Treatment of influenza
In patients one year of age and older who present with symptoms typical of influenza, when
influenza virus is circulating in the community. Efficacy has been demonstrated when treatment is
initiated within two days of first onset of symptoms. This indication is based on clinical studies of
naturally occurring influenza in which the predominant infection was influenza A
Oselta is indicated for the treatment of infants less than 1 year of age during a pandemic influenza
outbreak
The treating physician should take into account the pathogenicity of the circulating strain and the
underlying condition of the patient to ensure there is a potential benefit to the child.
Prevention of influenza

- Post-exposure prevention in individuals 1 year of age or older following contact with a clinically
diagnosed influenza case when influenza virus is circulating in the community.
- The appropriate use of Oselta for prevention of influenza should be determined on a case by case
basis by the circumstances and the population requiring protection. In exceptional situations (e.g.
in case of a mismatch between the circulating and vaccine virus strains, and a pandemic situation)
seasonal prevention could be considered in individuals one year of age or older.
- Oselta is indicated for post-exposure prevention of influenza in infants less than 1 year of age
during a pandemic influenza outbreak
Oselta is not a substitute for influenza vaccination.
The use of antivirals for the treatment and prevention of influenza should be determined on the
basis of official recommendations. Decisions regarding the use of Oseltamivir for treatment and
prophylaxis should take into consideration what is known about the characteristics of the
circulating influenza viruses, available information on influenza drug susceptibility patterns for
each season and the impact of the disease in different geographical areas and patient populations

Posology
Adults, and adolescents 13 years and over
Treatment: The recommended oral dose is 75 mg Oseltamivir twice daily for 5 days for
adolescents (13 to 17 years of age) and adults.
Body Weight Recommended dose for 5 days
> 40 kg 75 mg twice daily

Treatment should be initiated as soon as possible within the first two days of onset of symptoms
of influenza.
Post-exposure prevention: The recommended dose for prevention of influenza following close
contact with an infected individual is 75 mg Oseltamivir once daily for 10 days for adolescents
(13 to 17 years of age) and adults.
Body Weight Recommended dose for 10 days
> 40 kg 75 mg once daily
Therapy should begin as soon as possible within two days of exposure to an infected individual.
Prevention during an influenza epidemic in the community: The recommended dose for
prevention of influenza during a community outbreak is 75 mg Oseltamivir once daily for up to 6
weeks.
Children 1 to 12 years
Oselta 30 mg, 45 mg and 75 mg capsules and oral suspension are available for infants and
children 1 year of age or older
Treatment: The following weight-adjusted dosing regimens are recommended for treatment of
infants and children 1 year of age or older:
Body Weight Recommended dose for 5 days
10 kg to 15 kg 30 mg twice daily
> 15 kg to 23 kg 45 mg twice daily
> 23 kg to 40 kg 60 mg twice daily

> 40 kg 75 mg twice daily
Treatment should be initiated as soon as possible within the first two days of onset of symptoms
of influenza.
Post-exposure prevention: The recommended post-exposure prevention dose of Oselta is:
Body Weight Recommended dose for 10 days
10 kg to 15 kg 30 mg once daily
> 15 kg to 23 kg 45 mg once daily
> 23 kg to 40 kg 60 mg once daily
> 40 kg 75 mg once daily
Prevention during an influenza epidemic in the community: Prevention during an influenza
epidemic has not been studied in children below 12 years of age.
For infants below 1 year of age
In the absence of a suitable formulation, a pharmacy compounded preparation should
preferentially be used as the syringe provided in the Oselta 12 mg/ml powder for oral suspension
pack (with mg markings) does not allow for appropriate dose adjustments and commercially
available syringes (with ml markings) may lead to unacceptable dosing inaccuracies.
Treatment: The recommended treatment dose for infants less than 1 year of age is between 2
mg/kg twice daily and 3 mg/kg twice daily during a pandemic influenza outbreak. This is based
upon limited pharmacokinetic and safety data indicating that these doses provide plasma drug
exposures in the majority of patients similar to those shown to be clinically efficacious in older
children and adults. The following age-adjusted dosing regimens are recommended for treatment
of infants below 1 year of age:

Age Recommended dose for 5 days
0 to 1 month* 2 mg/kg twice daily
> 1 month to 3 months 2.5 mg/kg twice daily
> 3 months to 12 months 3 mg/kg twice daily
* There is no data available regarding the administration of Oselta to infants less than one month
of age.
Treatment should be initiated as soon as possible within the first two days of onset of symptoms
of influenza.
These age-based dosing recommendations are not intended for premature infants, i.e. those with a
postmenstrual age less than 37 weeks. Insufficient data are available for these patients, in whom
different dosing may be required due to the immaturity of physiological functions.
Post-exposure prevention: The recommended prophylaxis dose for infants less than 1 year of age
during a pandemic influenza outbreak is half of the daily treatment dose. This is based upon
clinical data in infants and children 1 year of age or older and adults showing that a prophylaxis
dose equivalent to half the daily treatment dose is clinically efficacious for the prevention of
influenza. The following age-adjusted dosing prophylaxis regimens are recommended for infants
below 1 year of age:
Age Recommended dose for 10 days
0 to 1 month* 2 mg/kg once daily
> 1 month to 3 months 2.5 mg/kg once daily
> 3 months to 12 months 3 mg/kg once daily
* There is no data available regarding the administration of Oselta to infants less than one month

of age.
These age-based dosing recommendations are not intended for premature infants, i.e. those with a
postmenstrual age less than 37 weeks. Insufficient data are available for these patients, in whom
different dosing may be required due to the immaturity of physiological functions.
For instructions on preparing the extemporaneous formulation, see section 6.6.
Special populations
Hepatic impairment
No dose adjustment is required either for treatment or for prevention in patients with hepatic
dysfunction. No studies have been carried out in paediatric patients with hepatic disorder.
Renal impairment
Treatment of influenza: Dose adjustment is recommended for adults and adolescents (13 to 17
years of age) with moderate or severe renal impairment. Recommended doses are detailed in the
table below.
Creatinine clearance Recommended dose for treatment
> 60 (ml/min) 75 mg twice daily
> 30 to 60 (ml/min) 30 mg (suspension or capsules) twice daily
> 10 to 30 (ml/min) 30 mg (suspension or capsules) once daily
≤ 10 (ml/min) Not recommended (no data available)
Haemodialysis patients 30 mg after each haemodialysis session
Peritoneal dialysis patients* 30 mg (suspension or capsules) single dose

