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FLUCLOXACILLIN 500MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance(s): FLUCLOXACILLIN / FLUCLOXACILLIN / FLUCLOXACILLIN

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PACKAGE LEAFLET: INFORMATION FOR
THE USER

Flucloxacillin 250mg, 500mg and 1g Powder
for Solution for Injection or Infusion
Read all of this leaflet carefully before you start using
this medicine because it contains important information
for you.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor
or nurse.
- If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not listed in this leaflet.
See section 4.
The name of your medicine is Flucloxacillin 250mg, 500mg
and 1g Powder for Solution for Injection or Infusion. In the rest
of this leaflet it is called Flucloxacillin Injection.
What is in this leaflet:
1. What Flucloxacillin Injection is and what it is used for
2. What you need to know before you use Flucloxacillin
Injection
3. How to use Flucloxacillin Injection
4. Possible side effects
5. How to store Flucloxacillin Injection
6. Contents of the pack and other information
1. WHAT FLUCLOXACILLIN INJECTION IS AND WHAT
IT IS USED FOR
Flucloxacillin belongs to a group of medicines called
penicillins, which are antibiotics. These medicines work by
killing bacteria that cause infections.
Flucloxacillin Injection is used for the treatment of a range of
bacterial infections including bone infections (osteomyelitis)
and infections within the lining of the heart (endocarditis).
It is also used to prevent infections that can occur during
major surgical operations such as heart and lung operations
(cardiothoracic surgery) and bone, joint and muscle
operations (orthopaedic surgery).
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
FLUCLOXACILLIN INJECTION
Do not use Flucloxacillin Injection:
• If you are allergic to flucloxacillin or any of the other
ingredients of this medicine (listed in section 6).
• If you are allergic to cephalosporins, penicillin, or any other
ß-lactam antibiotic.
• If you have had jaundice (yellow skin and whites of
eyes) or other liver problems when you have been given
flucloxacillin previously

1. NAME OF THE MEDICINAL PRODUCT
Flucloxacillin 250mg Powder for Solution for Injection or Infusion
Flucloxacillin 500mg Powder for Solution for Injection or Infusion
Flucloxacillin 1g Powder for Solution for Injection or Infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium flucloxacillin monohydrate equivalent to flucloxacillin 250mg
Sodium flucloxacillin monohydrate equivalent to flucloxacillin 500mg
Sodium flucloxacillin monohydrate equivalent to flucloxacillin 1g
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Powder for solution for injection or infusion (Powder for injection or infusion)
Flucloxacillin sodium is supplied as a white or almost white
crystalline powder
CLINICAL PARTICULARS
4.1 Therapeutic indications
Flucloxacillin is indicated for the treatment of infections due to pencillinase producing
staphylococci and other gram positive organisms susceptible to this anti-infective
(see Section 5.1).
Indications include osteomyelitis and endocarditis. Flucloxacillin is also indicated for
use as a prophylactic agent during major surgical procedures, when appropriate; for
example cardiothoracic and orthopaedic surgery.
Consideration should be given to official guidance on the appropriate use of
antibacterial agents.
4.2 Posology and method for administration
The dosage depends on the severity and nature of the infection.
Method of administration
The usual routes of administration for Flucloxacillin 250mg, 500mg and 1g Powder
for Solution for Injection or Infusion are by slow intravenous injection and intravenous
infusion. Flucloxacillin 250mg and 500mg Powder for Solution for Injection or Infusion
may also be administered by intramuscular, intra-articular or intrapleural injection.
Flucloxacillin 250mg may also be inhaled by nebuliser. The solutions must be prepared
as follows:
Adults and the elderly
Intramuscular: Add 1.5ml of water for injections to 250mg vial contents or 2ml of
water for injections to 500mg vial contents.
Intravenous: Dissolve 250 to 500mg in 5 to 10ml of water for injections or 1g in 15 to
20ml of water for injections. Administer by slow intravenous injection (over three to four
minutes). Flucloxacillin may also be added to infusion fluids or injected (suitably diluted)
into the drip tube over three to four minutes. Flucloxacillin may be added to most
intravenous fluids (eg water for injections, sodium chloride 0.9%, glucose 5%, sodium
chloride 0.18% with glucose 4%).
Intrapleural: Dissolve 250mg in 5 to 10ml of water for injections.
Intra-articular: Dissolve 250 to 500mg in up to 5ml of water for injections or 0.5%
lignocaine hydrochloride solution for injection.
Nebuliser Solution: Dissolve 125mg to 250mg of the vial contents in 3ml of water
for injections.
The usual adult dosage (including the elderly) is as follows:
By intramuscular injection 250mg every six hours
By slow intravenous injection or by infusion
250mg to 1g every six hours

