Piperacillin/Tazobactam 4g/0.5g Powder For Solution For Infusion.
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Piperacillin /Tazobactam 2g / 0.25g Piperacillin /Tazobactam 4g / 0.5g Powder for Solution for Infusion (Piperacillin/Tazobactam)
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.
• The full name of this medicine is Piperacillin/ Tazobactam 2g/0.25g or 4g/0.5g Powder for Solution for Infusion but within the leaflet it will be referred to as Piperacillin/ Tazobactam Powder.
In this leaflet:
T| What Piperacillin/Tazobactam Powder for Solution for Infusion is and what it is used for
^ Before you use Piperacillin/Tazobactam Powder
"3 How to use Piperacillin/Tazobactam Powder
4| Possible side effects
5| How to Store Piperacillin/Tazobactam Powder
"6 Further information
T| What Piperacillin/Tazobactam 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 Powder 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 Powder may be used to treat bacterial infections in patients with low white blood cell counts (reduced resistance to infections). Piperacillin/Tazobactam Powder 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 powder 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 Powder in combination with other antibiotics.
Before you use Piperacillin/Tazobactam Powder
Do not use Piperacillin/Tazobactam Powder
• 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 Powder.
Take special care with Piperacillin/Tazobactam Powder
• 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 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.
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:
• medicine 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. tablets enhancing 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/Tazobactam Powder 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 healthcare professional before receiving this product. Your doctor will decide if Piperacillin/Tazobactam Powder 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 Powder is right for you.
Driving and using machines
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The use of Piperacillin/Tazobactam Powder is not expected to affect the ability to drive or use machines.
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The following information is intended for medical or healthcare professionals only:
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Piperacillin/Tazobactam 2g/0.25g Powder for Solution for Infusion Piperacillin/Tazobactam 4g/0.5g Powder for Solution for Infusion powder for solution for infusion
|
Content of vial |
Volume of solvent* to be added to vial |
|
2g / 0.25 g (2g piperacillin and 0.25 g tacobactam) |
10ml |
|
4g / 0.50 g (4g piperacillin and 0.5 g tacobactam) |
20 ml |
Instructions for use
Piperacillin/Tazobactam Powder 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 *Compatible solvents for reconstitution:
• 0.9% (9mg/ml) sodium chloride for injection Sterile water for injections
• Glucose 5%
• Glucose 5% in sodium chloride 0.9% (9mg/ml) solution
The reconstituted solutions may be further diluted to the desired volume (e.g. 50ml to 150ml) with one of the following compatible solvents:
• 0.9% (9mg/ml) sodium chloride solution for injection
• Sterile water for injections
• Glucose 5%
• Glucose 5% in sodium chloride 0.9% (9mg/ml) solution
• Dextran 6% in 0.9% sodium chloride
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Important information about some of the ingredients of this product
Piperacillin/Tazobactam 2g/0.25g Powder for Solution for Infusion contains 4.7mmol (or 108mg) of sodium. Piperacillin/Tazobactam 4g/0.5g Powder for Solution for Infusion contains 9.4mmol (or 216mg) of sodium.
This should be taken into consideration if you are on a controlled sodium diet.
"3 How to use Piperacillin/Tazobactam Powder
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 4g/0.5g 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 usual dose for children with abdominal infections is 100mg /12.5mg/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 80mg/10mg/ 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 4g/0.5g of Piperacillin/Tazobactam Powder.
You will be given Piperacillin/Tazobactam Powder 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 Powder 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 Powder than you should
As you will receive Piperacillin/Tazobactam Powder 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 Powder
If you think you have not been given a dose of Piperacillin/Tazobactam Powder, 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 Powder can cause side effects, although not everybody gets them.
Your doctor may want to perform tests during your treatment to measure any changes.
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
Powder 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):
• 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
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• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov. uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
T| How to Store Piperacillin/Tazobactam Powder
Keep out of the reach and sight of children.
Do not use Piperacillin/Tazobactam Powder after the expiry date which is stated on the carton and vial after '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 25°C.
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 Powder contains
The active substances are piperacillin and tazobactam. Piperacillin/Tazobactam 2g/0.25g Powder for Solution for Infusion
Each vial contains 2g piperacillin (as sodium salt) and 0.25g tazobactam (as sodium salt). Piperacillin/Tazobactam 4g/0.5g Powder for Solution for Infusion
Each vial contains 4g piperacillin (as sodium salt) and 0.5g tazobactam (as sodium salt).
What Piperacillin/Tazobactam Powder looks like and contents of the pack
Powder for Solution for Infusion White to off-white powder.
Piperacillin/Tazobactam Powder is supplied in packs of 1 vial and enclosed in a carton with a package leaflet.
Marketing Authorisation Holder
Actavis Group PTC ehf
Reykjavikurvegi 76-78, 220 Hafnarfjordur
Iceland
Manufacturer Milpharm Limited
Ares, Odyssey Business Park, West End Road, South Ruislip HA4 6QD United Kingdom
APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate Hal Far, Birzebbugia BBG 3000 Malta
This leaflet was last revised in April 2014.
If you would like a leaflet with larger text, please contact 01721 385257.
^actavis
Actavis, Barnstaple, EX32 8NS, UK
Incompatibilities
Whenever Piperacillin/Tazobactam Powder 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 Powder should not be mixed with other substances in 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 Powder should not be used with solutions containing sodium bicarbonate.
Piperacillin/Tazobactam Powder should not be added to blood products or albumin hydrolysates
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Actavis, Barnstaple, EX32 8NS, UK
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