* Data derived from studies in continuous ambulatory peritoneal dialysis (CAPD) patients; the
clearance of Oseltamivir carboxylate is expected to be higher when automated peritoneal dialysis
(APD) mode is used. Treatment mode can be switched from APD to CAPD if considered
necessary by a nephrologist.
Prevention of influenza: Dose adjustment is recommended for adults and adolescents (13 to 17
years of age) with moderate or severe renal impairment as detailed in the table below.
Creatinine clearance Recommended dose for prevention
> 60 (ml/min) 75 mg once daily
> 30 to60 (ml/min) 30 mg (suspension or capsules) once daily
> 10 to 30 (ml/min) 30 mg (suspension or capsules) every second
day
≤ 10 (ml/min) Not recommended (no data available)
Haemodialysis patients 30 mg after every second haemodialysis
session
Peritoneal dialysis patients* 30 mg (suspension or capsules) once weekly
* Data derived from studies in continuous ambulatory peritoneal dialysis (CAPD) patients; the
clearance of Oseltamivir carboxylate is expected to be higher when automated peritoneal dialysis
(APD) mode is used. Treatment mode can be switched from APD to CAPD if considered
necessary by a nephrologist.
There is insufficient clinical data available in infants and children (12 years of age and younger)
with renal impairment to be able to make any dosing recommendation.
Elderly No dose adjustment is required, unless there is evidence of moderate or severe renal impairment.
Immunocompromised patients
Longer duration of seasonal prophylaxis up to 12 weeks has been evaluated in
immunocompromised patients
Method of administration
Oral use.
Adults, adolescents (13 to 17 years of age) or infants and children (1 year of age or older) who are
unable to swallow capsules may receive appropriate doses of Oselta suspension.

Oseltamivir is effective only against illness caused by influenza viruses. There is no evidence for
efficacy of Oseltamivir in any illness caused by agents other than influenza viruses.
Oselta is not a substitute for influenza vaccination. Use of Oselta must not affect the evaluation of
individuals for annual influenza vaccination. The protection against influenza lasts only as long as
Oselta is administered. Oselta should be used for the treatment and prevention of influenza only
when reliable epidemiological data indicate that influenza virus is circulating in the community.
Susceptibility of circulating influenza virus strains to Oseltamivir has been shown to be highly
variable. Therefore, prescribers should take into account the most recent information available on
Oseltamivir susceptibility patterns of the currently circulating viruses when deciding whether to use Oselta .
Severe concomitant condition
No information is available regarding the safety and efficacy of Oseltamivir in patients with any
medical condition sufficiently severe or unstable to be considered at imminent risk of requiring
hospitalisation.
Immunocompromised patients
The efficacy of Oseltamivir in either treatment or prophylaxis of influenza in
immunocompromised patients has not been firmly established.
Cardiac / respiratory disease
Efficacy of Oseltamivir in the treatment of subjects with chronic cardiac disease and/or respiratory
disease has not been established. No difference in the incidence of complications was observed
between the treatment and placebo groups in this population.
Paediatric population
No data allowing a dose recommendation for premature children (< 37 weeks post-menstrual
age*) are currently available.
* Time between first day of last normal menstrual period and day of assessment, gestational age
plus post-natal age.
Severe renal impairment
Dose adjustment is recommended for both treatment and prevention in adolescents (13 to 17 years of age) and adults with severe renal impairment. There is insufficient clinical data available in
infants and children (1 year of age or older) with renal impairment to be able to make any dosing
recommendation.
Neuropsychiatric events
Neuropsychiatric events have been reported during administration of Oselta in patients with
influenza, especially in children and adolescents. These events are also experienced by patients
with influenza without Oseltamivir administration. Patients should be closely monitored for
behavioral changes, and the benefits and risks of continuing treatment should be carefully
evaluated for each patient.

Pharmacokinetic properties of Oseltamivir, such as low protein binding and metabolism
independent of the CYP450 and glucuronidase systems (see section 5.2), suggest that clinically
significant drug interactions via these mechanisms are unlikely.
Probenecid
No dose adjustment is required when co-administering with probenecid in patients with normal
renal function. Co-administration of probenecid, a potent inhibitor of the anionic pathway of renal
tubular secretion, results in an approximate 2-fold increase in exposure to the active metabolite of
Oseltamivir.
Amoxicillin
Oseltamivir has no kinetic interaction with amoxicillin, which is eliminated via the same pathway,
suggesting that Oseltamivir interaction with this pathway is weak.

Renal elimination
Clinically important drug interactions involving competition for renal tubular secretion are
unlikely, due to the known safety margin for most of these substances, the elimination
characteristics of the active metabolite (glomerular filtration and anionic tubular secretion) and the
excretion capacity of these pathways. However, care should be taken when prescribing
Oseltamivir in subjects when taking co-excreted agents with a narrow therapeutic margin (e.g.
chlorpropamide, methotrexate, phenylbutazone).
Additional information
No pharmacokinetic interactions between Oseltamivir or its major metabolite have been observed
when co-administering Oseltamivir with paracetamol, acetylsalicylic acid, cimetidine, antacids
(magnesium and aluminium hydroxides and calcium carbonates), rimantadine or warfarin (in
subjects stable on warfarin and without influenza).

Pregnancy
While no controlled clinical studies have been conducted on the use of Oseltamivir in pregnant
women, there is limited data available from post-marketing and retrospective observational
surveillance reports. These data in conjunction with animal studies do not indicate direct or
indirect harmful effects with respect to pregnancy, embryonal/foetal or postnatal development.
Pregnant women may receive Oselta, after considering the available safety information, the
pathogenicity of the circulating influenza virus strain and the underlying condition of the pregnant
woman.

Breastfeeding
In lactating rats, Oseltamivir and the active metabolite are excreted in milk. Very limited
information is available on children breast-fed by mothers taking Oseltamivir and on excretion of
Oseltamivir in breast milk. Limited data demonstrated that Oseltamivir and the active metabolite
were detected in breast milk, however the levels were low, which would result in a subtherapeutic
dose to the infant. Considering this information, the pathogenicity of the circulating influenza
virus strain and the underlying condition of the breastfeeding woman, administration of
Oseltamivir may be considered, where there are clear potential benefits to breastfeeding mothers.
Fertility
Based on preclinical data, there is no evidence that Oselta has an effect on male or female
fertility.

Oselta has no influence on the ability to drive and use machines.

