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CHLORAMPHENICOL 1 G INJECTION

Active substance(s): CHLORAMPHENICOL SODIUM SUCCINATE / CHLORAMPHENICOL SODIUM SUCCINATE / CHLORAMPHENICOL SODIUM SUCCINATE

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Page 3

or are unsuitable. It is also used when oral chloramphenicol cannot be
Package leaflet: Information for the patient
used or when higher amounts of the medicine is needed in the blood.
®
Chloramphenicol prevents bacteria making an essential nutrient
required for growth and multiplication. In time, the number of bacteria
are reduced and the infection is controlled, so that treatment can be
continued using a more gentle antibiotic.
Chloramphenicol sodium succinate equivalent to 1 g chloramphenicol You must talk to a doctor if you do not feel better or if you feel worse.
2. What you need to know before you are given
Powder for solution for injection

Kemicetine
Injection

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
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 only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet:
1. What Kemicetine Injection is and what it is used for
2. What you need to know before you are given Kemicetine Injection
3. How Kemicetine Injection is given to you
4. Possible side effects
5. How to store Kemicetine Injection
6. Contents of the pack and other information

1. What Kemicetine Injection is and what it is
used for

This medicine contains chloramphenicol sodium succinate, which is
an antibiotic used to treat severe infections such as typhoid and
meningitis, and should only be used when other antibiotics do not help

Kemicetine Injection

Do not use Kemicetine Injection:
• If you have had an allergic reaction (e.g. rash, wheezing) to
chloramphenicol before.
• If you are pregnant, or are breast-feeding.
Warnings and precautions:
Talk to your doctor or pharmacist:
• If you have a history of kidney or liver disease.
• If you are already taking any other medicines which may also
cause bone marrow depression.
• If you have a cold, viral influenza, throat infection and before using
this medicine to prevent bacterial infections.
• If you have recently been or are about to be vaccinated.
This medicine is associated with various forms of anaemia (a
decrease in red blood cells, white blood cells and platelets), which in
turn leads to a loss of immunity and can progress into leukaemia. It
should only be prescribed if less toxic antibiotics are not available.
New born babies should be treated with care to avoid Grey Syndrome,
which is a serious condition arising from excessive toxic
chloramphenicol metabolites. Treatment should be terminated as soon
as symptoms are identified.
There is a risk of over-growth of non-susceptible organisms, which

can lead to severe diarrhoea up to a few months after this medicine is
given to the patient.
Other medicines and Kemicetine Injection:
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines, including medicines obtained without
a prescription.
The following medicines interact with Kemicetine Injection, which
affects the way that one or the other medicine works:
• anticoagulants of the coumarin-type (to thin your blood or stop it
clotting), antidiabetic agents (e.g. tolbutamide), anti-epileptic agents
(e.g. phenytoin and phenobarbital) or rifampicin (an antibiotic).
Pregnancy and breast-feeding
If you are pregnant, breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor for advice before being given
this medicine.
Driving and using machines
No effect on the ability to drive or use machinery is expected with
Kemicetine Injection.
Kemicetine Injection contains sodium
This medicinal product contains 71.2 mg sodium per dose. This
should be taken into consideration by patients on a controlled sodium
diet.

3. How Kemicetine Injection is given to you

Kemicetine Injection will be made into a solution and be given to you
by injection into a vein, or into a muscle under the direction of a
medical practitioner. Your doctor will prescribe the required amount
(the dose). The dose is decided by taking into account the severity of
your condition.
Adults:
The usual dosage for adults is; 1g of chloramphenicol every 6-8

