LOPRATIN 250 MG POWDER FOR SOLUTION FOR INJECTION - patient leaflet, side effects, dosage

Lopratin 250 mg Powder for Solution for Injection

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.

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- 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 lopratinyou 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.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before you are given Lopratin if:

You have recently received or are about to receive products that contain calcium.

You have recently had diarrhoea after having an antibiotic medicine.

You have ever had problems with your gut, in particular colitis (inflammation of the bowel).

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.

You experience or have previously experienced a combination of any of the following symptoms: rash, red skin, blistering of the lips eyes and mouth, skin peeling, high fever, flu-like symptoms, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (signs of severe skin reactions, see also section 4 “Possible side effects”).

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.

If you are diabetic or need to have your blood glucose level monitored you should not use certain blood glucose monitoring systems which may estimate blood glucose incorrectly while you are receiving ceftriaxone. If you use such systems check the instructions for use and tell your doctor, pharmacist or nurse. Alternative testing methods should be used if necessary.

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.

Lopratin contains sodium

This medicine contains 83 mg sodium (main component of cooking/table salt) in each gram powder for solution for injection. This is equivalent to 4.2% of the recommended maximum daily dietary intake of sodium for an adult.

• 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.

Adults, older people and children aged 12 years and over with a body weight greater than or equal to 50 kilograms (kg):

• 1 to 2 g 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 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.

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.

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 reactions (not known, frequency cannot be estimated from the available data)

If you get a severe skin reactios, 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 (Stevens-Johnson syndrome and toxic epidermal necrolysis which are also known as SJS and TEN).
• A combination of any of the following symptoms: widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome).

PL 04416/0503

Lopratin 250 mg powder for solution for injection

Jarisch-Herxheimer reaction which causes fever, chills, headache, muscle pain, and skin rash that is usually self-limiting. This occurs shortly after starting Ceftriaxone treatment for infections with spirochete such as Lyme disease.

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.
• 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).
• 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.
• 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 ceftriaxone. 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:or search for MHRA Yellow Card in Google play or Apple App store.. By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store lopratin

• ■ Keep this medicine out of the sight and reach of children

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• ■ Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.

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• ■ Powder for solution for injection:

• ■ Do not store above 25 °C.

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• ■ Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. 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.

Each vial contains 250 mg ceftriaxone (as ceftriaxone disodium, hydrated).

There are no other ingredients.

What Lopratin 250 mg looks like and contents of the pack

The powder is coloured white to yellowish.

Do not use Lopratin 250 mg if you notice the following: The solution is not clear.

Pack sizes 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

BiochemiestraBe 10

A-6250 Kundl

Austria

This leaflet was last revised in 09/2019

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

For full prescribing information please see the full Summary of Product Characteristics.

PL 04416/0503

Lopratin 250 mg powder for solution for injection

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”.

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.

PIL.0503.008.0d V037: PI in line with EC guidelines MSB

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.