Summary of the safety profile
The overall safety profile of Oselta is based on data from 6049 adult/adolescent and 1473
paediatric patients treated with Oselta or placebo for influenza, and on data from 3990
adult/adolescent and 253 paediatric patients receiving Oselta or placebo/no treatment for the
prophylaxis of influenza in clinical trials. In addition, 475 immunocompromised patients
(including 18 children, of these 10 Oselta and 8 placebos) received Oselta or placebo for the
prophylaxis of influenza.
In adults/adolescents, the most commonly reported adverse reactions (ARs) were nausea and vomiting in the treatment studies, and nausea in the prevention studies. The majority of these ARs
were reported on a single occasion on either the first or second treatment day and resolved
spontaneously within 1-2 days. In children, the most commonly reported adverse reaction was
vomiting. In the majority of patients, these ARs did not lead to discontinuation of Oselta.
The following serious adverse reactions have been rarely reported since Oseltamivir has been
marketed: Anaphylactic and anaphylactoid reactions, hepatic disorders (fulminant hepatitis,
hepatic function disorder and jaundice), angioneurotic oedema, Stevens-Johnson syndrome and
toxic epidermal necrolysis, gastrointestinal bleeding and neuropsychiatric disorders.
(Regarding neuropsychiatric disorders, see section 4.4.)
Tabulated list of adverse reactions
The ARs listed in the tables below fall into the following categories: Very common (≥1/10),
common (≥1/100 to < 1/10), uncommon (≥1/1,000 to < 1/100), rare (≥1/10,000 to < 1/1,000), and
very rare (< 1/10,000). ARs are added to the appropriate category in the tables according to the
pooled analysis from clinical studies.
Treatment and prevention of influenza in adults and adolescents:
In adult/adolescent treatment and prevention studies, ARs that occurred the most frequently at the
recommended dose (75 mg bid for 5 days for treatment and 75 mg od for up to 6 weeks for
prophylaxis) are shown in Table 1.
The safety profile reported in subjects who received the recommended dose of Oselta for
prophylaxis (75 mg once daily for up to 6 weeks) was qualitatively similar to that seen in the
treatment studies, despite a longer duration of dosing in the prophylaxis studies.

Table 1 Adverse reactions in studies investigating Oselta for treatment and prevention of
influenza in adults and adolescents or through post-marketing surveillance
System Organ
Class (SOC)
Adverse reactions according to frequency
Very common Common Uncommon Rare
Infections and
infestations
Bronchitis,
Herpes simplex,
Nasopharyngitis,
Upper respiratory
tract infections,
Sinusitis
Blood and
lymphatic
system disorders
Thrombocytopenia
Immune system
disorders
Hypersensitivity
reaction
Anaphylactic
reactions,
Anaphylactoid
reactions
Psychiatric
disorders
Agitation,
Abnormal
behaviour,
Anxiety,
Confusion,
Delusions,
Delirium,
Hallucination,
Nightmares, Selfinjury
Nervous system
disorders
Headache Insomnia Altered level of
consciousness,
Convulsion
Eye disorders Visual disturbance 

Cardiac
disorders
Cardiac
arrhythmia
Respiratory,
thoracic and
mediastinal
disorders
Cough, Sore
throat,
Rhinorrhea
Gastrointestinal
disorders
Nausea Vomiting
Abdominal pain
(incl. upper
abdominal pain),
Dyspepsia
Gastrointestinal
bleedings,
Haemorrhagic
colitis
Hepatobiliary
disorders
Elevated liver
enzymes
Fulminant
hepatitis, Hepatic
failure, Hepatitis
Skin and
subcutaneous
tissue disorders
Eczema,
Dermatitis, Rash,
Urticaria
Angioneurotic
oedema, Erythema
multiforme,
Stevens-Johnson
syndrome, Toxic
epidermal
necrolysis
General
disorders and
administration
site conditions
Pain
Dizziness (incl.
vertigo), Fatigue,
Pyrexia, Pain in
limb

Treatment and prevention of influenza in children:
A total of 1473 children (including otherwise healthy children aged 1-12 years old and asthmatic
children aged 6-12 years old) participated in clinical studies of Oseltamivir given for the treatment
of influenza. Of those, 851 children received treatment with Oseltamivir suspension. A total of

158 children received the recommended dose of Oselta once daily in a post-exposure prophylaxis
study in households (n = 99), a 6-week paediatric seasonal prophylaxis study (n = 49) and a 12-
week paediatric seasonal prophylaxis study in immunocompromised subjects (n = 10).
Table 2 shows the most frequently reported ARs from paediatric clinical trials.
Table 2 Adverse reactions in studies investigating Oselta for treatment and prevention of
influenza in children (age/weight-based dosing [30 mg to 75 mg o.d.])
System Organ
Class (SOC)
Adverse reactions according to frequency
Very common Common Uncommon Rare
Infections and
infestations
Otitis media,
Nervous system
disorders
Headache
Eye disorders: Conjunctivitis
(including red
eyes, eye
discharge and eye
pain)
Ear and
labyrinth
disorders:
Earache Tympanic
membrane
disorder
Respiratory,
thoracic and
mediastinal
disorders
Cough, Nasal
congestion
Rhinorrhoea
Gastrointestinal
disorders
Vomiting Abdominal pain
(incl. upper
abdominal pain),
Dyspepsia,
Nausea

Skin and
subcutaneous
tissue disorders
Dermatitis
(including
allergic and
atopic dermatitis)

Description of selected adverse reactions
Psychiatric disorders and nervous system disorders
Influenza can be associated with a variety of neurologic and behavioural symptoms which can
include events such as hallucinations, delirium, and abnormal behaviour, in some cases resulting
in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can
occur without obvious severe disease.
In patients with influenza who were receiving Oselta , there have been postmarketing reports of
convulsions and delirium (including symptoms such as altered level of consciousness, confusion,
abnormal behaviour, delusions, hallucinations, agitation, anxiety, nightmares), in a very few cases
resulting in self-injury or fatal outcomes. These events were reported primarily among paediatric
and adolescent patients and often had an abrupt onset and rapid resolution. The contribution of
Oselta to those events is unknown. Such neuropsychiatric events have also been reported in
patients with influenza who were not taking Oselta .
Hepato-biliary disorders
Hepato-biliary system disorders, including hepatitis and elevated liver enzymes in patients with
influenza-like illness. These cases include fatal fulminant hepatitis/hepatic failure.
Other special populations
Paediatric population (infants less than one year of age)

Safety information available on Oseltamivir administered for treatment of influenza in infants less
than one year of age from prospective and retrospective observational studies (comprising
together more than 2,400 infants of that age class), epidemiological databases research and
postmarketing reports suggest that the safety profile in infants less than one year of age is similar
to the established safety profile of children aged one year and older.
Elderly patients and patients with chronic cardiac and/or respiratory disease
The population included in the influenza treatment studies is comprised of otherwise healthy
adults/adolescents and patients “at risk” (patients at higher risk of developing complications
associated with influenza, e.g. elderly patients and patients with chronic cardiac or respiratory
disease). In general, the safety profile in the patients “at risk” was qualitatively similar to that in
otherwise healthy adults/adolescents.
Immunocompromised patients
In a 12-week prophylaxis study in 475 immunocompromised patients, including 18 children 1 to
12 years of age and older, the safety profile in the 238 patients who received Oseltamivir was
consistent with that previously observed in Oselta prophylaxis clinical studies.
Children with pre-existing bronchial asthma
In general, the adverse reaction profile in children with pre-existing bronchial asthma was
qualitatively similar to that of otherwise healthy children.

