Ceftriaxone 1 G Powder For Solution For Injection
170 mm
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Prueba N.° Version No. |
8 |
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Fecha Date |
16.01.2015 |
REIG JOFRE
a
Codigo Factory Code
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Ceftriaxone 1 g Powder for Solution for Injection or Infusion Ceftriaxone 2 g Powder for Solution for Injection or Infusion
(ceftriaxone sodium)
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Fecha y Firma / Date and Signed
Read all of this leaflet carefully before you start using 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 or your nurse.
• If you get any side effects talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Ceftriaxone Injection is and what it is used for
2. What you need to know before you are given Ceftriaxone Injection
3. How Ceftriaxone Injection will be given
4. Possible side effects
5. How to store Ceftriaxone Injection
6. Contents of the pack and other information
The name of your medicine is “Ceftriaxone 1 g Powder for Solution for Injection or Infusion” or “Ceftriaxone 2 g Powder for Solution for Injection or Infusion” referred to as Ceftriaxone Injection throughout this leaflet.
1. WHAT CEFTRIAXONE INJECTION IS AND WHAT IT IS USED FOR
Your medicine contains the active substance ceftriaxone, which is an antibiotic. It belongs to a group of antibiotics that are called cephalosporins. These types of antibiotic are similar to penicillin.
Ceftriaxone kills bacteria and it can be used against various sorts of infections.
Like all antibiotics, ceftriaxone is only effective against some types of bacteria. Thus it is only suitable for treating some types of infection.
Ceftriaxone can be used to treat:
• infection of the meninges (meningitis)
• serious bacterial infection of the blood (septicaemia)
• bone or joint infections
• infections of the respiratory tract (pneumonia)
• infections in the skin and soft tissues
• infections in patients having low numbers of white blood cells
• bacterial infection of the genitals (gonorrhoea). Ceftriaxone can also be used to help prevent infections before, during and after surgery in patients at risk of severe infections.
You must talk to a doctor if you do not feel better or if you feel worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CEFTRIAXONE INJECTION
You must not be given Ceftriaxone Injection if:
• you are allergic to ceftriaxone
• you are allergic to any other cephalosporin type antibiotic
• you have ever had a severe or sudden allergic reaction to any penicillin or to another beta-lactam antibiotic because you might also be allergic to this medicine.
The signs include sudden swelling of the throat or face which might make it difficult to breathe 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 ceftriaxone as an injection into a muscle.
Ceftriaxone Injection must not be given to babies if:
• the baby is premature
• the baby is newborn (up to 28 days) and has certain blood problems or jaundice (yellowing of the skin or whites of the eyes) or is about to be given another injection that contains calcium.
Ceftriaxone Injection should not be given by injection into a muscle:
• to infants under 2 years of age
• during pregnancy or breast-feeding.
If you feel uncertain, ask your doctor or nurse.
Warnings and precautions
Talk to your doctor or nurse before you are given Ceftriaxone Injection if:
• you have ever had an allergic reaction to penicillin or a similar antibiotic
• you have ever had an allergic reaction to anything else or have ever had asthma, since these increase the chance of you being allergic to ceftriaxone
• you have recently received or are about to receive calcium
• you have ever been told that your kidneys and/or liver do not work very well
• you have ever had bowel problems, particularly colitis (inflammation of the bowels)
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The following information is inter
Ceftriaxone 1 g Powder for Solution for Injection or Infusion
Ceftriaxone 2 g Powder for Solution for Injection or Infusion
(Ceftriaxone sodium)
Please refer to the Summary of Product Characteristics for full prescribing information.
Presentation
Ceftriaxone 1 g Powder for Solution for Injection or Infusion is supplied in a 10ml Type II clear & colourless glass vial with a bromobutyl stopper and aluminium and polypropylene cap.
Ceftriaxone 2 g Powder for Solution for Injection or Infusion is supplied in a 50ml Type II clear & colourless glass vial with a bromobutyl stopper and aluminium and polypropylene cap.
The vials contain a sterile white to yellowish crystalline powder. There are no excipients.
Each gram contains 3.6 mmol sodium.
The 1 g vials are packed in boxes of 1 or 5 vials.
Not all pack sizes may be marketed.
The 2 g vials are packed in boxes of 1 vial.
