For the use only of Registered Medical Practitioners or a Hospital or a Laboratory

I.V. AUGMENTIN 300mg (Paediatric) / 600mg/ 1.2g

1. GENERIC NAME

Amoxycillin and Potassium Clavulanate Injection IP 300mg/ 600mg/ 1.2g

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

I.V. AUGMENTIN 300 mg (Paediatric):

Each vial contains:
Amoxycillin Sodium IP (Sterile) 265 mg equivalent to Amoxycillin 250 mg
Potassium Clavulanate IP (Sterile) 60 mg equivalent to Clavulanic Acid 50 mg

I.V. AUGMENTIN 600 mg:

Each vial contains:
Amoxycillin Sodium IP (Sterile) 530 mg equivalent to Amoxycillin 500 mg
Potassium Clavulanate IP (Sterile) 119 mg equivalent to Clavulanic Acid 100 mg

I.V. AUGMENTIN 1.2 g:

Each vial contains:
Amoxycillin Sodium IP (Sterile) 1060 mg equivalent to Amoxycillin 1000 mg
Potassium Clavulanate IP (Sterile) 238 mg equivalent to Clavulanic Acid 200 mg

3. DOSAGE FORM AND STRENGTH

Sterile powder for injection.

4. CLINICAL PARTICULARS

4.1. Therapeutic Indications

AUGMENTIN should be used in accordance with local official antibiotic-prescribing guidelines and local
susceptibility data.

I.V. AUGMENTIN 300mg (Paediatric)/ 600mg/ 1.2g is indicated for short-term treatment of bacterial
infections at the following sites:

Upper respiratory tract infections (including ENT) e.g. recurrent tonsillitis, sinusitis, otitis media.

Lower respiratory tract infections e.g. acute exacerbation of chronic bronchitis, lobar and
bronchopneumonia.

Genito-urinary tract infections e.g. cystitis, urethritis, pyelonephritis.

Skin and soft tissue infections e.g. boils, abscesses, cellulitis, wound infections.

Bone and joint infections e.g. osteomyelitis.

Other infections e.g. intra-abdominal sepsis.

I.V. AUGMENTIN 300mg (Paediatric)/ 600mg/ 1.2g is also indicated for prophylaxis against infection which
may be associated with major surgical procedures such as gastrointestinal, pelvic, head and neck, cardiac,
renal, joint replacement and biliary tract.

Susceptibility to AUGMENTIN will vary with geography and time (see 5 Pharmacological Properties,
Pharmacodynamic Properties for further information). Local susceptibility data should be consulted where
available, and microbiological sampling and susceptibility testing performed where necessary.

Infections caused by amoxycillin-susceptible organisms are amenable to AUGMENTIN treatment due to its
amoxycillin content. Mixed infections caused by amoxycillin-susceptible organisms in conjunction with
AUGMENTIN-susceptible -lactamase producing organisms may therefore be treated with AUGMENTIN.

4.2. Posology and Method of Administration

• Dosage for the treatment of infections

Adults and children over 12 years:

Usually 1.2 g eight hourly. In more serious infections, increase
frequency to six-hourly intervals.
Children 3 months-12 years: Usually 30 mg/kg* AUGMENTIN eight hourly. In more serious
infections, increase frequency to six-hourly intervals.
Children 0-3 months: 30 mg/kg* AUGMENTIN every 12 hours in premature infants and
in full term infants during the perinatal period, increasing to eight
hours thereafter.
* Each 30 mg AUGMENTIN contains 25 mg amoxycillin and 5 mg clavulanate.

• Adult dosage for surgical prophylaxis

The usual dose is 1.2 g I.V. AUGMENTIN given at the induction of anaesthesia. Operations where there is a
high risk of infection, e.g. colorectal surgery, may require three, and up to four, doses of 1.2 g I.V.
AUGMENTIN in a 24-hour period. These doses are usually given at 0, 8, 16 (and 24) hours. This regimen
can be continued for several days if the procedure has a significantly increased risk of infection.

Clear clinical signs of infection at operation will require a normal course of intravenous or oral AUGMENTIN
therapy post-operatively.

