Piperacillin/Tazobaktam Aurobindo

Document: Piperacillin_Tazobaktam Aurobindo powder for solution for infusion ENG PL change

Package leaflet: Information for the user

Piperacillin/Tazobaktam Aurobindo 2 g / 0.25 g powder for solution for infusion

Piperacillin/Tazobaktam Aurobindo 4 g / 0.5 g powder for solution for infusion

(Piperacillin/Tazobactam)

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. 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Piperacillin/Tazobaktam Aurobindo is and what it is used for

2. What you need to know before you take Piperacillin/Tazobaktam Aurobindo

3. How to take Piperacillin/Tazobaktam Aurobindo

4. Possible side effects

5. How to store Piperacillin/Tazobaktam Aurobindo

6. Contents of the pack and other information

1. What Piperacillin/Tazobaktam Aurobindo is and what it is used for

Piperacillin belongs to the group of medicines known as “broad spectrum penicillin antibiotics”. It can kill many kinds of bacteria. Tazobactam can prevent some resistant bacteria from surviving the effects of piperacillin. This means that when piperacillin and tazobactam are given together, more types of bacteria are killed.

Piperacillin/Tazobaktam Aurobindo is used in adults and adolescents to treat bacterial infections, such as those affecting the lower respiratory tract (lungs), urinary tract (kidneys and bladder), abdomen, skin or blood. Piperacillin/Tazobaktam Aurobindo may be used to treat bacterial infections in patients with low white blood cell counts (reduced resistance to infections).

Piperacillin/Tazobaktam Aurobindo 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/Tazobaktam Aurobindo 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/Tazobaktam Aurobindo in combination with other antibiotics.

2. What you need to know before you take Piperacillin/Tazobaktam Aurobindo

Do not use Piperacillin/Tazobaktam Aurobindo

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

- if you are allergic (hypersensitive) to antibiotics known as penicillins, cephalosporins or other beta-lactamase inhibitors, as you may be allergic to Piperacillin/Tazobaktam Aurobindo.

Warnings and precautions

if you have allergies. If you have several allergies make sure you tell your doctor or other healthcare professional before 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 Other medicines and Piperacillin/Tazobaktam Aurobindo 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/Tazobaktam Aurobindo

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:

Medicines for gout (Probenecid). This can increase the time it takes for piperacillin and tazobactam to leave your body.
Medicines to thin your blood or to treat blood clots (e.g. heparin, warfarin or aspirin).
Medicines used to relax your muscles during surgery. Tell your doctor if you are going to have a general anaesthetic.
Methotrexate (medicine used to treat cancer, arthritis or psoriasis). Piperacillin and tazobactam can increase the time it takes for methotrexate to leave your body.
Medicines that reduce the level of potassium in your blood (e.g. tabletsenhancing urination or 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/Tazobaktam Aurobindo if you have to provide a blood or urine sample.

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 other healthcare professional before receiving this medicine. Your doctor will decide if Piperacillin/Tazobaktam Aurobindo is right for you.

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

Driving and using machines

The use of Piperacillin/Tazobaktam Aurobindo is not expected to affect the ability to drive or use machines.

Piperacillin/Tazobaktam Aurobindo contains sodium

Piperacillin/Tazobaktam Aurobindo 2g/0.25g

This medicinal product contains 4.7 mmol (or 108 mg) of sodium per vial of powder for solution for infusion.

This should be taken into consideration if you are on a controlled sodium diet.

Piperacillin/Tazobaktam Aurobindo 4g/0.5g

This medicinal product contains 9.4 mmol (or 216 mg) of sodium per vial of powder for solution for infusion.

This should be taken into consideration if you are on a controlled sodium diet.

3. How to take Piperacillin/Tazobaktam Aurobindo

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 adolescents aged 12 years or older

The recommended dose is 4 g / 0.5 g of piperacillin / 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 recommended 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 weight but the daily dose will not exceed 4 g / 0.5 g of Piperacillin/Tazobaktam Aurobindo.

You will be given Piperacillin/Tazobaktam Aurobindo until the sign of infection has gone completely (5 to 14 days).

Patients with kidney problems

Your doctor may need to reduce the dose of Piperacillin/Tazobaktam Aurobindo 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 take more Piperacillin/Tazobaktam Aurobindo than you should

As you will receive Piperacillin/Tazobaktam Aurobindo from a 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/Tazobaktam Aurobindo

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

The serious side effects of Piperacillin/Tazobaktam Aurobindo are:

serious skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) appearing initially as

reddish target-like spots or circular patches often with central blisters on the trunk. Additional signs

include ulcers in the mouth, throat, nose, extremities, genitals and conjunctivitis (red and swollen eyes).

The rash may progress to widespread blistering or peeling of the skin and potentially may be life

threatening

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)
severe or persistent diarrhoea accompanied by a fever or weakness
unexpected bleeding, particularly if you are taking anticoagulants such as warfarin.

