NALOXONE 400 MICROGRAMS/ML SOLUTION FOR INJECTION
Active substance: NALOXONE HYDROCHLORIDE DIHYDRATE
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806/LLD002/21/07
Package leaflet: Information for the Patient
B. Braun Melsungen AG 34209 Melsungen Germany
Naloxone 400 micrograms/ml
solution for injection naloxone hydrochoride
Read all of this leaflet carefully before this medicine is administered to you. - 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Naloxone is and what it is used for 2. Before Naloxone is administered to you 3. How Naloxone is administered 4. Possible side effects 5. How to store Naloxone 6. Further information Driving and using machines After receiving Naloxone for the reversal of the effects of opioids you must not drive, operate machinery or engage in any other physically or mentally demanding activity for at least 24 hours since the effects of opioids may possibly recur. Important information about some of the ingredients of Naloxone This medicinal product contains 3.8 mmol (88.5 mg) sodium per maximum daily dose of 10 mg naloxone hydrochloride. Please tell your doctor if you are on a low sodium diet, he/she will take it into account.
3. How Naloxone is administered
The usual doses given to you are Reversal of the unwanted effects of opioids Adults: 0.1 0.2 mg, if necessary additional injections of 0.1 mg may be given Children: 0.01 0.02 mg per kg body weight, if nec1. What is and what it is used for essary additional injections of the same dose may be given Naloxone is a drug used to counter the effects of opioid overdose, for example morphine overdose. Diagnosis of opioid overdose or intoxication Naloxone is used for reversal of unwanted effects of Adults: 0.4 2 mg, if necessary the injections can be repeated at intervals of 2 3 minutes. opioids for countering life-threatening depression The maximum dose of 10 mg should not of the central nervous system and respiratory sysbe exceeded. tem (breathing difficulties). Naloxone is used to diagnose an acute opioid over- Children: 0.01 mg per kg body weight, if necessary an additional injection of 0.1 mg per kg dose or intoxication. may be given Naloxone is used for reversal of depression of the central nervous system and respiratory system (breathing difficulties) in the newborn child whose Reversal of the unwanted effects of opioids in neonates whose mothers have received opioids mothers have received opioids. 0.01 mg per kg body weight, if necessary additional injections may be given 2. Before Naloxone is administered to you For reversal of the unwanted effects of opioids (in adults, children and also in neonates) patients are Naloxone must not be administered - If you are allergic (hypersensitive) to naloxone monitored to ensure that the desired effect of hydrochloride or to any of the ingredients of this Naloxone occurs. Additional doses may be given every 1 2 hours if necessary. medicinal product. Take special care with Naloxone and tell your doctor - If you are physically dependent on opioids (for example morphine) or have received high doses of these drugs (you may get strong withdrawal symptoms after receiving Naloxone because of a too rapid reversal of the opioid effect; these symptoms may be high blood pressure, palpitations, severe difficulties in breathing or cardiac arrest). - If you have any heart or circulation problems (because side effects like high or low blood pressure, palpitations or severe difficulties in breathing may be more likely). In elderly patients with heart or circulation problems or in those receiving medicines that can produce heart or circulation disorders (e.g. cocaine, methamphetamine, cyclic antidepressants, calcium channel blockers, beta-blockers, digoxin) Naloxone should be used with caution since serious side effects such as fast heart beat (ventricular tachycardia) and fibrillation have occurred. If you have the impression that the effect of Naloxone is too strong or too weak, talk to your doctor.
