Solivito N
Out of date information, search another1 :akorr 09-09-25 CE
PACKAGE LEAFLET: INFORMATION FOR THE USER
Solivito N® Powder for Concentrate for Solution for Infusion
Read all of this leaflet carefully before you start taking 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What is Solivito IN®' and what it is used for
2. Before you receive Solivito N®
3. How you are given Solivito N®
4. Possible side effects
5. How Solivito N® is stored
6. Further information
1. WHAT IS Solivito N® AND WHAT IT IS USED FOR
Solivito® N provides water-soluble vitamins into your bloodstream when you cannot eat normally. Vitamins are chemicals required in small amounts for the body to work normally.
Solivito N® is usually used as part of a balanced intravenous diet, together with proteins, fat, carbohydrates, other salts and other vitamins.
You should not receive Sollvlto N®:
• if you (or your child) are allergic (hypersensitive) to Solivito IN®1 or any of the ingredients of Solivito N® mentioned in section 6. If you develop a rash or other allergic reactions (like itching, swollen lips or face or shortness of breath), please inform your doctor.
Care should be taken when administering Solivito N®
Your doctor may want to do regular blood tests to check your condition.
This medicine may affect the result of other tests you may have.
It is important to tell any doctor doing tests that you are using Solivito N®.
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.
Inform your doctor if:
• you are taking phenytoin (medicine for epilepsy)
• you are taking any medicine for Parkinson's disease -levodopamine
• you are having injections of a drug called hydroxocobalamin (used in treatment of deficiency of vitamin B12 and used in the treatment of some types of eye conditions)
Pregnancy and breast-feeding
You should tell your doctor if you are pregnant, if you think you are pregnant or if you are breast-feeding. Your doctor will decide if you should receive Solivito N®.
Driving and using machines
Solivito N® has no effect on driving or using machines.
The dissolved and diluted Solivito N® will be given to you by infusion (IV drip).
Your doctor will decide on the correct dose for you to receive. Dosage
Adults and children weighing more than 10 kilograms
The usual daily dose for adults and children weighing more than 10 kg is one vial (dissolved to give 10 ml of solution).
Children weighing less than 10 kilograms
For children weighing less than 10 kg, the usual daily dose is 1 ml for each kg of body weight.
If you receive too much Solivito N®
It is very unlikely that you will receive more infusion than you should as your doctor or nurse will monitor you during the treatment. Flowever if you think that you have received too much Solivito IN®', inform your doctor or nurse as soon as possible.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
No known side effects have been reported with Solivito N®. However, if you notice any unwanted effects, please tell your doctor or nurse straight away.
5. HOW Sollvlto N® IS STORED
keep out of the reach and sight of children
Your doctor and hospital pharmacist are responsible for the correct storage, use and disposal of Solivito N® infusion. Keep the container in the outer carton to protect from light. Do not store above 25°C.
The solution must not be used after the expiry date shown on the label. The expiry date refers to the last day of that month.
Any solution remaining after treatment should be disposed via approved hospital procedures.
What Solivito N® infusions contain
Each vial of Solivito IN®1 contains the following active ingredients:
Thiamine Nitrate (B1) 3.1 mg
Sodium Riboflavine Phosphate (B2) 4.9 mg
Nicotinamide 40 mg
Pyridoxine hydrochloride (B6) 4.9 mg
Sodium pantothenate 16.5 mg
Biotin 60 micrograms
Folic acid 0.4 mg
Cyanocobalamin (B12) 5.0 micrograms Sodium Ascorbate (Vitamin C) 113 mg
Solivito N®also contains glycine, disodium edetate, methyl parahydroxy-benzoate and water for injections.
What Solivito N® looks like and contents of the pack
Solivito N® is a yellow powder containing water soluble vitamins. When the powder is dissolved, each vial contains 10 millilitres of solution.
Solivito N® is supplied in cartons containing 10 glass vials with a rubber stopper.
Marketing authorisation holder
Fresenius Kabi Limited Cestrian Court Eastgate Way Manor Park Runcorn Cheshire WA7INT UK
Manufacturer:
Fresenius Kabi AB,
S-751 74 Uppsala,
Sweden.