Ciprofloxacin 2 Mg/Ml Solution For Infusion
Artwork No.
Customer
Description
Market
Language
Size
Min. Font Size Page No. Version No. Date Softwa re
• severe allergic reaction (anaphylactic reaction, anaphylactic shock, serum sickness) which can be fatal (see Section 2: Take special care with Ciprofloxacin 2 mg/ml)
• disturbed coordination, unsteady walk (gait disturbance), pressure on the brain (intracranial pressure)
• visual colour distortions
• various skin eruptions or rashes (e.g. the potentially fatal Stevens-Johnson syndrome or toxic epidermal necrolysis)
• muscle weakness, tendon inflammation, worsening of the symptoms of myasthenia gravis(see Section 2: Take special care with Ciprofloxacin 2 mg/ml)
Frequency not known (cannot be estimated from the available data)
• troubles associated with the nervous system such as pain, burning, tingling, numbness and/ or weakness in extremities
• Abnormal fast heart rhythm, life-threatening irregular heart rhythm, alteration of the heart rhythm (called 'prolongation of QT interval1, seen on ECG, electrical activity of the heart)
5. HOW TO STORE CIPROFLOXACIN 2 mg/ml
Keep out of the reach and sight of children.
Do not use Ciprofloxacin 2 mg/ml after the expiry date which is stated on the carton; The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not refrigerate or freeze.
Keep container in the outer carton in order to protect from light.
Medicines should not be disposed of via wastewater or household waste. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Ciprofloxacin 2mg/ml contains
• The active substance in this medicine is ciprofloxacin.
• The 50 ml vial contains 100 mg of ciprofloxacin and the 100 ml vial contains 200 mg of ciprofloxacine.
• The other ingredients are sodium chloride, lactic acid, hydrochloric acid, and water for injection.
What Ciprofloxacin 2mg/ml looks like and contents of the pack
Solution for infusion
The solution is a clear, colourless or light yellow solution, free from visible particles.
Marketing Authorisation Holder and
Relonchem Limited,
27 Old Gloucester Street, London WCI 3 XX
tel:+44 (0)20 7419 5043 fax: +44 (0)20 7419 5024 e-mail: info@relonchem.com
Manufacturer
Zentiva a.s.,
92027 Hlohovec,
Nitrianska 100,
Slovak Republic.
This leaflet was last u pdated in 03/201 I Advice/medical education
Antibiotics are used to cure bacterial infections. They are ineffective against viral infections.
If your doctor has prescribed antibiotics, you need them precisely for your current illness.
Despite antibiotics, some bacteria may survive or grow. This phenomenon is called resistance: some antibiotic treatments become ineffective.
Misuse of antibiotics increases resistance. You may even help bacteria become resistant and therefore delay your cure or decrease antibiotic efficacy if you do not respect appropriate:
• dosage
• schedules
• duration of treatment
Consequently, to preserve the efficacy of this drug:
I - Use antibiotics only when prescribed.
2- Strictly follow the prescription.
3 - Do not re-use an antibiotic without medical prescription, even if you want to treat a similar illness.
4 - Never give your antibiotic to another person; maybe it is not adapted to her/his illness.
5 - After completion of treatment, return all unused drugs to
your chemist's shop to ensure they will be disposed of correctly
The following information is intended for medical or healthcare professionals only
Ciprofloxacin 2 mg/ml should be administered by intravenous infusion. For children, the infusion duration is 60 minutes. In adult patients, infusion time is 60 minutes for 400 mg and 30 minutes for 200 mg Ciprofloxacin 2 mg/ml. Slow infusion into a large vein will minimise patient discomfort and reduce the risk of venous irritation. The infusion solution can be infused either directly or after mixing with other compatible infusion solutions.
Unless compatibility with other infusion solutions/drugs has been confirmed, the infusion solution must always be administered separately. The visual signs of incompatibility are e.g. precipitation, clouding, and discolouration.
Incompatibility appears with all infusion solutions/drugs that are physically or chemically unstable at the pH of the solution (e.g. penicillins, heparin solutions), especially in combination with solutions adjusted to an alkaline pH (pH of the ciprofloxacin infusion solutions: 3.5-4.6).
After intravenous initiation of treatment, the treatment can be continued orally as well.