Renal Impairment

Adults

Mild impairment Moderate impairment Severe impairment

(creatinine clearance (creatinine clearance (creatinine clearance
>30 ml/min) 10-30 ml/min) <10 ml/min)
No change in dosage 1.2 g IV stat, 1.2 g IV stat, followed by 600 mg IV 24 hourly.
followed by 600 mg Dialysis decreases serum concentrations of
IV 12 hourly AUGMENTIN and an additional 600 mg IV dose may
need to be given during dialysis and at the end of
dialysis

Children

Similar reductions in dosage should be made for children.

Hepatic Impairment

Dose with caution; monitor hepatic function at regular intervals.

Administration

I.V. AUGMENTIN 600 mg/1.2 g may be administered either by intravenous injection or by intermittent
infusion. I.V. AUGMENTIN 600 mg/ 1.2 g is not suitable for intramuscular administration.

I.V. AUGMENTIN 300 mg (Paediatric) may be administered only by intravenous injection. It is not suitable
for intermittent infusion or intramuscular administration.

4.3. Contraindications

AUGMENTIN is contraindicated in patients with a history of hypersensitivity to beta-lactams, e.g. penicillins

and cephalosporins

AUGMENTIN is contraindicated in patients with a previous history of AUGMENTIN-associated

jaundice/hepatic dysfunction.

4.4. Special Warnings and Precautions for Use

Before initiating therapy with AUGMENTIN, careful enquiry should be made concerning previous
hypersensitivity reactions, cephalosporins, or other allergens.

Serious and occasionally fatal hypersensitivity reactions (including anaphylactoid and severe cutaneous
adverse reactions) have been reported in patients on penicillin therapy. These reactions are more likely to
occur in individuals with a history of penicillin hypersensitivity (see 4.3 Contraindications). If an allergic
reaction occurs, AUGMENTIN therapy must be discontinued and appropriate alternative therapy instituted.
Serious anaphylactic reactions require immediate emergency treatment with adrenaline. Oxygen, intravenous
(i.v.) steroids and airway management (including intubation) may also be required.

Changes in liver function tests have been observed in some patients receiving AUGMENTIN. The clinical
significance of these changes is uncertain but AUGMENTIN should be used with caution in patients with
evidence of hepatic dysfunction.

Cholestatic jaundice, which may be severe, but is usually reversible, has been reported rarely. Signs and
symptoms may not become apparent for up to six weeks after treatment has ceased.

In patients with renal impairment AUGMENTIN dosage should be adjusted as recommended in the Posology
and Method of Administration section.

AUGMENTIN should be avoided if infectious mononucleosis is suspected since the occurrence of a

morbilliform rash has been associated with this condition following the use of amoxycillin.

Prolonged use may also occasionally result in overgrowth of non-susceptible organisms.

Pseudomembranous colitis has been reported with the use of antibiotics and may range in severity from mild
to life-threatening. Therefore, it is important to consider its diagnosis in patients who develop diarrhoea during
or after antibiotic use. If prolonged or significant diarrhoea occurs or the patient experiences abdominal
cramps, treatment should be discontinued immediately and the patient investigated further.
Abnormal prolongation of prothrombin time [increased International Normalized Ratio (INR)] has been
reported rarely in patients receiving AUGMENTIN and oral anticoagulants. Appropriate monitoring should
be undertaken when anticoagulants are prescribed concurrently. Adjustments in the dose of oral
anticoagulants may be necessary to maintain the desired level of anticoagulation.

If the parenteral administration of high doses is necessary, the sodium content must be taken into account in
patients on a sodium restricted diet.

In patients with reduced urine output crystalluria has been observed very rarely, predominantly with parenteral
therapy. During administration of high doses of amoxycillin it is advisable to maintain adequate fluid intake
and urinary output in order to reduce the possibility of amoxycillin crystalluria (see 4.9 Overdose).

The presence of clavulanic acid in AUGMENTIN may cause a non-specific binding of IgG and albumin by
red cell membranes leading to a false positive Coombs test.

4.5. Drug Interactions

Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of
amoxycillin. Concomitant use with AUGMENTIN may result in increased and prolonged blood levels of
amoxycillin but not of clavulanate.

Concomitant use of allopurinol during treatment with amoxycillin can increase the likelihood of allergic skin
reactions. There are no data on the concomitant use of AUGMENTIN and allopurinol.

