Document: Piperacillin_Tazobactam Actavis powd f solu f inf ENG PL change

• Piperacillin_Tazobactam Actavis powder for solution for injection PL
• Piperacillin_Tazobactam Actavis powd f solu f inf ENG PL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Piperacillin/Tazobactam Actavis 2 g / 0.25 g powder for solution for infusion

Piperacillin/Tazobactam Actavis 4 g / 0.5 g powder for solution for infusion

piperacillin / tazobactam

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

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

- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if

their signs of illnessare the same as yours.

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Piperacillin/Tazobactam Actavis is and what it is used for

2. What you need to know before you use Piperacillin/Tazobactam Actavis

3. How to use Piperacillin/Tazobactam Actavis

4. Possible side effects

6. Contents of the pack and other information

1. What Piperacillin/Tazobactam Actavis is and what it is used for

Piperacillin belongs to the group of medicines known as “broad-spectrum penicillin antibiotics”. Itcan kill many kindsof bacteria. Tazobactam can preventsome resistant bacteria from survivingthe effects of piperacillin. This means that whenpiperacillin and tazobactam are given together, more types of bacteria are killed.

Piperacillin/Tazobactam Actavis is used in adults and adolescents to treat bacterial infections, such as thoseaffecting the lower respiratory tract (lungs),urinary tract (kidneys and bladder), abdomen,skinor blood. Piperacillin/Tazobactam Actavis may be used to treat bacterial infections in patientswith low white blood cell counts (reduced resistance to infections).

Piperacillin/Tazobactam Actavis is used in children aged 2-12 years to treat infections of the abdomen such as appendicitis, peritonitis (infection of the fluid and lining of the abdominal organs), and gallbladder (biliary) infections. Piperacillin/Tazobactam Actavis may be used to treat bacterial infections in patients with low white blood cell counts (reduced resistance to infections).

In certain serious infections, your doctor may consider using Piperacillin/Tazobactam Actavis in combination with other antibiotics.

2. What you need to know before you use Piperacillin/Tazobactam Actavis

Do not use Piperacillin/Tazobactam Actavis

- if you are allergic to piperacillinor tazobactam or any of the other ingredients of this medicine (listed in section 6).

- if you are allergic toantibiotics known aspenicillins,cephalosporins or other beta-lactamase inhibitors, as you may be allergic to Piperacillin/Tazobactam Actavis.

Take special care with Piperacillin/Tazobactam Actavis

- if you have allergies. If you have several allergies,make sure you tell your doctor or other healthcare professionalbefore receiving this product.

- if you are suffering from diarrhoea before, or if you develop diarrhoea during or after your treatment. In this case, make sure you tell your doctor or other healthcare professional immediately. Do not take any medicine for the diarrhoea without first checking with your doctor.

- if you have low levels of potassium in your blood. Your doctor may want to check your kidneys before you take this medicine and may perform regular blood tests during treatment.

- if you have kidney or liver problems, or are receiving haemodialysis. Your doctor may want to check your kidneys before you take this medicine, and may perform regular blood tests during treatment.

- if you are taking certain medicines (called anticoagulants) to avoid an excess of blood clotting (see also Using other medicines in this leaflet) or any unexpected bleeding occurs during the treatment. In this case, you should inform your doctor or other healthcare professional immediately.

- if you develop convulsions during the treatment. In this case, you should inform your doctor or other healthcare professional.

- if you think you developed a new or worsening infection. In this case, you should inform your doctor or other healthcare professional.

Children below 2 years

Piperacillin / tazobactam is not recommended for use in children below the age of 2 years due to insufficient data on safety and effectiveness.

Other medicines and Piperacillin/Tazobactam Actavis

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Some medicines may interact with piperacillin and tazobactam.

These include:

- medicinesto thin your blood or to treat blood clots (e.g. heparin, warfarin or aspirin).

- medicinesused to relax your muscles during surgery. Tell your doctor if you are going to have a

general anaesthetic.

- methotrexate (medicine used to treatcancer, arthritis or psoriasis). Piperacillin and tazobactam can

increase the time it takes for methotrexate to leave your body.

- medicinesthat reduce the level of potassium in your blood (e.g. tabletsenhancing urinationor some

medicines for cancer).

