0.9% Sodium Chloride Injection
PACKAGE LEAFLET: INFORMATION FOR THE USER © J-C 2011 gb-ie - aw_722h
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• 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 nurse.
1 What Sporanox I.V. is and what it is used for
2 Before you are given Sporanox I.V.
3 How you will be given Sporanox I.V.
4 Possible side effects
5 How Sporanox I.V. is stored
6 Further information
Sporanox I.V. is one of a group of medicines called “antifungals”. These medicines are used to treat infections caused by fungi including yeasts.
• Treat fungal infections of the internal organs.
• You are allergic (hypersensitive) to any of the ingredients in Sporanox I.V.
(listed in section 6 further information)
• You are pregnant, think you might be pregnant or are trying to become pregnant, (see the section on Pregnancy)
• Your kidney function is seriously reduced
• You cannot have sodium chloride by injection.
• You are taking any of the following medicines:
- terfenadine, astemizole or mizolastine (antihistamine for allergies)
- bepridil-used to treat angina (crushing chest pain)
- nisoldipine (used for high blood pressure)
- cisapride (used for stomach upsets)
- midazolam by mouth or triazolam (used to help you sleep or for anxiety)
- lovastatin, simvastatin or atorvastatin (used to lower cholesterol)
- pimozide and sertindole (for conditions affecting thoughts, feelings and/or behaviour)
- levacetylmethadol - for treatment of drug abuse (opioid-dependency)
- dihydroergotamine, ergotamine and eletriptan (for migraine headaches)
- ergometrine (ergonovine) and methylergometrine (methylergonovine) used after giving birth
- quinidine and dofetilide (for irregular heart beat rhythms)
Tell your doctor immediately: If you
have any unusual feelings of tingling, numbness or weakness in your hands or feet whilst taking Sporanox I.V..
If you experience any hearing loss symptoms. In very rare cases patients taking Sporanox have reported temporary or permanent hearing loss.
You must tell your doctor before you are given Sporanox I.V. if you suffer from or have suffered in the past from any of the following:
• Any liver problems or jaundice (yellowing of the skin). If your doctor decides to give you Sporanox I.V. the dose may have to be changed. Your doctor may give you instructions on symptoms to watch out for and ask you to have your blood checked.
• An allergic reaction to any other antifungal medicine.
• Heart problems, including heart failure (also called congestive heart failure or CHF), Sporanox I.V. could make it worse. If your doctor decides to give you Sporanox I.V. you should be told about the symptoms listed below to watch out for. If you get any of the following stop taking Sporanox I.V. and tell your doctor straight away. These may be signs of heart failure:
- shortness of breath
- unexpected weight gain
- swelling of your legs or stomach
- feel unusually tired
- wake up short of breath at night
• Are on a low salt diet.
• A kidney disorder, you may be monitored more closely or your dose of Sporanox I.V. may have to be changed.
There are some medicines that you should not take whilst being given Sporanox IV. These are listed under the heading “You should not be given Sporanox I.V. if:”.
Tell your doctor if you are using the following as they may stop Sporanox I.V. from working properly:
• rifampicin, rifabutin and isoniazid (antibiotics used to treat tuberculosis)
• phenytoin, carbamazepine and phenobarbital (anti-epileptics)
• St John’s Wort (a herbal medicine)
Do not use Sporanox I.V. within 2 weeks of taking these medicines.
Tell your doctor before taking any of
the following medicines as the dose of Sporanox I.V. or other treatments may need to be altered:
• clarithromycin or erythromycin (anitibiotics for infections)
• medicines that act on the heart and blood vessels (digoxin, disopyramide and calcium channel blockers such as dihydropyridines, verapamil and cilostazol)
• drugs that slow down blood clotting or thin the blood, such as warfarin
• methylprednisolone, budesonide, fluticasone and dexamethasone drugs given by mouth and injection for inflammation, asthma and allergies
• cyclosporin, tacrolimus, rapamycin (also known as sirolimus), which are usually given after an organ transplant
• medicines used in HIV-infected patients, such as ritonavir, indinavir and saquinavir
• medicines for cancer (such as busulphan, docetaxel, trimetrexate and a group of medicines known as vinca alkaloids)
• alfentanil and fentanyl (for pain)
• buspirone, alprazolam, brotizolam and midazolam when given by injection into a vein (for anxiety or to help you sleep)
• reboxetine (for depression)
• an antihistamine containing ebastine
• halofantrine (for malaria)
• repaglinide (for diabetes)
• cerivastatin (for lowering levels of cholesterol)
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or herbal medicines.
Sporanox I.V. is not normally given to children or the elderly. Your doctor may prescribe it in special cases.
Do not take Sporanox I.V. if you are pregnant, unless your doctor has told you to. If you are of child bearing age and could become pregnant, you should use contraceptives to make sure that you do not become pregnant while you are receiving your medicine. As Sporanox I.V. remains in the body for some time after you stop receiving it, you should continue to use some form of contraception until your next period after your treatment with Sporanox I.V. has finished.
If you do find that you are pregnant after receiving a course of Sporanox I.V., tell your doctor straight away.
Before taking any medicine - always tell your doctor if you are pregnant, think you might be pregnant or are trying to become pregnant.
You should stop breast-feeding before you are given Sporanox, as small amounts of the medicine could be present in your breast milk.