In common with other antibiotics, AUGMENTIN may affect the gut flora, leading to lower oestrogen
reabsorption and reduced efficacy of combined oral contraceptives.

The presence of clavulanic acid in AUGMENTIN may cause a non-specific binding of IgG and albumin by
red cell membranes leading to a false positive Coombs test.

In the literature there are rare cases of increased international normalised ratio in patients maintained on
acenocoumarol or warfarin and prescribed a course of amoxycillin. If co-administration is necessary, the
prothrombin time or international normalised ratio should be carefully monitored with the addition or
withdrawal of AUGMENTIN.

In patients receiving mycophenolate mofetil, reduction in pre-dose concentration of the active metabolite
mycophenolic acid of approximately 50% has been reported following commencement of oral amoxycillin
plus clavulanic acid. The change in pre-dose level may not accurately represent changes in overall MPA
exposure.

4.6. Use in Special Populations

Pregnancy

Reproduction studies in animals (mice and rats) with orally and parenterally administered AUGMENTIN have
shown no teratogenic effects. In a single study in women with preterm, premature rupture of the foetal
membrane (pPROM), it was reported that prophylactic treatment with AUGMENTIN may be associated with
an increased risk of necrotising enterocolitis in neonates. As with all medicines, use should be avoided in
pregnancy, especially during the first trimester, unless considered essential by the physician.

Lactation
AUGMENTIN may be administered during the period of lactation. With the exception of the risk of
sensitisation, associated with the excretion of trace quantities in breast milk, there are no detrimental effects
for the infant.

Renal Impairment

Adults

Mild impairment Moderate impairment Severe impairment

(creatinine clearance (creatinine clearance (creatinine clearance
>30 ml/min) 10-30 ml/min) <10 ml/min)
No change in dosage 1.2 g IV stat., 1.2 g IV stat., followed by 600 mg IV 24 hourly.
followed by 600 mg Dialysis decreases serum concentrations of
IV 12 hourly AUGMENTIN and an additional 600 mg IV dose may
need to be given during dialysis and at the end of
dialysis

Children

Similar reductions in dosage should be made for children.

Hepatic Impairment

Dose with caution; monitor hepatic function at regular intervals.

4.7. Effects on Ability to Drive and Use Machines

Adverse effects on the ability to drive or operate machinery have not been observed.

4.8. Undesirable Effects

Data from large clinical trials were used to determine the frequency of very common to rare undesirable
effects. The frequencies assigned to all other undesirable effects (i.e., those occurring at <1/10,000) were
mainly determined using post-marketing data and refer to a reporting rate rather than a true frequency.

The following convention has been used for the classification of frequency:

Very common ≥ 1/10

Common ≥ 1/100 and < 1/10
Uncommon ≥ 1/1000 and < 1/100
Rare ≥ 1/10,000 and < 1/1000
Very rare < 1/10,000

Infections and infestations:

Common Mucocutaneous candidiasis

Blood and lymphatic system disorders:

Rare Reversible leucopenia (including neutropenia) and thrombocytopenia

Very rare Reversible agranulocytosis and haemolytic anaemia. Prolongation of bleeding time and
prothrombin time

Immune system disorders:

Very rare Angioneurotic oedema, anaphylaxis, serum sickness-like syndrome, hypersensitivity vasculitis

Nervous system disorders:

Uncommon Dizziness, headache

Very rare Aseptic meningitis, convulsions. Convulsions may occur in patients with impaired renal
function or in those receiving high doses.

Vascular disorders

Rare Thrombophlebitis at the site of injection

Gastrointestinal disorders:

Common Diarrhoea

Uncommon Nausea, vomiting, indigestion

Very rare Antibiotic-associated colitis (including pseudomembranous colitis and haemorrhagic

colitis see 4.4 Special Warnings and Precautions for Use) are less likely to occur after
parenteral administration.

Hepatobiliary disorders

Uncommon A moderate rise in AST and/or ALT has been noted in patients treated with beta-lactam
class antibiotics, but the significance of these findings is unknown.

Very rare Hepatitis and cholestatic jaundice. These events have been noted with other penicillins and
cephalosporins.

Hepatic events have been reported predominantly in males and elderly patients and may be associated with
prolonged treatment.

