medication_name stringlengths 6 170 | section_title stringclasses 42
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|---|---|---|
Daptomycin 350 mg powder for solution for injection/infusion | Clinical particulars - Effects on ability to drive and use machines | Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
On the basis of reported adverse drug reactions, Daptomycin is presumed to be unlikely to produce an effect on the ability to drive or use machinery.
4.8 |
Daptomycin 350 mg powder for solution for injection/infusion | Clinical particulars - Undesirable effects | Undesirable effects
Summary of the safety profile
In clinical studies, 2011 adult subjects received daptomycin. Within these trials, 1221 subjects received a daily dose of 4 mg/kg, of whom 1108 were patients and 113 were healthy volunteers; 460 subjects received a daily dose of 6 mg/kg, of whom 304 were patients and ... |
Daptomycin 350 mg powder for solution for injection/infusion | Clinical particulars - Overdose | Overdose
In the event of overdose, supportive care is advised. Daptomycin is slowly cleared from the body by haemodialysis (approximately 15 % of the administered dose is removed over 4 hours) or by peritoneal dialysis (approximately 11 % of the administered dose is removed over 48 hours).
5. Pharmacological properties... |
Daptomycin 350 mg powder for solution for injection/infusion | Pharmacodynamic properties - Pharmacodynamic properties | Pharmacokinetic properties
Daptomycin pharmacokinetics are generally linear and time-independent at doses of 4 to 12 mg/kg administered as a single daily dose by 30-minute intravenous infusion for up to 14 days in healthy adult volunteers. Steady-state concentrations are achieved by the third daily dose.
Daptomycin adm... |
Daptomycin 350 mg powder for solution for injection/infusion | Pharmacodynamic properties - Pharmacokinetic properties | Preclinical safety data
Daptomycin administration was associated with minimal to mild degenerative/regenerative changes in skeletal muscle in the rat and dog. Microscopic changes in skeletal muscle were minimal (approximately 0.05 % of myofibres affected) and at the higher doses were accompanied by elevations in CPK. N... |
Daptomycin 350 mg powder for solution for injection/infusion | Pharmaceutical particulars - List of excipients | List of excipients
Sodium hydroxide
6.2 |
Daptomycin 350 mg powder for solution for injection/infusion | Pharmaceutical particulars - Incompatibilities | Incompatibilities
This medicinal product is not physically or chemically compatible with glucose-containing solutions. This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
6.3 |
Daptomycin 350 mg powder for solution for injection/infusion | Pharmaceutical particulars - Shelf life | Shelf life
3 years
After reconstitution: Chemical and physical in-use stability of the reconstituted solution in the vial has been demonstrated for 12 hours at 25 °C and up to 48 hours at 2 °C – 8 °C. Chemical and physical stability of the diluted solution in infusion bags is established as 12 hours at 25 °C or 24 hour... |
Daptomycin 350 mg powder for solution for injection/infusion | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
Store in a refrigerator (2 °C – 8 °C).
For storage conditions after reconstitution and after reconstitution and dilution of the medicinal product see section 6.3.
6.5 |
Daptomycin 350 mg powder for solution for injection/infusion | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
Single use 15 ml type I clear glass vial, sealed with a grey bromobutyl lyo rubber stopper and an aluminium cap with yellow plastic flip-off seal.
Available in packs containing 1, 5 or 10 vials. Not all pack sizes may be marketed.
6.6 |
Daptomycin 350 mg powder for solution for injection/infusion | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
In adults, daptomycin may be administered intravenously as an infusion over 30 minutes or as an injection over 2 minutes. Daptomycin should not be administered as a 2-minute injection to paediatric patients. Paediatric patients 7 to 17 years old should receive daptomy... |
Daptomycin 350 mg powder for solution for injection/infusion | Marketing authorisation holder | hameln pharma ltd
Nexus, Gloucester Business Park
Gloucester, GL3 4AG
United Kingdom
8. Marketing authorisation number(s)
PL 01502/0120
9. |
Daptomycin 350 mg powder for solution for injection/infusion | Date of first authorisation/renewal of the authorisation | 13/06/2022
10. |
Daptomycin 350 mg powder for solution for injection/infusion | Date of revision of the text | 04/01/2023 |
Daptomycin 350mg powder for solution for injection or infusion | Name of the medicinal product | Daptomycin 350 mg powder for solution for injection or infusion
2. |
Daptomycin 350mg powder for solution for injection or infusion | Qualitative and quantitative composition | Each vial contains 350 mg daptomycin.