Ciprofloxacin 2 mg/ml Solution for Infusion
RelonQhem
Ciprofloxacin
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you are given this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Ciprofloxacin 2 mg/ml is and what it is used for
2. Before you are given Ciprofloxacin 2 mg/ml
3. Howto use Ciprofloxacin 2 mg/ml
4. Possible side effects
5. Howto store Ciprofloxacin 2 mg/ml
6. Further information
I. WHAT CIPROFLOXACIN 2 MG/ML IS AND WHAT IT IS USED FOR
Ciprofloxacin 2 mg/ml is an antibiotic belonging to the fluoroquinolone family. The active substance is ciprofloxacin. Ciprofloxacin works by killing bacteria that cause infections. It only works with specific strains of bacteria.
Adults
Ciprofloxacin 2 mg/ml is used in adults to treat the following bacterial infections:
• respiratory tract infections
• long lasting or recurring ear or sinus infections
• urinary tract infections
• infections of the testicles
• genital organ infections in women
• gastro-intestinal tract infections and intra-abdominal infections
• skin and softtissue infections
• bone and joint infections
• to treat infections in patients with a very low white blood cell count (neutropenia)
• to prevent infections in patients with a very low white blood cell count (neutropenia)
• anthrax inhalation exposure
If you have a severe infection or one that is caused by more than one type of bacterium, you may be given additional antibiotic treatment in addition to Ciprofloxacin 2 mg/ml.
Children and adolescents
Ciprofloxacin 2 mg/ml is used in children and adolescents, under specialist medical supervision, to treat the following bacterial infections:
• lung and bronchial infections in children and adolescents suffering from cystic fibrosis
• complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis)
• anthrax inhalation exposure
Ciprofloxacin 2 mg/ml may also be used to treat other specific severe infections in children and adolescents when your doctor considered this necessary.
2. BEFORE YOU ARE GIVEN CIPROFLOXACIN 2 MG/ML
You must not be given Ciprofloxacin 2 mg/ml if you are:
• allergic (hypersensitive) to the active substance, to other quinolone drugs or to any of the other ingredients of Ciprofloxacin 2 mg/ml (see section 6)
• taking tizanidine (see Section 2: Taking other medicines)
Take special care with Ciprofloxacin 2 mg/ml
Before you are given Ciprofloxacin 2 mg/ml
Tell your doctor if you:
• have ever had kidney problems because your treatment may need to be adjusted
• suffer from epilepsy or other neurological conditions
• have a history of tendon problems during previous treatment with antibiotics such as Ciprofloxacin 2 mg/ml
• have myasthenia gravis (a type of muscle weakness)
• have a history of abnormal heart rhythms (arrythmias)
While under treatment with Ciprofloxacin 2 mg/ml
Tell your doctor immediately, if any of the following occurs during treatment with Ciprofloxacin 2 mg/ml.Your
doctor will decide whether treatment with Ciprofloxacin 2 mg/ml needs to be stopped.
• Heart problems
Caution should be taken when using this kind of medicine, if you were born with or have family history of prolonged QT interval (seen on ECG, electrical recording of the heart), have salt imbalance in the blood (especially low level of potassium or magnesium in the blood), have a very slow heart rhythm (called 'bradycardia'), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), you are female or elderly or you are taking other medicines that result in abnormal ECG changes (see section Taking other medicines).
• Severe, sudden allergic reaction (an anaphylactic reaction/shock, angio-oedema). Even with the first dose, there is a rare chance that you may experience a severe allergic reaction with the following symptoms: tightness in the chest, feeling dizzy, feeling sick or faint, or experience dizziness on standing. If this happens, tell your doctor immediately since the administration of Ciprofloxacin 2 mg/ml will have to be stopped.
Artwork No.
Customer
Description
Market
Language oize
Min. font : Page No. Version No.
Date Softwa re
• Pain and swelling in the joints, and tendinitis may
occur occasionally, particularly if you are elderly and are also being treated with corticosteroids. At the first sign of any pain or inflammation Ciprofloxacin 2 mg/ml will have to be stopped, rest the painful area. Avoid any unnecessary exercise as this might increase the risk of a tendon rupture.
• If you suffer from epilepsy or other neurological
conditions such as cerebral ischemia or stroke, you may experience side effects associated with the central nervous system. If this happens, stop taking Ciprofloxacin 2 mg/ml and contact your doctor immediately.