Method of administration Naloxone will be given to you always by intravenous or intramuscular injection (into a vein or into a muscle) or, after dilution, as intravenous infuTaking other medicines Please tell your doctor or pharmacist if you are tak- sion (over a longer period). Naloxone will be given ing or have recently taken any other medicines, by your anaesthetist or experienced physician. including medicines obtained without a prescrip- If you have any further questions on the use of this product, ask your doctor or pharmacist. tion. - If you are taking painkilling medication like buprenorphine, as the painkilling effect may become stronger while you are treated with 4. Possible side effects Naloxone. However, the reversal of unwanted effects, like respiratory depression caused by Like all medicines, Naloxone can cause side effects, although not everybody gets them. buprenorphine is limited. - If you are taking sedatives, as Naloxone may posThe frequency of side effects is classified into the sibly have a less rapid effect. - If you are taking any medication that may affect following categories: your heart or circulation (e.g. antihypertensive Very common in more than 1 in 10 patients drugs e.g. clonidine), even those not prescribed. Using Naloxone with food and drink Please inform your doctor if you drink alcohol. In patients with multi-intoxication (with opioids and sedatives or alcohol) Naloxone may have a less rapid effect. Pregnancy and breast-feeding There is no sufficient information available regarding the use of Naloxone in pregnant women. During pregnancy, your doctor will outweigh the benefit of Naloxone against possible risks to the embryo or to the foetus. It is not known whether Naloxone passes into breast milk and it has not been established whether infants who are breast-fed are affected by Naloxone. Therefore, breast-feeding should be avoided for 24 hours after treatment. Ask your doctor for advice before taking any medicine. Common Uncommon Rare Very rare in more than 1 in 100 patients, but less than 1 in 10 patients in more than 1 in 1,000 patients, but less than 1 in 100 patients in more than 1 in 10,000 patients, but less than 1 in 1,000 patients in less than 1 in 10,000 patients, including isolated reports
It may be difficult to know what side effects Naloxone has, because it is always given after other drugs have also been used. Immune system disorders Very rare: Allergic reactions (nettle rash, nasal catarrh or a cold, difficult breathing, Quinckes oedema (localised swelling causing large hives)), allergic shock.
B|BRAUN
1d1d0d0d1d0d1d0
1d1d0d0d1d0d1d0
806/LLD002/21/07
Nervous system disorders Common: Dizziness, headache. Uncommon: Involuntary trembling or quivering (tremor), sweating. Rare: Seizures, tension. Cardiac disorders Common: Fast heart beat. Uncommon: Changes in the way your heart beats, slow heart rate. Very rare: Fibrillation, cardiac arrest.
What Naloxone looks like and contents of the pack Naloxone is a clear and colourless solution in colourless glass ampoules containing 1 ml solution for injection. Pack sizes: 5 and 10 ampoules Not all pack sizes may be marketed.
5. How to store Naloxone Keep out of the reach and sight of children. Naloxone must not be administered after the expiry date, which is stated on the ampoule label and the carton. The expiry date refers to the last day of that month. Keep the ampoules in the outer carton in order to protect from light. Store below 25 C. Store diluted solutions below 25 C. 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.
Italy Luxembourg Norway Portugal Spain Sweden
Naloxone B. Braun 0,4 mg/ml soluzione iniettabile Naloxon B. Braun 0,4 mg/ml Injektionslsung Naloxon B. Braun 0,4 mg/ml injeksjonsvske, opplsning Naloxona B. Braun 0,4 mg/ml soluo injectvel Naloxona B. Braun 0,4 mg/ml solucin inyectable Naloxon B. Braun 0,4 mg/ml injektionsvtska, lsning
The Netherlands Naloxon HCl B. Braun 0,4 mg/ml, oplossing voor injectie United Kingdom Naloxone 400 micrograms/ml solution for injection
6. Further information What Naloxone contains The active substance is naloxone hydrochloride. Each ampoule with 1 ml contains 0.4 mg naloxone hydrochloride (as naloxone hydrochloride dihydrate). The other ingredients are sodium chloride, hydrochloric acid diluted (for pH adjustment) and water for injections. This leaflet was last approved in
11/2007
The following information is intended for medical For i.v. infusion Naloxone is diluted only with sodium chloride 0.9 % or glucose 5 %. 5 ampoules of or healthcare professionals only: Naloxone (2 mg) per 500 ml give 4 g/ml. Shelf-life after first opening: After first opening the medicinal product should be It is recommended that infusions of Naloxone should not be mixed with preparations containing used immediately. bisulphite, metabisulphite, long-chain or high-molecular-weight anions, or solutions with an alkaline Shelf-life after dilution Chemical and physical in-use stability has been pH. demonstrated for 24 hours below 25 C. From the microbiological point of view, the dilu- This medicinal product is for single use only. tions should be used immediately. If not used Please inspect the medicinal product visually prior immediately, in-use storage times and conditions to use (also after dilution). Use only clear and prior to use are the responsibility of the user and colourless solutions practically free from particles. would normally not be longer than 24 hours at 2 to 8 C, unless dilution has taken place in controlled and validated aseptic conditions.
