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LOPRATIN 250MG POWDER FOR SOLUTION FOR INJECTION

Active substance(s): CEFTRIAXONE SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Lopratin 250 mg Powder for Solution for Injection

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Ceftriaxone

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of
illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in
this leaflet. See section 4.

What is in this leaflet
1. What Lopratin is and what it is used for
2. What you need to know before you are given Lopratin
3. How Lopratin is given
4. Possible side effects
5. How to store Lopratin
6. Contents of the pack and other information

1

What Lopratin is and what it is used for

Lopratin is an antibiotic given to adults and children (including
newborn babies). It works by killing bacteria that cause infections.
It belongs to a group of medicines called cephalosporins.
Lopratin is used to treat infections of
• the brain (meningitis).
• the lungs.
• the middle ear.
• the abdomen and abdominal wall (peritonitis).
• the urinary tract and kidneys.
• bones and joints.
• the skin or soft tissues.
• the blood.
• the heart.

It can be given:
• to treat specific sexually transmitted infections (gonorrhoea
and syphilis).
• to treat patients with low white blood cell counts
(neutropenia) who have fever due to bacterial infection.
• to treat infections of the chest in adults with chronic bronchitis.
• to treat Lyme disease (caused by tick bites) in adults and
children including newborn babies from 15 days of age.
• to prevent infections during surgery.

2

What you need to know before you are
given Lopratin

You must not be given Lopratin if:
• You are allergic to ceftriaxone or any of the other
ingredients of this medicine (listed in section 6).
• You have had a sudden or severe allergic reaction to
penicillin or similar antibiotics (such as cephalosporins,
carbapenems or monobactams). The signs include sudden
swelling of the throat or face which might make it difficult to
breath or swallow, sudden swelling of the hands, feet and
ankles, and a severe rash that develops quickly.
• You are allergic to lidocaine and you are to be given
Lopratin as an injection into a muscle.

Lopratin must not be given to babies if:
• The baby is premature.
• The baby is newborn (up to 28 days of age) and has certain
blood problems or jaundice (yellowing of the skin or the
whites of the eyes) or is to be given a product that contains
calcium into their vein.

If you need a blood or urine test
If you are given Lopratin for a long time, you may need to have
regular blood tests. Lopratin can affect the results of urine
tests for sugar and a blood test known as the Coombs test. If
you are having tests:
• Tell the person taking the sample that you have been given
Lopratin.

Children
Talk to your doctor or pharmacist or nurse before your child is
administered Lopratin if:
• He/She has recently been given or is to be given a product
that contains calcium into their vein.

Other medicines and Lopratin
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
In particular, tell your doctor or pharmacist if you are taking any
of the following medicines:
• A type of antibiotic called an aminoglycoside.
• An antibiotic called chloramphenicol (used to treat
infections, particularly of the eyes).

Pregnancy and breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor for
advice before taking this medicine.

The doctor will consider the benefit of treating you with
Lopratin against the risk to your baby.

Driving and using machines
Lopratin can cause dizziness. If you feel dizzy, do not drive or
use any tools or machines. Talk to your doctor if you
experience these symptoms.

3

How Lopratin is given

Lopratin is usually given by a doctor or nurse. It can be given
as a drip (intravenous infusion) or as an injection directly into a
vein or into a muscle. Lopratin is made up by the doctor,
pharmacist or nurse and will not be mixed with or given to you
at the same time as calcium-containing injections.

The usual dose
Your doctor will decide the correct dose of Lopratin for you.
The dose will depend on the severity and type of infection;
whether you are on any other antibiotics; your weight and age;
how well your kidneys and liver are working. The number of
days or weeks that you are given Lopratin depends on what
sort of infection you have.

Warnings and precautions
Talk to your doctor or pharmacist or nurse before you are given Adults, older people and children aged 12 years and over
Lopratin if:
with a body weight greater than or equal to 50 kilograms (kg):
• You have recently received or are about to receive products • 1 to 2 g once a day depending on the severity and type of
that contain calcium.
infection. If you have a severe infection, your doctor will
• You have recently had diarrhoea after having an antibiotic
give you a higher dose (up to 4 g once a day). If your daily
medicine. You have ever had problems with your gut, in
dose is higher than 2 g, you may receive it as a single dose
particular colitis (inflammation of the bowel).
once a day or as two separate doses.
• You have liver or kidney problems.
• You have gall stones or kidney stones
• You have other illnesses, such as haemolytic anaemia (a
reduction in your red blood cells that may make your skin
pale yellow and cause weakness or breathlessness).
• You are on a low sodium diet.

