500 mg powder for solution for injection; 1 g powder for solution for injection; 1 g powder for solution for injection / infusion; 2 g powder for solution for infusion 
ceftriaxone (as ceftriaxone sodium)

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or nurse. If you get any side effects, talk to your doctor or nurse. This also applies to any side effects not mentioned in this information. See section 4.

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

1. What Ceftriaxone Stragen is and what it is used for

Ceftriaxone Stragen is an antibiotic given to adults and children (including newborns). It works by killing bacteria that cause infection. It belongs to a group of medicines called cephalosporins .

Ceftriaxone Stragen is used to treat infections in:

  • the brain ( meningitis ).
  • the lungs.
  • middle ear.
  • the abdomen or abdominal wall ( peritonitis ).
  • urinary tract and kidneys.
  • legs and joints.
  • skin or soft tissues.
  • the blood.
  • the heart.

It can be given:

  • to treat certain sexually transmitted diseases ( gonorrhea and syphilis ).
  • to treat patients with low white blood cell count ( neutropenia ) who have a fever caused by a bacterial infection.
  • to treat your chest infection in adults with chronic bronchitis.
  • to treat Lyme disease (caused by tick bites) in adults and children including newborns from 15 days of age.
  • to prevent infection during surgery.

Ceftriaxone contained in Ceftriaxone Stragen may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Ceftriaxone Stragen

You should not be treated with Ceftriaxone Stragen 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). Symptoms include sudden swelling of the throat or face which may make it difficult to breathe or swallow, sudden swelling of the hands, feet, and ankles, and severe rashes that develop rapidly.
  • You are allergic to lidocaine and you should receive Ceftriaxone Stragen as an injection into a muscle.

Ceftriaxone Stragen should not be given to infants if:

  • The baby is born prematurely.
  • The baby is newborn (up to 28 days of age) and has certain types of blood problems or jaundice (yellowing of the skin or whites of the eyes) or if the baby is to be given a product that contains calcium in a vein.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before you are treated with Ceftriaxone Stragen if:

  • you experience or have previously experienced a combination of some of the following symptoms: skin rash, redness, blisters on lips, eyes, and mouth, scaly skin, high fever, flu-like symptoms, increased levels of liver enzyme seen in blood tests, and an increase in a type of white blood cells ( eosinophilia ) and enlarged lymph nodes (signs of severe skin reactions, see also section 4 “Possible side effects”).
  • you have recently received or will receive products that contain calcium.
  • you have recently had diarrhea after taking an antibiotic, or if you have ever had stomach problems, especially colitis ( inflammation of the intestines).
  • you have liver or kidney problems.
  • you have gallstones or kidney stones.
  • you have other diseases, such as hemolytic anemia (a decrease in your red blood cells that can make your skin pale yellow and cause weakness or shortness of breath).
  • you are on a sodium controlled diet.

If you need a blood or urine sample

If you are being treated with Ceftriaxone Stragen for a long time, you may need to have regular blood tests. Ceftriaxone Stragen can affect the results of tests for sugar in the urine and a blood test called the Coombs test. If you are going to take a test:

  • Tell the person taking the test that you are being treated with Ceftriaxone Stragen.

Some blood glucose monitoring systems may measure your blood sugar incorrectly while you are receiving ceftriaxone. If you are diabetic or need to monitor your blood sugar level, do not use such systems. Read the instructions for use for your blood glucose monitoring system and talk to your doctor, pharmacist, or nurse. Alternative test methods should be used if necessary.

Children

Talk to your doctor, pharmacist, or nurse before treating your child with Ceftriaxone Stragen if:

  • he/she has recently received or will receive, a product that contains calcium in a vein.

Other medicines and Ceftriaxone Stragen

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

If you are taking any of the following medicines, tell your doctor or pharmacist in particular:

  • A type of antibiotic called an aminoglycoside.
  • An antibiotic called chloramphenicol (used to treat infections, especially in the eyes).

Pregnancy, breastfeeding, 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.

Your doctor will weigh the benefits of treating you with Ceftriaxone Stragen against the risk to your child.

Driving and using machines

Ceftriaxone Stragen may cause dizziness. If you feel dizzy, do not drive or use any tools or machines. Talk to your doctor if you experience any of these symptoms. 

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Ceftriaxone Stragen contains sodium

This medicine contains 82.8 mg of sodium (the main ingredient in table salt / table salt) per gram. This corresponds to 4.14% of the highest recommended daily intake of sodium for adults.

3. How Ceftriaxone Stragen is given

Ceftriaxone Stragen 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 muscle. Ceftriaxone Stragen is prepared by your doctor, pharmacist, or nurse and will not be mixed with or given at the same time as calcium-containing injections.

The usual dose is one

Your doctor will determine the correct dose of Ceftriaxone Stragen for you. Dose one depends on the severity and type of infection, whether you are on any other antibiotics, your weight and age, and how well your kidneys and liver are working. The number of days or weeks you receive Ceftriaxone Stragen depends on the type of infection you have.

Adults, the elderly, and children 12 years or older and weighing 50 kilograms (kg) or more:

  • 1 to 2 g once a day depending on the severity and type of infection. If you have a serious 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 can get it as a single dose once a day or as two separate doses.

Newborns and children from 15 days to 12 years of age with a body weight of less than 50 kg:

  • 50-80 mg Ceftriaxone Stragen for each kg of bodyweight of the child once daily depending on the severity and type of infection. If you have a serious infection, your doctor will give you a higher dose of up to 100 mg per kg of body weight up to a maximum of 4 g once daily. If your daily dose is higher than 2 g, you can get it as a single dose once a day or as two separate doses.
  • Children with a bodyweight of 50 kg or more should be given the usual dose one for adults.