Page 1

for signs of toxicity.
Healthcare Professional Information Leaflet
Premature Infants and Neonates: 25 mg/kg in divided doses.
®
In exceptional cases, such as patients with septicaemia or meningitis, dosage schedule up to 100
mg/kg/day may be prescribed. However, these high doses should be decreased as soon as
Chloramphenicol sodium succinate Equivalent to 1 g
clinically indicated. To prevent relapses, treatment should be continued after the temperature has
chloramphenicol Powder for Solution for Injection
returned to normal for 4 days in rickettsial diseases and for 8-10 days in typhoid fever.
The 10 % solution should be given by intravenous injection over a period of about a minute, or in a
large volume of fluid, by slow intravenous infusion. The concurrent administration of intravenous
After parenteral administration chloramphenicol is rapidly released from chloramphenicol sodium
Kemicetine Injection with topical treatment has been found to be very effective in the treatment of
succinate. Kemicetine (chloramphenicol) is a broad spectrum antibiotic and is active against many
osteomyelitic foci, abscesses, empyema and skin and urinary infections.
gram-positive organisms and gram-negative organisms, spirillae and rickettsia. It acts by
Method of administration
interfering with bacterial protein synthesis. Chloramphenicol is widely distributed in body tissues
To be given by intravenous or intramuscular injection.
and fluids and enters the cerebrospinal fluid. Chloramphenicol sodium succinate, free
In order to ensure rapid attainment of high blood levels, Kemicetine Injection is best administered
chloramphenicol and metabolites are excreted in the urine.
After intravenous administration of chloramphenicol succinate every 6 hours elimination half lives by intravenous injection. Where this is not possible, however, intramuscular administration may be
used, although it should be borne in mind that absorption may be slow and unpredictable.
were 4.03 hours for chloramphenicol and 2.65 hours for chloramphenicol succinate. After
intravenous chloramphenicol sodium succinate, steady state peak concentrations were reached The injection should be reconstituted with water for injections, sodium chloride injection, or
on average 18.0 minutes after cessation of the infusion. In infants and children aged 3 days to 16 dextrose injection 5 %.
The following dilution table may be useful for the administration of a proportion of the contents of a
years the apparent half-life was extremely variable ranging from 1.7 to 12.0 hours.
vial:
Indications
Kemicetine Injection should not be used for trivial infections due to the possibility of severe blood
Concentration Solution strength Volume of diluent Total volume after
dyscrasias which may prove fatal. Kemicetine Injection is indicated for typhoid, meningitis caused
to be added
dilution
by H. influenzae and other serious infections caused by bacteria susceptible to chloramphenicol. It 40%
400 mg/ml
1.7 ml
2.5 ml
is also indicated wherever chloramphenicol is deemed the antibiotic of choice and oral
25%
250 mg/ml
3.2 ml
4.0 ml
administration is not possible, or where higher than usual blood concentrations are required.

Kemicetine Injection

less toxic antibiotic is indicated by the results of such tests. The decision to continue use of
chloramphenicol, rather than another antibiotic when both are suggested by in vitro studies to be
effective against a specific pathogen, should be based upon severity of the infection, susceptibility
of the pathogen to the various antimicrobial drugs, and the efficacy of the various drugs in the
infection.
Bone marrow depression and blood disorders
Serious and fatal blood dyscrasias (aplastic anaemia, hypoplastic anaemia, thrombocytopenia,
granulocytopenia, and bone marrow depression) are known to occur after the administration of
chloramphenicol. In addition, there have been reports of aplastic anaemia attributed to
chloramphenicol, which later resulted in leukaemia. Blood dyscrasias have occurred after both
short-term and prolonged therapy with this drug. Chloramphenicol must not be used in the
treatment of any infection for which a less toxic antibiotic is available.