B|BRAUN
B. Braun Melsungen AG 34209 Melsungen Germany
1d1d0d0d1d0d1d0
Marketing Authorisation Holder and Manufacturer Vascular disorders Common: Increased or decreased blood pres- Marketing authorisation holder: sure (you may have a headache or B. Braun Melsungen AG feel faint). Carl-Braun-Strasse 1 34212 Melsungen Respiratory disorders Germany Very rare: Fluids on the lungs (pulmonary Postal address: oedema). 34209 Melsungen Germany Gastrointestinal disorders Phone: +49 5661/71-0 Very common: Nausea. Fax: +49 56 61/71-45 67 Common: Vomiting. Uncommon: Diarrhoea, dry mouth. Manufacturer: hameln pharmaceuticals gmbh Skin and subcutaneous tissue disorders Langes Feld 13, 31789 Hameln Very rare: Discoloration and lesions of the skin Germany (erythema multiforme). Phone: +49 51 51/5 81-0 Fax: +49 51 51/5 81-258 General disorders and administration site conditions Common: If too large a dose is given after an This medicinal product is authorised in the Member operation, you may become excited States of the EEA under the following names: and feel pain (because the painkilling effects of the medicines Austria Naloxon B. Braun 0,4 mg/ml you were given will have been counInjektionslsung teracted as well as the effects on Belgium Naloxon B. Braun 0,4 mg/ml your breathing). oplossing voor injectie Uncommon: Over breathing (hyperventilation), irritation of the vessel wall has been Denmark Naloxon B. Braun reported after i.v. administration; Finland Naloxon B. Braun 0,4 mg/ml local irritation and inflammation injektioneste, liuos have been reported after i.m. Germany Naloxon B. Braun 0,4 mg/ml administration. Injektionslsung If any of the side effects gets serious, or if you Greece Naloxon B. Braun 0,4 mg/ml notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Ireland Naloxone 400 micrograms/ml solution for injection
1d1d0d0d1d0d1d0
Package leaflet: Information for the Patient
B. Braun Melsungen AG 34209 Melsungen Germany
Naloxone 400 micrograms/ml
solution for injection naloxone hydrochoride
Read all of this leaflet carefully before this medicine is administered to you. - 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Naloxone is and what it is used for 2. Before Naloxone is administered to you 3. How Naloxone is administered 4. Possible side effects 5. How to store Naloxone 6. Further information Driving and using machines After receiving Naloxone for the reversal of the effects of opioids you must not drive, operate machinery or engage in any other physically or mentally demanding activity for at least 24 hours since the effects of opioids may possibly recur. Important information about some of the ingredients of Naloxone This medicinal product contains 3.8 mmol (88.5 mg) sodium per maximum daily dose of 10 mg naloxone hydrochloride. Please tell your doctor if you are on a low sodium diet, he/she will take it into account.
