AMOXICILLIN SODIUM 1G POWDER FOR SOLUTION FOR INJECTION

Active substance: AMOXICILLIN

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Children

Adults and the elderly

• by intramuscular injection: 500 mg every eight hours
•  intravenous injection or infusion: 500 mg every eight hours (or in
by
severe infection 1 g every six hours) may be given by slow intravenous
injection over three to four minutes or by infusion over 30 to 60 minutes.
•  prevent infections after surgery: the dose will vary according to
to
the type of surgery. Your doctor or nurse will tell you exactly how much
medicine you will need and when you will need it. You may need to have
1g injection into a vein before surgery, sometimes with another medicine
called gentamicin. This may be followed by a further 500 mg dose (oral or
injection) given 6 hours later.

Children up to 10 years of age

• 
most infections: 50 mg – 100 mg for every kilogram of body weight in
equal doses throughout the day
•  prevent infections after surgery: the dose will vary according to
to
the type of surgery. Your doctor or nurse will tell you exactly how much
medicine you will need and when you will need it.
- For children aged 5 to 10 years, the dose is usually half the adult dose,
see above.
- For children aged up to 5 years, the dose is usually one-quarter of the
adult dose, see above.

Care should be taken in newborns and young infants as there is the chance Patients with kidney problems
If you have kidney problems the dose might be lower than the usual dose.
of higher levels of amoxicillin in the blood.
Amoxicillin is removed by dialysis (artificial filtration and purification of the
Other medicines and Amoxicillin
blood).Therefore, patients receiving dialysis may require another dose of
Tell your doctor if you are taking, have recently taken or might take any
Amoxicillin at the end of their dialysis session.
other medicines, including medicines obtained without a prescription.
The following medicines can affect or be affected by treatment with Amoxicillin:


INFORMATION FOR HEALTH CARE PROFESSIONALS
Amoxicillin Sodium 250mg Powder for Solution for Injection
Amoxicillin Sodium 500mg Powder for Solution for Injection
Amoxicillin Sodium 1g Powder for Solution for Injection
Please refer to the Summary of Product Characteristics for further information

• Presentation
Amoxicillin Injection is available in vials containing the equivalent of 250mg, 500mg or 1g amoxicillin as amoxicillin sodium, presented as a powder for reconstitution.
• 
Posology and method of administration
Treatment of Infections in Adults and the Elderly
By intramuscular injection:
500mg every eight hours
By intravenous injection or infusion:
500mg every eight hours (or in severe infection 1g every six hours) may be given by slow iv injection over three to four minutes or by infusion over 30 to 60 minutes.
Treatment of Infection in Children up to 10 years
By intramuscular or intravenous injection or infusion:
50-100mg per kg bodyweight daily in divided doses.

Renal impairment

It may be necessary to reduce the total daily dosage depending on the degree of renal impairment.
As amoxicillin is removed by haemodialysis, patients receiving haemodialysis may require another dose of amoxicillin at the end of their dialysis.
Endocarditis prophylaxis

Dental
procedures
under
general anaesthesia

No special risk (ie,
no prosthetic heart
valves, no history
of endocarditis, not
more than a single
dose of a penicillin
in the previous
month)

Upper
respiratory
tract procedures under
general anaesthesia:

Special risk (with
prosthetic heart
valves, history of
endocarditis, or
receipt of more
than a single dose
of a penicillin in the
previous month)

Genito-urinary procedures under
general anaesthesia in patients
with no urinary tract infection:
Gastrointestinal, obstetric and
gynaecological procedures under
general anaesthesia for patients
with prosthetic heart valves or history of endocarditis:

Adults and the elderly:
1g amoxicillin iv at induction, followed by 500mg oral, iv or im amoxicillin six hours later
Children under 5 years:
Quarter adult dose
Children 5-10 years:
Half adult dose
Adults and the elderly:
1g amoxicillin iv with im or iv gentamicin at induction, followed by 500mg oral, iv or im amoxicillin six hours later
Children under 5 years:
Quarter adult dose plus gentamicin
Children 5-10 years:
Half adult dose plus gentamicin
NB Amoxicillin and gentamicin should not be mixed in the same syringe
Adults and the elderly:
1g amoxicillin iv with im or iv gentamicin at induction, followed by 500mg oral, iv or im amoxicillin six hours later
Children under 5 years:
Quarter adult dose plus gentamicin
Children 5-10 years:
Half adult dose plus gentamicin
NB Amoxicillin and gentamicin should not be mixed in the same syringe

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03/01/2014

Proof No.