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The following information is intended for medical or
healthcare professionals only:



For full prescribing information please see the full Summary of
Product Characteristics.
Method and route of administration of Lopratin 250 mg
powder for solution for injection/infusion

Lopratin 250 mg is injected into a vein (intravenous
administration); however, it can also be injected into a muscle
(intramuscular administration).

When reconstituted for intramuscular or intravenous injection,
the white to yellowish crystalline powder gives a pale yellow to
amber solution.
Intravenous injection (injection into a vein)
• Lopratin 250 mg for IV injection is dissolved in water for
injections BP.
• The content of a 250 mg vial is dissolved in 5 ml of water
for injections by swirling.

The duration of injection is between 2 and 4 minutes
directly into the vein or via the tubing of an intravenous
infusion.

Intravenous infusion (infusion into a vein)
• Lopratin 250 mg for infusion is administered as a short
intravenous infusion
• The infusion should be administered over at least 30
minutes.
• The content of the vial is dissolved in one of the following
calcium-free infusion solutions by swirling:
- Dextrose Injection BP 5% or
- 10%, Sodium Chloride Injection BP,
- Sodium Chloride and Dextrose Injection BP (0.45%
Sodium Chloride and 2.5% Dextrose),
- Dextran 6% in Dextrose Injection BP 5%,
- Hydroxyethyl Starch 6 - 10% infusions.
• See also section “Principal chemical intolerances”.
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Newborn babies, infants and children aged 15 days to 12
years with a body weight of less than 50 kg:
• 50-80 mg Lopratin for each kg of the child’s body weight
once a day depending on the severity and type of infection.
If you have a severe infection, your doctor will give you a
higher dose up to 100 mg for each kg of body weight to a
maximum of 4 g once a day. If your daily dose is higher
than 2 g, you may receive it as a single dose once a day or
as two separate doses.
• Children with a body weight of 50 kg or more should be
given the usual adult dose.

Newborn babies (0-14 days)
• 20 – 50 mg Lopratin for each kg of the child’s body weight
once a day depending on the severity and type of infection.
• The maximum daily dose is not to be more than 50 mg for
each kg of the baby’s weight.
People with liver and kidney problems
You may be given a different dose to the usual dose. Your
doctor will decide how much Lopratin you will need and will
check you closely depending on the severity of the liver and
kidney disease.
If you are given more Lopratin than you should
If you accidentally receive more than your prescribed dose,
contact your doctor or nearest hospital straight away.

If you forget to use Lopratin
If you miss an injection, you should have it as soon as
possible. However, if it is almost time for your next injection,
skip the missed injection. Do not take a double dose (two
injections at the same time) to make up for a missed dose.

Blood or sugar in your urine.
Oedema (fluid build-up).
Shivering.

Not known (Frequency cannot be estimated from the
available data)
• A secondary infection that may not respond to the antibiotic
previously prescribed
• Form of anaemia where red blood cells are destroyed
(haemolytic anaemia).
• Severe decrease in white blood cells (agranulocytosis).
• Convulsions.
• Vertigo (spinning sensation).
• Inflammation of the pancreas (pancreatitis). The signs
include severe pain in the stomach which spreads to your
back.
• Inflammation of the mucus lining of the mouth (stomatitis).
• Inflammation of the tongue (glossitis). The signs include
swelling, redness and soreness of the tongue.
• Problems with your gallbladder, which may cause pain,
feeling sick and being sick.
• A neurological condition that may occur in neonates with
severe jaundice (kernicterus).
• Kidney problems caused by deposits of calcium ceftriax
one. There may be pain when passing water (urine) or low
output of urine.
• A false positive result in a Coombs’ test (a test for some
blood problems).
• A false positive result for galactosaemia (an abnormal build
up of the sugar galactose).
• Lopratin may interfere with some types of blood glucose
tests - please check with your doctor.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme: www.mhra.gov.uk/yellowcard. By reporting side
effects, you can help provide more information on the safety of
this medicine.

If you stop using Lopratin
Do not stop taking Lopratin unless your doctor tells you to. If
you have any further questions on the use of this medicine,
ask your doctor or nurse.

