Vondip IV 200 mg Solution

VONDIP IV 200 mg contains voriconazole, one of a group of medicines called triazole antifungal agents. VONDIP IV 200 mg is an antifungal medicine. It works by killing or stopping the growth of the fungi that cause a wide variety of fungal infections and for the prevention of fungal infections in high risk bone marrow transplant recipients. VONDIP IV 200 mg should only be used under the supervision of a doctor.

VONDIP IV 200 mg should not be administered to you:

• if you are hypersensitive (allergic) to voriconazole or any of the other ingredients of VONDIP IV 200 mg (see section 6)
• if you have an abnormality of electrocardiogram (ECG) called ‘long QTc syndrome’
• if you suffer from serious liver problems
• if you are pregnant or breastfeeding (see Pregnancy and Breastfeeding).

The medicines in the following list must NOT be taken during your treatment with VONDIP IV 200 mg:

• cisapride (for stomach problems)
• pimozide (for treating mental illness)
• astemizole or terfenadine (to treat allergies)
• ivabradine (to treat heart failure)
• quinidine (for irregular heart beat)
• efavirenz (to treat HIV) in doses of 400 mg or more daily
• naloxegol (to treat constipation specifically caused by pain medicines, called opioids, e.g., morphine, oxycodone, fentanyl, tramadol, codeine)
• tolvaptan (to treat low blood sodium levels or to slow kidney function decline in patients with polycystic kidney disease)
• lurasidone (to treat symptoms of mental disorders)
• venetoclax (to treat patients with chronic lymphocytic leukaemia - CLL)
• ritonavir (to treat HIV) in doses of 400 mg or more twice daily
• carbamazepine (to treat severe seizures)
• phenobarbitone (for severe insomnia and seizures)
• rifampicin (to treat tuberculosis)
• rifabutin (to treat tuberculosis)
• ergot alkaloids (e.g. ergotamine, dihydroergotamine; for migraine)
• sirolimus and everolimus (given to transplant patients)
• St John’s Wort (herbal supplement).

You will not be expected to give yourself VONDIP IV 200 mg. It will be given to you by a person who is qualified to do so. VONDIP IV 200 mg will be given to you by intravenous infusion (injected into a vein) over a period of 1 to 2 hours. Your doctor will prescribe the appropriate dose according to your condition. Children: Children aged between 12 and 16 years of age should be dosed as adults. Your doctor will tell you how long your treatment with VONDIP IV 200 mg will last.

If you have the impression that the effect of VONDIP IV 200 mg is too strong or too weak, tell your doctor or pharmacist.

If you are administered more VONDIP IV 200 mg than you should Since a healthcare professional will administer VONDIP IV 200 mg, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdose.

If you forget to use VONDIP IV 200 mg Since a healthcare professional will administer VONDIP IV 200 mg, it is unlikely that the dose will be missed.

If you stop using VONDIP IV 200 mg When VONDIP IV 200 mg treatment is stopped by your doctor you should not experience any effects. However, if you were taking medicines containing ciclosporin or tacrolimus you must mention this to your doctor, as the dose will need to be adjusted.

