Patient leaflet - Levofloxacin 5 mg / ml solution for infusion
1. What Levofloxacin solution for infusion is and what it is used for
The name of your medicine is Levofloxacin solution for infusion. Levofloxacin solution for infusion contains a medicine called levofloxacin. This belongs to a group of medicines called antibiotics. Levofloxacin is a ‘quinolone’ antibiotic. It works by killing the bacteria that cause infections in your body.
Levofloxacin solution for infusion can be used to treat infections of the:
- Lungs, in people with pneumonia
- Urinary tract, including your kidneys or bladder
- Prostate gland, where you have a long lasting infection
- Skin and underneath the skin, including muscles. This is sometimes called ‘soft tissue’
In some special situations, Levofloxacin solution for infusion may be used to lessen the chances of getting a pulmonary disease named anthrax or worsening of the disease after you are exposed to the bacteria causing anthrax.
2. What you need to know before you use Levofloxacin solution for infusion
Do not use Levofloxacin:
If you are allergic to levofloxacin, any other quinolone antibiotic such as
moxifloxacin, ciprofloxacin or ofloxacin or any of the other ingredients of this medicine (listed in section 6)
Signs of an allergic reaction include: a rash, swallowing or breathing problems,
swelling of your lips, face, throat or tongue
- If you have ever had epilepsy
If you have ever had a problem with your tendons such as tendonitis that was
related to treatment with a ‘quinolone antibiotic’. A tendon is the cord that joins your muscle to your skeleton
- If you are a child or a growing teenager
- If you are pregnant, might became pregnant or think you may be pregnant
- If you are breast-feeding
Do not use this medicine if any of the above applies to you. If you are not sure, talk to your doctor, nurse or pharmacist before you are given Levofloxacin solution for infusion.
Warnings and precautions
Talk to your doctor, nurse or pharmacist before using Levofloxacin solution for infusion if:
- You are 60 years of age or older
You are using corticosteroids, sometimes called steroids (see “Other medicines
and Levofloxacin solution for infusion”)
- You have received a transplantation
- You have ever had a fit (seizure)
- You have had damage to your brain due to a stroke or other brain injury
- You have kidney problems
You have something known as ‘glucose – 6 –phosphate dehydrogenase
deficiency’. You are more likely to have serious problems with your blood when taking this medicine.
- You have ever had mental health problems
You have ever had 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 Other medicines and Levofloxacin solution for infusion).
You have been diagnosed with an enlargement or “bulge” of a large blood
vessel (aortic aneurysm or large vessel peripheral aneurysm).
- You have experienced a previous episode of aortic dissection (a tear in the aorta wall).
- You have been diagnosed with leaking heart valves (heart valve regurgitation).
You have a family history of aortic aneurysm or aortic dissection or congenital
heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome or Ehlers-Danlos syndrome, Turner syndrome, Sjögren’s syndrome [an inflammatory autoimmune disease], or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet’s disease, high blood pressure, or known atherosclerosis, rheumatoid arthritis [a disease of the joints] or endocarditis [an infection of the heart]).
- You are diabetic
- You have ever had liver problems
- You have myasthenia gravis
- You have nerve problems (peripheral neuropathy)
You have ever developed a severe skin rash or skin peeling, blistering and/or
mouth sores after taking levofloxacin.
Serious skin reactions
Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with the use of levofloxacin.
SJS/TEN can appear initially as reddish target-like spots or circular patches
often with central blisters on the trunk. Also, ulcers of mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur. These serious skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread peeling of the skin and life-threatening complications or be fatal.
DRESS appears initially as flu-like symptoms and a rash on the face then an
extended rash with a high body temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.
A red, scaly widespread rash with bumps under the skin (including your skin
folds, chest, abdomen (including stomach), back and arms) and blisters accompanied by fever. The symptoms usually appear at the initiation of treatment (acute generalized exanthematous pustulosis).
If you develop a serious rash or another of these skin symptoms, stop taking levofloxacin and contact your doctor or seek medical attention immediately. You should not take fluoroquinolone/quinolone antibacterial medicines, including levofloxacin, if you have experienced any serious adverse reaction in the past when taking a quinolone or fluoroquinolone. In this situation, you should inform your doctor as soon as possible.
Talk to your doctor, nurse or pharmacist when you are taking your medicine
If you feel sudden, severe pain in your abdomen, chest or back, which can be
symptoms of aortic aneurysm and dissection, go immediately to an emergency room. Your risk may be increased if you are being treated with systemic corticosteroids.
If you start experiencing a rapid onset of shortness of breath, especially when
you lie down flat in your bed, or you notice swelling of your ankles, feet or abdomen, or a new onset of heart palpitations (sensation of rapid or irregular heartbeat), you should inform a doctor immediately.
