PABRINEX INTRAMUSCULAR HIGH POTENCY SOLUTION FOR INJECTION
Active substance: THIAMINE HYDROCHLORIDE
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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. Please keep this leaflet. You may need to read it again. you have any further questions, ask your If doctor. you suffer from any side effects that get If serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. In this leaflet: 1. What Pabrinex Intramuscular injection is and what it is used for 2. Before Pabrinex Intramuscular injection is given 3. How Pabrinex Intramuscular injection is given 4. Possible side effects 5. How to store Pabrinex Intramuscular injection 6. Further 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: in alcoholism after infections after operations in certain psychiatric states. 2. BEFORE PABRINEX INTRAMUSCULAR INJECTION IS GIVEN You MUST NOT be given Pabrinex Intramuscular injection if you have: n allergy (hypersensitivity) to any of the a ingredients in the product (see Section 6 What Pabrinex contains) a history of sensitivity to vitamins B and/or C. Take special care with Pabrinex Intramuscular injection Pabrinex should be given with extreme caution if you have: ever had a mild allergic reaction (sneezing or mild asthma) to any previous injections of vitamin B1 (thiamine). This could mean that you may have become hypersensitive, and could have a more severe allergic reaction if given Pabrinex Intramuscular injection. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. These include: Levodopa (used in the treatment of Parkinsons disease) - Pabrinex Intramuscular injection interferes with the effects of this medicine. Vitamin B1 (thiamine) injections - if you are on repeated injections of such preparations, Pabrinex Intramuscular injection may cause a severe reaction if you have become hypersensitive. 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. 3. HOW PABRINEX INTRAMUSCULAR INJECTION IS GIVEN Pabrinex Intramuscular, the contents of which are mixed from two vials, 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 vials (one pair) twice daily for up to 7 days.
Children: Pabrinex Intramuscular injection is not usually given to children; however, suitable doses according to the childs age are:
Age under 6 years 6-10 years 10-14 years 14 years and older Dose 1/4 of the adult dose 1/3 of the adult dose 1/2 to 2/3 of the adult dose one adult dose
5. HOW TO STORE PABRINEX INTRAMUSCULAR INJECTION Keep out of the reach and sight of children. Pabrinex Intramuscular injection should be stored in a refrigerator at 2C to 8C but not frozen, and protected from light. The product must not be used after the expiry date printed on the outer carton and vial labels. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Pabrinex Intramuscular injection contains The active ingredients are:
VIAL 1 thiamine hydrochloride (vitamin B1) riboflavin (vitamin B2) pyridoxine hydrochloride (vitamin B6) VIAL 2 ascorbic acid (vitamin C) nicotinamide 5ml 250mg 4mg 50mg 2ml 500mg 160mg
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 product, ask your doctor. 4. POSSIBLE SIDE EFFECTS Like all medicines, Pabrinex Intramuscular injection can cause side effects, although not everybody gets them. Allergic reaction - if following your injection you experience symptoms such as sneezing or mild asthma (chest tightness and wheezing) tell your doctor immediately. This may be an indication that you are sensitive to Pabrinex Intramuscular injection and should not be given a repeat dose. Severe allergic reaction (Anaphylatic shock) may result from repeated injections of this product. Symptoms may include: swelling of the face and or throat, rash, severe itching, difficulty in breathing and loss of consciousness due to very low blood pressure. Low blood pressure and feeling of pins and needles (mild paraesthesia) - can occur in some patients given Pabrinex Intramuscular injection. Mild ache - some swelling may develop at the site where Pabrinex is injected. If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
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 yellow coloured glass vials containing 5ml or 2ml of sterile solution. Pack sizes contain 10 pairs of 5ml and 2ml ampoules Marketing Authorisation Holder Archimedes Pharma UK Limited 250 South Oak Way, Green Park Reading, RG2 6UG, UK. Manufacturer Wlfing Pharma GmbH Bethelner Landstrae 18 D-31028 Gronau/Leine Germany. Pabrinex is a registered trade mark This leaflet was last approved: December 2012
DESCRIPTION: Pabrinex Intramuscular User Testing PIL ARCHIMEDES REF.: XXXXXX VERSION No.: 0.9 DATE:18/12/2012 YELLOWDOT REF: 11582 REASON FOR CHANGE: Update approval date bottom of page 2 (MK) SIZE: 210mm x 158mm COLOURS:Black TEXT SIZE: 9pt LEADING: 9.5pt (3.3mm) FONTS: ITC New Baskerville Regular, Bold and Italic Times, Symbol