VONDIP IV 200 mg can have side effects. Not all side effects reported for VONDIP IV 200 mg are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using VONDIP IV 200 mg, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop using VONDIP IV 200 mg and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to VONDIP IV 200 mg. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• sepsis (blood poisoning). Symptoms include fast heart rate, fever or chills, fast breathing
• jaundice, severe liver problems
• severe skin rashes (blisters, peeling, raw areas), red-purple rash that spreads and forms blisters
• heart rhythm problems including very fast heartbeat and very slow heartbeat
• difficulty breathing due to fluid in your lungs and other problems with breathing, chest pain.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• flu-like symptoms, inflammation of the sinuses
• anaemia (feeling weak or dizzy) and other blood cell changes which your doctor will detect by taking a blood test
• blood tests showing a decrease in potassium or sodium levels (causing irregular heartbeat, confusion, seizures, fatigue unconsciousness) or a decrease in blood sugar levels (causing heart palpitations, fatigue, pale skin, shakiness, sweating, hunger, irritability)
• agitation, anxiety, confusion, depression, hallucinations (hearing or seeing things which are not there), problems sleeping
• dizziness, headache, convulsions (fits), tingling or burning in the hands or feet (pins and needles), muscle problems (arms or legs are difficult to move), trembling
• blurred vision, changes to the colours you see, sensitivity of your eyes to the light, eye bleeding and other problems with your sight. These side effects are mild, fully reversible and normally resolve themselves within an hour
• low blood pressure, inflammation of a vein (which may be associated with the formation of a blood clot)
• heartburn, piles, abdominal distension (bloating), stomach pains, swelling of the lips, diarrhoea, feeling or being sick, indigestion, constipation, swollen gums
• changes in liver function (detected by blood tests)
• hair loss, redness or purple discolouration of the skin, swelling of the face, sunburn or severe skin reaction following exposure to light or sun, itchiness, rash, widespread blistering rash and skin peeling
• back pain
• kidney failure, blood in the urine, changes in kidney function, decreased creatinine (detected by blood tests)
• feeling weak or lacking strength, chest pain, chills, fever, inflammation at the injection site, swelling of the extremities.

Less frequent side effects:

• swelling or inflammation of the large intestine (colon) due to infection
• blood tests showing a severe decrease in number of white or red blood cells, small purplish or red spots, blood clots, increase in a type of white blood cell which may be associated with allergic reaction, disorder of blood clotting system, enlarged lymph nodes
• overactive thyroid (symptoms include irritability, fast heartbeat, increased sweating, weight loss)
• underactive thyroid (symptoms include weight gain, extreme tiredness and depression)
• blood tests showing increased cholesterol
• sleepiness during infusion of VONDIP IV 200 mg, problems with coordination, swelling of the brain, abnormal brain function, due to liver not functioning Parkinson-like symptoms (continuous spasms, muscle contractions, irregular jerky movements and slow movements), nerve injury resulting in weakness, numbness or pain (usually in hands or feet), abnormal eye movement, abnormal sense of taste
• inflammation of the eyes and eyelid, clouding of the cornea which affects sight, double vision, damage to the eye nerves, swelling of the optic (eye) nerve, which results in problems seeing, prolonged involuntary upward gaze of the eyes
• problems hearing, ringing in the ears, sensation of spinning when standing still
• diagnosed with an infection of the lymphatic system
• inflammation of the upper small intestine, problems with the pancreas, swollen tongue, peritonitis (inflammation of the lining of the abdominal cavity)
• inflammation of the gallbladder, gallstones, enlarged liver, hepatitis (inflammation of the liver), loss of consciousness due to liver failure
• skin rashes, swelling or inflammation of the skin, hives, skin redness and irritation, freckles and pigmented spots, eczema, psoriasis (scaly, itchy, dry patches of skin)
• arthritis (swollen or painful joints)
• kidney problems (damage to the kidney, proteins in the urine, inflammation of the kidney)
• blood chemistry changes (increased blood urea, increased blood cholesterol).

The following side effects have been reported but the frequency for them to occur is not known:

• skin cancer
• prominent rash on the cheeks and nose (“butterfly rash”), freckles
• inflammation, tenderness and swelling of the bones.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of VONDIP IV 200 mg. You can also send an email directly to the company, [email protected], to ensure safety of the product.

Store all medicines out of reach of children. Store at or below 25 °C. Reconstitution of the vial must take place under aseptic conditions for microbial control. After reconstitution with 19 mL of Water for Injections, the reconstituted solution should be used immediately. If the reconstituted solution is not used immediately, the reconstituted solution will remain suitable for its intended use up to 72 hours, store at 2 - 8 °C (in a refrigerator). Do not freeze. Protect from light. Keep the vial in the carton until required for use. Do not use after the expiry date stated on the carton.

Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).