Posology and method of administration
Ceftriaxone may be administered by slow intravenous injection, by slow intravenous infusion or by deep intramuscular injection after reconstitution of the solution according to the directions given below.
Diluents containing calcium, (e.g. Ringer’s solution or Hartmann’s solution), should not be used to reconstitute ceftriaxone vials or to further dilute a reconstituted vial for intravenous administration because a precipitate can form. Precipitation of ceftriaxone-calcium can also occur when ceftriaxone is mixed with calcium-containing solutions in the same intravenous administration line. Therefore, ceftriaxone and calcium-containing solutions must not be mixed or administered simultaneously.
The intramuscular method of administration should only be used in exceptional clinical situations and should undergo a risk-benefit assessment.
Adults and children 12 years and over with a body weight > 50 kg
Standard therapeutic dosage: 1 g once daily.
Severe infections: 2 - 4 g daily, normally as a single dose every 24 hours.
The duration of therapy varies according to the course of the disease. As with antibiotic therapy in general, administration of ceftriaxone should be continued for a
• you have other illnesses, such as blood problems
• you are on a low sodium diet.
Tell your doctor if you develop any of the following during or after treatment with ceftriaxone:
• diarrhoea, particularly if it is severe or has blood in it
• tiredness, pale or yellowish coloured skin, shortness of breath, dizziness, headache, cold hands and feet, chest pain
• pain in the centre of your abdomen and possibly spreading to your back, feeling sick or being sick
Your doctor may wish to discontinue this medicine and give appropriate treatment.
If you develop new symptoms during the course of an existing infection, inform your doctor as these may be due to a second infection.
Deposits of ceftriaxone salt in the kidneys and gallbladder have been reported (see Section 4: Possible side effects). Small infants and children are more likely to have this condition; however it should disappear after completion or discontinuation of therapy.
This medicine can affect the results of some blood tests (such as the Coombs’ test). It is important to tell the doctor that you are using this medicine if you are to have any blood tests.
This medicine can also affect the results of some types of urine tests for sugar. If you have diabetes and routinely test your urine, tell your doctor. This is because a different type of urine test may have to be used to monitor your diabetes while you are having this medicine.
Children
Ceftriaxone Injection should not be given to newborn babies (especially if premature) who are at risk of developing bilirubin encephalopathy (a disease of the brain associated with high levels of bilirubin in blood).
As higher doses of ceftriaxone may cause problems in the gall bladder, the doctor will avoid doses more than 80 mg/kg body weight.
Other medicines and ceftriaxone
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
This medicine can be affected by other medicines that are removed by the kidneys. This is especially if these other medicines also affect how well the kidneys work. There are many medicines that can do this, so you should check with your doctor or nurse before using this medicine.
In particular, tell your doctor or nurse if you are taking:
• oral contraceptive (the pill). Ceftriaxone can stop the pill from working. Use extra non-hormonal contraceptive measures, such as condoms, while you are using ceftriaxone and for one month afterwards.
• chloramphenicol (used to treat infections)
• anticoagulants (medicines to thin the blood)
• probenecid (used to treat gout)
• amsacrine (an anti-cancer medicine)
• fluconazole (an anti-fungal medicine)
• vancomycin or other antibiotics (used to treat infections).
This medicine should not be administered simultaneously with intravenous (into a vein) calcium.
Pregnancy and breast-feeding
• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby you must tell your doctor before you are given ceftriaxone.
• Although there is limited data available on use of this medicine in pregnant women, it should only be given to a pregnant woman if it is really necessary.
• This medicine should be given with caution to women who are breast-feeding. This is because small amounts of it enter the milk and thus the breast-fed infant.
• In pregnancy and breast-feeding this medicine should not be given intramuscularly (into the muscle) with lidocaine.
Driving and using machines
You may get dizzy when using this medicine. Talk to your doctor if this happens to you and do not drive or use any tools or machines.
Ceftriaxone Injection contains sodium.
Each gram ceftriaxone contains 3.6 mmol (83 mg) sodium. To be taken into consideration by patients on a controlled sodium diet.
3. HOW CEFTRIAXONE INJECTION WILL BE GIVEN
Ceftriaxone will be given to you by a doctor or nurse in one of the following ways:
• as a slow injection into a vein
• as an injection into a large muscle (such as the muscle in your arm)
• as an infusion through a small tube into one of your veins
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minimum of 48 to 72 hours after the patient has become afebrile or evidence of bacterial eradication has been obtained.
