Salataz

Piperacillin sodium, tazobactam sodium.

Each vial contains 4 g piperacillin (as sodium salt) and 0.5 g tazobactam (as sodium salt).
There are no other ingredients.

Piperacillin belongs to the group of medicines known as "broad-spectrum penicillin antibiotics". It can kill many kinds of bacteria. SALATAZ 4 g/0.5 g powder for solution for infusion 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.

SALATAZ 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. SALATAZ 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).
SALATAZ 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. SALATAZ 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, the doctor may consider using SALATAZ 4 g/0.5 g powder for solution for infusion in combination with other antibiotics.

The doctor or other healthcare professional will give the patient this medicine through an infusion (a drip for 30 minutes) into one of the veins. The dose of medicine given to the patient depends on what the patient is being treated for, the age, and whether or not the patient has kidney problems.
Use in adults and adolescents aged 12 years or older: The usual dose for adults is 4 g/0.5 g piperacillin/tazobactam given every 6-8 hours, which is given into one of the veins (directly into the blood stream).
Use in 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 the 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 the veins (directly into the blood stream).
The doctor will calculate the dose depending on the child's weight but the daily dose will not exceed 4 g / 0.5 g of SALATAZ 4 g/0.5 g powder for solution for infusion.
The patient will be given SALATAZ 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: The doctor may need to reduce the dose of SALATAZ 4 g/0.5 g powder for solution for infusion or how often the patient is given it. The doctor may also want to test the blood to make sure that the treatment is at the right dose, especially if the patient has to take this medicine for a long time.
If the patient misses a dose of SALATAZ 4 g/0.5 g powder for solution for infusion: If thinking of not having been given a dose of SALATAZ 4 g/0.5 g powder for solution for infusion, tell the doctor or other healthcare professional immediately.
If there are any further questions on the use of this medicine, ask the doctor, pharmacist or nurse.

If the patient receives more SALATAZ 4 g/0.5 g powder for solution for infusion than the patient should: As the patient will receive SALATAZ 4 g/0.5 g powder for solution for infusion from a doctor or other healthcare professional, the patient is unlikely to be given the wrong dose. However, if side effects, such as convulsions, are experienced or thinking too much has been given, tell the doctor immediately.

Do not use SALATAZ 4 g/0.5 g powder for solution for infusion: If allergic to piperacillin or tazobactam or any of the other ingredients of this medicine (listed in Description); If allergic to antibiotics known as penicillins, cephalosporins or other beta-lactamase inhibitors, as the patient may be allergic to SALATAZ 4 g/0.5 g powder for solution for infusion.

Talk to the doctor, pharmacist or nurse before using SALATAZ 4 g/0.5 g powder for solution for infusion: If there are allergies. If there are several allergies, make sure to tell the doctor or other healthcare professional before receiving this product.
If suffering from diarrhoea before, or if diarrhoea is developed during or after the treatment. In this case, make sure to tell the doctor or other healthcare professional immediately. Do not take any medicine for the diarrhoea without first checking with the doctor.
If there are low levels of potassium in the blood. The doctor may want to check the kidneys before the patient takes this medicine and may perform regular blood tests during treatment.
If there are kidney or liver problems, or receiving haemodialysis. The doctor may want to check the kidneys before the patient takes this medicine, and may perform regular blood tests during treatment.
If taking certain medicines (called anticoagulants) to avoid an excess of blood clotting (see also Interactions) or any unexpected bleeding occurs during the treatment. In this case, the patient should inform the doctor or other healthcare professional immediately.
If convulsions are developed during the treatment. In this case, the patient should inform the doctor or other healthcare professional.
If patient has developed a new or worsening infection. In this case, they should inform the doctor or other healthcare professional.
Effect on laboratory tests: Tell the doctor or laboratory staff that SALATAZ 4 g/0.5 g powder for solution for infusion is being taken if blood or urine sample is to be provided.
SALATAZ 4 g/0.5 g powder for solution for infusion contains sodium: This medicinal product contains 9.44 mmol (217 mg) of sodium per vial of powder for solution for infusion. This should be taken into consideration if the patient is on a controlled sodium diet.
Driving and using machines: The use of SALATAZ 4 g/0.5 g powder for solution for infusion is not expected to affect the ability to drive or use machines.
Use in Children: Piperacillin / tazobactam is not recommended for use in children below the age of 2 years due to insufficient data on safety and effectiveness.

If patient is pregnant or breast-feeding, thinking may be pregnant or planning to have a baby, ask the doctor or pharmacist before taking this medicine. The doctor will decide if SALATAZ 4 g/0.5 g powder for solution for infusion is right for the patient.
Piperacillin and tazobactam can pass to a baby in the womb or through breast milk. If the patient is breast-feeding, the doctor will decide if SALATAZ 4 g/0.5 g powder for solution for infusion is right for the patient.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If there are any side effects, talk to the doctor, pharmacist or nurse. This includes any side effects not listed in this monograph.
The serious side effects of SALATAZ 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; severe rash, itching or hives on the skin; yellowing of the eyes or skin; damage to blood cells (the signs include: being breathless when not expecting it, red or brown urine, nose-bleeds and bruising).
If any of the previously mentioned is noticed, see a doctor straight away. For frequency of these reactions, refer to the following information.
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.

Tell the doctor or pharmacist if taking, have recently taken or might take any other medicines. 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 the body.
Medicines to thin the blood or to treat blood clots (e.g. heparin, warfarin or aspirin).
Medicines used to relax the muscles during surgery. Tell the doctor if patient is 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 the body.
Medicines that reduce the level of potassium in the blood (e.g. tablets enhancing urination or some medicines for cancer).
Medicines containing the other antibiotics tobramycin or gentamycin. Tell the doctor if there are kidney problems.

The following information is intended for 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 following table, using one of the compatible solvents for reconstitution. Swirl until dissolved. (See table.)

Click on icon to see table/diagram/image

*Compatible solvents for reconstitution: 0.9% (9 mg/ml) sodium chloride solution for injection; Sterile water for injections; Glucose 5%.
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.
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: 0.9% (9 mg/ml) sodium-chloride solution for injection; Glucose 5%; Sterile water for injections; Dextran 6% in 0.9% sodium chloride.
Incompatibilities: 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 substances unless compatibility is proven.
Due to chemical instability, piperacillin/tazobactam should not be used in solutions that contain 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.

Unopened vials: Do not store above 25°C.
For single use only. Discard any unused solution.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.

Penicillins

J01CR05 - piperacillin and beta-lactamase inhibitor ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.

POM

Powd for soln for infusion (vial) 1 x 10's.