CEFUROXIMA 750 mg Powder For Injectable Solution
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Інструкція із застосування KEFUROXIMA K24 PARMAKEUTIKALS
Зміст інструкції
CEFUROXIMA K24 Pharmaceuticals 750 mg powder for injectable solution, 1.5 g powder for infusion solution
Cefuroxima
Read this leaflet carefully before you are given this medicine as it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or nurse.
- If any side effects occur, including those not listed in this leaflet, ask your doctor or nurse.
Contents of this leaflet:
- 1. What CEFUROXIMA K24 Pharmaceuticals is and what it is used for
- 2. What you need to know before CEFUROXIMA K24 Pharmaceuticals is given to you
- 3. How CEFUROXIMA K24 Pharmaceuticals is given
- 4. Possible side effects
- 5. How to store CEFUROXIMA K24 Pharmaceuticals
- 6. Contents of the pack and other information
1. What CEFUROXIMA K24 Pharmaceuticals is and what it is used for
CEFUROXIMA K24 Pharmaceuticals is an antibiotic used in adults and children. It works by killing the
bacteria that cause infections and belongs to a group of medicines called cephalosporins.
CEFUROXIMA K24 Pharmaceuticals is used to treat infections:
- lungs and chest
- urinary tract
- skin and soft tissues
- abdomen
CEFUROXIMA K24 Pharmaceuticals is also used:
- to prevent infections during surgery
2. What you need to know before you are given CEFUROXIMA K24 Pharmaceuticals
You must not be given CEFUROXIMA K24 Pharmaceuticalsif:
- if you are allergic( hypersensitive) to any antibiotic of the cephalosporin classor to any of the other components of CEFUROXIMA K24 Pharmaceuticals
- if you have had a severe allergic reaction ( hypersensitivity) to any other types of beta-lactam antibiotics (penicillins, monobactams and carbapenems).
- Talk to your doctor beforestarting treatment with CEFUROXIMA K24 Pharmaceuticals if you think this applies to you, because in this case you must not be given CEFUROXIMA K24 Pharmaceuticals. -
Pay particular attention with CEFUROXIMA K24 Pharmaceuticals
Pay attention to some symptoms such as allergic reactions and gastrointestinal disorders such as diarrhea while you are
treated with CEFUROXIMA K24 Pharmaceuticals. This will reduce the risk of possible problems. See ( Conditions
for which you should pay attention) in section 4. If you have had any allergic reaction to other antibiotics
such as penicillin, you may also be allergic to CEFUROXIMA K24 Pharmaceuticals.
If you need blood or urine tests
CEFUROXIMA K24 Pharmaceuticals may interfere with the results of urine or blood tests for the
presence of sugar and the blood test known as the Coombs' test. If you are undergoing these tests:
- Inform the person taking the samplethat you are being treated with CEFUROXIMA K24 Pharmaceuticals. -
Other medicines and CEFUROXIMA K24 Pharmaceuticals
Tell your doctor if you are taking any other medicines, if you have started taking any recently or
if you start taking new ones. This includes over-the-counter medicines.
Some medicines can affect the activity of CEFUROXIMA K24 Pharmaceuticals, or make it more likely
that you have side effects. These include:
- aminoglycoside type antibiotics
- diuretic drugssuch as furosemide
- probenecid
- oral anticoagulants
- Tell your doctorif this applies to you. You may need further checks to monitor kidney function while you are being treated with CEFUROXIMA K24 Pharmaceuticals. -
Contraceptive pill
CEFUROXIMA K24 Pharmaceuticals may reduce the effectiveness of the contraceptive pill. If you are taking the pill
contraceptive while being treated with CEFUROXIMA K24 Pharmaceuticals you should also use a
barrier method of contraception(such as a condom). Ask your doctor for advice.
Pregnancy, breastfeeding and fertility
Tell your doctor before you are given CEFUROXIMA K24 Pharmaceuticals:
- if you are pregnant, if you think you may be, or are planning a pregnancy
- if you are breastfeeding
The doctor will assess the benefit of treatment with CEFUROXIMA K24 Pharmaceuticals against the risk to your
baby.
Driving and operating machinery
Do not drive vehicles or operate machinery if you do not feel well.
Important information about some excipients of CEFUROXIMA K24 Pharmaceuticals
CEFUROXIMA K24 Pharmaceuticals contains sodium. You need to take the following into consideration if you are
following a diet to control sodium.
| Dosage of CEFUROXIMA K24 Pharmaceuticals | Quantity per vial |
3. How CEFUROXIMA K24 Pharmaceuticals is administered
CEFUROXIMA K24 Pharmaceuticals is generally administered by a doctor or a nurse. It
can be administered as an intravenous infusionor as an injectiondirectly into a vein or into the muscle.