Acute, uncomplicated gonorrhoea: A single dose of 250 mg intramuscularly should be administered. Simultaneous administration of probenecid is not indicated.
Peri-operative prophylaxis: Usually 1 g as a single intramuscular or slow intravenous dose. In colorectal surgery, 2 g should be given intramuscularly (dosages greater than 1 g should be divided and injected at more than one site), or by slow intravenous infusion, in conjunction with a suitable agent against anaerobic bacteria.
Elderly
These dosages do not require modification in elderly patients provided that renal and hepatic function are satisfactory (see below).
Neonates, infants and children up to 12 years
The following dosage schedules are recommended for once daily administration:
Neonates
A daily dose of 20-50 mg/kg bodyweight intravenously, not to exceed 50 mg/kg.
In the neonate, the intravenous dose should be given over 60 minutes to reduce the displacement of bilirubin from albumin, thereby reducing the potential risk of bilirubin encephalopathy (see section 4.4 of the Summary of Product Characteristics).
Infants and children of up to 12 years with a body weight < 50 kg
Standard therapeutic dosage: 20-50 mg/kg bodyweight once daily
In severe infections up to 80 mg/kg bodyweight daily may be given.
For children with body weights of 50 kg or more, the usual adult dosage should be used. Doses of 50 mg/kg or over should be given by slow intravenous infusion over at least 30 minutes. Doses greater than 80 mg/kg body weight should be avoided because of the increased risk of biliary precipitates.
Renal and hepatic impairment In patients with impaired renal function, there is no need for the dosage to be reduced provided liver function is intact. Only in cases of pre-terminal renal failure (creatinine clearance < 10 ml/min) should the daily dose of ceftriaxone be limited to 2 g or less.
In patients with liver damage there is no need for the dosage to be reduced provided renal function is intact.
|
Prueha N.° Version No. |
8 |
|
Fecha Date |
16.01.2015 |
REIG JOFRE
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Codigo Factory Code
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The dose and how your doctor gives it to you depend on the type of infection and how bad the infection is. It also depends on your age, weight and how well your kidneys are working. Your doctor will explain this to you.
The length of treatment will depend on the type of infection and the course of the disease. In general treatment should be continued for at least 2-3 days after you have started to recover.
The recommended doses are:
Adults, the elderly and children aged 12 years and over who weigh 50 kg or more
• The usual dose is 1 g once a day. In serious infections, this can be increased to 2-4 g a day, normally as a single dose every 24 hours. Your doctor will decide the duration of therapy which depends on the course of the infection.
• The usual dose for gonorrhoea is a single dose of 250 mg as an injection into a muscle.
• To prevent infections during surgery, the doctor may give you between 1 g and 2 g as one or two injections or as an infusion before your operation.
Children up to 12 years
• The doctor will work out the dose based on the child’s body weight. It will usually be given to the child once a day.
• Up to 80 mg per kg may be given in severe infections.
• Children weighing 50 kg or more can receive the usual adult dosage.
• Doses of 50 mg per kg or over needs slow intravenous infusion over at least 30 minutes.
Newborn babies
• The doctor will work out the dose based on the baby’s body weight. It will usually be given to the baby once a day, by intravenous infusion over 1 hour.
• More than 50 mg per day must not be given, even in severe infections.
People with liver or kidney problems
• For people with kidney problems the dose does not need to be reduced if liver function is normal. If the condition of the kidney is very poor (creatinine clearance of < 10 ml/min) the daily dose of ceftriaxone should not exceed 2 g in adult patients.
• People with liver problems do not need the dose reducing unless they have kidney problems as well.
• In severe kidney impairment accompanied by liver problems the blood ceftriaxone concentrations should be monitored regularly and the dosage adjusted.
• If you are on dialysis, the doctor will do tests to make sure you are on the right dose.
If the patient is a child under 2 years old or a pregnant or breast-feeding woman, ceftriaxone should only be given by slow injection into a vein.
If you are given too much ceftriaxone
This medicine is usually given to you by a doctor or nurse. If you think you may have received too much medicine please tell your doctor or nurse at once.
If you think you have missed an injection please tell your doctor or nurse.
