intravenous injection).

Uncommon side effects

- Infection with fungi or resistant bacteria especially during prolonged and/or repeated use, such as thrush (candida - a yeast infection of the vagina, mouth or skin folds).

- Allergic reactions such as:

o Fever and lymph node swellings (serum sickness). o Drug fever.

o Rapid skin and tissue swellings, especially of the face (angioneurotic oedema). o Swelling of the throat (laryngeal oedema). o Low number of red blood cells (haemolytic anaemia). o Inflammation of the blood vessels of the skin (allergic vasculitis). o Kidney inflammation (allergic nephritis).

- Severe allergic, sometimes blistering skin reactions such as:

o Widespread red skin rash with small pus-containing blisters (exfoliative dermatitis). o Life-threatening disease with formation of blisters on the skin (Lyell’s syndrome).

o Skin rash, which may blister, and looks like small targets (central dark spots

surrounded by a paler area, with a dark ring around the edge (exudative erythema multiforme).

o A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form, causing extensive peeling of the skin (more than 30% of the body surface (toxic epidermal necrolysis).

- Increase in certain enzymes produced by the liver (transaminases)

- Crystals in your urine (crystalluria)

- Acute inflammation of the kidney (acute interstitial nephritis)

Rare side effects

- Dizziness

- Headache

- Sudden, abrupt, brief, involuntary, jerk-like contractions of a muscle or muscle group (myoclonus) and seizures (in renal insufficiency or at very high intravenous doses)

Very rare side effects

- Stopping of bone marrow activity (myelosuppression) and changes in the number of blood cells (granulocytopenia, thrombocytopenia, anaemia, pancytopenia).

- Prolongation of bleeding and clotting (prothrombin) time.

- Life-threatening anaphylactic shock.

- Inflammation of the large intestine (Pseudomembranous colitis) - see above.

- Acute renal failure with excretion of urine crystals.

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 POWDER FOR SOLUTION FOR INJECTION/INFUSION

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 Do not store above 25 °C.

Use only freshly prepared solutions.

Reconstituted/diluted solution should be used immediately.

Do not use this medicine if you notice the following: solutions with cloudiness and precipitations

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.

What Ampicillin powder for solution for injection/infusion contains

- The active ingredient is ampicillin (as ampicillin sodium).

- There are no other ingredients.

Ampicillin 250 mg powder for solution for injection/infusion:

One vial contains 266 mg of ampicillin sodium (equivalent to 250 mg of ampicillin).

Ampicillin 500 mg powder for solution for injection/infusion:

One vial contains 531 mg of ampicillin sodium (equivalent to 500 mg of ampicillin).

Ampicillin 1 g powder for solution for injection/infusion:

One vial contains 1063 mg of ampicillin sodium (equivalent to 1000 mg of ampicillin). Ampicillin 2 g powder for solution for injection/infusion:

One vial contains 2126 mg of ampicillin sodium (equivalent to 2000 mg of ampicillin).

What Ampicillin powder for solution for injection/infusion looks like and contents of the pack

White to off white crystalline powder

Ampicillin 250 mg powder for solution for injection/infusion:

Pack with 1 glass vial with dark grey bromobutyl rubber stopper and light yellow flip off aluminium seal containing 266 mg powder for solution for injection/infusion.

Ampicillin 500 mg powder for solution for injection/infusion:

Pack with 1 glass vial with dark grey bromobutyl rubber stopper and blue flip off aluminium seal containing 531 mg powder for solution for injection/infusion.

Ampicillin 1 g powder for solution for injection/infusion:

Pack with 1 glass vial with dark grey bromobutyl rubber stopper and green flip off aluminium seal containing 1063 mg powder for solution for injection/infusion.

Ampicillin 2 g powder for solution for injection/infusion:

Pack with 1 glass vial with dark grey bromobutyl rubber stopper and brown flip off aluminium seal containing 2126 mg powder for solution for injection/infusion.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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:

Preparation of the injection solution:

Ampicillin 250 mg powder for solution for injection/infusion

The 10 % injection/infusion solution is prepared by dissolving 0,26 g powder in 2,5 ml water for injections.

Ampicillin 500mg powder for solution for injection/infusion

The 10 % injection/infusion solution is prepared by dissolving 0.53 g powder in 5 ml water for injections.

Ampicillin 1 g powder for solution for injection/infusion

The 10 % injection/infusion solution is prepared by dissolving 1.06 g powder in 10 ml water for injections.

Ampicillin 2 g powder for solution for injection/infusion

The 10 % injection/infusion solution is prepared by dissolving 2.12 g powder in 20 ml water for injections.

The solutions should always be prepared freshly before use and checked for clarity.

Use only clear solutions for injection or infusion! Do not use solutions with cloudiness or precipitation.

Compatibility

Ampicillin solutions should always be administered separately, unless the compatibility with other infusion solutions or medicines has been established.

Ampicillin solutions are compatible with 0.9% (9 mg/ml) sodium chloride solution, 5% (50mg/ml) glucose solution and Ringer solution.

Ampicillin solutions should not be mixed with aminoglycosides, metronidazole and injectable tetracycline derivatives such as oxytetracycline, rolitetracycline and doxycycline. Visual signs of incompatibility are precipitation, clouding and discolouration.

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