Reports of overdoses with Oselta have been received from clinical trials and during postmarketing
experience. In the majority of cases reporting overdose, no adverse events were reported.
Adverse events reported following overdose were similar in nature and distribution to those
observed with therapeutic doses of Oselta, described in section 4.8 Undesirable effects.
No specific antidote is known.
Paediatric population
Overdose has been reported more frequently for children than adults and adolescents. Caution
should be exercised when preparing Oselta oral suspension and when administering Oselta
products to children.

Pharmacotherapeutic group: Antivirals for systemic use, neuraminidase inhibitors ATC code:
J05AH02
Oseltamivir phosphate is a pro-drug of the active metabolite (Oseltamivir carboxylate). The active
metabolite is a selective inhibitor of influenza virus neuraminidase enzymes, which are
glycoproteins found on the virion surface. Viral neuraminidase enzyme activity is important both
for viral entry into uninfected cells and for the release of recently formed virus particles from
infected cells, and for the further spread of infectious virus in the body.
Oseltamivir carboxylate inhibits influenza A and B neuraminidases in vitro. Oseltamivir
phosphate inhibits influenza virus infection and replication in vitro. Oseltamivir given orally
inhibits influenza A and B virus replication and pathogenicity in vivo in animal models of
influenza infection at antiviral exposures similar to that achieved in man with 75 mg twice daily.

Antiviral activity of Oseltamivir was supported for influenza A and B by experimental challenge
studies in healthy volunteers.
Neuraminidase enzyme IC50 values for Oseltamivir for clinically isolated influenza A ranged
from 0.1 nM to 1.3 nM, and for influenza B was 2.6 nM. Higher IC50 values for influenza B, up
to a median of 8.5 nM, have been observed in published studies.
Clinical studies
Treatment of influenza infection
Oseltamivir is effective only against illnesses caused by influenza virus. Statistical analyses are
therefore presented only for influenza-infected subjects. In the pooled treatment study population,
which included both influenza-positive and -negative subjects (ITT), primary efficacy was
reduced proportionally to the number of influenza-negative individuals. In the overall treatment
population, influenza infection was confirmed in 67 % (range 46 % to 74 %) of the recruited
patients. Of the elderly subjects, 64 % were influenza-positive and of those with chronic cardiac
and/or respiratory disease 62 % were influenza-positive. In all phase III treatment studies, patients
were recruited only during the period in which influenza was circulating in the local community.
Adults and adolescents 13 years of age and older: Patients were eligible if they reported within 36
hours of onset of symptoms, had fever ≥ 37.8 °C, accompanied by at least one respiratory
symptom (cough, nasal symptoms or sore throat) and at least one systemic symptom (myalgia,
chills/sweats, malaise, fatigue or headache). In a pooled analysis of all influenza-positive adults
and adolescents (N = 2,413) enrolled into treatment studies, Oseltamivir 75 mg twice daily for 5
days reduced the median duration of influenza illness by approximately one day from 5.2 days (95
% CI 4.9 – 5.5 days) in the placebo group to 4.2 days (95 % CI 4.0 – 4.4 days; p ≤ 0.0001).
The proportion of subjects who developed specified lower respiratory tract complications (mainly bronchitis) treated with antibiotics was reduced from 12.7 % (135/1,063) in the placebo group to
8.6 % (116/1,350) in the Oseltamivir treated population (p = 0.0012).
Treatment of influenza in high risk populations: The median duration of influenza illness in
elderly subjects (≥ 65 years) and in subjects with chronic cardiac and/or respiratory disease
receiving Oseltamivir 75 mg twice daily for 5 days was not reduced significantly. The total
duration of fever was reduced by one day in the groups treated with oseltamivir. In the influenzapositive
elderly, Oseltamivir significantly reduced the incidence of specified lower respiratory
tract complications (mainly bronchitis) treated with antibiotics from 19 % (52/268) in the placebo
group to 12 % (29/250) in the Oseltamivir treated population (p = 0.0156).
In influenza-positive patients with chronic cardiac and/or respiratory disease, the combined
incidence of lower respiratory tract complications (mainly bronchitis) treated with antibiotics was
17 % (22/133) in the placebo group and 14 % (16/118) in the Oseltamivir treated population (p =
0.5976).
Treatment of influenza in children: In a study of otherwise healthy children (65 % influenzapositive)
aged 1 to 12 years (mean age 5.3 years) who had fever (≥ 37.8 °C) plus either cough or
coryza, 67 % of influenza-positive patients were infected with influenza A and 33 % with
influenza B. Oseltamivir treatment, started within 48 hours of onset of symptoms, significantly
reduced the time to freedom from illness (defined as the simultaneous return to normal health and
activity and alleviation of fever, cough and coryza) by 1.5 days (95 % CI 0.6 – 2.2 days; p <
0.0001) compared to placebo. Oseltamivir reduced the incidence of acute otitis media from 26.5
% (53/200) in the placebo group to 16 % (29/183) in the Oseltamivir treated children (p = 0.013).
A second study was completed in 334 asthmatic children aged 6 to 12 years old of which 53.6 %
were influenza-positive. In the Oseltamivir treated group, the median duration of illness was not
reduced significantly. By day 6 (the last day of treatment) FEV1 had increased by 10.8 % in the
Oseltamivir treated group compared to 4.7 % on placebo (p = 0.0148) in this population.

The European Medicines Agency has deferred the obligation to submit the results of studies with
Oselta in one or more subsets of the paediatric population in influenza. See section 4.2 for
information on paediatric use.
Treatment of influenza B infection: Overall, 15 % of the influenza-positive population were
infected by influenza B, proportions ranging from 1 to 33 % in individual studies. The median
duration of illness in influenza B infected subjects did not differ significantly between the
treatment groups in individual studies. Data from 504 influenza B infected subjects were pooled
across all studies for analysis. Oseltamivir reduced the time to alleviation of all symptoms by 0.7
days (95 % CI 0.1 – 1.6 days; p = 0.022) and the duration of fever (≥ 37.8 °C), cough and coryza
by one day (95 % CI 0.4 – 1.7 days; p < 0.001) compared to placebo.
Prevention of influenza
The efficacy of Oseltamivir in preventing naturally occurring influenza illness has been
demonstrated in a post-exposure prevention study in households and two seasonal prevention
studies. The primary efficacy parameter for all of these studies was the incidence of laboratoryconfirmed
influenza. The virulence of influenza epidemics is not predictable and varies within a
region and from season to season, therefore the number needed to treat (NNT) in order to prevent
one case of influenza illness varies.
Post-exposure prevention: In a study in contacts (12.6 % vaccinated against influenza) of an index
case of influenza, Oseltamivir 75 mg once daily was started within 2 days of onset of symptoms in
the index case and continued for seven days. Influenza was confirmed in 163 out of 377 index
cases. Oseltamivir significantly reduced the incidence of clinical influenza illness occurring in the
contacts of confirmed influenza cases from 24/200 (12 %) in the placebo group to 2/205 (1 %) in
the Oseltamivir group (92 % reduction [95 % CI 6 – 16; p ≤ 0.0001]). The number needed to treat
(NNT) in contacts of true influenza cases was 10 (95 % CI 9 – 12) and was 16 (95 % CI 15 – 19)