If you stop using Ceftriaxone
It is important to finish the course of treatment your doctor has prescribed, even if you start to feel better. If you do not finish the course of treatment, your infection may get worse again.
If you do not feel well at the end of the prescribed treatment course or feel worse during treatment, you should talk to your doctor.
If you have any further questions on the use of this medicine ask your doctor, pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects although not everybody gets them.
If any of the following serious side effects happen, stop taking this medicine and tell your doctor immediately or go to your nearest hospital accident and emergency department:
• a severe allergic reaction; signs may include sudden wheeziness, difficulty swallowing and tightness of the chest, sudden swelling of the eyelids, face, lips, throat or mouth, sudden swelling of the hands, feet or ankles
• a severe skin rash that develops quickly with blisters or peeling of the skin and may involve the eyes, mouth, throat and genitals
• diarrhoea that is severe, or has blood in it, with stomach pain or fever. This can be a sign of a serious bowel inflammation (called “pseudomembranous colitis”) that can happen after using antibiotics.
Other possible side effects:
If any of the following happen, inform your doctor:
Very common: may affect more than 1 in 10 people
• in children: gallbladder problems which may cause pain, feeling sick and being sick
Common: may affect up to 1 in 10 people
• nausea (feeling sick), vomiting (being sick)
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In severe renal impairment accompanied by hepatic insufficiency, the plasma concentration of ceftriaxone should be determined at regular intervals and the dosage adjusted appropriately.
In patients undergoing dialysis, no additional supplementary dosing is required following the dialysis. Serum concentrations should be monitored, however, to determine whether dosage adjustments are necessary, since the elimination rate in these patients may be reduced.
Instructions for use and handling
Preparation of solutions for injection and infusion
The use of freshly prepared solutions is recommended. These maintain potency for at least 6 hours at or below 25°C or 24 hours at 2-8°C. Protect from light.
This medicinal product must not be mixed with other medicinal products except those mentioned below.
After addition of the recommended reconstitution solution specified below, shake well (up to 60 seconds) until the contents of the vial have dissolved completely. Reconstituted solutions should be inspected visually. Only clear solutions free of visible particles should be used.
The reconstituted product is for single use only and any unused solution must be discarded.
When reconstituted for intramuscular or intravenous injection, the white to yellowish crystalline powder gives a pale yellow to amber solution.
Ceftriaxone should not be mixed in the same syringe with any drug other than 1% w/v Lidocaine Injection BP (for intramuscular injection only).
Intramuscular injection:
1 g ceftriaxone should be dissolved in 3.5 ml of 1 % w/v Lidocaine Injection BP The solution should be administered by deep intramuscular injection. Dosages greater than 1 g should be divided and injected at more than one site. Not more than 1 g should be injected on either side of the body. The maximum dose by intramuscular injection should not exceed 2 g.
Solutions in lidocaine should not be administered intravenously.
Intravenous injection:
1 g ceftriaxone should be dissolved in 10 ml of Water for Injections BP The injection should be administered over at least 2 - 4 minutes directly into the vein or via the tubing of an intravenous infusion.
Intravenous infusion:
2 g ceftriaxone should be dissolved in 40 ml of one of the following calcium-free solutions: Sodium Chloride Intravenous Infusion BP 0.9%, Sodium Chloride and Glucose Intravenous Infusion BP (sodium chloride 0.45% and glucose 2.5%), Glucose Intravenous Infusion BP 5% or 10%, Dextran 6% in Glucose Intravenous Infusion BP 5%. The infusion should be administered over at least 30 minutes.
• loose stools or diarrhoea
• liver problems, shown by changes in blood tests that check how your liver is working
• allergic reactions; these include skin rash, itching, hives, nettle rash, swellings of the skin and joints
• pain and hardness when injected into a muscle
• pain or a burning feeling when injected into a vein.
Uncommon: may affect up to 1 in 100 people
• kidney problems including passing less urine than is normal
• other types of infection, such as those caused by fungi and yeasts, e.g. thrush
• headache, dizziness, vertigo (a feeling that you or your surroundings are moving)
• a sore mouth, inflammation of the tongue
• loss of appetite, pain in the abdomen
Rare: may affect up to 1 in 1,000 people
• in adults: problems with your gallbladder which may cause pain, feeling sick and being sick
• blood problems; signs include feeling tired, being short of breath, bleeding, bruising easily
• inflammation of the pancreas; signs include severe pain in the stomach (caused by inflammation of the pancreas)
• kidney stones
• blood or sugar in your urine
• high temperature (fever) or shivering.