One ml provides 50 mg of daptomycin after reconstitution with 7 ml of sodium chloride 9 mg/ml (0.9%) solution.
For the full list of excipients, see section 6.1.
3. |
Daptomycin 350mg powder for solution for injection or infusion | Pharmaceutical form | Powder for solution for injection or infusion
A pale yellow to light brown lyophilised cake or powder.
4. |
Daptomycin 350mg powder for solution for injection or infusion | Clinical particulars - Therapeutic indications | Therapeutic indications
Daptomycin is indicated for the treatment of the following infections (see also sections 4.4 and 5.1).
• Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI).
• Adult patients with right-sided infective endocarditis (RIE) due to ... |
Daptomycin 350mg powder for solution for injection or infusion | Clinical particulars - Posology and method of administration | Posology and method of administration
Clinical studies in patients employed infusion of daptomycin over at least 30 minutes. There is no clinical experience in patients with the administration of daptomycin as an injection over 2 minutes. This mode of administration was only studied in healthy subjects. However, when c... |
Daptomycin 350mg powder for solution for injection or infusion | Clinical particulars - Contraindications | Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 |
Daptomycin 350mg powder for solution for injection or infusion | Clinical particulars - Special warnings and precautions for use | Special warnings and precautions for use
General
If a focus of infection other than cSSTI or RIE is identified after initiation of daptomycin therapy consideration should be given to instituting alternative antibacterial therapy that has been demonstrated to be efficacious in the treatment of the specific type of inf... |
Daptomycin 350mg powder for solution for injection or infusion | Clinical particulars - Interaction with other medicinal products and other forms of interaction | Interaction with other medicinal products and other forms of interaction
Daptomycin undergoes little to no Cytochrome P450 (CYP450)-mediated metabolism. It is unlikely that daptomycin will inhibit or induce the metabolism of medicinal products metabolised by the P450 system.
Interaction studies for daptomycin were perf... |
Daptomycin 350mg powder for solution for injection or infusion | Clinical particulars - Fertility, pregnancy and lactation | Fertility, pregnancy and lactation
Pregnancy
No clinical data on pregnancies are available for daptomycin. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Daptomycin should not be used du... |
Daptomycin 350mg powder for solution for injection or infusion | Clinical particulars - Effects on ability to drive and use machines | Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
On the basis of reported adverse drug reactions, daptomycin is presumed to be unlikely to produce an effect on the ability to drive or use machinery.
4.8 |
Daptomycin 350mg powder for solution for injection or infusion | Clinical particulars - Undesirable effects | Undesirable effects
Summary of the safety profile
In clinical studies, 2,011 adult subjects received daptomycin. Within these trials, 1,221 subjects received a daily dose of 4 mg/kg, of whom 1,108 were patients and 113 were healthy volunteers; 460 subjects received a daily dose of 6 mg/kg, of whom 304 were patients a... |
Daptomycin 350mg powder for solution for injection or infusion | Clinical particulars - Overdose | Overdose
In the event of overdose, supportive care is advised. Daptomycin is slowly cleared from the body by haemodialysis (approximately 15% of the administered dose is removed over 4 hours) or by peritoneal dialysis (approximately 11% of the administered dose is removed over 48 hours).
5. Pharmacological properties
5... |
Daptomycin 350mg powder for solution for injection or infusion | Pharmacodynamic properties - Pharmacodynamic properties | Pharmacokinetic properties
Daptomycin pharmacokinetics are generally linear and time-independent at doses of 4 to 12 mg/kg administered as a single daily dose by 30-minute intravenous infusion for up to 14 days in healthy adult volunteers. Steady-state concentrations are achieved by the third daily dose.
Daptomycin adm... |
Daptomycin 350mg powder for solution for injection or infusion | Pharmacodynamic properties - Pharmacokinetic properties | Preclinical safety data
Daptomycin administration was associated with minimal to mild degenerative/regenerative changes in skeletal muscle in the rat and dog. Microscopic changes in skeletal muscle were minimal (approximately 0.05% of myofibres affected) and at the higher doses were accompanied by elevations in CPK. No... |
Daptomycin 350mg powder for solution for injection or infusion | Pharmaceutical particulars - List of excipients | List of excipients
Sodium hydroxide
6.2 |
Daptomycin 350mg powder for solution for injection or infusion | Pharmaceutical particulars - Incompatibilities | Incompatibilities
Daptomycin not physically or chemically compatible with glucose-containing solutions. This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
6.3 |
Daptomycin 350mg powder for solution for injection or infusion | Pharmaceutical particulars - Shelf life | Shelf life
2 years
After reconstitution: Chemical and physical in-use stability of the reconstituted solution in the vial has been demonstrated for 12 hours at 25°C and up to 48 hours at 2°C – 8°C. Chemical and physical stability of the diluted solution in infusion bags is established as 12 hours at 25°C or 24 hours at... |
Daptomycin 350mg powder for solution for injection or infusion | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
Store in a refrigerator (2°C – 8°C).