in the whole population (ITT) regardless of infection status in the index case.
The efficacy of Oseltamivir in preventing naturally occurring influenza illness has been
demonstrated in a post-exposure prevention study in households that included adults, adolescents,
and children aged 1 to 12 years, both as index cases and as family contacts. The primary efficacy
parameter for this study was the incidence of laboratory-confirmed clinical influenza in the
households. Oseltamivir prophylaxis lasted for 10 days. In the total population, there was a
reduction in the incidence of laboratory-confirmed clinical influenza in households from 20 %
(27/136) in the group not receiving prevention to 7 % (10/135) in the group receiving prevention
(62.7 % reduction [95 % CI 26.0 – 81.2; p = 0.0042]). In households of influenza-infected index
cases, there was a reduction in the incidence of influenza from 26 % (23/89) in the group not
receiving prevention to 11 % (9/84) in the group receiving prevention (58.5 % reduction [95 % CI
15.6 – 79.6; p = 0.0114]).
According to subgroup analysis in children at 1 to 12 years of age, the incidence of laboratoryconfirmed
clinical influenza among children was significantly reduced from 19 % (21/111) in the
group not receiving prevention to 7 % (7/104) in the group receiving prevention (64.4 % reduction
[95 % CI 15.8 – 85.0; p = 0.0188]). Among children who were not already shedding virus at
baseline, the incidence of laboratory-confirmed clinical influenza was reduced from 21 % (15/70)
in the group not receiving prevention to 4 % (2/47) in the group receiving prevention (80.1 %
reduction [95 % CI 22.0 – 94.9; p = 0.0206]). The NNT for the total paediatric population was 9
(95 % CI 7 – 24) and 8 (95 % CI 6, upper limit not estimable) in the whole population (ITT) and
in paediatric contacts of infected index cases (ITTII), respectively.
Prevention during an influenza epidemic in the community: In a pooled analysis of two other
studies conducted in unvaccinated otherwise healthy adults, Oseltamivir 75 mg once daily given
for 6 weeks significantly reduced the incidence of clinical influenza illness from 25/519 (4.8 %) in
the placebo group to 6/520 (1.2 %) in the Oseltamivir group (76 % reduction [95 % CI 1.6 – 5.7; p 

= 0.0006]) during a community outbreak of influenza. The NNT in this study was 28 (95 % CI 24
– 50).
A study in elderly residents of nursing homes, where 80 % of participants received vaccine in the
season of the study, Oseltamivir 75 mg once daily given for 6 weeks significantly reduced the
incidence of clinical influenza illness from 12/272 (4.4 %) in the placebo group to 1/276 (0.4 %)
in the Oseltamivir group (92 % reduction [95 % CI 1.5 – 6.6; p = 0.0015]). The NNT in this study
was 25 (95 % CI 23 – 62).
Prophylaxis of influenza in immunocompromised patients: A double-blind, placebo-controlled,
randomised study was conducted for seasonal prophylaxis of influenza in 475
immunocompromised patients (388 patients with solid organ transplantation [195 placebo; 193
oseltamivir], 87 patients with haemopoetic stem cell transplantation [43 placebo; 44 oseltamivir],
no patient with other immunosuppressant conditions), including 18 children 1 to 12 years of age.
The primary endpoint in this study was the incidence of laboratory-confirmed clinical influenza as
determined by viral culture and/or a four-fold rise in HAI antibodies. The incidence of
laboratory-confirmed clinical influenza was 2.9 % (7/238) in the placebo group and 2.1 % (5/237)
in the Oseltamivir group (95 % CI -2.3 % – 4.1 %; p = 0.772).
Specific studies have not been conducted to assess the reduction in the risk of complications.
Oseltamivir resistance
Clinical studies: The risk of emergence of influenza viruses with reduced susceptibility or frank
resistance to Oseltamivir has been examined during Roche-sponsored clinical studies. All patients
who were found to carry oseltamivir-resistant virus did so transiently, cleared the virus normally
and showed no clinical deterioration.

Patient Population Patients with Resistance Mutations (%)
Phenotyping* Geno- and Phenotyping*
Adults and adolescents 4/1,245 (0.32 %) 5/1,245 (0.4 %)
Children (1-12 years) 19/464 (4.1 %) 25/464 (5.4 %)
* Full genotyping was not performed in all studies.
There has been no evidence for emergence of drug resistance associated with the use of Oselta in
clinical studies conducted to date in post-exposure (7 days), post-exposure within household
groups (10 days) and seasonal (42 days) prevention of influenza in immunocompetent patients.
There was no resistance observed during a 12-week prophylaxis study in immunocompromised
patients.
Clinical and surveillance data: Natural mutations associated with reduced susceptibility to
Oseltamivir in vitro have been detected in influenza A and B viruses isolated from patients
without exposure to oseltamivir. Resistant strains selected during Oseltamivir treatment have been
isolated from both immunocompetent and immunocompromised patients. Immunocompromised
patients and young children are at a higher risk of developing oseltamivir-resistant virus during
treatment.
Oseltamivir-resistant viruses isolated from oseltamivir-treated patients and oseltamivir-resistant
laboratory strains of influenza viruses have been found to contain mutations in N1 and N2
neuraminidases. Resistance mutations tend to be viral sub-type specific. Since 2007 resistance
associated H275Y mutation in seasonal H1N1 strains has become widespread. The susceptibility
to Oseltamivir and the prevalence of such viruses appear to vary seasonally and geographically. In
2008, H275Y was found in > 99 % of circulating H1N1 influenza isolates in Europe. The 2009
H1N1 influenza (“swine flu”) was almost uniformly susceptible to Oseltamivir, with only
sporadic reports of resistance in connection with both therapeutic and prophylactic regimens.