- medicines containing the other antibiotics tobramycin or gentamycin. Tell your doctor if you have

kidney problems.

Effect on laboratory tests

Tell the doctor or laboratory staff that you are taking Piperacillin/Tazobactam Actavis if you have to provide a blood or urine sample.

Pregnancy and breast-feeding

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.

Piperacillin and tazobactamcan pass to a baby in the womb or through breast milk. If you are breast-feeding, your doctor will decide if Piperacillin/Tazobactam Actavisis right for you.

Driving and using machines

The use of Piperacillin/Tazobactam Actavis is not expected to affectthe ability to drive or use machines.

Important information about some of the ingredients of Piperacillin/Tazobactam Actavis

Piperacillin/Tazobactam Actavis 2 g / 0.25 gcontains 4.7 mmol (or 108 mg) of sodium.

Piperacillin/Tazobactam Actavis 4 g / 0.5 gcontains 9.4 mmol (or 216 mg) of sodium.

This shouldbe taken into consideration if you areon a controlled-sodium diet.

3. How to use Piperacillin/Tazobactam Actavis

Your doctor or other healthcare professionalwill give you this medicine through an infusion (a drip for 30 minutes) into one of your veins. The dose of medicine given to you depends on what you are being treated for, your age, and whether or not you have kidney problems.

Adults and adolescentsaged 12years or older

The usual dose is 4 g / 0.5 g ofpiperacillin/ tazobactam given every 6-8 hours, which is given into one of your veins(directly into the blood stream).

Children aged 2 to 12 years

The usual dose for children with abdominal infections is 100 mg / 12.5 mg / kg of body weight of piperacillin / tazobactam given every 8 hours into one of your veins (directly into the blood stream). The usual dose for children with low white blood cell counts is 80 mg / 10 mg / kg of body weight of piperacillin / tazobactam given every 6 hours into one of your veins (directly into the blood stream).

Your doctor will calculate the dose depending on your child’s weightbut the daily dose will not exceed 4 g / 0.5 g of Piperacillin/Tazobactam Actavis.

You will be given Piperacillin/Tazobactam Actavis until the sign ofinfection has gone completely(5 to 14 days).

Patients withkidney problems

Your doctor may need to reduce the dose of Piperacillin/Tazobactam Actavis or how often you are given it. Your doctor may also want to test your blood to make sure that your treatment is at the right dose, especially if you have to take this medicine for a long time.

If you receivemore Piperacillin/Tazobactam Actavis than you should

As you will receive Piperacillin/Tazobactam Actavis froma doctor or other healthcare professional, you are unlikely to be given the wrong dose. However, if you experience side effects, such as convulsions,or think you have been given too much, tell your doctor immediately.

If you miss a dose of Piperacillin/Tazobactam Actavis

If you think you have not been given a dose of Piperacillin/Tazobactam Actavis,tell your doctor or other healthcare professional immediately.

If you have any further questions on the use of this product, ask your doctor or other healthcare professional.

4. Possible side effects

Like all medicines, Piperacillin/Tazobactam Actaviscan cause side effects, although not everybody gets them.

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 other healthcare professional.

The serious side effects of Piperacillin/Tazobactam Actavis are:

- swelling of the face, lips, tongue or other parts of the body

- shortness of breath, wheezing or trouble breathing

- severe rash, itching or hives on the skin

- yellowing of the eyes or skin

- damage to blood cells (the signs include: being breathless when you do not expect it, red or brown urine, nosebleeds and bruising)

If you notice any of the above, see a doctor straight away. For frequency of these reactions, refer to the information below.

Common side effects (may affect up to 1 in 10 people):

- skin rashes

Uncommon side effects (may affect up to 1 in 100 people):

- (abnormal) decrease in white blood cells (leukopenia, neutropenia) and platelets

(thrombocytopenia)

- allergic reaction

- headache, sleeplessness

- low blood pressure, inflammation of the veins (felt as tenderness or redness in the affected area)

- jaundice (yellow staining of the skin or whites of the eyes), inflammation of the mucous lining of the mouth, constipation, indigestion, stomach upset

- increase of certain enzymes in the blood (alanine aminotransferase increased, aspartate aminotransferase increased)

- itching, nettle rash

- increase of muscle metabolism product in the blood (blood creatinine increased)