Warnings and precautions
Talk to your doctor before using Flucloxacillin Injection:
• If you have had any allergies especially to any other drugs
(particularly penicillin)
• If you are suffering from liver or kidney problems
• If you have heart failure
• If you have syphilis (a sexually transmitted disease)
• If you have leptospirosis (Weil’s disease)
• If you suffer from porphyria (an inherited blood disorder)
Special care should be taken in newborn babies to avoid
overdose or high levels of a chemical in the blood which
can lead to brain damage.
If any of the above statements apply to you, speak to your
doctor or nurse before you are given Flucloxacillin Injection.
Other medicines and Flucloxacillin Injection
Taking other medicine while you are being given Flucloxacillin
Injection can affect how it or the other medicine works. Tell
your doctor if you are taking, have recently taken or might
take any other medicines.
Please particularly check with your doctor if you are taking or
need to take any of the following:
• oral contraceptives that contain oestrogen e.g. the
combined pill. If you are using this type of medicine you
should take additional precautions to prevent pregnancy
while you are receiving Flucloxacillin Injection and for
at least seven days afterwards. If these seven days run
beyond the end of a packet of contraceptive pills you
should start the next packet immediately without a break.
• probenecid, a drug used for the treatment of gout
• methotrexate, a drug used in the treatment of cancer
• certain other “bacteriostatic” antibiotics (antibiotics that
stop bacteria growing but do not kill them), such as
chloramphenicol and tetracycline
Flucloxacillin Injection may interfere with various laboratory
tests.
If you have any doubts about whether you should be given
this medicine then talk to your doctor.
Pregnancy and breast-feeding
You should let your doctor know immediately if you are
pregnant or trying for a baby before this medicine is
administered.
You should not breast-feed whilst being given Flucloxacillin
Injection. You should let your doctor know if you are
breast-feeding while you are having treatment with
Flucloxacillin Injection.
Driving and using machines
Flucloxacillin Injection is not known to affect your ability to
drive or use machines.

