Piperacillin/Tazobactam 4g/0.5g Powder For Solution For Injection Or Infusion
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PACKAGE LEAFLET:
INFORMATION FOR THE USER
Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion
Read all of this leaflet carefully before you start using this medicine.
• 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 symptoms are the same as yours.
• 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.
In this leaflet:
1. What Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion is and what it is used for
2. Before you use Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion.
3. How to use Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion
4. Possible side effects
5. How to store Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion
6. Further information
1. What Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion 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/Tazobactam 4 g/0.5 g powder for solution for infusion 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/Tazobactam 4 g/0.5 g powder for solution for infusion may be used to treat bacterial infections in patients with low white blood cell counts (reduced resistance to infections).
Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion 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 4 g/0.5 g powder for solution for infusion 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 4 g/0.5 g powder for solution for infusion in combination with other antibiotics.
2. Before you use Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion
Do not use Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion
• if you are allergic (hypersensitive) to piperacillin or tazobactam.
• if you are allergic (hypersensitive) to antibiotics known as penicillins, cephalosporins or other beta-lactamase inhibitors, as you may be allergic to Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion.
Take special care with Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion
• 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 prevent blood clots (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 (fits) 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.
Using other medicines
Please tell your doctor or other healthcare professional if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Some medicines may interact with piperacillin and tazobactam.
These include:
• medicines for gout (e.g. 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. diuretics - medicines that increase the amount of urine you produce or some medicines for cancer).
• medicines containing the other antibiotics tobramycin or gentamicin. This is particularly important if you have kidney problems. Tell your doctor if this applies to you.
Effect on laboratory tests
Tell the doctor or laboratory staff that you are taking Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion if you have to provide a blood or urine sample.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are trying to become pregnant, tell your doctor or other healthcare professional before receiving this product. Your doctor will decide if Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion 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/Tazobactam 4 g/0.5 g powder for solution for infusion is right for you.
Driving and using machines
The use of Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion is not expected to affect the ability to drive or use machines.
Important information about some of the ingredients of Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion
Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion contains 9.44 mmol (217 mg) of sodium.
This should be taken into consideration if you are on a controlled-sodium diet.
3. How to use Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion
Your doctor or other healthcare professional will 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 usual dose is 4 g/0.5 g 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 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).
The following information is intended for medical or healthcare professionals only:
Instructions for use
Piperacillin/tazobactam 4 g/0.5 g is administered by intravenous infusion (over 30 minutes).
Intravenous use
Each vial of Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion should be reconstituted with 20 ml of one of the following diluents:
• Sterile Water for Injection
• 9 mg/ml (0.9%) Sodium Chloride for Injection
Swirl until dissolved.
The reconstituted solution should be further diluted to at least 50 ml with one of the reconstitution diluents, or with Dextrose 5% in Water.
This medicinal product must not be mixed with other medicinal products except those mentioned in above.
Whenever piperacillin/tazobactam is used concurrently with another antibiotic (e.g. aminoglycosides), the substances must be administered separately. The mixing of beta-lactam antibiotics with an aminoglycoside in vitro can result in substantial inactivation of the aminoglycoside.
Piperacillin/tazobactam should not be mixed with other substances in a syringe or infusion bottle since compatibility has not been established.
Piperacillin/tazobactam should be administered through an infusion set separately from any other drugs unless compatibility is proven.
Due to chemical instability, piperacillin/tazobactam should not be used in solutions containing only sodium bicarbonate.
Lactated Ringer's solution is not compatible with piperacillin/tazobactam.
Piperacillin/tazobactam should not be added to blood products or albumin hydrolysates.
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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/Tazobactam 4 g/0.5 g powder for solution for infusion.
You will be given Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion 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/Tazobactam 4 g/0.5 g powder for solution for infusion 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 receive more Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion than you should
As you will receive Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion 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/Tazobactam 4 g/0.5 g powder for solution for infusion
If you think you have not been given a dose of Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion, 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 4 g/0.5 g powder for solution for infusion can 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 4 g/0.5 g powder for solution for infusion are:
• swelling of the face, lips, tongue or other parts of the body
• shortness of breath, wheezing or trouble breathing
• serious illness with blistering of the skin, mouth, eyes and genitals (e.g. Stevens-Johnson syndrome) or serious sloughing (toxic epidermal necrolysis)
• 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):
• diarrhoea, vomiting, nausea
• skin rashes
Uncommon side 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 (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):
• (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 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' test), 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 illness with blistering of the skin, mouth, eyes and genitals (Stevens-Johnson Syndrome)
• blood urea nitrogen increased
Piperacillin therapy has been associated with an increased incidence of fever and rash in cystic fibrosis patients.
Also you can help make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.
5. How to store Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion
Keep out of the reach and sight of children.
Do not use Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion after the expiry date which is stated on the vial label and carton.
The expiry date refers to the last day of that month.
Unopened vials: This medicinal product does not require any special temperature storage conditions.
Keep the vials in the outer carton.
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 of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion contains
• The active substances are piperacillin and tazobactam.
• Each vial contains 4 g piperacillin (as sodium salt) and 0.5 g tazobactam (as sodium salt).
• There are no other ingredients.
What Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion looks like and contents of the pack
Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion is a white to off-white powder for solution for infusion packaged in glass vials
Packs containing 1 or 12 vials.
Marketing Authorisation Holder and Manufacturer:
Hospira UK Limited Queensway Royal Leamington Spa Warwickshire, CV31 3RW United Kingdom
This leaflet was last approved in 05/2013
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