3. How Naloxone is administered
The usual doses given to you are Reversal of the unwanted effects of opioids Adults: 0.1 0.2 mg, if necessary additional injections of 0.1 mg may be given Children: 0.01 0.02 mg per kg body weight, if nec1. What is and what it is used for essary additional injections of the same dose may be given Naloxone is a drug used to counter the effects of opioid overdose, for example morphine overdose. Diagnosis of opioid overdose or intoxication Naloxone is used for reversal of unwanted effects of Adults: 0.4 2 mg, if necessary the injections can be repeated at intervals of 2 3 minutes. opioids for countering life-threatening depression The maximum dose of 10 mg should not of the central nervous system and respiratory sysbe exceeded. tem (breathing difficulties). Naloxone is used to diagnose an acute opioid over- Children: 0.01 mg per kg body weight, if necessary an additional injection of 0.1 mg per kg dose or intoxication. may be given Naloxone is used for reversal of depression of the central nervous system and respiratory system (breathing difficulties) in the newborn child whose Reversal of the unwanted effects of opioids in neonates whose mothers have received opioids mothers have received opioids. 0.01 mg per kg body weight, if necessary additional injections may be given 2. Before Naloxone is administered to you For reversal of the unwanted effects of opioids (in adults, children and also in neonates) patients are Naloxone must not be administered - If you are allergic (hypersensitive) to naloxone monitored to ensure that the desired effect of hydrochloride or to any of the ingredients of this Naloxone occurs. Additional doses may be given every 1 2 hours if necessary. medicinal product. Take special care with Naloxone and tell your doctor - If you are physically dependent on opioids (for example morphine) or have received high doses of these drugs (you may get strong withdrawal symptoms after receiving Naloxone because of a too rapid reversal of the opioid effect; these symptoms may be high blood pressure, palpitations, severe difficulties in breathing or cardiac arrest). - If you have any heart or circulation problems (because side effects like high or low blood pressure, palpitations or severe difficulties in breathing may be more likely). In elderly patients with heart or circulation problems or in those receiving medicines that can produce heart or circulation disorders (e.g. cocaine, methamphetamine, cyclic antidepressants, calcium channel blockers, beta-blockers, digoxin) Naloxone should be used with caution since serious side effects such as fast heart beat (ventricular tachycardia) and fibrillation have occurred. If you have the impression that the effect of Naloxone is too strong or too weak, talk to your doctor.
Method of administration Naloxone will be given to you always by intravenous or intramuscular injection (into a vein or into a muscle) or, after dilution, as intravenous infuTaking other medicines Please tell your doctor or pharmacist if you are tak- sion (over a longer period). Naloxone will be given ing or have recently taken any other medicines, by your anaesthetist or experienced physician. including medicines obtained without a prescrip- If you have any further questions on the use of this product, ask your doctor or pharmacist. tion. - If you are taking painkilling medication like buprenorphine, as the painkilling effect may become stronger while you are treated with 4. Possible side effects Naloxone. However, the reversal of unwanted effects, like respiratory depression caused by Like all medicines, Naloxone can cause side effects, although not everybody gets them. buprenorphine is limited. - If you are taking sedatives, as Naloxone may posThe frequency of side effects is classified into the sibly have a less rapid effect. - If you are taking any medication that may affect following categories: your heart or circulation (e.g. antihypertensive Very common in more than 1 in 10 patients drugs e.g. clonidine), even those not prescribed. Using Naloxone with food and drink Please inform your doctor if you drink alcohol. In patients with multi-intoxication (with opioids and sedatives or alcohol) Naloxone may have a less rapid effect. Pregnancy and breast-feeding There is no sufficient information available regarding the use of Naloxone in pregnant women. During pregnancy, your doctor will outweigh the benefit of Naloxone against possible risks to the embryo or to the foetus. It is not known whether Naloxone passes into breast milk and it has not been established whether infants who are breast-fed are affected by Naloxone. Therefore, breast-feeding should be avoided for 24 hours after treatment. Ask your doctor for advice before taking any medicine. Common Uncommon Rare Very rare in more than 1 in 100 patients, but less than 1 in 10 patients in more than 1 in 1,000 patients, but less than 1 in 100 patients in more than 1 in 10,000 patients, but less than 1 in 1,000 patients in less than 1 in 10,000 patients, including isolated reports
It may be difficult to know what side effects Naloxone has, because it is always given after other drugs have also been used. Immune system disorders Very rare: Allergic reactions (nettle rash, nasal catarrh or a cold, difficult breathing, Quinckes oedema (localised swelling causing large hives)), allergic shock.
B|BRAUN
1d1d0d0d1d0d1d0
1d1d0d0d1d0d1d0
806/LLD002/21/07
Nervous system disorders Common: Dizziness, headache. Uncommon: Involuntary trembling or quivering (tremor), sweating. Rare: Seizures, tension. Cardiac disorders Common: Fast heart beat. Uncommon: Changes in the way your heart beats, slow heart rate. Very rare: Fibrillation, cardiac arrest.
What Naloxone looks like and contents of the pack Naloxone is a clear and colourless solution in colourless glass ampoules containing 1 ml solution for injection. Pack sizes: 5 and 10 ampoules Not all pack sizes may be marketed.