Date

Artwork No.

471870

tom.robertson

English

Proof By

UK

Language

To treat infections the usual doses are:

IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.

Talk to you doctor before you are given Amoxicillin if you:
• have a history of allergies, especially allergies to drugs
• 
have problems passing water (urine) or suffer from repeat urinary tract
infections
• have glandular fever
• 
have problems with the functions of your kidneys. Your doctor may
monitor you during treatment
• have a problem with your heart
• 
have syphilis, because of the risks of a reaction known as Jarisch-Herxheimer reaction (see also section 4 “Possible side effects”)
• 
have undiagnosed sore throat (pharyngitis) or a type of cancer known
as lymphatic lymphoma, which affects white blood cells
• have HIV
•  on a sodium controlled diet.
are
If any of the above applies to you speak to your doctor or nurse before
being given Amoxicillin.

Your doctor will decide how much you need each day and how often the
injections should be given.

Warning! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our clientʼs brief,
the final responsibility must be taken by our client.

Warnings and precautions

Your medicine will be given to you by injection into a muscle (intramuscularly) or into a vein (intravenously) or as an infusion into a vein.

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 are allergic (hypersensitive) to amoxicillin or penicillin. There are no
other ingredients in this medicine (see section 6)
• have had an allergic (hypersensitive) reaction to any antibiotic
• have previously been told that your infection cannot be treated with amoxicillin or ampicillin.
You should not be given Amoxicillin if any of the above applies to you.
If you are unsure speak to your doctor, nurse or pharmacist.

3. How Amoxicillin is given
You will never give yourself this medicine. Amoxicillin will be given to you by
a doctor or nurse.

7pt

You should not be given Amoxicillin if you

This should be considered if you are on a controlled sodium diet.

Min. Point Size

2. What you need to know before you are given
 Amoxicillin Injection

Amoxicillin sodium 1000 mg powder for solution for injection contains 59.4 mg of
sodium.

200 x 390

• treat infections caused by bacteria in different parts of the body
• prevent inflammation of the inner lining of the heart (endocarditis)
• treat Lyme disease.

Amoxicillin sodium 500 mg powder for solution for injection contains 29.7 mg of
sodium.

Size

Amoxicillin is used in adults and children to:

Amoxicillin sodium 250 mg powder for solution for injection contains 14.9 mg of
sodium.

-

The name of your medicine is Amoxicillin Sodium Powder for Solution for
Injection. The vials contain a medicine called sodium amoxicillin. Amoxicillin belongs to a group of medicines called aminopenicillin antibiotics, which
stop the growth of bacteria that cause infections.

Important information about some of the ingredients of Amoxicillin

Profile

1. What Amoxicillin is and what it is used for

Small amounts of this medicine can be passed into breast milk. Ask your
doctor for advice before breast‑feeding.

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What Amoxicillin is and what it is used for
What you need to know before you are given Amoxicillin
How Amoxicillin is given
Possible side effects
How to store Amoxicillin
Contents of the pack and other information

Item Code

1.
2.
3.
4.
5.
6.

If you are pregnant or think you may be pregnant or are planning to have a
baby ask your doctor for advice before you are given Amoxicillin.

Amoxicillin Sodium leaflet

What is in this leaflet:

Pregnancy and Breast-feeding

Description

Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor, pharmacist or nurse.
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.

Colours Used

-
-
-


Wockhardt UK Limited

Read all of this leaflet carefully before you are given this medicine
because it contains important information for you.

Customer

Sodium Amoxicillin (referred to as Amoxicillin in the remainder of the leaflet)

• oral anticoagulants, medicines that stop your blood clotting
• oral contraceptives that contain oestrogen
•  medicine known as methotrexate used in the treatment of cancer
a
• 
other types of antibacterial treatments such as bacteriostatic agents (e.g.
chloramphenicol) and tetracyclines
• 
medicines used to treat gout, such as probenecid and allopurinol.
T
 ell your doctor if you are taking Amoxicillin as it may affect the results of
blood or urine tests.