These doses may be doubled in severe infections. Doses of up to 8g daily have been
suggested for endocarditis or osteomyelitis.
During surgical prophylaxis, doses of 1 to 2g should be given intravenously at induction
of anaesthesia followed by 500mg six hourly intravenously or intramuscularly.
By intrapleural injection
250mg once daily
By intra-articular injection
250mg to 500mg once daily
By nebuliser
125mg to 250mg every six hours
Paediatric population
Any route of administration may be used. For children under two years old, a quarter
of the adult dose should be administered. For children two to ten years old, half of the
adult dose should be administered.
Renal impairment
Dosage reduction is not usually required. In severe renal failure, however, (creatinine
clearance less than 10ml/min) a reduction in dose or extension of dose interval should
be considered.
No supplementary dosages need be administered during or at the end of the dialysis
period, as flucloxacillin is not significantly removed by dialysis.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Flucloxacillin should not be given to patients with a history of hypersensitivity to
s-lactam antibiotics (e.g. penicillins, cephalosporins).
Flucloxacillin is contraindicated in patients with a previous history of flucloxacillinassociated jaundice/hepatic dysfunction.
Ocular or subconjunctival administration is contraindicated.
4.4 Special warning and precautions for use
Flucloxacillin should be given with caution to patients with a history of allergy,
especially to drugs. Before initiating therapy with flucloxacillin, careful enquiry should
be made concerning previous hypersensitivity reactions to s-lactams. Cross sensitivity
between penicillins and cephalosporins is well documented. Serious and occasionally
fatal hypersensitivity reactions (anaphylaxis) have been reported in patients receiving
s-lactam antibiotics. These reactions are more likely to occur in individuals with a
history of s-lactam hypersensitivity. Desensitisation may be necessary if treatment is
essential.
Care is necessary if very high doses of flucloxacillin are given, especially if renal
function is poor, because of the risk of nephrotoxicity and/or neurotoxicity.
The intrathecal route should be avoided. Care is also necessary if large doses of sodium
salts are given to patients with impaired renal function or heart failure. Flucloxacillin
should be used with caution in patients with evidence of hepatic dysfunction (see
section 4.8). Renal, hepatic and haematological status should be monitored during
prolonged and high-dose therapy (e.g. osteomyelitis, endocarditis). Prolonged use may
occasionally result in overgrowth of non-susceptible organisms.
Care is required when treating some patients with spirochaete infections such as
syphilis or leptospirosis because the Jarisch-Herxheimer reaction may occur shortly
after treatment with a penicillin is started.
In case of severe and persistent diarrhoea, the possibility of pseudomembranous colitis
should be considered; flucloxacillin therapy should be discontinued.
Contact with flucloxacillin should be avoided since skin sensitisation may occur.
Caution is advised in patients with porphyria.
Special caution is essential in the newborn because of the risk of hyperbilirubinemia.
Studies have shown that, at high dose following parenteral administration, flucloxacillin

Flucloxacillin Injection contains sodium
Flucloxacillin Injection 250mg contains less than 1mmol
sodium (23 mg) per vial i.e. essentially sodium free.
Flucloxacillin Injection 500mg and 1g contain 1.13mmol and
2.26mmol of sodium per vial respectively. To be taken into
consideration by patients on a controlled sodium diet.
3. HOW TO USE FLUCLOXACILLIN INJECTION
Your doctor or nurse will prepare your injection by mixing
the Flucloxacillin Injection powder with a liquid such as
water for injections, either in the vial or in another container.
The mixture is usually injected into a muscle, or into a vein
when it will be given slowly over three to four minutes
using a syringe or drip (infusion). In certain circumstances
Flucloxacillin Injection can be injected directly into an infected
joint or the chest wall, or breathed in as a mist.
Flucloxacillin is usually given as an intramuscular
injection, slow intravenous injection and intravenous
infusion. It may also be given by articular or intrapleural
injection or inhaled. Flucloxacillin should not be given
into the eye or the spine.
Adults
The recommended dose by intramuscular injection or
infusion is 250mg every six hours. The recommended adult
dose by intravenous injection is 250mg to 1g every six
hours. These doses may be doubled in severe infections.
Doses of up to 8g a day may be required for osteomyelitis
or endocarditis. To prevent surgical infections you will be
given 1 to 2g with your anaesthetic followed by 500mg
every six hours.
Use in children
The recommended dose for children aged two to ten years
is half the adult dose. The recommended dose for children
under two years old is a quarter of the adult dose.
Special care should be taken in newborn babies to
prevent the risk of overdosing.
Injections into joints or the chest, or inhalation of
Flucloxacillin Injection
The usual doses are:
• into infected joint - 250 to 500 mg once a day
• into chest - 250 mg once daily
• by inhaler – 125 to 250 mg every six hours
Severe kidney disease
If you have severe kidney failure you may be given a lower
dose or you may receive your doses less frequently.
Your doctor will decide the dose that is best for you. If you do
not understand, or are in any doubt, ask your doctor or nurse.