- fever, injection site reaction

- yeast infection (candidal superinfection)

Rare side effects (may affect up to 1 in 1,000 people) :

- severe allergic reaction (anaphylactic/anaphylactoid reaction, including shock)

- flushed red skin

- a certain form of infection of the colon (pseudomembranous colitis), abdominal pain

- inflammation of the liver (hepatitis), increase of a blood pigments breakdown product (bilirubin), increase of certain enzymes in the blood (blood alkaline phosphatase increased, gamma-glutamyltransferase increased)

- skin reactions with redness and formation of skin lesions (exanthema, erythema multiforme), skin reactions with blistering (bullous dermatitis)

- joint and muscle pain

- poor kidney functions and kidney problems

- rigors chill / rigidity

Very rare side effects (may affect up to 1 in 10,000 people):

- prolonged time for blood clot formation (prolonged partial thromboplastin time, prothrombin time prolonged), abnormal lab test (positive direct Coombs), increase of platelets (thrombocythaemia)

- decrease of potassium in the blood (hypokalaemia), decrease of blood sugar (glucose), decrease of the blood protein albumin, decrease of blood total protein

- detachment of the top layer of the skin all over the body (toxic epidermal necrolysis), serious bodywide allergic reaction with skin and mucous lining rashes and various skin eruptions (Stevens-Johnson Syndrome)

- blood urea nitrogen increased

Piperacillin therapy has been associated with an increased incidence of fever and rash in cystic fibrosis patients.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Piperacillin/Tazobactam Actavis

Keep out of the reach and sight of children.

Do not use Piperacillin/Tazobactam Actavisafter the expiry date which is stated on the carton and vialafter “EXP”.The expiry date refers to the last day of that month.

Unopened vials: Store in the original package in order to protect from light.Store below 25⁰C.

For single use only.Discard any unused solution.

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

6. Contents of the pack and other information

What Piperacillin/Tazobactam Actavis contains

Each vial contains 2 g piperacillin (as sodium salt) and 0.25 g tazobactam(as sodium salt).

Each vial contains 4 g piperacillin(assodium salt)and 0.5 g tazobactam(assodium salt).

What Piperacillin/Tazobactam Actavis looks like and contents of the pack

Powder for solution for infusion

White to off-white powder.

Piperacillin/Tazobactam Actavis is supplied in packs of 1 or 12 vials and enclosed in a carton with a package leaflet.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

[To be completed nationally]

Manufacturer

[To be completed nationally]

This leaflet was last approved in 10 October 2014

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The following information is intended for medical or healthcare professionals only:

Instructions for use

Piperacillin/Tazobactam Actavis will be given by intravenous infusion (a drip for 30 minutes).

Intravenous use

Reconstitute each vial with the volume of solvent shown in the table below, using one of the compatible solvents for reconstitution. Swirl until dissolved.

Content of vial	Volume of solvent* to be added to vial
2 g / 0.25 g (2 g piperacillin and 0.25 g tacobactam)	10 ml
4 g / 0.50 g (4 g piperacillin and 0.5 g tacobactam)	20 ml

*Compatible solvents for reconstitution:

- Sterile water for injections

- Glucose 5%

- Glucose 5% in sodium chloride 0.9% (9 mg/ml) solution

The reconstituted solutions may be further diluted to the desired volume (e.g. 50 ml to 150 ml) with one of the following compatible solvents:

- Sterile water for injections

- Glucose 5%

- Glucose 5% in sodium chloride 0.9% (9 mg/ml) solution

- Dextran 6% in 0.9% sodium chloride

Incompatibilities

Whenever Piperacillin/Tazobactam Actavis is used concurrently with another antibiotic (e.g. aminoglycosides), the substances must be administered separately. The mixing of beta-lactam antibiotics with aminoglycosides, in vitro, can result in substantial inactivation of the aminoglycoside.

Piperacillin/Tazobactam Actavis should not be mixed with other substancesin a syringe or infusion bottle since compatibility has not been established.

Lactated Ringer’s (Hartmann´s) solution is not compatible with piperacillin/tazobactam.

Because of chemical instability, Piperacillin/Tazobactam Actavis should not be used with solutions containing sodium bicarbonate.

Piperacillin/Tazobactam Actavis should not be added to blood products or albumin hydrolysates.