• You may experience psychiatric reactions after first administration of ciprofloxacin. If you suffer from depression or psychosis, your symptoms may become worse under treatment with Ciprofloxacin 2 mg/ml .If this happens, stop taking Ciprofloxacin 2 mg/ml and contact your doctor immediately.
• You may experience symptoms of neuropathy such as pain, burning, tingling, numbness and/or weakness. If this happens, stop taking Ciprofloxacin 2 mg/ml and contact your doctor immediately.
• Diarrhoea may develop while you are on antibiotics, including Ciprofloxacin 2 mg/ml, or even several weeks after you have stopped using them. If it becomes severe or persistent or you notice that your stool contains blood or mucus tell your doctor immediately. Ciprofloxacin 2 mg/ml treatment will have to be stopped immediately, as this can be life-threatening. Do not take medicines that stop or slow down bowel movements.
• Tell the doctor or laboratory staff that you are taking Ciprofloxacin 2 mg/ml if you have to provide a blood or urine sample.
• Ciprofloxacin 2 mg/ml may cause liver damage. If you notice any symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or tenderness of the stomach, Ciprofloxacin 2 mg/ml must be stopped immediately.
• Ciprofloxacin 2 mg/ml may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems you should see your doctor immediately. A blood test will be taken to check possible reduction of white blood cells (agranulocytosis). It is important to inform your doctor about your medicine.
• Tell your doctor if you or a member of your family is known to have a deficiency in glucose-6-phosphate dehydrogenase (G6PD), since you may experience a risk of anemia with ciprofloxacin.
• Your skin becomes more sensitive to sunlight or ultraviolet (UV) light under treatment with Ciprofloxacin 2 mg/ml. Avoid exposure to strong sunlight or artificial UV light such as sunbeds.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription.
Do not use Ciprofloxacin 2 mg/ml together with tizanidine, because this may cause side effects such as low blood pressure and sleepiness (see Section 2: "You must not be given Ciprofloxacin 2 mg/ml if you are").
You must tell your doctor if you are taking other medicines that can alter your heart rhythm: medicines that belong to the group of anti-arrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (that belong to the group of macrolides), some antipsychotics.
The following medicines are known to interact with Ciprofloxacin 2 mg/ml in your body. Using Ciprofloxacin 2 mg/ml together with these medicines can influence the therapeutic effect of these medicines. It can also increase the probability of experiencing side effects.
Tell your doctor if you are taking:
• warfarin or other oral anti-coagulants (to thin the blood)
• probenecid (for gout)
• methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis)
• theophylline (for breathing problems)
• tizanidine (for muscle spasticity in multiple sclerosis)
• clozapine (an antipsychotic)
• rop ini role (for Parkinson's disease)
• phenytoin (for epilepsy)
Ciprofloxacin 2 mg/ml may increase the levels of the following medicines in your blood:
• pentoxifylline (for circulatory disorders)
• caffeine
Taking Ciprofloxacin 2 mg/ml with food and drink
Food and drink does not affect your treatment with Ciprofloxacin 2 mg/ml.
Pregnancy and breast-feeding
It is preferable to avoid the use of Ciprofloxacin 2 mg/ml during pregnancy. Tell your doctor if you are planning to get pregnant.
Do not take Ciprofloxacin 2 mg/ml during breast feeding because ciprofloxacin is excreted in breast milk and can be harmful for your child.
Driving and using machines
Ciprofloxacin 2 mg/ml may make you feel less alert. Some neurological adverse events can occur. Therefore, make sure you know how you react to Ciprofloxacin 2 mg/ml before driving a vehicle or operating machinery. If in doubt, talk to your doctor.
Important information about some of the ingredients ofCiprofloxacin 2 mg/ml
Ciprofloxacin 2 mg/ml contains 900mg sodium chloride per 100ml of solution. This should be taken into consideration by patients on a controlled sodium diet. Check with your doctor if you are unsure about this.
3. HOW TO USE CIPROFLOXACIN 2 MG/ML
Your doctor will explain to you exactly how much Ciprofloxacin 2 mg/ml you will be given as well as how often and for how long. This will depend on the type of infection you have and how bad it is.
Tell your doctor if you suffer from kidney problems because your dose may need to be adjusted.
Treatment usually lasts between 5 and 21 days, but may be longer for severe infections.