Pabrinex Intramuscular High Potency, Solution for injection
(Vitamins B & C Injection)
Read all of this leaflet carefully before you start taking this medicine. Please keep this leaflet. You may need to read it again. you have any further questions, ask your If doctor. you suffer from any side effects that get If serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. In this leaflet: 1. What Pabrinex Intramuscular injection is and what it is used for 2. Before Pabrinex Intramuscular injection is given 3. How Pabrinex Intramuscular injection is given 4. Possible side effects 5. How to store Pabrinex Intramuscular injection 6. Further 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: in alcoholism after infections after operations in certain psychiatric states. 2. BEFORE PABRINEX INTRAMUSCULAR INJECTION IS GIVEN You MUST NOT be given Pabrinex Intramuscular injection if you have: n allergy (hypersensitivity) to any of the a ingredients in the product (see Section 6 What Pabrinex contains) a history of sensitivity to vitamins B and/or C. Take special care with Pabrinex Intramuscular injection Pabrinex should be given with extreme caution if you have: ever had a mild allergic reaction (sneezing or mild asthma) to any previous injections of vitamin B1 (thiamine). This could mean that you may have become hypersensitive, and could have a more severe allergic reaction if given Pabrinex Intramuscular injection. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. These include: Levodopa (used in the treatment of Parkinsons disease) - Pabrinex Intramuscular injection interferes with the effects of this medicine. Vitamin B1 (thiamine) injections - if you are on repeated injections of such preparations, Pabrinex Intramuscular injection may cause a severe reaction if you have become hypersensitive. 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. 3. HOW PABRINEX INTRAMUSCULAR INJECTION IS GIVEN Pabrinex Intramuscular, the contents of which are mixed from two vials, 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 vials (one pair) twice daily for up to 7 days.
Children: Pabrinex Intramuscular injection is not usually given to children; however, suitable doses according to the childs age are:
Age under 6 years 6-10 years 10-14 years 14 years and older Dose 1/4 of the adult dose 1/3 of the adult dose 1/2 to 2/3 of the adult dose one adult dose
5. HOW TO STORE PABRINEX INTRAMUSCULAR INJECTION Keep out of the reach and sight of children. Pabrinex Intramuscular injection should be stored in a refrigerator at 2C to 8C but not frozen, and protected from light. The product must not be used after the expiry date printed on the outer carton and vial labels. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Pabrinex Intramuscular injection contains The active ingredients are:
VIAL 1 thiamine hydrochloride (vitamin B1) riboflavin (vitamin B2) pyridoxine hydrochloride (vitamin B6) VIAL 2 ascorbic acid (vitamin C) nicotinamide 5ml 250mg 4mg 50mg 2ml 500mg 160mg
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 product, ask your doctor. 4. POSSIBLE SIDE EFFECTS Like all medicines, Pabrinex Intramuscular injection can cause side effects, although not everybody gets them. Allergic reaction - if following your injection you experience symptoms such as sneezing or mild asthma (chest tightness and wheezing) tell your doctor immediately. This may be an indication that you are sensitive to Pabrinex Intramuscular injection and should not be given a repeat dose. Severe allergic reaction (Anaphylatic shock) may result from repeated injections of this product. Symptoms may include: swelling of the face and or throat, rash, severe itching, difficulty in breathing and loss of consciousness due to very low blood pressure. Low blood pressure and feeling of pins and needles (mild paraesthesia) - can occur in some patients given Pabrinex Intramuscular injection. Mild ache - some swelling may develop at the site where Pabrinex is injected. If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
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 yellow coloured glass vials containing 5ml or 2ml of sterile solution. Pack sizes contain 10 pairs of 5ml and 2ml ampoules Marketing Authorisation Holder Archimedes Pharma UK Limited 250 South Oak Way, Green Park Reading, RG2 6UG, UK. Manufacturer Wlfing Pharma GmbH Bethelner Landstrae 18 D-31028 Gronau/Leine Germany. Pabrinex is a registered trade mark This leaflet was last approved: December 2012
DESCRIPTION: Pabrinex Intramuscular User Testing PIL ARCHIMEDES REF.: XXXXXX VERSION No.: 0.9 DATE:18/12/2012 YELLOWDOT REF: 11582 REASON FOR CHANGE: Update approval date bottom of page 2 (MK) SIZE: 210mm x 158mm COLOURS:Black TEXT SIZE: 9pt LEADING: 9.5pt (3.3mm) FONTS: ITC New Baskerville Regular, Bold and Italic Times, Symbol
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