General Information
Absorption
Oseltamivir is readily absorbed from the gastrointestinal tract after oral administration of
Oseltamivir phosphate (pro-drug) and is extensively converted by predominantly hepatic esterases
to the active metabolite (Oseltamivir carboxylate). At least 75 % of an oral dose reaches the
systemic circulation as the active metabolite. Exposure to the pro-drug is less than 5 % relative to
the active metabolite. Plasma concentrations of both pro-drug and active metabolite are proportional
to dose and are unaffected by co-administration with food.
Distribution
The mean volume of distribution at steady state of the Oseltamivir carboxylate is approximately 23
litres in humans, a volume equivalent to extracellular body fluid. Since neuraminidase activity is
extracellular, Oseltamivir carboxylate distributes to all sites of influenza virus spread.
The binding of the Oseltamivir carboxylate to human plasma protein is negligible (approximately 3
%).
Biotransformation
Oseltamivir is extensively converted to Oseltamivir carboxylate by esterases located predominantly
in the liver. In vitro studies demonstrated that neither Oseltamivir nor the active metabolite is a
substrate for, or an inhibitor of, the major cytochrome P450 isoforms. No phase 2 conjugates of
either compound have been identified in vivo.
Elimination Absorbed Oseltamivir is primarily (> 90 %) eliminated by conversion to Oseltamivir carboxylate. It
is not further metabolised and is eliminated in the urine. Peak plasma concentrations of Oseltamivir
carboxylate decline with a half-life of 6 to 10 hours in most subjects. The active metabolite is
eliminated entirely by renal excretion. Renal clearance (18.8 l/h) exceeds glomerular filtration rate
(7.5 l/h) indicating that tubular secretion occurs in addition to glomerular filtration. Less than 20 %
of an oral radiolabelled dose is eliminated in faeces.
Special populations
Children
Infants less than 1 year of age: Limited pharmacokinetic and safety data are available for infants
less than 1 year of age. Pharmacokinetic modeling was undertaken using these data in addition to
data from studies in adults and infants and children 1 year of age or older. The results demonstrate
that doses of 3 mg /kg twice daily for infants aged 3 to 12 months and 2.5 mg /kg twice daily for
infants aged between 1 and 3 months provide exposures similar to those shown to be clinically
efficacious in adults and infants and children 1 year of age or older (see sections 4.1 and 4.2). There
are currently no data available in infants less than 1 month of age using Oselta .
Infants and children 1 year of age or older: The pharmacokinetics of Oseltamivir has been
evaluated in single-dose pharmacokinetic studies in infants, children and adolescents 1 to 16 years
of age. Multiple-dose pharmacokinetics were studied in a small number of children enrolled in a
clinical efficacy study. Younger children cleared both the pro-drug and its active metabolite faster
than adults, resulting in a lower exposure for a given mg/kg dose. Doses of 2 mg/kg give
Oseltamivir carboxylate exposures comparable to those achieved in adults receiving a single 75 mg
dose (approximately 1 mg/kg). The pharmacokinetics of Oseltamivir in children and adolescents 12
years of age or older are similar to those in adults.

Elderly
Exposure to the active metabolite at steady state was 25 to 35 % higher in elderly (age 65 to 78
years) compared to adults less than 65 years of age given comparable doses of oseltamivir. Halflives
observed in the elderly were similar to those seen in young adults. On the basis of drug
exposure and tolerability, dosage adjustments are not required for elderly patients unless there is
evidence of moderate or severe renal impairment (creatinine clearance below 60 ml /min).
Renal impairment
Administration of 100 mg Oseltamivir phosphate twice daily for 5 days to patients with various
degrees of renal impairment showed that exposure to Oseltamivir carboxylate is inversely
proportional to declining renal function. For dosing, see section 4.2.
Hepatic impairment
In vitro studies have concluded that exposure to Oseltamivir is not expected to be increased
significantly nor is exposure to the active metabolite expected to be significantly decreased in
patients with hepatic impairment.

Preclinical data reveal no special hazard for humans based on conventional studies of safety
pharmacology, repeated-dose toxicity and genotoxicity. Results of the conventional rodent
carcinogenicity studies showed a trend towards a dose-dependent increase in the incidence of some
tumours that are typical for the rodent strains used. Considering the margins of exposure in relation
to the expected exposure in the human use, these findings do not change the benefit-risk of Oselta in
its adopted therapeutic indications.

Teratology studies have been conducted in rats and rabbits at doses of up to 1,500 mg/kg/day and
500 mg/kg/day, respectively. No effects on foetal development were observed. A rat fertility study
up to a dose of 1,500 mg/kg/day demonstrated no adverse reactions on either sex. In pre- and postnatal
rat studies, prolonged parturition was noted at 1,500 mg/kg/day: the safety margin between
human exposure and the highest no-effect dose (500 mg/kg/day) in rats is 480-fold for Oseltamivir
and 44-fold for the active metabolite, respectively. Foetal exposure in the rats and rabbits was
approximately 15 to 20 % of that of the mother.
In lactating rats, Oseltamivir and the active metabolite are excreted in the milk. Limited data
indicate that Oseltamivir and the active metabolite are excreted in human milk. Extrapolation of the
animal data provides estimates of 0.01 mg/day and 0.3 mg/day for the respective compounds.
A potential for skin sensitisation to Oseltamivir was observed in a "maximisation" test in guinea
pigs. Approximately 50 % of the animals treated with the unformulated active substance showed
erythema after challenging the induced animals. Reversible irritancy of rabbits' eyes was detected.
Whereas very high oral single doses of Oseltamivir phosphate salt, up to the highest dose tested
(1,310 mg/kg), had no adverse reactions in adult rats, such doses resulted in toxicity in juvenile 7-
day-old rat pups, including death. These reactions were seen at doses of 657 mg/kg and higher. At
500 mg/kg, no adverse reactions were seen, including upon chronic treatment (500 mg/kg/day
administered from 7 to 21 days post partum).

Croscarmellose sodium
Pregelatinised starch
Ludipress
Povidone K30

Talc
Colloidal silicon dioxide

Not applicable

Do not store above 30 °C.

Immediate Container:
Al-Foil 249mm : Plain Aluminum foil.
PVC/ACLAR Film : Clear & transparent
Secondary packaging (outer)
Carton : Colored printed carton, Dimensions 89x 68 x 16 mm
Insert/Leaflet : PIL 150 x 480 mm

Any unused product or waste material should be disposed of in accordance with local requirements.
Extemporaneous formulation
When Oselta powder for oral suspension is not available
When commercially manufactured Oselta powder for oral suspension is not available, patients who are unable to swallow capsules may receive appropriate doses of Oselta prepared in a pharmacy or
prepared at home.
For infants less than 1 year of age, the pharmacy preparation should be preferred to home
preparation. Detailed information on the home preparation can be found in the package leaflet of
Oselta capsules under “Making Oselta suspension at home”.
Syringes of appropriate volume and grading should be provided for administering the pharmacy
compounded suspension as well as for the procedures involved in the home preparation. In both
cases, the correct volumes should preferably be marked on the syringes.
Pharmacy compounding
Pharmacy compounded 6 mg/ml suspension prepared from capsules
Adults, adolescents and infants and children 1 year of age or older who are unable to swallow
intact capsules
This procedure describes the preparation of a 6 mg/ml suspension that will provide one patient with
enough medicine for a 5-day course of treatment or a 10-day course of prophylaxis.
The pharmacist may compound a 6 mg/ml suspension from Oselta 30 mg, 45 mg or 75 mg capsules
using water containing 0.05 % w/v sodium benzoate added as a preservative.
First, calculate the total volume needed to be compounded and dispensed to provide a 5-day course
of treatment or a 10-day course of prophylaxis for the patient. The total volume required is
determined by the weight of the patient according to the recommendation in the table below. To
allow for accurate volume withdrawal of up to 10 doses (2 withdrawals per daily treatment dose for
5 days), the column indicating measurement loss is to be considered for compounding.