Signs and symptoms usually occur during or shortly after treatment but in some cases may not become
apparent until several weeks after treatment has ceased. These are usually reversible. Hepatic events may be
severe and in extremely rare circumstances, deaths have been reported. These have almost always occurred
in patients with serious underlying disease or taking concomitant medications known to have the potential for
hepatic effects.

Skin and subcutaneous tissue disorders

Uncommon Skin rash, pruritus, urticaria

Rare Erythema multiforme

 Very rare Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative-dermatit is ,
acute generalised exanthemous pustulosis (AGEP), drug reaction with eosinophilia and
systemic symptoms (DRESS)

If any hypersensitivity dermatitis reaction occurs, treatment should be discontinued.

Renal and urinary disorders

Very rare Interstitial nephritis, crystalluria (see 4.9 Overdose)

4.9. Overdose

Gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident.
Gastrointestinal symptoms may be treated symptomatically with attention to the water electrolyte balance.

Amoxycillin crystalluria, in some cases leading to renal failure, has been observed (see 4.4 Special Warnings
and Precautions for Use).

AUGMENTIN can be removed from the circulation by haemodialysis.

Amoxycillin has been reported to precipitate in bladder catheters after intravenous administration of large
doses. A regular check of patency should be maintained.

5. PHARMACOLOGICAL PROPERTIES

5.1. Mechanism of Action

Amoxycillin is a semisynthetic antibiotic with a broad spectrum of antibacterial activity against many gram-
positive and gram-negative micro-organisms. Amoxycillin is, however, susceptible to degradation by beta-
lactamases and therefore the spectrum of activity of amoxycillin alone does not include organisms which
produce these enzymes.

Clavulanic acid is a beta-lactam, structurally related to the penicillins, which possesses the ability to inactivate
a wide range of beta-lactamase enzymes commonly found in micro-organisms resistant to penicillins and
cephalosporins. In particular, it has good activity against the clinically important plasmid mediated beta-
lactamases frequently responsible for transferred drug resistance. It is generally less effective against
chromosomally-mediated type 1 beta-lactamases.

The presence of clavulanic acid in amoxycillin-clavulanate formulations protects amoxycillin from

degradation by beta-lactamase enzymes and effectively extends the antibacterial spectrum of amoxycillin to
include many bacteria normally resistant to amoxycillin and other penicillins and cephalosporins. Thus
amoxycillin-clavulanate possesses the distinctive properties of a broad spectrum antibiotic and a beta-
lactamase inhibitor.

5.2. Pharmacodynamic Properties

Resistance to many antibiotics is caused by bacterial enzymes which destroy the antibiotic before it can act
on the pathogen. The clavulanate in AUGMENTIN anticipates this defence mechanism by blocking the ß-
lactamase enzymes, thus rendering the organisms susceptible to amoxycillin’s rapid bactericidal effect at
concentrations readily attainable in the body.
Clavulanate by itself has little antibacterial activity; however, in association with amoxycillin as
AUGMENTIN it produces an antibiotic agent of broad spectrum with wide application in hospital and general
practice.

In the list below, organisms are categorised according to their in vitro susceptibility to AUGMENTIN.

In vitro susceptibility of micro-organisms to AUGMENTIN

Where clinical efficacy of AUGMENTIN has been demonstrated in clinical trials this is
indicated with an asterisk (*).

Organisms that do not produce beta-lactamase are identified (with †). If an isolate is
susceptible to amoxycillin, it can be considered susceptible to AUGMENTIN.