can displace bilirubin from plasma protein binding sites, and may therefore predispose
to kernicterus in a jaundiced baby. In addition, special caution is essential in the
newborn because of the potential for high serum levels of flucloxacillin due to a
reduced rate of renal excretion.
The occurrence at the treatment initiation of a feverish generalised erythema
associated with pustula may be a symptom of acute generalised exanthematous
pustulosis (AGEP) (see section 4.8). In case of AGEP diagnosis, flucloxacillin should be
discontinued and any subsequent administration of flucloxacillin contra-indicated.
Sodium content: Flucloxacillin for Injection 250mg, 500mg and 1g contains
approximately 0.57mmol, 1.13mmol and 2.26mmol of sodium respectively per vial.
This should be included in the daily allowance of patients on sodium restricted diets.
4.5 Interaction with other medicinal products and other forms of interaction
Other antibacterials: Since bacteriostatic drugs such as chloramphenicol and
tetracycline may interfere with the bactericidal effect of penicillins in the treatment of
meningitis or in other situations in which a rapid bactericidal effect is necessary, it is
best to avoid concurrent therapy.
Immunosuppressants: There is reduced excretion of methotrexate (increased risk
of toxicity).
Oral contraceptives: Flucloxacillin may decrease the efficacy of oestrogen-containing
oral contraceptives.
Uricosuric agents: Plasma concentrations of flucloxacillin are enhanced if probenecid
is given concurrently.
Interference with diagnostic tests: Penicillins may produce false-positive results
with the direct antiglobulin (Coombs’) test, falsely high urinary glucose results with the
copper sulphate test and falsely high urinary protein results, but glucose enzymatic
tests (e.g. Clinistix) and bromophenol blue tests (e.g. Multistix or Albustix) are not
affected.
4.6 Fertility, pregnancy and lactation
Pregnancy
There has been no evidence of a teratogenic effect in animals or untoward effect in
humans. However, use in pregnancy should be reserved for essential cases.
Breastfeeding
Trace quantities of penicillin can be detected in breast milk with the potential for
hypersensitivity reactions (e.g. drug rashes) in the breast-fed neonate or acute
alterations in the neonatal bowel flora with resultant diarrhoea.
4.7 Effects on ability to drive and use machines
Not relevant.
4.8 Undesirable effects
Blood and lymphatic system disorders: Transient leucopenia, thrombocytopenia,
haemolytic anaemia, agranulocytosis and neutropenia (which might have some
immunological basis); prolongation of bleeding time and defective platelet function
are generally associated with large intravenous doses of flucloxacillin or impaired
renal function.
Immune system disorders: The most common adverse effects are sensitivity reactions
including urticaria, maculo-papular rashes, pruritus, fever, joint pains and angioedema.
Anaphylaxis occasionally occurs and has sometimes been fatal. Late sensitivity
reactions may include serum sickness-like reactions (featuring symptoms such as
arthralgia, rash, urticaria, fever, angioedema, lymphadenopathy), haemolytic anaemia,
nephropathy and acute interstitial nephritis, which is reversible when treatment is
discontinued.