- If you are having nausea, feeling generally unwell, have severe discomfort or on-going pain or worsening pain in the stomach area or vomiting – see a doctor straight away as this could be a sign of an inflamed pancreas (acute pancreatitis).
- If you start experiencing sudden involuntary jerks, twitches of the muscles or muscle contractions - see a doctor straight away as this could be signs of myoclonus. Your doctor may need to stop treatment with levofloxacin and to start an appropriate treatment.
- If you are experiencing fatigue, skin pale, bruising, uncontrolled bleeding, fever, sore throat and serious deterioration of your general condition, or a feeling that your resistance to infection may be decreased - see a doctor straight away as this could be signs of blood disorders. Your doctor should monitor your blood with blood counts. In case of abnormal blood counts, your doctor may need to stop treatment.
Pain and swelling in the joints and inflammation or rupture of tendons may occur rarely. Your risk is increased if you are elderly (above 60 years of age), have received an organ transplant, have kidney problems or if you are being treated with corticosteroids. Inflammation and ruptures of tendons may occur within the first 48 hours of treatment and even up to several months after stopping of Levofloxacin therapy. At the first sign of pain or inflammation of a tendon (for example in your ankle, wrist, elbow, shoulder or knee), stop taking Levofloxacin, contact your doctor and rest the painful area. Avoid any unnecessary exercise as this might increase the risk of a tendon rupture.
You may rarely experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/or weakness especially in the feet and legs or hands and arms. If this happens, stop taking Levofloxacin and inform your doctor immediately in order to prevent the development of potentially irreversible condition.
Prolonged, disabling and potentially irreversible serious side effects
Fluoroquinolone/quinolone antibacterial medicines, including Levofloxacin, have been associated with very rare but serious side effects, some of them being long lasting (continuing months or years), disabling or potentially irreversible. This includes tendon, muscle and joint pain of the upper and lower limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, numbness or burning (paraesthesia), sensory disorders including impairment of vision, taste and smell, and hearing, depression, memory impairment, severe fatigue, and severe sleep disorders.
If you experience any of these side effects after taking Levofloxacin, contact your doctor immediately prior to continuing treatment. You and your doctor will decide on continuing the treatment considering also an antibiotic from another class. If you are not sure if any of the above applies to you, talk to your doctor, nurse or pharmacist before being given Levofloxacin solution for infusion.
Other medicines and Levofloxacin solution for infusion
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Levofloxacin solution for infusion can affect the way some other medicines work. Also some medicines can affect the way Levofloxacin solution for infusion works.
In particular, tell your doctor if you are taking any of the following medicines. This is because it can increase the chance of you getting side effects, when taken with Levofloxacin solution for infusion:
- Corticosteroids, sometimes called steroids – used for inflammation. You may be more likely to have inflammation and/or breakage of your tendons.
- Warfarin – used to thin the blood. You may be more likely to have a bleed. Your doctor may need to take regular blood tests to check how well your blood can clot.
Theophylline – used for breathing problems. You are more likely to have a fit
(seizure) if taken with Levofloxacin solution for infusion.
- Non-steroidal anti-inflammatory drugs (NSAIDS) – used for pain and inflammation such as aspirin, ibuprofen, fenbufen, ketoprofen and indomethacin. You are more likely to have a fit (seizure) if taken with Levofloxacin solution for infusion.
- Ciclosporin – used after organ transplants. You may be more likely to get the side effects of ciclosporin.
- Medicines known to affect the way your heart beats. This includes medicines used for abnormal heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide and amiodarone), for depression (tricyclic antidepressants such as amitriptyline and imipramine) for psychiatric disorders (antipsychotics), and for bacterial infections (‘macrolide’ antibiotics such as erythromycin, azithromycin and clarithromycin).
- Probenecid – used for gout. Your doctor may want to use a lower dose, if you have kidney problems.
- Cimetidine - used for ulcers and heartburn. Your doctor may want to use a lower dose, if you have kidney problems.
Tell your doctor if any of the above applies to you.
Urine tests for opiates
Urine tests may show ‘false-positive’ results for strong painkillers called ‘opiates’ in people taking Levofloxacin. If your doctor is due to take a urine test, tell them you are taking Levofloxacin.
Tuberculosis tests
This medicine may cause “false negative” results for some tests used in laboratory to search for the bacteria causing tuberculosis.