Commonly susceptible species

Gram-positive aerobes:
Bacillius anthracis
Enterococcus faecalis
Gardnerella vaginalis
Listeria monocytogenes
Nocardia asteroides
Streptococcus pneumoniae* †
Streptococcus pyogenes*†
Streptococcus agalactiae* †
Viridans group streptococcus†
Streptococcus spp. (other β-hemolytic)*†
Staphylococcus aureus (methicillin susceptible)*
Staphylococcus saprophyticus (methicillin susceptible)
Coagulase negative staphylococcus (methicillin susceptible)
Gram-negative aerobes:
Bordetella pertussis
Haemophilus influenzae*
Haemophilus parainfluenzae
Helicobacter pylori
Moraxella catarrhalis*
Neisseria gonorrhoeae
Pasteurella multocida
Vibrio cholerae
Other:
Borrelia burgdorferi
Leptospira ictterohaemorrhagiae
Treponema pallidum
Gram positive anaerobes:
Clostridium spp.
Peptococcus niger
Peptostreptococcus magnus
Peptostreptococcus micros
Peptostreptococcus spp.
Gram-negative anaerobes:
Bacteroides fragilis
Bacteroides spp.
 Capnocytophaga spp.
Eikenella corrodens
Fusobacterium nucleatum
Fusobacterium spp.
Porphyromonas spp.
Prevotella spp.
Species for which acquired resistance may be a problem
Gram-negative aerobes:
Escherichia coli*
Klebsiella oxytoca
Klebsiella pneumoniae*
Klebsiella spp.
Proteus mirabilis
Proteus vulgaris
Proteus spp.
Salmonella spp.
Shigella spp.
Gram-positive aerobes:
Corynebacterium spp.
Enterococcus faecium
Inherently resistant organisms
Gram-negative aerobes:
Acinetobacter spp.
Citrobacter freundii
Enterobacter spp.
Hafnia alvei
Legionella pneumophila
Morganella morganii
Providencia spp.
Pseudomonas spp.
Serratia spp.
Stenotrophomas maltophilia
Yersinia enterolitica
Others:
Chlamydia pneumoniae
Chlamydia psittaci
Chlamydia spp.
Coxiella burnetti
Mycoplasma spp.

5.3. Pharmacokinetic Properties

The pharmacokinetics of the two components of AUGMENTIN are closely matched. Both clavulanate and
amoxycillin have low levels of serum binding; about 70% remains free in the serum.

Doubling the dosage of AUGMENTIN approximately doubles the serum levels achieved.

6. NONCLINICAL PROPERTIES

6.1. Animal Toxicology and Pharmacology

 No further information of relevance.

7. DESCRIPTION

General Description

AUGMENTIN (beta-lactam antibacterial penicillin coformulated with a beta- lactamase inhibitor) is an

antibiotic agent with a notably broad spectrum of activity against the commonly occurring bacterial pathogens
in general practice and hospital. The beta-lactamase inhibitory action of clavulanate extends the spectrum of
amoxycillin to embrace a wider range of organisms, including many resistant to other beta-lactam antibiotics.
Chemical Structure

AUGMENTIN is a coformulation of amoxycillin trihydrate and potassium clavulanate.

Amoxycillin trihydrate

Chemical name (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl) acetamido]-3,3-

dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid
trihydrate.
Structural formula

Molecular formula C16H19N3O5 S·3H2O

Relative molecular mass 365.4 (anhydrous)

419.4 (trihydrate form)

Potassium clavulanate

Chemical name Potassium (Z)-(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-

oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate.
Structural formula

Molecular formula C8H8NO5K

Relative molecular mass 237.3 (as the potassium salt)

199.2 (as the free acid)

Excipients: None.

8. PHARMACEUTICAL PARTICULARS
8.1. Incompatibilities

I.V. AUGMENTIN 300mg (Paediatric) / 600mg/ 1.2g should not be mixed with blood products, other
proteinaceous fluids such as protein hydrolysates or with intravenous lipid emulsions.

If AUGMENTIN is prescribed concurrently with an aminoglycoside, the antibiotics should not be mixed in
the syringe, intravenous fluid container or giving set because loss of activity of the aminoglycoside can
occur under these conditions.

8.2. Shelf Life

The expiry date is indicated on the label and packaging.

8.3. Packaging Information

Clear glass vial in a carton.

All presentations may not be marketed in the country.

8.4. Storage and Handling Information

300 mg vial: Store at a temperature between 2°C to 8°C.

600 mg vial: Store at a temperature not exceeding 25°C.

1.2 g vial: Store at a temperature not exceeding 25°C.

Use immediately after reconstitution. Do not freeze.

Keep out of reach of children.

SINGLE USE VIAL ONLY

300 mg vial: To reconstitute dissolve in 5 ml sterile Water for Injections IP (Final volume 5.25 ml)

600 mg vial: To reconstitute dissolve in 10 ml sterile Water for Injections IP (Final volume 10.5 ml)

1.2 g vial: To reconstitute dissolve in 20 ml sterile Water for Injections IP (Final volume 20.9 ml)

A transient pink coloration may or may not appear during reconstitution. Reconstituted solutions are normally
colourless or a pale, straw colour.