Usual dose
The appropriate dose of CEFUROXIMA K24 Pharmaceuticals will be decided by the doctor and depends on: the severity and type of infection; whether you are undergoing treatment with other antibiotics; your body weight and age; the condition of your kidneys.
Newborn babies (from 0 to 3 weeks)
For each kg of the baby's body weight, 30 to 100 mg of CEFUROXIMA K24 Pharmaceuticals per day will be administered, divided into two or three doses.
Infants (over 3 weeks) and children
For each kg of the newborn or child's body weight, 30 to 100 mg of CEFUROXIMA K24 Pharmaceuticals per day will be administered, divided into three or four doses.
Adults and adolescents
750 mg to 1.5 g of CEFUROXIMA K24 Pharmaceuticals two, three or four times a day.
Maximum dose: 6 g per day.
Patients with kidney problems
If you have kidney problems, your doctor may change the dose.
- Talk to your doctorif this applies to you. -
4. Possible side effects
Like all medicines, CEFUROXIMA K24 Pharmaceuticals can cause side effects, although not everybody gets them.
Conditions for which you should pay attention
A small number of people treated with CEFUROXIMA K24 Pharmaceuticals experience an allergic reaction or a potentially serious skin reaction. The symptoms of these reactions include:
- severe allergic reaction.Signs include raised, itchy rash, swelling,sometimes on the face or mouth causing difficulty breathing.
- skin rashwith the formation of blistersresembling small targets(a dark spot in the center surrounded by a clear area with a black ring around the edge).
- widespread rashwith blistersand skin peeling.(These may be signs of Stevens-Johnson syndromeor toxic epidermal necrolysis).
- fungal infectionsin rare cases, medicines like CEFUROXIMA K24 Pharmaceuticals can cause an overgrowth of fungi (Candida) in the body, which can lead to fungal infections (such as thrush). This side effect is more likely if you take CEFUROXIMA K24 Pharmaceuticals for a long time.
- Contact your doctor or nurse immediately if you experience any of these symptoms.-
| 750 mg | 42 mg |
| 1,5 g | 83 mg |
Common side effects
These may affect up to 1in 10patients:
- pain at the injection site, swelling and redness along the vein. Tell your doctorif any of these conditions worries you. Common side effects that can be detected by blood tests:
- increases in substances (enzymes) produced by the liver
- changes in the number of white blood cells (neutropeniaor eosinophilia)
- low levels of red blood cells (anemia)
Uncommon side effects
These may affect up to 1in 100patients:
- skin rash, itching, bumpy rash (urticaria)
- diarrhea, nausea, stomach pain Tell your doctorif you experience any of these conditions. Uncommon side effects that can be detected by blood tests:
- low levels of white blood cells (leukopenia)
- increased bilirubin (a substance produced by the liver)
- positive Coombs test
Other side effects
Other side effects have been reported in a very small number of people, but their exact frequency is
unknown:
- fungal infections
- high temperature (fever)
- allergic reactions
- inflammation of the colon (large intestine) causing diarrhea usually with blood and mucus, stomach pain
- inflammation in the kidneys and blood vessels
- too fast destruction of red blood cells (hemolytic anemia)
- skin rash with the formation of blisters resembling small targets (a dark spot in the center surrounded by a clear area with a black ring around the edge) erythema multiforme.
- Tell your doctorif you experience any of these conditions. Side effects that can be detected by blood tests:
- decrease in the number of platelets (cells that help blood clotting - thrombocytopenia)
- increased levels of azotemia and creatinine in the blood
If you get side effects
- Tell your doctor or pharmacist.This includes any side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store CEFUROXIMA K24 Pharmaceuticals
Before reconstitution, the product must be stored protected from light at a temperature below 25 °C.
The product must be used immediately after reconstitution.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the package after Scad. The expiry date refers to the last day of that month. The expiry date refers to the product in intact packaging,
correctly stored.
Do not dispose of any medicine in wastewater or household waste. The doctor or nurse will dispose of the
medicines that are no longer used. This will help protect the environment.