Pregnancy and breast-feeding
Do not have this medicine if:
- You are pregnant, might become pregnant or think you may be pregnant
- You are breast-feeding or planning to breast-feed
Driving and using machines
You may get side effects after taking this medicine, including feeling dizzy, sleepy, a spinning feeling (vertigo) or changes to your eyesight. Some of these side effects can affect you being able to concentrate and your reaction speed. If this happens, do not drive or carry out any work that requires a high level of attention.
Levofloxacin solution for infusion contains sodium
Levofloxacin contains 186.3 mg of sodium (main component of cooking table/salt) in each 50 ml bag. This is equivalent to 9.32% of the recommended maximum daily dietary intake of sodium for an adult.
Levofloxacin contains 372 mg of sodium (main component of cooking table/salt) in each 100 ml bag. This is equivalent to 18.63% of the recommended maximum daily dietary intake of sodium for an adult.
3. How to use Levofloxacin solution for infusion
- Levofloxacin solution for infusion is a medicine for use in hospitals
- It will be given to you by a doctor or nurse as an injection. The injection will be into one of your veins and be given over a period of time (this is called an intravenous infusion)
For 250 mg Levofloxacin solution for infusion, the infusion time should be
30 minutes or more
For 500 mg Levofloxacin solution for infusion, the infusion time should be
60 minutes or more
- Your heart rate and blood pressure should be closely monitored. This is because an unusual fast beating of the heart and a temporary lowering of blood pressure are possible side effects that have been seen during the infusion of a similar antibiotic. If your blood pressure drops noticeably while you are being given the infusion, it will be stopped straight away.
How much Levofloxacin solution for infusion is given
If you are not sure why you are being given Levofloxacin solution for infusion or have any questions about how much Levofloxacin solution for infusion is being given to you, speak to your doctor, nurse or pharmacist.
- Your doctor will decide on how much Levofloxacin you should have
- The dose will depend on the type of infection you have and where the infection is in your body
- The length of your treatment will depend on how serious your infection is ✂-----------------------------------------------------------------------------------------------------------------------------------------------------------------
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Package leaflet: Information for the user
Levofloxacin 5 mg/ml
solution for infusion
Levofloxacin
Special populations
Impaired renal function (creatinine clearance ≤ 50 ml/min)
Dose regimen 250 mg/24 h 500 mg/24 h 500 mg/12 h Creatinine clearance first dose:
250 mg
first dose: 500 mg
first dose: 500 mg 50 - 20 ml/min then:
125 mg/24 h
then:
250 mg/24 h
then : 250 mg/12 h 19 - 10 ml/min then:
125 mg/48 h
then:
125 mg/24 h
then:
125 mg/12 h < 10 ml/min (including
haemodialysis and
CAPD) 1
then:
125 mg/48 h
then:
125 mg/24 h
then:
125 mg/24 h
1 No additional doses are required after haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).
Impaired liver function
No adjustment of dosage is required since levofloxacin is not metabolised to any relevant extent by the liver and is mainly excreted by the kidneys.
Elderly population
No adjustment of dosage is required in the elderly, other than that imposed by consideration of renal function (See section 4.4 “Tendinitis and tendon rupture” and QT interval prolongation).
Paediatric population
Levofloxacin is contraindicated in children and growing adolescents (see section 4.3).
Method of administration
Levofloxacin solution for infusion is only intended for slow intravenous infusion; it is administered once or twice daily. The infusion time must be at least 30 minutes for 250 mg or 60 minutes for 500 mg Levofloxacin solution for infusion (see section 4.4).
List of excipients
Sodium chloride
Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections.
Incompatibilities
Levofloxacin should not be mixed with heparin or alkaline solutions (e.g. sodium hydrogen carbonate).
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Special precautions for storage
Keep the bag in the outer package in order to protect from light. Store below 25ºC. Inspect visually prior to use.
Only clear solutions without particles should be used.
Adults and elderly
- Pneumonia: 500 mg once or twice daily
- Infection of urinary tract, including your kidneys or bladder: 500 mg once daily
- Prostate gland infection: 500 mg once daily
Infection of skin and underneath the skin, including muscles: 500 mg once or
twice daily
Adults and the elderly with kidney problems
Your doctor may need to give you a lower dose.
Use in children and adolescents:
This medicine must not be given to children or teenagers.
Protect your skin from sunlight
Keep out of direct sunlight while taking this medicine and for 2 days after you stop having it. This is because your skin will become much more sensitive to the sun and may burn, tingle or severely blister if you do not take the following precautions:
- Make sure you use high factor sun cream
- Always wear a hat and clothes which cover your arms and legs
- Avoid sun beds
If you use more Levofloxacin solution for infusion than you should
It is unlikely that your doctor or nurse will give you too much medicine. Your doctor and nurse will monitor your progress, and check the medicine you are given. Always ask if you are not sure why you are getting a dose of medicine. Having too much Levofloxacin may cause the following effects to happen: convulsive fits (seizures), feeling confused, dizzy, less conscious, having tremor and heart problems - leading to uneven heart beats as well as feeling sick (nausea).
