Piperacillin/Tazobactam 2 G/0.25 G Powder For Solution For Infusion.
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1 What Piperacillin/Tazobactam is and what it is used for
2 Before you use Piperacillin/Tazobactam
3 How to use Piperacillin/Tazobactam
PACKAGE LEAFLET:
INFORMATION FOR THE USER
Piperacillin/Tazobactam 2 g/0.25 g Powder for Solution for Infusion
Piperacillin/Tazobactam 4 g/0.5 g Powder for Solution for Infusion
Piperacillin/Tazobactam A SANDOZ
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 is and what it is used for
2. Before you use Piperacillin/Tazobactam
3. How to use Piperacillin/Tazobactam
4. Possible side effects
5. How to store Piperacillin/Tazobactam
6. Further information
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 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 may be used to treat bacterial infections in patients with low white blood cell counts (reduced resistance to infections).
Piperacillin/Tazobactam is used in children aged 2-12 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 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 in combination with other antibiotics.
Do not use Piperacillin/Tazobactam
• 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.
Take special care with Piperacillin/Tazobactam
• 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 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 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 is right for you.
Driving and using machines
The use of Piperacillin/Tazobactam is not expected to affect the ability to drive or use machines.
Important information about some of the ingredients of this product
Piperacillin/Tazobactam 2 g/250 mg] contains 4.72 mmol (109 mg) of sodium. Piperacillin/Tazobactam 4 g/500 mg] contains 9.44 mmol (217 mg) of sodium. This should be taken into consideration if you are on a controlled sodium diet.
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 and older
The usual dose is 4g / 0.5g 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).
Your doctor will calculate the dose depending on your child’s weight but the single dose will not exceed 4 g / 0.5 g of Piperacillin/Tazobactam.
You will be given Piperacillin/Tazobactam 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 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.
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The following information is intended for medical or healthcare professionals only:
Instructions for use
Piperacillin/Tazobactam 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.
When swirled constantly, reconstitution generally occurs within 3 minutes (for details on handling, please see below).
|
Content of vial |
Volume of solvent1 to be added to vial |
|
2 g/0.25 g (2 g piperacillin and 0.25 g tacobactam) |
10 ml |
|
4 g/0.5 g (4 g piperacillin and 0.5 g tacobactam) |
20 ml |
• Compatible solvents for reconstitution:
• water for injection;
• sodium chloride 9 mg/ml (0.9 %) solution in water for injection;
• glucose 50 mg/ml (5 %) solution in water for injection;
• glucose 50 mg/ml (5 %) solution in sodium chloride 9 mg/ml (0.9%) solution.
The reconstituted solutions should be withdrawn from the vial by syringe. When reconstituted as directed, the vial contents withdrawn by syringe will provide the labelled amount of piperacillin and tazobactam.
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4 Possible side effects
5 How to store Piperacillin/Tazobactam
6 Further Information
If you receive more Piperacillin/Tazobactam than you should
As you will receive Piperacillin/Tazobactam by 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 Piperacillin/Tazobactam
If you think you have not been given a dose of Piperacillin/Tazobactam, tell your doctor or other healthcare professional immediately.
If you have any further questions on the use of this product, ask your doctor or healthcare professional.
Like all medicines, Piperacillin/Tazobactam 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 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.
Possible side effects are listed according to the following categories:
• common: affects 1 to 10 users in 100
• uncommon: affects 1 to 10 users in 1,000
• rare: affects 1 to 10 users in 10,000
• very rare: affects less than 1 user in 10,000
Common side effects:
• diarrhoea, vomiting, nausea
• skin rashes
Uncommon side effects:
• 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:
• (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:
• 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.
Keep out of the reach and sight of children.
Do not use Piperacillin/Tazobactam after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.
Powder:
This medicinal product does not require any special storage conditions.
For storage conditions of the reconstituted and diluted medicinal product, see at the end of the package leaflet ‘The following information is intended for medical or healthcare professionals only’.
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 protect the environment. 2 1
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:
• sodium chloride 9 mg/ml (0.9 %) solution in water for injection
• glucose 50 mg/ml (5 %) solution in water for injection;
• dextran (grade 40) 60 mg/ml (6%) solution in sodium chloride 9 mg/ml (0.9%) solution.
Incompatibilities
This product must not be mixed or co-administrated with any aminoglycoside. 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 (Hartmann’s) solution is not compatible with piperacillin / tazobactam.
Piperacillin / tazobactam should not be added to blood products or albumin hydrolysates.
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Other ingredients:
The medicinal product contains no other ingredients than the active substances.
What Piperacillin/Tazobactam looks like and contents of the pack
Piperacillin/Tazobactam 2 g / 0.25 g] is a white to off-white powder for solution for infusion packaged in glass vials. The vials are packed in carton boxes.
Each box contains 1,5, 10, 12 or 50 glass vials.
Not all pack sizes may be marketed.
Piperacillin/Tazobactam 4 g / 0.5 g] is a white to off-white powder for solution for infusion packaged in glass bottles. The bottles are packed in carton boxes.
Each box contains 1,5, 10, 12 or 50 glass bottles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz Limited
Frimley Business Park, Frimley, Camberley, Surrey,
GU16 7SR. United Kingdom
Manufacturer:
Sandoz GmbH
Biochemiestrasse 10, 6250 Kundl,
Austria
This leaflet was last approved in 03/2015
What Piperacillin/Tazobactam contains
• Active substances:
The active substances are piperacillin and tazobactam.
Each vial contains 2 g piperacillin (as sodium salt) and 0.25 g tazobactam (as sodium salt).
Each bottle contains 4 g piperacillin (as sodium salt) and 0.5 g tazobactam (as sodium salt).