B Complex PLUS (Vit. B1+B6+B12)

Thiamini hydrochloridum + Pyridoxini hydrochloridum + Cyanocobalaminum

1 ml solution for injection contains thiamine hydrochloride 50 mg, pyridoxine hydrochloride 50 mg and cyanocobalamin 0.5 mg (1 ampoule of 2 ml: thiamine hydrochloride 100 mg, pyridoxine hydrochloride 100 mg, cyanocobalamin 1 mg). Excipients with known effect: lidocaine hydrochloride 20 mg and benzyl alcohol 40 mg per 2 ml solution.

Indication: Peripheral nervous system disorders of various aetiologies (neuritis, polyneuropathies including diabetic and alcoholic, retrobulbar neuritis, facial nerve palsy, trigeminal neuralgia, radicular syndromes, herpes zoster, cervico-brachial syndrome, etc.); also used as adjuvant therapy or during convalescence.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications - Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 - Severe conduction disorders and acute decompensated heart failure - Pregnancy and lactation. At daily doses of vitamin B6 up to 25 mg there are no concerns regarding pregnancy and lactation. This product contains 100 mg of active substance per 2 ml ampoule, which is why it should not be administered in these cases. - Children. B Complex plus must not be given to children under 12 years of age because of its benzyl alcohol content and high vitamin dose.

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use B Complex Plus must be given only intramuscularly (i.m.) and not intravenously (i.v.) into the bloodstream. Accidental intravenous injection must be monitored either by a physician or in a hospital setting, depending on the severity of the symptoms that occur. Administration of the injectable solution containing vitamins B1 and B6 may very rarely cause hypersensitivity reactions of the anaphylactic shock type. In such cases, appropriate resuscitation measures are required. This medicinal product may cause neuropathies if used for longer than six months. B Complex Plus contains sodium, but less than 1 mmol (23 mg) of sodium per dosing unit (2 ml), i.e. essentially "sodium-free". B Complex Plus contains benzyl alcohol. Benzyl alcohol is associated with an increased risk of serious adverse reactions, including […]