Package leaflet: Information for the user. {Product name} 100 mg/100 mg/1 mg/20 mg/2 ml solution for injection

Transcription

1 Package leaflet: Information for the user {Product name} 100 mg/100 mg/1 mg/20 mg/2 ml solution for injection Pyridoxini hydrochloridum, Thiamini hydrochloridum, Cyanocobalaminum, Lidocaini hydrochloridum Read all of this leaflet carefully before you start using this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What {Product name} is and what it is used for 2. What you need to know before you use {Product name} 3. How to use {Product name} 4. Possible side effects 5. How to store {Product name} 6. Contents of the pack and other information 1. What {Product name} is and what it is used for Active substances of {Product name} are pyridoxine hydrochloride (vitamin B6), thiamine hydrochloride (vitamin B1), cyanocobalamin (vitamin B12), lidocaine hydrochloride. {Product name} is used for treatment of haematologic and neurologic symptoms caused by continuous deficiency of vitamins B1, B6 and B12 in adults and children over 12 years. 2. What you need to know before you use {Product name} Do not use {Product name} - if you are allergic to pyridoxine hydrochloride (vitamin B6), thiamine hydrochloride (vitamin B1), cyanocobalamin (vitamin B12), lidocaine hydrochloride or any of the other ingredients of this medicine (listed in section 6); - if you have severe cardiac conduction disorders and acute decompensated cardiac failure; - during pregnancy and breast-feeding period. Due to benzyl alcohol content the medicinal product must not be administered to newborn babies, especially to premature newborn babies. Administration limits are 90 mg and more benzyl alcohol per day: children under 3 years of age may develop toxic and anaphylactoid reactions.

2 Warnings and precautions This medicine should be injected only intramuscularly (i.m.), not into a vein (i.v.). If accidentally injected into a vein, your doctor will monitor you or you will be hospitalised depending on the severity of the symptoms. Other medicines and {Product name} Tell your doctor if you are using, have recently used or might use any other medicines. Particularly important are the following medicines: - sulfite-containing solutions (vitamin B1 decomposes sulfite solutions containing acid. Other vitamins may be inactivated in the presence of degradation products of vitamin B1); - isoniazid, cycloserine - used in the treatment of tuberculosis; - D-penicillamine - used in the treatment of rheumatoid arthritis; - epinephrine - used in the treatment of severe allergic (anaphylactic) reactions; - norepinephrine - used in the treatment of depression and low blood pressure; - sulfonamides - antibiotics, which are also used in the treatment of inflammatory bowel diseases; - levodopa - are used in the treatment of Parkinson's disease. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before taking this medicine. The safe daily dose of vitamin B6 during pregnancy and breast-feeding is up to 25 mg. As the vitamin B6 content of this medicinal product is 100 mg in one 2 ml ampoule, it must not be used during pregnancy and breast-feeding. Driving and using machines There is no or negligible influence on the ability to drive and use machines. {Product name} contains benzyl alcohol Each ampoule of {Product name} contains 40 mg benzyl alcohol. Must not be given to premature babies or neonates. May cause toxic reactions and allergic reactions in infants and children up to 3 years old. This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially sodium-free. This medicine contains potassium, less than 1 mmol sodium (39 mg) per dose, i.e. essentially potassium-free. 3. How to use {Product name} Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. This medicine should be injected only intramuscularly (i.m.), not into a vein (i.v.). If accidentally injected into a vein, your doctor will monitor you or you will be hospitalised depending on the severity of the symptoms. Your doctor will determine the appropriate dose and frequency of injections.

3 Adults and children over 12 years In case of severe and acute symptoms: one injection (2 ml) is usually administered once a day to achieve high levels of active substances in blood. When the acute phase has subsided and for less serious symptoms one injection is administered 2-3 times a week. Elderly Dose adjustments are not required. Paediatric population {Product name} solution for injection should not be administered to children under 12 years old. Instruction of ampoule opening: 1) Turn the ampoule with coloured point up. If there is any solution in the upper part of the ampoule, gently tap with your finger to get all the solution to the lower part of the ampoule. 2) Use both hands to open; while holding the lower part of the ampoule in one hand, use the other hand to break off the upper part of the ampoule in the direction away from the coloured point (see the pictures below). If you are given more {Product name} than you should As this medicine is given to you under medical supervision, so it is unlikely that you will be given more or not enough {Product name} than you should. If you have the impression that the effect of {Product name} is too strong or too weak, talk to your doctor or nurse. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Undesirable effects are evaluated on the basis of their frequency as follows: Rare (affect less than 1 in people) - Hypersensitivity reactions (e.g. skin rash, respiratory inhibition, shock, angioedema). Benzyl alcohol: Hypersensitivity reactions.

4 Very rare (affect less than 1 in people) - Palpitations (tachycardia). - Severe sweating, acne, skin reactions with itching and hives. Not known (cannot be estimated from the available data) - Vertigo, clouding of consciousness. - Slow heart rate (bradycardia), heart rhythm disorders. - Vomiting. - Seizures. - Systemic reactions, including central nervous system excitement and/or depression (balance disorder, nervousness, feeling of danger, euphoria, confusion, dizziness, clouding of consciousness, tinnitus, blurred or double vision, vomiting, feeling of cold or hot, numbness), may occur as a result of rapid injection (inadvertent intravenous injection, injection into tissues with good blood supply) or overdose. Reporting of side effects If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via: [To be completed nationally] By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store {Product name} Store in a refrigerator (2 o C 8 o C). Do not freeze. Store in the original package in order to protect from light. Keep out of the sight and reach of children. Once ampoule has been opened, the content should be used immediately. Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. 6. Contents of the pack and other information What {Product name} contains - The active substances are pyridoxine hydrochloride (vitamin B6), thiamine hydrochloride (vitamin B1), cyanocobalamin (vitamin B12), lidocaine hydrochloride. 1 ml of solution for injection contains: 50 mg pyridoxine hydrochloride, 50 mg thiamine hydrochloride, 0.5 mg cyanocobalamin, 10 mg lidocaine hydrochloride. One ampoule (2 ml) contains: 100 mg pyridoxine hydrochloride, 100 mg thiamine hydrochloride, 1 mg cyanocobalamin, 20 mg lidocaine hydrochloride.

5 - The other ingredients are benzyl alcohol, sodium triphosphate pentabasic, sodium hydroxide (for ph adjustment), potassium hexacyanoferrate (III), water for injections. What {Product name} looks like and contents of the pack Clear red solution for injection (injection). {Product name} is produced in 2 ml amber glass ampoules. 5 ampoules are placed into a PVC liner. 1, 2 or 5 liners are placed into a cardboard box. Pack size: 5, 10 or 25 ampoules. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer AS KALCEKS Krustpils iela 53, Rīga, LV-1057, Latvia Tel.: kalceks@kalceks.lv This medicinal product is authorised in the Member States of the EEA under the following names: Estonia Neiratax Latvia Neiratax 100 mg/100 mg/1 mg/20 mg/2 ml šķīdums injekcijām Lithuania Neiratax 100 mg/100 mg/1 mg/20 mg/2 ml injekcinis tirpalas Czech Republic Neiraxin Hungary Neiratax 100 mg/100 mg/1 mg/20 mg/2 ml oldatos injekció Bulgaria Neiraxin B 100 mg/100 mg/1 mg/20 mg/2 ml разтвор инжекционен Poland Neiraxin B Slovakia Neiraxin Romania Neiraxin soluţie injectabilă The Netherlands Neiraxin 100 mg/100 mg/1 mg/20 mg/2 ml oplossing voor injectie This leaflet was last revised in 06/2017