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

Commonside effects(may affect up to 1 in 10 people)

diarrhoea, vomiting, nausea
skin rashes

Uncommonside effects(may affect up to 1 in 100 people)

thrush
(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 (yellowing 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)

Rareside effects(may affect up to 1 in 1,000 people) are:

(abnormal) decrease of red blood cells or blood pigment / haemoglobin, (abnormal) decrease of red blood cells due to premature breakdown (degradation) (haemolytic anaemia), small spot bruising (purpura), bleeding of the nose (epistaxis) and bleeding time prolonged, (abnormal) increase of a specific type of white blood cells (eosinophilia)
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):

severe decrease of granular white blood cells (agranulocytosis), severe decrease of red blood cells, white blood cells and platelets (pancytopenia)
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 [To be completed nationally]. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Piperacillin/Tazobaktam Aurobindo

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 vials after EXP. The expiry date refers to the last day of that month.

Powder:

Store in the original package in order to protect from light.

Store below 25⁰C.

For single use only.

Discard any unused solution.

Reconstituted and/or diluted Piperacillin/Tazobactam Aurobindo should be used immediately.

From a microbiological point of view, the product should be used immediately.

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 to protect the environment.

6. Contents of the pack and other information

What Piperacillin/Tazobaktam Aurobindo contains

The active substances are piperacillin and tazobactam.

Each vial contains piperacillin sodium corresponding to 2 g piperacillin and tazobactam sodium corresponding to 0.25 g tazobactam.

Eachvial contains piperacillin sodium corresponding to 4 g piperacillin and tazobactam sodium corresponding to 0.5 g tazobactam.

There are no other ingredients.

What Piperacillin/Tazobaktam Aurobindo lookslike and contents of the pack

Powder for solution for infusion

White to off-white powder.

Piperacillin/Tazobaktam Aurobindo is supplied in packs of 1, 10 and 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 revised in 2015-09-24

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

Piperacillin/Tazobaktam Aurobindo 2 g/0.25 g

Piperacillin/Tazobaktam Aurobindo4 g/0.5 g

powder for solution for infusion

This is an extract from the Summary of Product Characteristics to assist in the administration of Piperacillin/Tazobaktam Aurobindo. When determining appropriateness of use in a particular patient, the prescriber should be familiar with the SPC.

For slow intravenous infusion.

Incompatibilities with diluents and other medicinal products

LACTATED RINGER’S (HARTMAN’S) SOLUTION IS NOT COMPATIBLE WITH PIPERACILLIN / TAZOBACTAM AUROBINDO.
WHEN USED CONCURENTLY WITH ANOTHER ANTIBIOTICS [E.G. AMINIGLYCOSIDES], PIPERACILLIN/TAZOBAKTAM AUROBINDO BE ADMINISTERED SEPARATELY. MIXING OF PIPERACILLIN/TAZOBAKTAM AUROBINDO WITH AN AMINOGLYCOSIDE IN VITRO CAN CAUSE INACTIVATION OF THE AMINOGLYCOSIDE.
PIPERACILLIN/TAZOBAKTAM AUROBINDO SHOULD NOT BE MIXED WITH OTHER DRUGS IN A SYRINGE OR INFUSION BOTTLE SINCE COMPATIBILITY HAS NOT BEEN ESTABLISHED.
DUE TO CHEMICAL INSTABILITY, PIPERACILLIN/TAZOBAKTAM AUROBINDO SHOULD NOT BE USED IN SOLUTION THAT CONTAIN SODIUM BICARBONATE.
PIPERACILLIN/TAZOBAKTAM AUROBINDO SHOULD NOT BE ADDED TO BLOOD PRODUCTS OR ALBUMIN HYDROLYSATES.

Instructions for use and handling and disposal

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 from particles.

For single use only. Discard any unused solution.

Any unused medicinal product or waste material should be discarded in accordance with local requirements.

Sterile diluents for preparation of the reconstituted solution:

• Sterile Water for Injection

• 9 mg/ml (0.9%) Sodium Chloride for Injection

• Dextrose 50 mg/ml (5%) in water

• Dextrose 50 mg/ml (5%) in sodium chloride 9 mg/ml (0.9%) solution

Dilution directions (for intravenous infusion)

Each vial Piperacillin/Tazobaktam Aurobindo 2 g/0.25 g should be reconstituted with 10 ml of the above diluents.

Each vial Piperacillin/Tazobaktam Aurobindo 4 g/0.5 g should be reconstituted with 20 ml of the above diluents.

Swirl until dissolved.

The reconstituted solution should be further diluted to a total volume of 50 ml to 100 ml with one of the reconstitution diluents or with dextran 60 mg/ml (6%) in sodium chloride 9 mg/ml (0.9%) solution.

Intravenous infusion should be given over 20-30 minutes.

SPECIAL PRECAUTIONS FOR STORAGE

Store in the original package in order to protect from light

Store below 25⁰C.

Reconstituted and/or diluted Piperacillin/Tazobactam Aurobindo should be used immediately.

From a microbiological point of view, once opened, the product should be used immediately.