Sporanox I.V. can sometimes cause dizziness, blurred/double vision or hearing loss. If you have these symptoms, do not drive or use machines.
© J-C 2011 GB-IE - AW_72211
Your medicine will be given to you by your doctor or nurse. Sporanox I.V. concentrate is mixed with the sodium chloride solution in the bag and is then given by slow injection into a vein.
This is called an intravenous (I.V.) infusion and will usually take about an hour. For the first two days, you will be given two infusions each day. From Day three onwards you will be given one infusion each day.
The recommended dosage is as follows: Adults:
Day 1 and Day 2 of the treatment:
Two 1-hour infusions of 200 mg Sporanox I.V. will be given each day as a 60 ml infusion.
From Day 3 onwards:
One 1-hour infusion of 200 mg Sporanox I.V. will be given each day as a 60 ml infusion.
Since this medicine will be given to you by a doctor or nurse, it is unlikely that you will be given too much or that a dose will be missed. However, if you are worried, tell your doctor or nurse.
Like all medicines, Sporanox I.V. can cause side effects, although not everybody gets them.
Medicines can cause serious allergic reactions.
Stop taking Sporanox I.V. and contact your doctor immediately if you have:
• any sudden wheeziness, difficulty in breathing, swelling of the face, rash, itching (especially affecting the whole body) or a severe skin disorder (widespread rashes with peeling skin and blisters in the mouth, eyes and genitals, or rashes with small pustules or blisters).
• severe lack of appetite, feeling sick, being sick, unusual tiredness, abdominal (stomach) pain, unusually dark urine, or pale stools. These may be symptoms of severe liver problems.
You should also let your doctor know immediately if you have any of the side effects below:
• Symptoms that resemble heart failure such as shortness of breath, unexpected weight gain, swelling of the legs, unusual fatigue (tiredness), repeated waking at night.
• A tingling sensation, sensitivity to light, numbness or weakness in the limbs.
• Blurred vision/double vision, ringing in your ears, lose the ability to control your urine or increased need to urinate (pass water)
• If you experience any symptoms of hearing loss
Other side effects include:
Very common side effects (occur in more than 1 in 10 patients)
• feeling sick (nausea)
Common side effects (occur in less than 1 in 10 patients) are:
• muscle weakness (possible symptom of low blood levels of potassium)
• headache, dizziness
• stomach ache, being sick (vomiting), diarrhoea, constipation
• increases in specific liver function tests (hepatic enzyme increased), inflammation of the liver (hepatitis), yellowing of the skin (jaundice)
• rash, itching
• general swelling
• fever or high temperature
• shortness of breath
Uncommon side effects (occur in less than 1 in 100 patients) are:
• high blood sugar levels
• unpleasant taste
• muscle pain
The following side effects have been reported in patients taking Sporanox I.V. with unknown frequency:
• certain blood disorders which may increase the risk of bleeding, bruising or infections
• excess of triglycerides in the blood
• high blood pressure
• hair loss
• painful joints
• menstrual disorders
• erectile dysfunction
• severe upper stomach pain, often with nausea and vomiting due to inflammation of the pancreas (pancreatitis)
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
Sporanox I.V. will be kept in the hospital pharmacy.
The product should not be used after the expiry date printed on the inner and outer packaging. The expiry date refers to the last day of that month.
Do not store Sporanox I.V. concentrate above 25°C.
Store in the original container.
Do not store the bag containing Sodium Chloride above 25°C. Do not freeze. Protect the mixed solution from direct sunlight. Once mixed, the product should be used immediately.
• The active ingredient in Sporanox I.V. is itraconazole (10mg of itraconazole per ml).
• The other ingredients are hydroxypropyl-p-cyclodextrin, propylene glycol, hydrochloric acid concentrated, sodium hydroxide and water for injections.
• Sodium Chloride, water for injections.
It is a kit containing a clear, colourless concentrated solution for intravenous (I.V.) infusion, which means the solution needs to be diluted before use. Sporanox I.V. comes in a 25 millilitre (ml) ampoule, together with a bag containing a clear, colourless Sodium Chloride solution and an extension line. These two solutions will be mixed together to give a clear, colourless solution before they are given directly into your veins.
One ml of Sporanox I.V. concentrate contains 10 milligrams (mg) of itraconazole. When the Sporanox I.V. concentrate is added to the bag containing sodium chloride solution, each ml of the mixed solution contains 3.33 mg itraconazole.
The Sodium Chloride bag is a plastic polypropylene infusion bag, which contains 50 ml of Sodium Chloride solution. One ml of solution contains 9 mg sodium chloride. It is used to dilute the Sporanox I.V. concentrate making it easier to be given.
Marketing Authorisation Holder:
Janssen-Cilag Ltd, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire HP12 4EG, UK
Sporanox I.V. 10mg/ml concentrate and solvent for solution for infusion are manufactured by:
Sociedade Tecnica Farmaceutica S.A. Estrada Consiglieri Pedroso, 69-B Queluz
2730-055 Barcarena Portugal
This medicinal product is authorised in the member states of the EEA under the following names:
® Registered trademark
For information in large print, tape, CD or Braille, phone 0800 731 8450 (UK) or 1800 709122 (IRE)
This leaflet was last approved in 08/2012