If you forget to use Levofloxacin solution for infusion
Your doctor or nurse will have instructions on when to give you this medicine. It is unlikely that you will not be given the medicine as it has been prescribed. However, if you think you might have missed a dose inform your doctor or nurse.
If you stop using Levofloxacin solution for infusion
Your doctor or nurse will continue giving you Levofloxacin even you are feeling better. If the treatment is stopped too soon, your condition may get worse or the bacteria may become resistant to the medicine. After a few days treatment with the solution for infusion, your doctor may decide to switch you to the tablet form of this medicine to complete your course of treatment.
If you have any further questions on the use of this product, ask your doctor, nurse or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. These affects are normally mild to moderate and often disappear after a short time.
Stop having Levofloxacin solution for infusion and tell a doctor or nurse straight away if you notice the following side effects:
Very rare (may affect up to 1 in 10,000 people)
You have an allergic reaction. The signs may include a rash, swallowing or
breathing problems, swelling of your lips, face, throat, or tongue
Stop having Levofloxacin solution for infusion and tell a doctor or nurse straight away if you notice any of the following serious side effects – you may need urgent medical treatment:
Rare (may affect up to 1 in 1,000 people)
Watery diarrhoea which may have blood in it, possibly with stomach cramps and
a high temperature. These could be signs of a severe bowel problem
Pain and inflammation in your tendons or ligaments which could lead to rupture.
The Achilles tendon is affected most often
- Fits (convulsions)
- Seeing or hearing things that are not there (hallucinations, paranoia)
Feeling depressed, mental problems, feeling restless (agitation), abnormal
dreams or nightmares
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). See also section 2.
- Syndrome associated with impaired water excretion and low levels of sodium (SIADH).
Lowering of your blood sugar levels (hypoglycaemia) or lowering of your blood
sugar levels leading to coma (hypoglycaemic coma). This is important for people that have diabetes
Very rare (may affect up to 1 in 10,000 people)
- Burning, tingling, pain or numbness. These may be signs of something called ‘neuropathy’
Not known (frequency cannot be estimated from the available data):
Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal
necrolysis. These can appear as reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms. See also section 2.
A red, scaly widespread rash with bumps under the skin (including your skin
folds, chest, abdomen (including stomach), back and arms) and blisters accompanied by fever. The symptoms usually appear at the initiation of treatment (acute generalized exanthematous pustulosis). See section 2.
Loss of appetite, skin and eyes becoming yellow in colour, dark-coloured urine,
itching, or tender stomach (abdomen). These may be signs of liver problems which may include a fatal failure of the liver
Change in your opinion and thoughts (psychotic reactions) with a risk of having
suicidal thoughts or actions
Nausea, feeling generally unwell, discomfort or pain in the stomach area or
vomiting. These could be signs of an inflamed pancreas (acute pancreatitis). See section 2.
If your eyesight becomes impaired or if you have any other eye disturbances whilst taking Levofloxacin solution for infusion, consult an eye specialist immediately. Very rare cases of long lasting (even up to months or years) or permanent adverse drug reactions, such as tendon inflammations, tendon rupture, joint pain, pain in the limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, burning, numbness or pain (neuropathy), depression, fatigue, sleep disorders, memory impairment, as well as impairment of hearing, vision, and taste and smell have been associated with administration of quinolone and fluoroquinolone antibiotics in some cases irrespective of pre-existing risk factors. Cases of an enlargement and weakening of the aortic wall or a tear in the aortic wall (aneurysms and dissections), which may rupture and may be fatal, and of leaking heart valves have been reported in patients receiving fluoroquinolone. See also section 2.