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If you are given more Flucloxacillin Injection than you
should
A doctor or nurse will give you this medicine. If you think
you may have received too much Flucloxacillin Injection,
please tell your doctor or nurse immediately. Symptoms
of an overdose may include fits, behaviour disorders, fever,
weakness, breathlessness, bleeding more easily and longer
than usual, or changes to the salt levels in the blood.
If you think you have missed a dose of Flucloxacillin
Injection
A doctor or a nurse will give you this medicine. If you think
you have missed a dose, please tell your doctor or nurse.
If you have any further questions on the use of this medicine,
ask your doctor or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Tell your doctor immediately if you notice any of the
following side effects as they may be a sign of an allergic
or sensitivity reaction:
• rash
• itching
• redness and blistering of the skin
• fever
• aching joints
• swelling of the face, throat or hands
• difficulty breathing
• anaemia
• kidney problems
• blood problems (causing a sore throat, mouth ulcers,
repeated infections or a tendency to bleed easily)
• fits (convulsions) and other problems affecting the nervous
system
• Serious skin reactions
• A red, scaly rash with bumps under the skin and blisters
(exanthematous pustulosis).
Also tell your doctor immediately if you develop any of
the following:
• tenderness of the upper abdomen which may indicate
inflammation of the liver or jaundice (yellow skin and
whites of eyes)
• severe diarrhoea. Treatment with Flucloxacillin can affect
the normal bacteria in the gut, causing a new infection
(pseudomembranous colitis)
Hepatitis (inflammation of the liver) and jaundice may be long
lasting. They are more likely in the elderly or patients who
have been given flucloxacillin for more than two weeks.
You should tell your doctor if you develop any of the
symptoms above, even if they occur some weeks after
you have stopped having the injections.
Some patients with spirochaete infections such as syphilis or leptospirosis may
experience a Jarisch-Herxheimer reaction shortly after treatment with a penicillin is
started. Symptoms include fever, chills, headache and reaction at the site of lesions.
The reaction can be dangerous in cardiovascular syphilis or where there is a serious
risk of increased local damage such as with optic atrophy.
Metabolism and nutrition disorders: Electrolyte disturbances, such as hypokalaemia,
due to administration of large amounts of sodium (see Section 4.4), are generally
associated with large intravenous doses of flucloxacillin or impaired renal function.
Psychiatric disorders: Hallucinations.
Nervous system disorders: Convulsions and other signs of central nervous system
toxicity are generally associated with large intravenous doses of flucloxacillin or
impaired renal function. Encephalopathy has been reported following intrathecal
administration and can be fatal. Coma may develop with high doses of flucloxacillin.
Respiratory, thoracic and mediastinal disorders: Acute, severe dyspnoea;
bronchospasm.
Gastrointestinal disorders: Diarrhoea, nausea and vomiting, reported with flucloxacillin,
commonly occur after oral or parenteral administration. Pseudomembranous colitis
has been reported with most antibiotics. Prolonged use of penicillins may lead to the
development of oral candidiasis.
Hepatobiliary disorders: Changes in liver function test results may occur, but are
reversible when treatment is discontinued. Hepatitis and cholestatic jaundice have
been reported. These reactions are related neither to the dose nor to the route of
administration; administration for more than two weeks and increasing age are
risk factors. The onset of these effects may be delayed for up to two months
post-treatment; in several cases the course of the reactions has been protracted and
lasted for some months. In very rare cases, a fatal outcome has been reported, almost
always in patients with serious underlying disease.
Skin and subcutaneous tissue disorders: Erythema multiforme; Stevens-Johnson
syndrome; toxic epidermal necrolysis (Lyell’s syndrome); erythema nodosum;
pemphigoid reactions; non-thrombocytopenic purpura; vasculitis.
Frequency not known: AGEP - acute generalized exanthematous pustulosis
(see section 4.4).
Congenital, familial and genetic disorders: Acute attacks of porphyria (refer to section 4.4).
General disorders and administration site conditions: Phlebitis has followed
intravenous infusion.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected adverse
reactions via the national reporting system:
United Kingdom
Yellow Card Scheme
www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie

Other side effects include:
• shortness of breath
• difficulty in breathing or wheezing
• tender red lumps under the skin
• blistering of the skin
• red or purple skin discolouration
• inflammation of blood vessels, often with skin rash
• severe attacks of porphyria (an inherited blood disorder)
• hallucinations
• feeling sick
• being sick
• thrush in the mouth
• coma
• high salt levels in the blood
• low blood levels of potassium which can cause muscle
weakness, twitching or abnormal heart rhythm
• redness and pain around the area of infusion
If you have syphilis
Patients who have syphilis or leptospirosis (Weil’s disease)
have occasionally suffered from a type of reaction (JarischHerxheimer reaction) shortly after their injection, with fever,
chills, headache and sometimes heart or eye problems.
If you receive high doses or a long course of treatment
Your doctor may take blood tests during your treatment to
check your liver, kidneys and blood, particularly if you receive
high doses or a long course of treatment.
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
national reporting systems listed below.
United Kingdom
Yellow Card Scheme
www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
E-mail: medsafety@hpra.ie
By reporting side effects you can help provide more
information on the safety of this medicine.
5. HOW TO STORE FLUCLOXACILLIN INJECTION
Keep this medicine out of the sight and reach of children.
• Flucloxacillin Injection should not be used after the expiry
date given on the vial. The expiry date refers to the last day
of that month.
4.9 Overdose
Symptoms
With high parenteral doses of penicillins, neurotoxicity (e.g. convulsions,
encephalopathy), blood disorders (e.g. neutropenia, haemolytic anaemia, prolongation
of bleeding time, defective platelet function) or electrolyte disturbances may occur.
Treatment
Treatment is symptomatic. Flucloxacillin is not removed from the circulation by
haemodialysis.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Beta-lactamase resistant penicillins, ATC code: J01CF05.
Mechanism of action
Flucloxacillin is bactericidal with a similar mode of action to benzylpenicillin.
It is resistant to staphylococcal penicillinase and therefore active against
penicillinaseproducing and non-penicillinase-producing staphylococci. It has minimum
inhibitory concentrations in the range of 0.25 to 0.5μg per ml.
Pharmacodynamic effects
Its activity against streptococci such as Streptococcus pneumoniae and Str. pyogenes
is less than that of benzylpenicillin but sufficient to be useful when these organisms
are present with penicillin-resistant staphylococci. It is virtually ineffective against
Enterococcus faecalis.
5.2 Pharmacokinetic properties
After the intramuscular administration of a single 250 or 500mg dose of flucloxacillin
to volunteers, mean peak concentrations of the drug in serum were approximately
10.5 and 16mg.l-1 respectively. Mean urinary excretion of flucloxacillin following its
intramuscular use is 61% of the administered dose.
Absorption
Flucloxacillin may also be administered by intravenous bolus injection or by slow
intravenous infusion. High serum levels of the drug are achieved by these modes
of administration: 30 minutes and 2 hours after a single 500mg intravenous bolus
injection of flucloxacillin the mean serum concentration of the drug was 38 and
7.5mg.l-1, respectively; 30 minutes and 3 hours after a single 1g intravenous bolus
injection of flucloxacillin, the mean serum concentrations were 60 and 4mg.l-1
respectively. The administration of 2g flucloxacillin by intravenous infusion over
20 minutes resulted in mean serum concentrations of 244 and 27.7mg.l-1 15 minutes
and 120 minutes respectively after the end of the infusion.
Elimination
The percentage of a dose of intravenous flucloxacillin recovered in urine in an 8 hour
collection period varies from 60 to 76%.
About 95% of flucloxacillin in the circulation is bound to plasma proteins. Flucloxacillin
has been reported to have a plasma half-life of approximately one hour. The half-life is
prolonged in neonates.
The serum half-life of flucloxacillin in patients with severe kidney disease has been
reported as 135 to 173 minutes. No significant difference in the half-life was found
between patients on or off haemodialysis.
Flucloxacillin is not removed by haemodialysis. Flucloxacillin is metabolised to a limited
extent and the unchanged drug and metabolites are excreted in the urine by glomerular
filtration and renal tubular secretion. Up to 90% of an intramuscular dose is excreted in
the urine within six hours. Only small amounts are excreted in the bile.
Flucloxacillin is unlikely to be excreted in breast milk to any significant extent.
Similarly, placental transfer is unlikely to occur to any appreciable extent.