Volume of pharmacy compounded 6 mg/ml suspension prepared based upon the patient's
weight
Body weight
(kg)
Total volume to compound per
patient weight
(ml)
Measurement loss not considered
Total volume to compound per
patient weight
(ml)
Measurement loss considered
10 kg to 15 kg 50 ml 60 ml or 75 ml*
> 15 kg to 23 kg 75 ml 90 ml or 100 ml*
> 23 kg to 40 kg 100 ml 125 ml
> 40 kg 125 ml 137.5 ml (or 150 ml)*
* Depending on the capsule strength used.
Second, determine the number of capsules and the amount of vehicle (water containing 0.05 % w/v
sodium benzoate added as a preservative) that is needed to prepare the total volume (calculated
from the table above) of pharmacy compounded 6 mg/ml suspension as shown in the table below:
Number of capsules and amount of vehicle needed to prepare the total volume of a pharmacy
compounded 6 mg/ml suspension
Total volume of
compounded
suspension to be
prepared
Required number of Oselta capsules
(mg of Oseltamivir)
Required volume
of vehicle
75 mg 45 mg 30 mg
50 ml 4 capsules
(300 mg)
Please use
alternative
capsule strength*
10 capsules
(300 mg)
49.5 ml
60 ml Please use
alternative
8 capsules 12 capsules 59.5 ml

capsule strength*
(360 mg) (360 mg)
75 ml 6 capsules
(450 mg)
10 capsules
(450 mg)
15 capsules
(450 mg)
74 ml
90 ml Please use
alternative
capsule strength*
12 capsules
(540 mg)
18 capsules
(540 mg)
89 ml
100 ml 8 capsules
(600 mg)
Please use
alternative
capsule strength*
20 capsules
(600 mg)
98.5 ml
125 ml 10 capsules
(750 mg)
Please use
alternative
capsule strength*
25 capsules
(750 mg)
123.5 ml
137.5 ml 11 capsules
(825 mg)
Please use
alternative
capsule strength*
Please use
alternative
capsule strength*
136 ml

* There is no combination of this capsule strength that can be used to achieve the target
concentration; therefore, please use an alternative capsule strength.
Third, follow the procedure below for compounding the 6 mg/ml suspension from Oselta capsules:
1. In a glass beaker of suitable size place the stated amount of water containing 0.05 % w/v sodium
benzoate added as a preservative.
2. Open the stated amount of Oselta capsules and transfer the content of each capsule directly to the
preserved water in the glass beaker.
3. With a suitable stirring device, stir for 2 minutes.
(Note: The drug substance, Oseltamivir phosphate, readily dissolves in water. The suspension is

caused by some of the excipients of Oselta capsules, which are insoluble.)
4. Transfer the suspension to an amber glass or amber polyethyleneterephthalate (PET) bottle. A
funnel may be used to eliminate any spillage.
5. Close the bottle using a child-resistant cap.
6. Put an ancillary label on the bottle indicating “Shake Gently Before Use”.
(Note: This compounded suspension should be gently shaken prior to administration to minimize
the tendency for air entrapment.)
7. Instruct the parent or caregiver that any remaining material following completion of therapy must
be discarded. It is recommended that this information be provided by either affixing an ancillary
label to the bottle or adding a statement to the pharmacy label instructions.
8. Place an appropriate expiration date label according to storage condition (see section 6.3).
Place a pharmacy label on the bottle that includes the patient's name, dosing instructions, use by
date, name of medicinal product and any other required information to be in compliance with local
pharmacy regulations. Refer to the table below for the proper dosing instructions.
Dosing chart for pharmacy-compounded 6 mg/ml suspension prepared from Oselta capsules
for infants and children 1 year of age or older
Body weight
(kg)
Dose
(mg)
Volume per dose
6 mg/ml
Treatment dose
(for 5 days)
Prophylaxis dose
(for 10 days)
10 kg to 15 kg 30 mg 5 ml 5 ml twice daily 5 ml once daily
> 15 kg to 23 kg 45 mg 7.5 ml 7.5 ml twice daily 7.5 ml once daily 

> 23 kg to 40 kg 60 mg 10 ml 10 ml twice daily 10 ml once daily
> 40 kg 75 mg 12.5 ml 12.5 ml twice
daily
12.5 ml once
daily
Dispense the pharmacy compounded suspension with a graduated oral syringe for measuring small
amounts of suspension. If possible, mark or highlight the graduation corresponding to the
appropriate dose (according to the dosing table above) on the oral syringe for each patient.
The appropriate dose must be mixed by the caregiver with an equal quantity of sweet liquid food,
such as sugar water, chocolate syrup, cherry syrup, dessert toppings (like caramel or fudge sauce) to
mask the bitter taste.
Infants less than 1 year of age
This procedure describes the preparation of a 6 mg/ml suspension that will provide one patient with
enough medication for a 5-day course of treatment or a 10-day course of prophylaxis.
The pharmacist may compound a 6 mg/ml suspension from Oselta 30 mg, 45 mg or 75 mg capsules
using water containing 0.05 % w/v sodium benzoate added as a preservative.
First, calculate the total volume needed to be compounded and dispensed for each patient. The total
volume required is determined by the weight of the patient according to the recommendation in the
table below. To allow for accurate volume withdrawal of up to 10 doses (2 withdrawals per daily
treatment dose for 5 days), the column indicating measurement loss is to be considered for
compounding.
Volume of pharmacy compounded 6 mg/ml suspension prepared based upon the patient's
weight
Body weight Total volume to compound per Total volume to compound per

(kg)
patient weight
(ml)
Measurement loss not considered
patient weight
(ml)
Measurement loss considered
≤ 7 kg up to 40 ml 50 ml
> 7 kg to 10 kg 50 ml 60 ml or 75 ml*
* Depending on the capsule strength used.
Second, determine the number of capsules and the amount of vehicle (water containing 0.05 % w/v
sodium benzoate added as a preservative) that is needed to prepare the total volume (calculated
from the table above) of pharmacy compounded 6 mg/ml suspension as shown in the table below:
Number of capsules and amount of vehicle needed to prepare the total volume of a pharmacy
compounded 6 mg/ml suspension
Total volume of
compounded
suspension to be
prepared
Required number of Oselta capsules
(mg of Oseltamivir)
Required volume
of vehicle
75 mg 45 mg 30 mg
30 ml Please use
alternative
capsule strength*
4 capsules
(180 mg)
6 capsules
(180 mg)
29.5 ml
50 ml 4 capsules
(300 mg)
Please use
alternative
capsule strength*
10 capsules
(300 mg)
49.5 ml
60 ml Please use
alternative
capsule strength*
8 capsules
(360 mg)
12 capsules
(360 mg)
59.5 ml
75 ml 6 capsules 10 capsules 15 capsules 74 ml