For storage conditions after reconstitution and after reconstitution and dilution of the medicinal product see section 6.3.
6.5 |
Daptomycin 350mg powder for solution for injection or infusion | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
Single use 10 ml type I glass vials with bromobutyl rubber stoppers and sealed with flip-off seal.
Packs containing 1 vial or 5 vials.
Not all pack sizes may be marketed.
6.6 |
Daptomycin 350mg powder for solution for injection or infusion | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
In adults, daptomycin may be administered intravenously as an infusion over 30 minutes or as an injection over 2 minutes. Daptomycin should not be administered as a 2-minute injection to paediatric patients. Paediatric patients 7 to 17 years old should receive daptomy... |
Daptomycin 350mg powder for solution for injection or infusion | Marketing authorisation holder | Zentiva Pharma UK Limited
12 New Fetter Lane
London
EC4A 1JP
UK
8. Marketing authorisation number(s)
PL 17780/1042
9. |
Daptomycin 350mg powder for solution for injection or infusion | Date of first authorisation/renewal of the authorisation | 12/04/2022
10. |
Daptomycin 350mg powder for solution for injection or infusion | Date of revision of the text | 12/04/2022 |
Daptomycin 350mg Powder for Solution for Injection/ Infusion | Name of the medicinal product | Daptomycin 350 mg powder for solution for injection/infusion
2. |
Daptomycin 350mg Powder for Solution for Injection/ Infusion | Qualitative and quantitative composition | Daptomycin 350 mg powder for solution for injection/infusion
Each vial contains 350 mg daptomycin.
One ml provides 50 mg of daptomycin after reconstitution with 7 ml of sodium chloride 9 mg/ml (0.9%) solution.
Excipient(s) with known effect
Each vial of 350 mg contains approximately 3,2 mg sodium.
For the full list ... |
Daptomycin 350mg Powder for Solution for Injection/ Infusion | Pharmaceutical form | Powder for solution for injection/infusion
A pale yellow to light brown lyophilised cake or powder.
4. |
Daptomycin 350mg Powder for Solution for Injection/ Infusion | Clinical particulars - Therapeutic indications | Therapeutic indications
Daptomycin is indicated for the treatment of the following infections (see sections 4.4 and 5.1).
- Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI).
- Adult patients with right-sided infective endocarditis (RIE) due to Staphylococcus ... |
Daptomycin 350mg Powder for Solution for Injection/ Infusion | Clinical particulars - Posology and method of administration | Posology and method of administration
Clinical studies in patients employed infusion of daptomycin over at least 30 minutes. There is no clinical experience in patients with the administration of daptomycin as an injection over 2 minutes. This mode of administration was only studied in healthy subjects. However, when c... |
Daptomycin 350mg Powder for Solution for Injection/ Infusion | Clinical particulars - Contraindications | Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 |
Daptomycin 350mg Powder for Solution for Injection/ Infusion | Clinical particulars - Special warnings and precautions for use | Special warnings and precautions for use
General
If a focus of infection other than cSSTI or RIE is identified after initiation of daptomycin therapy consideration should be given to instituting alternative antibacterial therapy that has been demonstrated to be efficacious in the treatment of the specific type of inf... |
Daptomycin 350mg Powder for Solution for Injection/ Infusion | Clinical particulars - Interaction with other medicinal products and other forms of interaction | Interaction with other medicinal products and other forms of interaction
Daptomycin undergoes little to no Cytochrome P450 (CYP450)-mediated metabolism. It is unlikely that daptomycin will inhibit or induce the metabolism of medicinal products metabolised by the P450 system.
Interaction studies for daptomycin were perf... |
Daptomycin 350mg Powder for Solution for Injection/ Infusion | Clinical particulars - Fertility, pregnancy and lactation | Fertility, pregnancy and lactation
Pregnancy
No clinical data on pregnancies are available for daptomycin. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Daptomycin should not be used du... |
Daptomycin 350mg Powder for Solution for Injection/ Infusion | Clinical particulars - Effects on ability to drive and use machines | Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
On the basis of reported adverse drug reactions, daptomycin is presumed to be unlikely to produce an effect on the ability to drive or use machinery.