Your doctor will give you each dose by slow infusion through a vein into your bloodstream. For children, the infusion duration is 60 minutes. In adult patients, infusion time is 60 minutes for 400 mg Ciprofloxacin 2 mg/ml and 30 minutes for 200 mg Ciprofloxacin 2 mg/ml . Administering the infusion slowly helps prevent immediate side effects occurring.
Remember to drink plenty of fluids while you are taking Ciprofloxacin 2 mg/ml.
If you stop your course of Ciprofloxacin 2 mg/ml
• It is important that you finish the course of
treatment even if you begin to feel better after a few days. If you stop using this medicine too soon your infection may not be completely cured and the symptoms of the infection may return or get worse. You might also develop resistance to the antibiotic.
If you have any more questions about the use of this product, askyour doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ciprofloxacin 2 mg/ml can cause side effects, although not everybody will experience them.
If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
Common side effects (between I and 10 in every 100 people are likely to get these):
• nausea, diarrhoea, vomiting
• joint pains in children
• local reaction at the injection site, rash
• temporary increased amounts of substances in the blood (transaminases)
Uncommon side effects (between I and 10 in every 1,000 people are likely to get these):
• fungal superinfections
• a high concentration of eosinophils, a type of white blood cell, increased or decreased amounts of a blood doting facto r (th ro m bo cytes)
• loss of appetite (anorexia)
• hyperactivity, agitation, confusion, disorientation, hallucinations
• headache, dizziness, sleeping problems, taste disorders, pins and needles, unusual sensitivity to stimuli of the senses, seizures (see Section 2: Take special care with Ciprofloxacin 2 mg/ml), giddiness
• eyesight problems
• loss of hearing
• rapid heartbeat (tachycardia)
• expansion of the blood vessels (vasodilation), low blood pressure
• abdominal pain, digestive problems such as stomach upset (indigestion/heartburn), wind
• liver disorders, increased amounts of one substance in the blood (bilirubin), jaundice (cholestatic icterus)
• itching, hives
• joint pain in adults
• poor kidney function, kidney failure
• pains in your muscles and bones, feeling unwell (asthenia),fever,fluid retention
• increase in blood alkaline phosphatase (a certain substance in the blood)
Rare side effects (between I and 10 in every 10,000 people
are likely to get these):
• inflammation of the bowel (colitis) linked to antibiotic use (can be fatal in rare cases) (see Section 2: Take special care with Ciprofloxacin 2 mg/ml)
• changes to the blood count (leukopenia, leukocytosis, neutropenia, anaemia), a drop in the number of red and white blood cells and platelets (pancytopenia), which may be fatal, bone-marrow depression which may also be fatal (see Section 2: Take special care with Ciprofloxacin 2 mg/ml)
• allergic reaction, allergic swelling (oedema), rapid swelling of the skin and mucous membranes (angiooedema), severe allergic reaction (anaphylactic shock) which can be life-threatening (see Section 2: Take special care with Ciprofloxacin 2 mg/ml)
• increased blood sugar (hyperglycemia)
• anxiety reaction, strange dreams, depression, mental disturbances (psychotic reactions) (see Section 2: Take special care with Ciprofloxacin 2 mg/ml)
• decreased skin sensitivity, tremor, migraine, disorder of sense of smell (olfactory disorders)
• tinnitus, impaired hearing
• fainting, inflammation of the blood vessel (vasculitis)
• shortness of breath including asthmatic symptoms
• pancreatitis
• hepatitis, death of liver cells (liver necrosis) very rarely leading to life-threatening liver failure
• sensitivity to light (see Section 2: Take special care with Ciprofloxacin 2 mg/ml), small, pin-point bleeding under the skin (petechiae)
• muscle pain, inflammation of the joints, increased muscle tone, cramping, tendon rupture especially of the large tendon at the back of the ankle (Achilles tendon) (see Section 2: Take special care with Ciprofloxacin 2 mg/ml)
• blood or crystals in the urine (see Section 2: Take special care with Ciprofloxacin 2 mg/ml), urinary tract inflammation
• excessive sweating
• abnormal levels of a clotting factor (prothromibin) increased levels of the enzyme amylase
Very rare side effects (less than I in every 10,000 people
are likely to get these):
• a special type of reduced red blood cell count (haemolytic anaemia); a dangerous drop in a type of white blood cells (agranulocytosis)