4





Possible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them. The following side effects
may happen with this medicine:

Severe allergic reactions (not known, frequency cannot be
estimated from the available data)
If you have a severe allergic reaction, tell a doctor straight away.
The signs may include:
• Sudden swelling of the face, throat, lips or mouth. This can
make it difficult to breathe or swallow.
• Sudden swelling of the hands, feet and ankles.
Severe skin rashes (not known, frequency cannot be
estimated from the available data)
If you get a severe skin rash, tell a doctor straight away.
• The signs may include a severe rash that develops quickly,
with blisters or peeling of the skin and possibly blisters in
the mouth.
Other possible side effects:

Common (may affect up to 1 in 10 people)
• Abnormalities with your white blood cells (such as a
decrease of leucocytes and an increase of eosinophils) and
platelets (decrease of thrombocytes).
• Loose stools or diarrhoea.
• Changes in the results of blood tests for liver functions.
• Rash.
Uncommon (may affect up to 1 in 100 people)
• Fungal infections (for example, thrush).
• A decrease in the number of white blood cells
(granulocytopenia).
• Reduction in number of red blood cells (anaemia).
• Problems with the way your blood clots. The signs may
include bruising easily and pain and swelling of your joints.
• Headache.
• Dizziness.
• Feeling sick or being sick.
• Pruritis (itching).
• Pain or a burning feeling along the vein where Lopratin has
been given. Pain where the injection was given.
• A high temperature (fever).
• Abnormal kidney function test (blood creatinine increased).

Rare (may affect up to 1 in 1,000 people)
• Inflammation of the large bowel (colon). The signs include
diarrhoea, usually with blood and mucus, stomach pain and
fever.
• Difficulty in breathing (bronchospasm).
• A lumpy rash (hives) that may cover a lot of your body,
feeling itchy and swelling.

Intramuscular injection (injection into a muscle)
• Lopratin 250 mg can be administered by the intramuscular
route.
• Treatment with injection into a muscle is only justified in
exceptional cases and after a careful risk/benefit
evaluation.
• The content of the 250 mg injection vial is dissolved
completely in 1 ml of 1.06% lidocaine hydrochloride solution
for injection by swirling
• The solution is injected deeply into the buttocks muscle
(intragluteally).
• No more than 1 g Lopratin should be injected on one side.
• An injection into the blood vessels must be strictly avoided.
(Please note the manufacturer's information on the risks of
lidocaine hydrochloride in the relevant information documents
on the respective lidocaine preparations used).
For other routes of administration other strengths of
Ceftriaxone are available.

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5

How to store Lopratin

The solutions should be used immediately after their
reconstitution.
Only clear solutions should be used.
The contents of the vials, once opened, should be used
immediately.
Any unused injection or infusion solutions should be
disposed of.

Storage: Keep the container in the outer carton to protect it
from light.
Children: Keep out of the reach and sight of children.

Use-by-date: Do not use Lopratin after the expiry date, which
is stated on the pack. The expiry date refers to the last day of
that month.

Disposal: Medicines should not be disposed via wastewater
or household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help
protect the environment.

6

Contents of the pack and other information

What Lopratin 250 mg contains:
The active substance is ceftriaxone disodium 3.5 H2O.
Each 250 mg vial contains 250 mg ceftriaxone (as hydrated
disodium). There are no other ingredients.

What Lopratin 250 mg looks like and contents of the pack
Lopratin 250 mg: powder for solution for infusion or injection
Lopratin 250 mg is a white to yellowish crystalline powder. The
ready-to-use solutions are pale yellow to amber.
Do not use Lopratin 250 mg if you notice the following: The
solution is not clear.
Lopratin 250 mg, powder for solution for injection or infusion is
supplied in packs of 1, 5, 10, 25, 50 and 100 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz Ltd, Frimley Business Park, Frimley, Camberley,
Surrey, GU16 7SR, UK.

Manufacturer
Sandoz GmbH, Biochemiestraße 10, A-6250 Kundl, Austria.

This leaflet was last revised in 04/2014.

Miscibility
As a matter of principle, ceftriaxone solutions must always be
administered separately from other solutions for infusion.

Under no circumstances must ceftriaxone solutions be
mixed with solutions containing calcium.

Principal chemical intolerances
Lopratin 250 mg must never be mixed with any of the following
solutions:


solutions containing calcium such as Hartmann's and
Ringer's solutions.
• aminoglycosides (when given concurrently, these
preparations must be administered separately)
• Lopratin 250 mg must not be administered in the same
syringe as other antibiotics or other bactericidal agents.
A chemical intolerance of ceftriaxone has also been reported
with amsacrine (antitumour agent), vancomycin (antibiotic) and
fluconazole (fungicide).

Artwork Proof Box
Ref: V022 - SPC & PIL update - article 30
Proof no.
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Date prepared:
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Colours:
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Dimensions: 140 x 315 mm

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Font size:
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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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