Newborn babies (0-14 days)

  • 20-50 mg Ceftriaxone Stragen for each kg of body weight of the child once daily depending on the severity and type of infection.
  • The maximum daily dose should not exceed 50 mg per kg of body weight of the child.

People with liver and kidney problems

You may be given a different dose than the standard dose. Your doctor will decide how much Ceftriaxone Stragen you need and will monitor you carefully depending on how severe your liver or kidney disease is.

If you take more Ceftriaxone Stragen than you should

If you accidentally get more than the prescribed dose, contact your doctor or nearest hospital immediately.

If you forget to use Ceftriaxone Stragen

If you miss an injection, get it as soon as possible. However, if it is soon time for your next injection, skip the missed injection. Do not take a double dose (two injections at the same time) to compensate for a missed dose.

If you stop using Ceftriaxone Stragen

Do not stop taking Ceftriaxone Stragen unless your doctor tells you to. If you have any further questions on the use of this product, 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 occur with this medicine:

Severe allergic reactions (frequency not known, cannot be calculated from the available data)

If you get a severe allergic reaction, tell your doctor immediately.

Symptoms may include:

  • Sudden swelling of the face, neck, lips, or mouth. This may make it difficult to breathe or swallow.
  • Sudden swelling of hands, feet, or ankles.

Severe skin reactions (not known frequency, can not be calculated from the available data)

If you get severe skin reactions, tell your doctor immediately. 
Symptoms may include:

  • Severe skin rash that develops suddenly, with blisters or scaling of the skin and possibly blisters in the mouth (Steven-Johnson syndrome and toxic epidermal necrolysis also known as SJS and TEN).
  • A combination of some of the following symptoms: scattered skin rash, high body temperature, elevated liver enzyme levels, abnormal blood levels ( eosinophilia ), enlarged lymph nodes, and effects on other organs (drug reaction with eosinophilia and systemic symptoms also known as DRESS or hypersensitivity syndrome).
  • Jarisch-Herxheimer reaction causes fever, chills, headache, muscle aches, and a rash which is usually transient. This occurs shortly after treatment with ceftriaxone Stragen spiroket- against infection s such as Lyme disease has started.


Other possible side effects:

Common (may affect up to 1 in 10 people)

  • Abnormalities in your white blood cells (such as a decrease in leukocytes and an increase in eosinophils ) and platelets (decrease in platelets ).
  • Loose stools or diarrhea.
  • Changes in the results of blood tests for liver function.
  • Rash.

Uncommon (may affect up to 1 in 100 people)

  • Fungal infections (eg cod).
  • A decrease in the number of white blood cells ( granulocytopenia ).
  • A decrease in the number of red blood cells ( anemia ).
  • Problems with blood clotting ability. Symptoms may include bruising and joint pain and swelling.
  • Headache.
  • Dizziness.
  • Nausea or vomiting.
  • Pruritus ( itching ).
  • Pain or a burning sensation along the vein in which Ceftriaxone Stragen was given. Pain where the injection was given.
  • High body temperature (fever).
  • Abnormal kidney function test (increased blood creatinine).

Rare (may affect up to 1 in 1,000 people)

  • Inflammation of the colon ( colon ). Symptoms include diarrhea, usually with blood and mucus, abdominal pain, and fever.
  • Difficulty breathing.
  • Elevated rash ( hives ) that can cover large parts of your body, and itchy feeling, and swelling.
  • Blood or sugar in the urine.
  • Edema (fluid retention).
  • Overindulge.

No known frequency (cannot be calculated from the available data)

  • A secondary infection may not respond to the antibiotic previously prescribed.
  • A type of anemia in which red blood cells are destroyed ( hemolytic anemia ).
  • Severe decrease in white blood cells ( agranulocytosis ).
  • Cramps.
  • Dizziness (a tingling sensation).
  • Inflammation of the pancreas ( pancreatitis ). Symptoms include severe abdominal pain that spreads to your back.
  • Inflammation of the mucous membrane of the mouth ( stomatitis ).
  • Inflammation of the tongue ( glossitis ). Symptoms include swelling, redness, and soreness of the tongue.
  • Problems with the gallbladder, which can cause pain, nausea, and vomiting.
  • A neurological condition that can occur in newborns with severe jaundice (kernicterus).
  • Kidney problems caused by precipitation of calcium ceftriaxone. Pain may occur when urinating, or urine production may decrease.
  • A false positive result for the Coombs test (a test for certain blood problems).
  • A false positive test for galactosemia (an abnormal accumulation of galactose sugar).
  • Ceftriaxone Stragen may interfere with certain types of blood glucose tests – ask 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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Ceftriaxone Stragen

Keep this medicine out of the sight and reach of children. 

Do not use this medicine after the expiry date which is stated on the carton and vials after EXP.

The expiration date is the last day of the specified month.

Store the vials in the outer carton. Sensitive to light.

Prepared solution / diluted solution should be used immediately

Do not use Ceftriaxone Stragen if the solution is cloudy

For single use only

Discard any remaining solution. 

Medicines should not be disposed of via wastewater. The doctor or nurse discards all medicines that are no longer used. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is ceftriaxone sodium equivalent to 500 mg, 1 g, or 2 g ceftriaxone
  • The product does not contain any excipients

What the medicine looks like and the contents of the pack

Ceftriaxone Stragen is a white to yellowish powder. The powder is supplied in a single-dose vial packaged in a carton. Each carton contains 10 vials.

Marketing Authorisation Holder

Stragen Nordic A / S

Helsingørsgade 8C

3400 Hillerød

Denmark

Tel: +45 48 10 88 10

Email: info@stragen.dk

Manufacturer

Mitim Srl

Via Cacciamali 34-38,

25125 Brescia

Italy

Muhammad Nadeem

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