Tell your doctor if any of the following side effects gets serious or lasts longer than a few days:
Common (may affect up to 1 in 10 people)
- Sleeping problems
- Headache, feeling dizzy
- Feeling sick (nausea, vomiting) and diarrhoea
- Increase in the level of some liver enzymes in your blood
- Reactions at the site of infusion
- Inflammation of the vein
Uncommon (may affect up to 1 in 100 people)
Changes in the number of other bacteria or fungi, infection by fungi named
Candida, which may need to be treated
Changes in the number of white blood cells shown up in the results of some
blood tests (leukopenia, eosinophilia)
Feeling stressed (anxiety), feeling confused, feeling nervous, feeling sleepy,
trembling, a spinning feeling (vertigo)
- Shortness of breath (dyspnoea)
Changes in the way things taste, loss of appetite, stomach upset or indigestion
(dyspepsia), pain in your stomach area, feeling bloated (flatulence) or constipation
- Itching and skin rash, severe itching or hives (urticaria), sweating too much (hyperhidrosis)
- Joint pain or muscle pain
Blood tests may show unusual results due to liver (bilirubin increased) or kidney
(creatinine increased) problems
General weakness
Rare (may affect up to 1 in 1,000 people)
- Bruising and bleeding easily due to a lowering in the number of blood platelets (thrombocytopenia)
- Low number of white blood cells (neutropenia)
- Exaggerated immune response (hypersensitivity)
- Tingly feeling in your hands and feet (paraesthesia)
- Problems with your hearing (tinnitus) or eyesight (blurred vision)
- Unusual fast beating of your heart (tachycardia) or low blood pressure (hypotension)
- Muscle weakness. This is important in people with myasthenia gravis (a rare disease of the nervous system).
- Changes in the way your kidney works and occasional kidney failure which may be due to an allergic kidney reaction called interstitial nephritis.
- Fever
- Sharply demarcated, erythematous patches with/without blistering that develop within hours of administration of levofloxacin and heals with postinflammatory residual hyperpigmentation; it usually recurs at the same site of the skin or mucous membrane upon subsequent exposure of levofloxacin
- Memory impairment
Not known (frequency cannot be estimated from the available data):
- Lowering in red blood cells (anemia): this can make the skin pale or yellow due to damage of the red blood cells; lowering in the number of all types of blood cells (pancytopenia)
- Bone marrow stops producing new blood cells, this may cause tiredness, lower ability to fight infection and uncontrolled bleeding (bone marrow failure)
Fever, sore throat and a general feeling of being unwell that does not go away.
This may be due to a lowering in the number of white blood cells (agranulocytosis).
- Loss of circulation (anaphylactic like shock)
- Increase of your blood sugar levels (hyperglycaemia). This is important for people that have diabetes.
- Changes in the way things smell, loss of smell or taste (parosmia, anosmia, ageusia)
- Feeling very excited, elated, agitated or enthusiastic (mania)
- Problems moving and walking (dyskinesia, extrapyramidal disorders)
- Temporary loss of consciousness or posture (syncope)
- Temporary loss of vision, inflammation of the eye
- Impairment or loss of hearing
- Abnormal fast heart rhythm, life-threatening irregular heart rhythm including cardiac arrest, alteration of the heart rhythm (called ‘prolongation of QT interval’, seen on ECG, electrical activity of the heart)
- Difficulty breathing or wheezing (bronchospasm)
- Allergic lung reactions
- Pancreatitis
- Inflammation of the liver (hepatitis)
- Increased sensitivity of your skin to sun and ultraviolet light (photosensitivity), darker areas of skin (hyperpigmentation)
- Inflammation of the vessels that carry blood around your body due to an allergic reaction (vasculitis)
- Inflammation of the tissue inside the mouth (stomatitis)
- Muscle rupture and muscle destruction (rhabdomyolysis)
- Joint redness and swelling (arthritis)
- Pain, including pain in the back, chest and extremities
- Sudden, involuntary jerks, twitches of the muscles or muscle contractions (myoclonus)
- Attacks of porphyria in people who already have porphyria (a very rare metabolic disease)
- Persistent headache with or without blurred vision (benign intracranial hypertension)
Reporting of side effects
If you get any side effects, talk to your doctor 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.
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the 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 Levofloxacin solution for infusion
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 outer package and bag after EXP. The expiry date refers to the last day of that month. Keep the bag in the outer package in order to protect from light. Store below 25ºC.
Do not use Levofloxacin solution for infusion if the solution is not clear, if the solution is not green to yellow and/or if it is not free from particles. Do not throw away any medicines via wastewater or household waste. Ask your nurse or 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 Levofloxacin solution for infusion contains
- The active substance is levofloxacin.
- Each ml of solution for infusion contains 5 mg of levofloxacin (as hemihydrate)
- The other ingredients are: sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment) and water for injections.
What Levofloxacin Solution for infusion looks like and contents of the pack
Plastic bags:
Polypropylene bag containing 50 ml of solution for infusion with a twist-off -port: Packs: 1 or 10 bags of 50 ml
Polypropylene bag containing 100 ml of solution for infusion with a twist-off -port: Packs: 1 or 10 bags of 100 ml
Marketing Authorisation Holder and Manufacturer
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó, nº 8, 8A – 8B
Fervença
2705 – 906 Terrugem SNT
Portugal
This leaflet was last revised in 10/2025
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