Patient monitoring
Because of its toxic nature it is important to monitor serum levels of this antibiotic particularly in
new-born and premature infants, in the elderly, in patients with renal or hepatic disease and in
those receiving other drugs with which chloramphenicol may interact.
It is essential that adequate haematologic functions be closely monitored during treatment with
chloramphenicol. While haematologic determinations may detect early peripheral haematologic
changes, such as leucopoenia, reticulocytopenia, or granulocytopenia, before they become
irreversible, such determinations cannot be relied on to detect bone marrow depression prior to
the development of aplastic anaemia.
It is desirable that patients be hospitalized during therapy, so that appropriate laboratory
determinations and clinical observations can be made.
Baseline haematologic determinations should be made and determinations repeated
approximately every two days during therapy. The drug should be discontinued upon appearance
20%
200
mg/ml
4.2
ml
5.0
ml
Dosage and administration
of reticulocytopenia, leucopoenia, thrombocytopenia, anaemia, or any other haematologic findings
Contraindications
and
warnings
Posology
attributable to chloramphenicol. However, such determinations do not exclude the possible later
The dose administered and the concentration used is dependent on the severity of the infection. Kemicetine Injection is contraindicated in patients with a previous history of sensitivity and/or toxic appearance of the irreversible type of bone marrow depression.
reactions to chloramphenicol. It is also contraindicated in pregnancy and whilst breast feeding.
Repeated courses of the drug should be avoided if at all possible. Treatment should not be
The recommended standard dosage is as follows:
Kemicetine Injection is to be administered only under the direction of a medical practitioner. It
continued longer than required to produce a cure with little or no risk of relapse of the disease.
Adults: The equivalent of 1 g of chloramphenicol every 6-8 hours.
should be reserved for serious infections caused by organisms susceptible to its antimicrobial
Concurrent therapy with other drugs that may cause bone marrow depression should be avoided.
Elderly: The usual adult dosage should be given subject to normal hepatic and renal function.
effects when less toxic antibiotics are ineffective or contraindicated. However, chloramphenicol
The following may become apparent after chloramphenicol treatment: dryness of the mouth,
Children: The equivalent of 50 mg/kg chloramphenicol, according to body weight, daily in divided may be chosen to initiate antibiotic therapy based on the clinical impression. In vitro sensitivity tests
nausea and vomiting, diarrhoea, urticaria, optic neuritis with blurring or temporary loss of vision,
doses every 6 hours (this dose should not be exceeded). The patient should be carefully observed should be performed concurrently so that the drug may be discontinued as soon as possible if a
peripheral neuritis, headache and depression. Chloramphenicol has been shown to interact with,

Page 2

and enhance the effects of coumarin anticoagulants, some hypoglycaemic agents (e.g.
tolbutamide) and phenytoin. When given concurrently, a dose reduction of these agents may,
therefore, be necessary. Plasma concentration of chloramphenicol may be reduced with
concomitant usage of phenobarbital and rifampicin. Chloramphenicol may impede the
development of immunity and should therefore not be given during active immunisation.

Superinfections
The use of chloramphenicol, as with other antibiotics, may result in an overgrowth of
nonsusceptible organisms, including fungi. If infections caused by nonsusceptible organisms
appear during therapy, appropriate measures should be taken.
Clostridium difficile associated diarrhoea (CDAD) has been reported with use of nearly all
antibacterial agents, including chloramphenicol, and may range in severity from mild diarrhoea to
Hepatic or Renal Impairment
fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to
Excessive chloramphenicol serum levels may result from administration of the recommended
overgrowth of C difficile.
dose to patients with impaired liver or kidney function, including that due to immature metabolic
C. difficile produces toxins A and B which contribute to the development of CDAD.
processes in the infant. Dosage should be adjusted accordingly or, preferably, the serum
Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these
concentration should be determined at appropriate intervals.
infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be
Grey syndrome in infants and neonates
considered in all patients who present with diarrhoea following antibiotic use. Careful medical
Precaution should be used in therapy of premature and full-term neonates to avoid "Grey
history is necessary since CDAD has been reported to occur over two months after the
Syndrome" toxicity. Serum drug levels should be carefully monitored during therapy of the neonate administration of antibacterial agents.
(newborn infant).
Pharmaceutical precautions
Toxic reactions, including fatalities, have occurred in premature infants and neonates. The signs
Keep container in the outer carton.
and symptoms associated with these reactions have been referred to as the "Grey Syndrome".
Although "Grey Syndrome" has been reported in neonates born to mothers after having received Package quantities
chloramphenicol during labour, in most cases therapy with chloramphenicol has been instituted
Individual vials containing Kemicetine Injection equivalent to 1 g chloramphenicol.
within the first 48 hours of life. The following summarizes the clinical and laboratory
POM
determinations that have been made on these patients.
Symptoms first appeared after 3 to 4 days of continued treatment with high doses of
PL 41871/0015
chloramphenicol. The symptoms appeared in the following order: abdominal distension with or
Keep all medicines out of the sight and reach of children.
without emesis, progressive pallid cyanosis, vasomotor collapse, frequently accompanied by
Manufactured by:
irregular respiration, death within a few hours of onset of these symptoms.
Actavis Italy S.p.A ,
The progression of symptoms from onset to death was accelerated with higher dose schedules. 10 Via Pasteur,
Serum drug levels revealed unusually high concentrations of chloramphenicol (over 90 mcg/mL Nerviano,
after repeated doses).
Milan,
Termination of therapy upon early evidence of the associated symptomatology frequently reversed Italy.
the process with complete recovery following.
Marketing Authorisation Holder:
General
Essential Pharma Ltd
Chloramphenicol must not be used in the treatment of trivial infections or where it is not indicated, 7 Egham Business Village,
as in colds, viral influenza, infections of the throat or as a prophylactic agent to prevent bacterial
Crabtree Road,
infections.
Egham, Surrey,