Measure bar should be 150mm at 100% scale

PACKAGE LEAFLET: INFORMATION FOR THE USER
Amoxicillin Sodium 250 mg, 500 mg and 1000 mg Powder
for Solution for Injection

By reporting side effects you can help provide more information on the
safety of this medicine.

Colours Used

5. How to store Amoxicillin Injection

• 
changes in the levels of white blood cells (shown in blood tests), which
can make infections more likely

Pharma
Code

Marketing Authorisation Holder

reductions in the levels of blood platelets in the blood (shown in blood
• 
tests), which may lead to bruising more easily or bleeding for longer if
you cut yourself or have a nosebleed

Manufacturer

• fits or hallucinations (hearing or seeing things that aren’t there)

To listen to or request a copy of this leaflet in Braille, large print or audio
please call, free of charge:

changes in your salt and electrolyte levels (shown in blood tests)
• 
• 
patients with glandular fever and other lymphoid disorders (e.g. lymphatic leukaemia or HIV) may be at higher risk of developing a rash
(see also section 2 “Warnings and precautions”)
• 
feeling or being sick, sore mouth and tongue, diarrhoea or candida (yeast)
infection
• 
inflammation of the large bowel with diarrhoea that may contain blood,
pain, and high temperature (fever)

Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK
CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK

Other formats:

0800 198 5000 (UK only).
Please be ready to give the following information:
Product name
Amoxicillin Sodium for
injection 250 mg

Reference numbers

Amoxicillin Sodium for
injection 500 mg

PL 29831/0012

PL 29831/0010

•  skin reaction known as ‘erythema multiforme’ which has symptoms
a
Amoxicillin Sodium for
PL 29831/0011
such as: itchy reddish purple patches on the skin, especially on the
injection 1000 mg
palms of the hands and soles of the feet, ‘hive-like’ raised swollen areas
on the skin, tender areas on the surfaces of the mouth, eyes and private This is a service provided by the Royal National Institute of Blind People.
parts. You may have a high temperature (fever) and feel very tired
For the Republic of Ireland please call + 353 52 36253.
a
•  rare allergic reaction called Stevens-Johnson syndrome which causes Leaflet Prepared: 12/2013
severe illness with ulcers on the mouth, lips and skin
• coma
• 
liver problems such as hepatitis and jaundice, which may cause yellowing
of the skin or whites of the eyes, pale stools or dark urine, blisters, redness or bruising of the skin.

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Method of Administration
Intravenous Injection:
Dissolve 250mg in 5mL Water for Injections Ph Eur (final volume 5.2mL).
Dissolve 500mg in 10mL Water for Injections Ph Eur (final volume 10.4mL).
Dissolve 1g in 20mL Water for Injections Ph Eur (final volume 20.8mL).
Amoxicillin Sodium for Injection BP, when diluted may be injected slowly into a vein or infusion line over three to four minutes.
Intravenous Infusion:
Prepare as above and add to an iv solution in a minibag or in-line burette. Administer over 30 to 60 minutes. Alternatively the appropriate volume of iv fluid may be
transferred from the infusion bag into the vial, using a suitable reconstitution device, and drawn back into the bag after dissolution.
Intramuscular Injection:
Add 1.5mL Water for Injections Ph Eur to 250mg and shake vigorously (final volume 1.7mL).
Add 2.5mL Water for Injections Ph Eur to 500mg and shake vigorously (final volume 2.9mL).
• Incompatibilities
If amoxicillin is prescribed concurrently with an aminoglycoside, the antibiotics should not be mixed in the syringe, intravenous fluid container or giving set because
under these conditions, loss of activity of the aminoglycoside can occur. Amoxicillin and aminoglycoside injections should be administered at separate sites.
Amoxicillin should not be mixed with blood products or other proteinaceous fluids (eg protein hydrolysates) or with intravenous lipid emulsions.
Amoxicillin should not be mixed with ciprofloxacin.
• Shelf life and special precautions for storage
Unopened: 36 months.
Store below 25oC.
Reconstituted solutions should be administered immediately after preparation.
• Instructions for use/handling
The vials are not suitable for multidose use.
Date leaflet last revised: 12/2013
The information in this leaflet applies only to Amoxicillin Sodium 250mg Powder for Solution for Injection, Amoxicillin Sodium 500mg Powder for Solution
for Injection and Amoxicillin Sodium 1g Powder for Solution for Injection.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the
medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

105842/4

03/01/2014
Date

471870

1
Proof No.

English

tom.robertson

UK

Proof By

IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.