6. Package Contents and Other Information
What CEFUROXIMA K24 Pharmaceuticals contains
CEFUROXIMA K24 Pharmaceuticals 750 mg powder for injectable solution
One vial contains:
Sodium cefuroxime 789 mg
equivalent to Cefuroxime 750 mg
CEFUROXIMA K24 Pharmaceuticals 1.5 g powder for infusion solution
One vial contains:
Sodium cefuroxime 1.578 g
equivalent to Cefuroxime 1.5 g
Description of the appearance of CEFUROXIMA K24 Pharmaceuticals and package contents
CEFUROXIMA K24 Pharmaceuticals is packaged in colorless type III glass vials with a butyl rubber stopper
and aluminum cap;
CEFUROXIMA K24 Pharmaceuticals 750 mg powder for injectable solution 50 or 100 vials of powder
CEFUROXIMA K24 Pharmaceuticals 1.5 g powder for infusion solution 1, 50 or 100 vials of powder
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
K24 Pharmaceuticals S.r.l. - Via Generale Orsini 46 - 80132 Napoli
Manufacturer
Biopharma S.r.l. – Via delle Gerbere, 22/30 – 00134 – Santa Palomba (Roma)
The following information is intended exclusively for doctors or healthcare professionals:
Instructions for reconstitution
Addition of volumes and concentrations of the solution that may be useful if fractional doses are required.
| F Addition of volumes and concentrations of the solution that may be useful if fractional doses are required | |||
| Vial type | l Amount of water to add (ml) and | Approximate concentration of cefuroxime (mg/ml)** | |
| 750 mg powder for injectable solution | |||
| 750 mg | intramuscular bolus intravenous | d 3 ml at least 6 ml | 216 116 |
| a 1.5 g powder for infusion solution | |||
| 1.5 g | n intravenous infusion | 15 ml* | 94 |
*Reconstituted solution to be added to 50 or 100 ml of compatible infusion liquid (see compatibility information
below).
**The resulting volume of the cefuroxime solution in the reconstitution medium is increased due to the distribution factor of
the active ingredient, which leads to the concentrations listed in mg/ml.
Compatibility
1.5 g of cefuroxime sodium reconstituted with 15 ml of water for injections can be added to an
injectable solution of metronidazole (500 mg/100 ml) and both maintain their activity for up to 24 hours at
below 25°C.
1.5 g of cefuroxime sodium is compatible with azlocillin 1 g (in 15 ml) or 5 g (in 50 ml) for up to 24 hours
at 4°C or 6 hours below 25°C.
Cefuroxime sodium (5 mg/ml) in an injectable solution of xylitol 5% w/v or 10% w/v can be stored
for up to 24 hours at 25°C.
Cefuroxime sodium is compatible with aqueous solutions containing up to 1% lidocaine hydrochloride.
Cefuroxime sodium is compatible with the following infusion fluids. It maintains activity for up to 24 hours at
room temperature in:
Sodium chloride 0.9% w/v for injectable preparations BP
Glucose 5% for injectable preparations BP
Sodium chloride 0.18% w/v plus Glucose 4% for injectable preparations BP
Glucose 5% and Sodium chloride 0.9% for injectable preparations
Glucose 5% and Sodium chloride 0.45% for injectable preparations
Glucose 5% and Sodium chloride 0.225% for injectable preparations
Glucose 10% for injectable preparations
Inverted sugar 10% in water for injectable preparations
Ringer's solution for injectable preparations USP
Ringer's lactate solution for injectable preparations USP
Sodium lactate M/6 for injectable preparations
Compound sodium lactate for injectable preparations BP (Hartmann's solution)
The stability of cefuroxime sodium in sodium chloride 0.9% w/v for injectable preparations BP and
in glucose 5% for injectable preparations is not affected by the presence of sodium phosphate hydrocortisone.
Cefuroxime sodium has also been found to be compatible for 24 hours, at room temperature, when mixed in
intravenous infusion with:
Heparin (10 and 50 units/ml) in sodium chloride 0.9% injectable solution; Potassium chloride (10 and 40
mEqL) in sodium chloride 0.9% injectable solution.
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- Країна реєстрації
- Лікарська формаPowder for injectable solution, 750 MG
- Код АТХJ01DC02
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до KEFUROXIMA K24 PARMAKEUTIKALSЛікарська форма: Film-coated tablet, 250 MGДіюча речовина: ЦефуроксимВиробник: EG S.P.A.Потрібен рецептЛікарська форма: Film-coated tablet, 250 MGДіюча речовина: ЦефуроксимВиробник: MYLAN S.P.A.Потрібен рецептЛікарська форма: Coated tablet, 125 MGДіюча речовина: ЦефуроксимВиробник: SANDOZ S.P.A.Потрібен рецепт
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Часті запитання
KEFUROXIMA K24 PARMAKEUTIKALS потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у KEFUROXIMA K24 PARMAKEUTIKALS — Цефуроксим. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
KEFUROXIMA K24 PARMAKEUTIKALS виробляється компанією K24 PHARMACEUTICALS S.R.L.. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування KEFUROXIMA K24 PARMAKEUTIKALS з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати KEFUROXIMA K24 PARMAKEUTIKALS у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (Цефуроксим) включають KEFUROXIMA EG, KEFUROXIMA MYLAN, KEFUROXIMA SANDOTS. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