5. How to store Naloxone Keep out of the reach and sight of children. Naloxone must not be administered after the expiry date, which is stated on the ampoule label and the carton. The expiry date refers to the last day of that month. Keep the ampoules in the outer carton in order to protect from light. Store below 25 C. Store diluted solutions below 25 C. 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.
Italy Luxembourg Norway Portugal Spain Sweden
Naloxone B. Braun 0,4 mg/ml soluzione iniettabile Naloxon B. Braun 0,4 mg/ml Injektionslsung Naloxon B. Braun 0,4 mg/ml injeksjonsvske, opplsning Naloxona B. Braun 0,4 mg/ml soluo injectvel Naloxona B. Braun 0,4 mg/ml solucin inyectable Naloxon B. Braun 0,4 mg/ml injektionsvtska, lsning
The Netherlands Naloxon HCl B. Braun 0,4 mg/ml, oplossing voor injectie United Kingdom Naloxone 400 micrograms/ml solution for injection
6. Further information What Naloxone contains The active substance is naloxone hydrochloride. Each ampoule with 1 ml contains 0.4 mg naloxone hydrochloride (as naloxone hydrochloride dihydrate). The other ingredients are sodium chloride, hydrochloric acid diluted (for pH adjustment) and water for injections. This leaflet was last approved in
11/2007
The following information is intended for medical For i.v. infusion Naloxone is diluted only with sodium chloride 0.9 % or glucose 5 %. 5 ampoules of or healthcare professionals only: Naloxone (2 mg) per 500 ml give 4 g/ml. Shelf-life after first opening: After first opening the medicinal product should be It is recommended that infusions of Naloxone should not be mixed with preparations containing used immediately. bisulphite, metabisulphite, long-chain or high-molecular-weight anions, or solutions with an alkaline Shelf-life after dilution Chemical and physical in-use stability has been pH. demonstrated for 24 hours below 25 C. From the microbiological point of view, the dilu- This medicinal product is for single use only. tions should be used immediately. If not used Please inspect the medicinal product visually prior immediately, in-use storage times and conditions to use (also after dilution). Use only clear and prior to use are the responsibility of the user and colourless solutions practically free from particles. would normally not be longer than 24 hours at 2 to 8 C, unless dilution has taken place in controlled and validated aseptic conditions.
B|BRAUN
B. Braun Melsungen AG 34209 Melsungen Germany
1d1d0d0d1d0d1d0
Marketing Authorisation Holder and Manufacturer Vascular disorders Common: Increased or decreased blood pres- Marketing authorisation holder: sure (you may have a headache or B. Braun Melsungen AG feel faint). Carl-Braun-Strasse 1 34212 Melsungen Respiratory disorders Germany Very rare: Fluids on the lungs (pulmonary Postal address: oedema). 34209 Melsungen Germany Gastrointestinal disorders Phone: +49 5661/71-0 Very common: Nausea. Fax: +49 56 61/71-45 67 Common: Vomiting. Uncommon: Diarrhoea, dry mouth. Manufacturer: hameln pharmaceuticals gmbh Skin and subcutaneous tissue disorders Langes Feld 13, 31789 Hameln Very rare: Discoloration and lesions of the skin Germany (erythema multiforme). Phone: +49 51 51/5 81-0 Fax: +49 51 51/5 81-258 General disorders and administration site conditions Common: If too large a dose is given after an This medicinal product is authorised in the Member operation, you may become excited States of the EEA under the following names: and feel pain (because the painkilling effects of the medicines Austria Naloxon B. Braun 0,4 mg/ml you were given will have been counInjektionslsung teracted as well as the effects on Belgium Naloxon B. Braun 0,4 mg/ml your breathing). oplossing voor injectie Uncommon: Over breathing (hyperventilation), irritation of the vessel wall has been Denmark Naloxon B. Braun reported after i.v. administration; Finland Naloxon B. Braun 0,4 mg/ml local irritation and inflammation injektioneste, liuos have been reported after i.m. Germany Naloxon B. Braun 0,4 mg/ml administration. Injektionslsung If any of the side effects gets serious, or if you Greece Naloxon B. Braun 0,4 mg/ml notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Ireland Naloxone 400 micrograms/ml solution for injection
1d1d0d0d1d0d1d0
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.