Vials containing 1000 mg of amoxicillin powder for solution for injection are
available in single packs.

Warning! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our clientʼs brief,
the final responsibility must be taken by our client.

• difficulty breathing, or shortness of breath

Language

Vials containing 250 mg or 500 mg of amoxicillin sodium powder for solution for injection are available in packs of 10 vials.

Amoxicillin is supplied as a vial of powder for making up as an injection.

Market

other severe skin reactions such as: changes in skin colour, bumps
• 
under the skin, blistering, pustules, peeling, redness, pain, itching,
scaling, and a drug rash associated with changes to white blood cells.

7pt

What Amoxicillin looks like and the contents of the pack

Min. Point Size

• 
kidney problems that may lead to back pain, and pain when passing
water (urine), or crystals in the urine.

200 x 390

There are no other ingredients. However, please see section 2 for further
important information about sodium in Amoxicillin.

Size

• 
reduction in red blood cells (shown in blood tests), which can make the
skin pale and cause you to feel tired, weak, dizzy, or short of breath

Each vial of amoxicillin sodium 1000 mg powder for solution for injection
contains 1000 mg sodium amoxicillin.

-

Each vial of amoxicillin sodium 500 mg powder for solution for injection
contains 500 mg sodium amoxicillin.

Profile

Other side effects of Amoxicillin may include:
• 
delayed allergic reaction (that can occur more than seven days after
starting treatment with Amoxicillin), symptoms include rashes, high temperature (fever), joint pain, and enlargement of lymph nodes (glands)

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Each vial of amoxicillin sodium 250 mg powder for solution for injection
contains 250 mg sodium amoxicillin.

Item Code

The active ingredient is sodium amoxicillin.

Amoxicillin Sodium leaflet

6. Contents of the pack and other information
What Amoxicillin contains

Description

• 
severe allergic reaction (anaphylaxis). Symptoms include rash or itching of the skin, swelling of the face, lips, mouth, tongue or throat that
may cause difficulty in swallowing or breathing
• 
patients with syphilis leptospirosis may experience a reaction known as
Jarisch-Herxheimer, which can cause high temperature (fever), chills,
headache and worsening of skin lesions.

Medicines should not be disposed of via wastewater or household waste.
Your doctor or nurse will dispose of medicines no longer required. These
measures will help protect the environment.

Wockhardt UK Limited

Tell your doctor or nurse straight away if you notice any of the
following serious side effects:

• 
Reconstituted solutions should be used immediately after preparation.

Customer

Like all medicines, Amoxicillin can cause side effects, although not everybody gets them.

• Store below 25ºC, in the original container.

Measure bar should be 150mm at 100% scale

4. Possible side effects

N/A

If you think that a dose of Amoxicillin has been missed, speak to your doctor or
Keep this medicine out of the sight and reach of children.
nurse.
•  not use this medicine after the expiry date which is stated on the
Do
If you have further questions on the use of this medicine, ask your doctor or
label. The expiry date refers to the last day of that month.
nurse.

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If you think you have missed a dose of Amoxicillin

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The doctor will assess your condition and decide how to treat an overdose.

If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at: http://www.mhra.
gov.uk/yellowcard

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Reporting of side effects

This medicine is given to you by a doctor or a nurse. It is unlikely that you
will be given too much. However, if you think you have been given too
much Amoxicillin speak to your doctor or nurse immediately.The symptoms
of an overdose include the presence of crystals in the urine which cannot
be seen by the patient.

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If you are given too much Amoxicillin

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Source: Medicines and Healthcare Products Regulatory Agency

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

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