TW20 8RB
UK
This leaflet was last updated: 11/2016.
Kem1gVPFInj/PL/UK/3

Page 4

hours.
Use in children and adolescents:
The usual dose for children is; 50 mg/kg of chloramphenicol daily in
divided doses every 6 hours (no more than this should be given); and
25 mg/kg daily in divided equal doses every 6 hours in new-born and
premature infants.
The doctor may give you more in certain cases e.g. if you have
septicaemia or meningitis (100 mg/kg/day), but should then be
decreased as soon as appropriate. Your doctor will decide how long
you need to be treated for.
During treatment your doctor will carry out blood tests to check that:
• Your blood is functioning properly as Kemicetine Injction can
damage your blood cells.
• Your liver and kidneys are functioning properly as Kemicetine
Injection may affect these organs.
If you are given more Kemicetine Injection than you should
In the case of serious overdosage, charcoal haemoperfusion may be
effective in removing chloramphenicol from your blood.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Tell your doctor immediately if any of the following side effects occur:
• Severe allergic reaction e.g. red raised areas on your skin which
may look like spots or be several inches across, which cause
itchiness.
• Grey Syndrome – usually in new-born or premature infants, where
the skin appears grey, and the infant is listless and weak.
• White blood cell counts (which fight infection) can also drop,
increasing the chance of infections, bruising and fever.
• Anaemia (a low red blood cell count) that can leave you feeling tired

and lethargic.
Other side effects may occur, but, the frequency cannot be estimated
from the available data:
• Dry mouth.
• Nausea (feeling sick), vomiting (being sick) and diarrhoea.
• Headache.
• Depression.
• Inflammation or damage to the nerves causing numbness, tingling,
pain or muscle weakness.
• Blurring, inflammation or temporary loss of vision.
• Chloramphenicol may slow down development of immunity, and
you may develop infections more frequently, which are difficult to
fight off.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any 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.

5. How to store Kemicetine Injection

Your medicine should not be used after the expiry date given on the
vial after EXP. The expiry date refers to the last day of that month.
Keep container in the outer carton. Keep this medicine out of the sight
and reach of children.

6. Contents of the pack and other information
What Kemicetine Injection contains:
The active substance is Chloramphenicol Sodium Succinate. There are
no other ingredients found in Kemicetine Injection.
(See end of Section 2 for further information on sodium).
What Kemicetine Injection looks like and contents of the pack

Kemicetine Injection is available as single glass vials. Each vial
contains a freeze-dried powder containing the equivalent of 1 g
chloramphenicol.
Marketing Authorisation Holder:
Essential Pharma Ltd
7 Egham Business Village
Crabtree Road, Egham
Surrey, TW20 8RB, UK
Manufacturer:
Actavis Italy S.p.A,
10 Via Pasteur,
Nerviano, Milan,
Italy.
This leaflet was last revised in 11/2016.

Kem1gVPFInj/PL/UK/3

Expand Transcript

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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