4.8 |
Daptomycin 350mg Powder for Solution for Injection/ Infusion | Clinical particulars - Undesirable effects | Undesirable effects
Summary of the safety profile
In clinical studies, 2,011 adult subjects received daptomycin. Within these trials, 1,221 subjects received a daily dose of 4 mg/kg, of whom 1,108 were patients and 113 were healthy volunteers; 460 subjects received a daily dose of 6 mg/kg, of whom 304 were patients a... |
Daptomycin 350mg Powder for Solution for Injection/ Infusion | Clinical particulars - Overdose | Overdose
In the event of overdose, supportive care is advised. Daptomycin is slowly cleared from the body by haemodialysis (approximately 15% of the administered dose is removed over 4 hours) or by peritoneal dialysis (approximately 11% of the administered dose is removed over 48 hours).
5. Pharmacological properties
5... |
Daptomycin 350mg Powder for Solution for Injection/ Infusion | Pharmacodynamic properties - Pharmacodynamic properties | Pharmacokinetic properties
Daptomycin pharmacokinetics are generally linear and time-independent at doses of 4 to 12 mg/kg administered as a single daily dose by 30-minute intravenous infusion for up to 14 days in healthy adult volunteers. Steady-state concentrations are achieved by the third daily dose.
Daptomycin adm... |
Daptomycin 350mg Powder for Solution for Injection/ Infusion | Pharmacodynamic properties - Pharmacokinetic properties | Preclinical safety data
Daptomycin administration was associated with minimal to mild degenerative/regenerative changes in skeletal muscle in the rat and dog. Microscopic changes in skeletal muscle were minimal (approximately 0.05% of myofibres affected) and at the higher doses were accompanied by elevations in CPK. No... |
Daptomycin 350mg Powder for Solution for Injection/ Infusion | Pharmaceutical particulars - List of excipients | List of excipients
Sodium hydroxide
6.2 |
Daptomycin 350mg Powder for Solution for Injection/ Infusion | Pharmaceutical particulars - Incompatibilities | Incompatibilities
Daptomycin is not physically or chemically compatible with glucose-containing solutions. This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
6.3 |
Daptomycin 350mg Powder for Solution for Injection/ Infusion | Pharmaceutical particulars - Shelf life | Shelf life
3 years
After reconstitution:
Chemical and physical in-use stability of the reconstituted solution in the vial has been demonstrated for 12 hours at 25°C and up to 48 hours at 2°C – 8°C.
From a microbiological point of view the product should be used immediately. If not used immediately, in-use storage t... |
Daptomycin 350mg Powder for Solution for Injection/ Infusion | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
Store in a refrigerator (2°C – 8°C).
For storage conditions after reconstitution and after reconstitution and dilution of the medicinal product see section 6.3.
6.5 |
Daptomycin 350mg Powder for Solution for Injection/ Infusion | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
Daptomycin 350 mg powder for solution for injection/infusion: Single use 15 ml type I clear glass vials with type I rubber stoppers and aluminium closures with yellow plastic flip off caps.
Pack sizes: 1 vial or 5 vials.
Not all pack sizes may be marketed.
6.6 |
Daptomycin 350mg Powder for Solution for Injection/ Infusion | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
In adults, daptomycin may be administered intravenously as an infusion over 30 minutes or as an injection over 2 minutes. Daptomycin should not be administered as a 2-minute injection to paediatric patients. Paediatric patients 7 to 17 years old should receive daptomy... |
Daptomycin 350mg Powder for Solution for Injection/ Infusion | Marketing authorisation holder | Xellia Pharmaceuticals ApS
Dalslandsgade 11, København S,
Copenhagen,
Denmark 2300
8. Marketing authorisation number(s)
PL 17815/0065
9. |
Daptomycin 350mg Powder for Solution for Injection/ Infusion | Date of first authorisation/renewal of the authorisation | 22/09/2017
10. |
Daptomycin 350mg Powder for Solution for Injection/ Infusion | Date of revision of the text | 11/2021 |
Daptomycin 500 mg powder for solution for injection/infusion | Name of the medicinal product | Daptomycin 500 mg powder for solution for injection / infusion
2. |
Daptomycin 500 mg powder for solution for injection/infusion | Qualitative and quantitative composition | Daptomycin 500 mg powder for solution for injection / infusion
Each vial contains 500 mg daptomycin.