• Your doctor, nurse or pharmacist will be responsible for storing
and preparing Flucloxacillin Injection before use and for
checking that the vials have not passed their expiry date.
• The medicine should not be used if it shows any signs of
deterioration such as going cloudy.
• Do not store above 25°C
• Once the solution has been diluted 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
protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Flucloxacillin Injection contains
The active substance is flucloxacillin as sodium flucloxacillin
monohydrate.
There are no other ingredients.
What Flucloxacillin Injection looks like and contents of
the pack
Flucloxacillin Injection is a white or almost white powder for
solution for injection/infusion.
Flucloxacillin Injection is available in packs of 10 vials.
Other formats
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print or audio please call, free of charge:
0800 198 5000 (UK Only)
Please be ready to give the following information
Product name
Reference number
Flucloxacillin 250mg
PL 29831/0091
Powder for Solution for
Injection or Infusion
Flucloxacillin 500mg
PL 29831/0092
Powder for Solution for
Injection or Infusion
PL 29831/0093
Flucloxacillin 1g Powder for
Solution for Injection or Infusion
This is a service provided by the Royal National Institute of
Blind People.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Wockhardt UK Ltd,
Ash Road North, Wrexham, LL13 9UF, UK
Manufacturer: CP Pharmaceuticals Ltd,
Ash Road North, Wrexham, LL13 9UF, UK
This leaflet was last revised in 03/2017.
104276/5
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to
those included in other sections.
PHARMACEUTICAL PARTICULARS
6.1 List of excipients
None
6.2 Incompatibilities
Flucloxacillin may be administered in combination with other antibiotics including
ampicillin to produce a wider spectrum of antibacterial activity. If used concurrently with
an aminoglycoside the two antibiotics should not be mixed in the syringe, container
or giving set as precipitation may occur. Flucloxacillin should not be mixed with blood
products or other proteinaceous fluids (e.g. protein hydrolysates) or with intravenous
lipid emulsions.
The following drugs are incompatible with flucloxacillin: amiodarone, atropine sulphate,
buprenorphine, calcium gluconate, chlorpromazine hydrochloride, ciprofloxacin,
clarithromycin, diazepam, dobutamine, hydrochloride, erythromycin lactobionate,
gentamicin sulphate, metoclopramide hydrochloride, morphine sulphate, netilmicin
sulphate, ofloxacin, papaveretum, pethidine hydrochloride, prochlorperazine edisylate,
promethazine hydrochloride, tobramycin and verapamil hydrochloride.
6.3 Shelf life
3 years
The unreconstituted dry powder is stable for 3 years. For the reconstituted solution,
chemical and physical in-use stability has been demonstrated for 24 hours at 2-8°C.
From a microbiological point of view, once opened, the product should be used
immediately. If not used immediately, in-use storage times and conditions prior to
use are the responsibility of the user and would normally not be longer than 24 hours
at 2-8°C, unless reconstitution has taken place in controlled and validated aseptic
conditions.
6.4 Special precautions for storage
Do not store above 25°C
6.5 Nature and contents of container
Flucloxacillin for Injection is supplied in Type II clear glass vials containing 250mg,
500mg or 1g of flucloxacillin equivalent. The vials are closed with a Type I chlorobutyl
rubber stopper, sealed with an aluminium ring. The vials are packed in cartons of
10 vials.
6.6 Special precautions for disposal. None.
7. MARKETING AUTHORISATION HOLDER
Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK
8. MARKETING AUTHORISATION NUMBER(S)
Flucloxacillin for Injection 250mg
- PL 29831/0091 and PA 1339/8/1
Flucloxacillin for Injection 500mg
- PL 29831/0092 and PA 1339/8/2
Flucloxacillin for Injection 1g
- PL 29831/0093 and PA 1339/8/3
9. DATE OF FIR ST AUTHORISATION/RENEWAL OF THE AUTHORISATION
3 March 2008 (UK)
Date of first authorisation:

13 June 2008 (Ireland)
10. DATE OF REVISION OF THE TEXT
March 2017

104276/5

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Customer

Wockhardt UK Limited

Colours Used

Description

Flucloxacillin inj leaflet

Process Black

Item Code

104276/5

Keyline

Profile

n-a

Size

210 x 297mm

Min. Point Size

8.5pt (Main Body) / 6pt (cut off section) / 7pt (Variables)

Market

UK

Language

English

Proof By

MPI

Proof No.

3

Date

08/03/2017

Artwork No.

832855

Pharma
Code

n-a

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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