Very rare: may affect up to 1 in 10,000 people
• inflammation of the large bowel; signs include diarrhoea, pain in the abdomen and fever
• problems with the way your blood clots; signs include bruising easily and pain and swelling of your joints
• changes in the number of white blood cells in your blood; signs include fever, severe chills, sore throat or mouth ulcers
• positive results in a type of blood test called a Coombs’ test.
Additional side effects in children
• deposits of ceftriaxone-calcium salt have been reported in the lungs and kidneys of newborn babies.
Reporting of side effects
If you get any side effects talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE CEFTRIAXONE INJECTION
• Keep this medicine out of the sight and reach of children.
• Do not store above 25”C. Keep the vial in the outer carton in order to protect from light.
• Once reconstituted, this medicine should be used within 24 hours if stored at a temperature of 2-8”C or within 6 hours if stored at 25”C.
• Do not use this medicine after the expiry date which is stated on the label and carton after EXP The expiry date refers to the last day of that month.
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 Ceftriaxone 1 g Powder for Solution for Injection or Infusion contains:
The active substance is ceftriaxone. Each vial contains 1 g of ceftriaxone as the sodium salt.
There are no other ingredients.
What Ceftriaxone 2 g Powder for Solution for Injection or Infusion contains:
The active substance is ceftriaxone. Each vial contains 2 g of ceftriaxone as the sodium salt.
There are no other ingredients.
What Ceftriaxone Injection looks like and contents of the pack
Ceftriaxone Injection is an almost white to yellowish crystalline powder, supplied in a glass vial. Before it is given to the patient the powder is dissolved in sterile liquid. The ready-to-use solutions are pale yellow to amber.
Ceftriaxone 1 g vials are available in packs of 1 vial and 5 vials. Not all pack sizes may be marketed.
Ceftriaxone 2 g vials are available in packs of 1 vial.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and manufacturer: Laboratorio Reig Jofre, SA,
Gran Capitan, 10-08970 Sant Joan Despi,
Barcelona (Spain)
This leaflet was last revised in May 2014
Displacement value
|
Vial size |
Diluent |
Volume of diluent added |
Approximate resulting volume of ceftriaxone solution |
Approximate displacement volume |
|
1 g |
1% lidocaine hydrochloride injection |
3.5 ml |
4.0 ml |
0.5 ml |
|
1 g |
Water for Injections |
10 ml |
10.5 ml |
0.5 ml |
|
2 g |
0.9% sodium chloride solution |
40.0 ml |
41.0 ml |
1.0 ml |
Any unused product or waste material should be disposed of in accordance with local requirements.
Incompatibilities
Do not use diluents containing calcium, such as Ringer’s solution or Hartmann’s solution, to reconstitute ceftriaxone vials or to further dilute a reconstituted vial for intravenous administration because a precipitate can form.
Precipitation of ceftriaxone-calcium can also occur when ceftriaxone is mixed with calcium-containing solutions in the same intravenous administration line. Ceftriaxone must not be mixed or administered simultaneously with calcium-containing intravenous solutions, including continuous calcium-containing infusions such as parenteral nutrition via a Y-site. However, in patients other than neonates, ceftriaxone and calcium-containing solutions may be administered sequentially of one another if the infusion lines are thoroughly flushed between infusions with a compatible fluid. In vitro studies using adult and neonatal plasma from umbilical cord blood demonstrated that neonates have an increased risk of precipitation of ceftriaxone-calcium.
Based on literature reports ceftriaxone is incompatible with amsacrine, vancomycin, fluconazole and aminoglycosides.
Shelf life
Unopened:
Powder: 3 years.
Opened and after reconstitution:
For reconstituted solutions, chemical and physical in-use stability has been demonstrated for 6 hours at 25°C and for 24 hours at 2-8°C. Protect from light.
From a microbiological point of view, once opened, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C or 6 hours at 25°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Special precautions for storage
Unopened: Do not store above 25°C. Keep the container
in the outer carton in order to protect from light.
This leaflet was last revised in December 2014.
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