(450 mg) (450 mg) (450 mg)
* There is no combination of this capsule strength that can be used to achieve the target
concentration; therefore, please use an alternative capsule strength.
Third, follow the procedure below for compounding the 6 mg/ml suspension from Oselta capsules:
1. In a glass beaker of suitable size place the stated amount of water containing 0.05 % w/v sodium
benzoate added as a preservative.
2. Open the stated amount of Oselta capsules and transfer the content of each capsule directly to the
preserved water in the glass beaker.
3. With a suitable stirring device, stir for 2 minutes.
(Note: The drug substance, Oseltamivir phosphate, readily dissolves in water. The suspension is
caused by some of the excipients of Oselta capsules, which are insoluble.)
4. Transfer the suspension to an amber glass or amber polyethyleneterephthalate (PET) bottle. A
funnel may be used to eliminate any spillage.
5. Close the bottle using a child-resistant cap.
6. Put an ancillary label on the bottle indicating “Shake Gently Before Use”.
(Note: This compounded suspension should be gently shaken prior to administration to minimize
the tendency for air entrapment.)
7. Instruct the parent or caregiver that any remaining material following completion of therapy must
be discarded. It is recommended that this information be provided by either affixing an ancillary

label to the bottle or adding a statement to the pharmacy label instructions.
8. Place an appropriate expiration date label according to storage condition .
Place a pharmacy label on the bottle that includes the patient's name, dosing instructions, use by
date, name of medicinal product and any other required information to be in compliance with local
pharmacy regulations. Refer to the table below for the proper dosing instructions.
Dosing chart for pharmacy compounded 6 mg/ml suspension prepared from Oselta capsules
for infants 0 to 30 days of age (less than one month of age)
Body Weight
(rounded to
the nearest 0.5
kg)
Dose
(mg)
Volume per
dose
(6 mg/ml)
Treatment
Dose
(for 5 days)
Prophylaxis
Dose
(for 10 days)
Dispenser size
to use
(grading 0.1 ml)
3 kg 6 mg 1.0 ml 1.0 ml twice
daily
1.0 ml once daily 1.0 ml (or 2.0
ml)
3.5 kg 7 mg 1.2 ml 1.2 ml twice
daily
1.2 ml once daily 2.0 ml
4 kg 8 mg 1.3 ml 1.3 ml twice
daily
1.3 ml once daily 2.0 ml
4.5 kg 9 mg 1.5 ml 1.5 ml twice
daily
1.5 ml once daily 2.0 ml
Dosing chart for pharmacy compounded 6 mg/ml suspension prepared from Oselta capsules
for infants of 31 to 90 days of age (more than one month to three months of age)
Body Weight
(rounded to
the nearest 0.5
kg)
Dose
(mg)
Volume per
dose
(6 mg/ml)
Treatment
Dose
(for 5 days)
Prophylaxis
Dose
(for 10 days)
Dispenser size
to use
(grading 0.1 ml

4 kg 10 mg 1.7 ml 1.7 ml twice
daily
1.7 ml once daily 2.0 ml (or 3.0
ml)
4.5 kg 11.25 mg 1.9 ml 1.9 ml twice
daily
1.9 ml once daily 2.0 ml (or 3.0
ml)
5 kg 12.5 mg 2.1 ml 2.1 ml twice
daily
2.1 ml once daily 3.0 ml
5.5 kg 13.75 mg 2.3 ml 2.3 ml twice
daily
2.3 ml once daily 3.0 ml
6 kg 15 mg 2.5 ml 2.5 ml twice
daily
2.5 ml once daily 3.0 ml
6.5 kg 16.25 mg 2.7 ml 2.7 ml twice
daily
2.7 ml once daily 3.0 ml
Dosing chart for pharmacy compounded 6 mg/ml suspension prepared from Oselta capsules
for infants 91 to less than 365 days of age (more than three months to twelve months of age)
Body Weight
(rounded to
the nearest 0.5
kg)
Dose
(mg)
Volume per
dose
(6 mg/ml)
Treatment
Dose
(for 5 days)
Prophylaxis
Dose
(for 10 days)
Dispenser size
to use
(grading 0.1 ml)
6 kg 18 mg 3.0 ml 3.0 ml twice
daily
3.0 ml once daily 3.0 ml (or 5.0
ml)
6.5 kg 19.5 mg 3.3 ml 3.3 ml twice
daily
3.3 ml once daily 5.0 ml
7 kg 21 mg 3.5 ml 3.5ml twice
daily
3.5 ml once daily 5.0 ml
7.5 kg 22.5 mg 3.8 ml 3.8 ml twice
daily
3.8 ml once daily 5.0 ml
8 kg 24 mg 4.0 ml 4.0 ml twice
daily
4.0 ml once daily 5.0 ml

8.5 kg 25.5 mg 4.3 ml 4.3 ml twice
daily
4.3 ml once daily 5.0 ml
9 kg 27 mg 4.5 ml 4.5 ml twice
daily
4.5 ml once daily 5.0 ml
9.5 kg 28.5 mg 4.8 ml 4.8 ml twice
daily
4.8 ml once daily 5.0 ml
10 kg 30 mg 5.0 ml 5.0 ml twice
daily
5.0 ml once daily 5.0 ml
Dispense the pharmacy compounded suspension with a graduated oral syringe for measuring small
amounts of suspension. If possible, mark or highlight the graduation corresponding to the
appropriate dose (according to the dosing tables above) on the oral syringe for each patient.
The appropriate dose must be mixed by the caregiver with an equal quantity of sweet liquid food,
such as sugar water, chocolate syrup, cherry syrup, dessert toppings (like caramel or fudge sauce) to
mask the bitter taste.
Home preparation
When commercially manufactured Oselta oral suspension is not available, a pharmacy compounded
suspension prepared from Oselta capsules can be used (see detailed instructions above). If the
pharmacy compounded suspension is also not available, Oselta suspension may be prepared at
home. The pharmacy compounded suspension is the preferred option in infants less than 1 year of
age.
When appropriate capsule strengths are available for the dose needed, the dose is given by opening
the capsule and mixing its contents with no more than one teaspoon of a suitable sweetened food
product. The bitter taste can be masked by products such as sugar water, chocolate syrup, cherry
syrup, dessert toppings (like caramel or fudge sauce). The mixture should be stirred and given entirely to the patient. The mixture must be swallowed immediately after its preparation.
When only 75 mg capsules are available, and doses of 30 mg or 45 mg are needed, the preparation
of Oselta suspension involves additional steps. Detailed instructions can be found in the package
leaflet of Oselta capsules under “Making Oselta suspension at home”.