Patient Leaflet Updated 03-Oct-2018 | Kyowa Kirin Ltd
Pabrinex Intramuscular High Potency Injection
PACKAGE LEAFLET: INFORMATION FOR THE USER
Pabrinex® Intramuscular High Potency, Solution for injection
(Vitamins B & C Injection)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet:
1. What Pabrinex Intramuscular injection is and what it is used for
2. What you need to know before you are given Pabrinex Intramuscular injection
3. How Pabrinex Intramuscular injection is given
4. Possible side effects
5. How to store Pabrinex Intramuscular injection
6. Contents of the pack and other information
1. WHAT PABRINEX INTRAMUSCULAR INJECTION IS AND WHAT IT IS USED FOR
Vitamins B and C are important for a number of bodily functions including releasing energy from food and in the formation of healthy skin, bones and teeth.
Pabrinex Intramuscular High Potency, Solution for injection (‘Pabrinex’) provides additional vitamins B and C to correct deficiencies that may have occurred, for example:
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PABRINEX INTRAMUSCULAR INJECTION
You MUST NOT be given Pabrinex Intramuscular injection:
Warnings and precautions
Talk to your doctor before taking Pabrinex Intramuscular injection.
Pabrinex should be given with extreme caution if you have:
Other medicines and Pabrinex Intramuscular injection
Tell your doctor or pharmacist if you are taking, or have recently taken, or might take, any other medicines:
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, planning to become pregnant or breast-feeding. Ask your doctor or pharmacist before taking any medicine.
Driving and using machines
Pabrinex Intramuscular is not expected to affect your ability to drive or operate machinery.
Pabrinex Intramuscular contains sodium and benzyl alcohol:
This medicine contains approximately 67 mg sodium (main component of cooking/table salt) in each 7 ml dose (1 pair of ampoules). This is equivalent to 3.4% of the WHO recommended maximum daily intake of 2 g sodium for an adult
This medicine contains approximately 139 mg benzyl alchohol in each 7 ml dose (1 pair of ampoules) which is equivalent to 19.9 mg/ml:
3. HOW PABRINEX INTRAMUSCULAR INJECTION IS GIVEN
Pabrinex Intramuscular, the contents of which are mixed from two ampoules, is usually given by slow injection into your gluteal (bottom) muscle by a healthcare professional.
This medicine is for injection into a muscle only and should not be given by any other route.
Dosage for adults including the elderly:
7ml of the mixed ampoules (one pair) twice daily for up to 7 days.
Use in children and adolescents: Pabrinex Intramuscular injection is not usually given to children; however, suitable doses according to the child’s age are:
under 6 years 1/4 of the adult dose
6-10 years 1/3 of the adult dose
10-14 years 1/2 to 2/3 of the adult dose
14 years and older one adult dose
The exact dose you will be given will be decided by your doctor who will monitor your condition and determine what treatment you need. If you feel that you have been given an inappropriate dose or if you would like more information about Pabrinex Intramuscular injection, speak to your doctor.
If you are given more Pabrinex Intramuscular injection than you should
This product will be given to you under medical supervision. It is therefore unlikely that you will be given too much. However, if you feel unwell, you should tell your doctor immediately.
If you have any further questions on the use of this medicine, ask your doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist 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 PABRINEX INTRAMUSCULAR INJECTION
Keep this medicine out of the sight and reach of children.
Pabrinex Intramuscular injection should be stored in a refrigerator at 2°C to 8°C but not frozen, and protected from light. Do not use this medicine after the expiry date which is stated on the outer carton and ampoule labels after “EXP”. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Pabrinex Intramuscular injection contains
The active substances are:
AMPOULE 1 (5 ml)
thiamine hydrochloride (vitamin B1) - 250mg
riboflavin (vitamin B2) - 4mg
pyridoxine hydrochloride (vitamin B6) - 50mg
AMPOULE 2 (2 ml)
ascorbic acid (vitamin C) - 500mg
nicotinamide - 160mg
The other ingredients are: edetic acid, sodium hydroxide, benzyl alcohol and water for injections.
What Pabrinex Intramuscular injection looks like and contents of the pack
The product is supplied in pairs of amber coloured glass ampoules containing 5 ml or 2 ml of sterile solution. Pack sizes contain 10 pairs of 5 ml and 2 ml ampoules
Marketing Authorisation Holder
This leaflet was last revised: 07/2018