Intravenous Injection:

The stability of I.V. AUGMENTIN 300mg (Paediatric) / 600mg/ 1.2g solution is concentration dependent,
thus I.V. AUGMENTIN 300mg (Paediatric) / 600mg/ 1.2g should be used immediately upon reconstitution
and given by slow intravenous injection over a period of 3-4 minutes. I.V. AUGMENTIN 300mg (Paediatric)
/ 600mg/ 1.2g solutions should be used within 20 minutes of reconstitution. AUGMENTIN may be injected
directly into a vein or via a drip tube.

Intravenous Infusion:
Alternatively, I.V. AUGMENTIN 600 mg and 1.2 gm may be infused in Water for Injections IP or Sodium
Chloride Intravenous Injection IP (0.9% w/v). Add, without delay*, 600 mg reconstituted solution to 50 ml
infusion fluid or 1.2 g reconstituted solution to 100 ml infusion fluid (e.g. using a minibag or in-line burette).
Infuse over 30-40 minutes and complete within four hours of reconstitution. For other appropriate infusion
fluids, see Stability and Compatibility section.

*Solutions should be made up to full infusion volume immediately after reconstitution.

Any residual antibiotic solutions should be discarded.

Therapy can be started parenterally and continued with an oral preparation. Treatment should not be extended
beyond 14 days without review.

Stability and Compatibility

Intravenous infusions of I.V. AUGMENTIN 600 mg and 1.2 gm may be given in a range of different
intravenous fluids. Satisfactory antibiotic concentrations are retained at 5°C and at room temperature (25°C)
in the recommended volume of the following infusion fluids. If reconstituted and maintained at room
temperature, infusions should be completed within the times stated.

Intravenous infusion fluids Stability period at 25°C

Water for Injections IP 4 hours

Sodium Chloride Intravenous Infusion IP 4 hours

(0.9% w/v)
Sodium Lactate Intravenous Infusion IP 4 hours
(one-sixth molar)
Compound Sodium Chloride Intravenous 3 hours
Infusion IP (Ringer's Solution)
Compound Sodium Lactate Intravenous 3 hours
Infusion IP (Ringer-Lactate Solution;
Hartmann's Solution)
Potassium Chloride and Sodium Chloride 3 hours
Intravenous Infusion IP

Reconstituted solutions should not be frozen.

I.V. AUGMENTIN 600 mg and 1.2 gm is less stable in infusions containing glucose, dextran or bicarbonate.
Reconstituted solutions of I.V. AUGMENTIN 600 mg and 1.2 gm should therefore not be added to such
infusions but may be injected into the drip tubing over a period of 3-4 minutes.

For storage at 5°C, the reconstituted solution should be added to pre-refrigerated infusion bags which can be
stored for up to 8 hours. Thereafter, the infusion should be administered immediately after reaching room
temperature.

Intravenous infusion fluids Stability period at 5°C

Water for Injections IP 8 hours
 Sodium Chloride Intravenous Infusion IP 8 hours
(0.9% w/v)

9. PATIENT COUNSELLING INFORMATION

Registered Medical Practitioners may counsel their patients about the Special Warnings and Precautions for
Use, Drug Interactions, Undesirable Effects, and any relevant contra-indications of I.V. AUGMENTIN 300mg
(Paediatric) / 600mg/ 1.2g. Patients may also be informed about Posology, Method of Administration and
Storage/Handling Information as applicable.

10. DETAILS OF MANUFACTURER

The Manufacturing Site details are mentioned on the label and packaging.

For further information, please contact:

GlaxoSmithKline Pharmaceuticals Limited.
Registered Office:
Dr. Annie Besant Road, Worli,
Mumbai 400 030, India.

11. DETAILS OF PERMISSION OR LICENSE NUMBER WITH DATE

Manufacturing License number is indicated on the label and packaging.

12. DATE OF REVISION

23 October 2019

Trade marks are owned by or licensed to the GSK group of companies.

Version: AUG-IV/PI/IN/2019/01

Adapted from Augmentin IV GDS version 31 / IPI version 12 dated 13 June 2019.