One ml provides 50 mg of daptomycin after reconstitution with 10 ml of sodium chloride 9 mg/ml (0.9 %) solution.
For the full list of excipients, see section 6.1.
3. |
Daptomycin 500 mg powder for solution for injection/infusion | Pharmaceutical form | Powder for solution for injection or infusion
A lyophilized yellow or yellowish powder.
Reconstituted solution is clear, colourless to very slightly greenish yellow.
4. |
Daptomycin 500 mg powder for solution for injection/infusion | Clinical particulars - Therapeutic indications | Therapeutic indications
Daptomycin is indicated for the treatment of the following infections (see sections 4.4 and 5.1).
- Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI).
- Adult patients with right-sided infective endocarditis (RIE) due to Staphylococc... |
Daptomycin 500 mg powder for solution for injection/infusion | Clinical particulars - Posology and method of administration | Posology and method of administration
Clinical studies in patients employed infusion of daptomycin over at least 30 minutes. There is no clinical experience in patients with the administration of daptomycin as an injection over 2 minutes.
This mode of administration was only studied in healthy subjects. However, when c... |
Daptomycin 500 mg powder for solution for injection/infusion | Clinical particulars - Contraindications | Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 |
Daptomycin 500 mg powder for solution for injection/infusion | Clinical particulars - Special warnings and precautions for use | Special warnings and precautions for use
General
If a focus of infection other than cSSTI or RIE is identified after initiation of Daptomycin therapy consideration should be given to instituting alternative antibacterial therapy that has been demonstrated to be efficacious in the treatment of the specific type of inf... |
Daptomycin 500 mg powder for solution for injection/infusion | Clinical particulars - Interaction with other medicinal products and other forms of interaction | Interaction with other medicinal products and other forms of interaction
Daptomycin undergoes little to no Cytochrome P450 (CYP450)-mediated metabolism. It is unlikely that daptomycin will inhibit or induce the metabolism of medicinal products metabolised by the P450 system.
Interaction studies for daptomycin were perf... |
Daptomycin 500 mg powder for solution for injection/infusion | Clinical particulars - Fertility, pregnancy and lactation | Fertility, pregnancy and lactation
Pregnancy
No clinical data on pregnancies are available for daptomycin. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Daptomycin should not be used du... |
Daptomycin 500 mg powder for solution for injection/infusion | Clinical particulars - Effects on ability to drive and use machines | Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
On the basis of reported adverse drug reactions, Daptomycin is presumed to be unlikely to produce an effect on the ability to drive or use machinery.
4.8 |
Daptomycin 500 mg powder for solution for injection/infusion | Clinical particulars - Undesirable effects | Undesirable effects
Summary of the safety profile
In clinical studies, 2011 adult subjects received daptomycin. Within these trials, 1221 subjects received a daily dose of 4 mg/kg, of whom 1108 were patients and 113 were healthy volunteers; 460 subjects received a daily dose of 6 mg/kg, of whom 304 were patients and ... |
Daptomycin 500 mg powder for solution for injection/infusion | Clinical particulars - Overdose | Overdose
In the event of overdose, supportive care is advised. Daptomycin is slowly cleared from the body by haemodialysis (approximately 15 % of the administered dose is removed over 4 hours) or by peritoneal dialysis (approximately 11 % of the administered dose is removed over 48 hours).
5. Pharmacological properties... |
Daptomycin 500 mg powder for solution for injection/infusion | Pharmacodynamic properties - Pharmacodynamic properties | Pharmacokinetic properties
Daptomycin pharmacokinetics are generally linear and time-independent at doses of 4 to 12 mg/kg administered as a single daily dose by 30-minute intravenous infusion for up to 14 days in healthy adult volunteers. Steady-state concentrations are achieved by the third daily dose.
Daptomycin adm... |
Daptomycin 500 mg powder for solution for injection/infusion | Pharmacodynamic properties - Pharmacokinetic properties | Preclinical safety data
Daptomycin administration was associated with minimal to mild degenerative/regenerative changes in skeletal muscle in the rat and dog. Microscopic changes in skeletal muscle were minimal (approximately 0.05 % of myofibres affected) and at the higher doses were accompanied by elevations in CPK. N... |
Daptomycin 500 mg powder for solution for injection/infusion | Pharmaceutical particulars - List of excipients | List of excipients
Sodium hydroxide
6.2 |
Daptomycin 500 mg powder for solution for injection/infusion | Pharmaceutical particulars - Incompatibilities | Incompatibilities
This medicinal product is not physically or chemically compatible with glucose-containing solutions. This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
6.3 |
Daptomycin 500 mg powder for solution for injection/infusion | Pharmaceutical particulars - Shelf life | Shelf life
3 years
After reconstitution: Chemical and physical in-use stability of the reconstituted solution in the vial has been demonstrated for 12 hours at 25 °C and up to 48 hours at 2 °C – 8 °C. Chemical and physical stability of the diluted solution in infusion bags is established as 12 hours at 25 °C or 24 hour... |
Daptomycin 500 mg powder for solution for injection/infusion | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
Store in a refrigerator (2 °C – 8 °C).
For storage conditions after reconstitution and after reconstitution and dilution of the medicinal product see section 6.3.
6.5 |
Daptomycin 500 mg powder for solution for injection/infusion | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
Single use 15 ml type I clear glass vial, sealed with a grey bromobutyl lyo rubber stopper and an aluminium cap with blue plastic flip-off seal.
Available in packs containing 1, 5 or 10 vials. Not all pack sizes may be marketed.
6.6 |
Daptomycin 500 mg powder for solution for injection/infusion | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
In adults, daptomycin may be administered intravenously as an infusion over 30 minutes or as an injection over 2 minutes. Daptomycin should not be administered as a 2-minute injection to paediatric patients. Paediatric patients 7 to 17 years old should receive daptomy... |
Daptomycin 500 mg powder for solution for injection/infusion | Marketing authorisation holder | hameln pharma ltd
Nexus, Gloucester Business Park
Gloucester, GL3 4AG
United Kingdom
8. Marketing authorisation number(s)
PL 01502/0121
9. |
Daptomycin 500 mg powder for solution for injection/infusion | Date of first authorisation/renewal of the authorisation | 13/06/2022
10. |
Daptomycin 500 mg powder for solution for injection/infusion | Date of revision of the text | 04/01/2023 |
Daptomycin 500mg Powder for Solution for Injection/ Infusion | Name of the medicinal product | Daptomycin 500 mg powder for solution for injection/infusion
2. |
Daptomycin 500mg Powder for Solution for Injection/ Infusion | Qualitative and quantitative composition | Daptomycin 500 mg powder for solution for injection/infusion
Each vial contains 500 mg daptomycin.
One ml provides 50 mg of daptomycin after reconstitution with 10 ml of sodium chloride 9 mg/ml (0.9%) solution.
Excipient(s) with known effect
Each vial of 500 mg contains approximately 4,6 mg sodium.
For the full list... |
Daptomycin 500mg Powder for Solution for Injection/ Infusion | Pharmaceutical form | Powder for solution for injection/infusion
A pale yellow to light brown lyophilised cake or powder.
4. |
Daptomycin 500mg Powder for Solution for Injection/ Infusion | Clinical particulars - Therapeutic indications | Therapeutic indications
Daptomycin is indicated for the treatment of the following infections (see sections 4.4 and 5.1).
- Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI).
- Adult patients with right-sided infective endocarditis (RIE) due to Staphylococcus ... |
Daptomycin 500mg Powder for Solution for Injection/ Infusion | Clinical particulars - Posology and method of administration | Posology and method of administration
Clinical studies in patients employed infusion of daptomycin over at least 30 minutes. There is no clinical experience in patients with the administration of daptomycin as an injection over 2 minutes. This mode of administration was only studied in healthy subjects. However, when c... |
Daptomycin 500mg Powder for Solution for Injection/ Infusion | Clinical particulars - Contraindications | Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 |
Daptomycin 500mg Powder for Solution for Injection/ Infusion | Clinical particulars - Special warnings and precautions for use | Special warnings and precautions for use
General
If a focus of infection other than cSSTI or RIE is identified after initiation of daptomycin therapy consideration should be given to instituting alternative antibacterial therapy that has been demonstrated to be efficacious in the treatment of the specific type of inf... |
Daptomycin 500mg Powder for Solution for Injection/ Infusion | Clinical particulars - Interaction with other medicinal products and other forms of interaction | Interaction with other medicinal products and other forms of interaction
Daptomycin undergoes little to no Cytochrome P450 (CYP450)-mediated metabolism. It is unlikely that daptomycin will inhibit or induce the metabolism of medicinal products metabolised by the P450 system.
Interaction studies for daptomycin were perf... |
Daptomycin 500mg Powder for Solution for Injection/ Infusion | Clinical particulars - Fertility, pregnancy and lactation | Fertility, pregnancy and lactation
Pregnancy
No clinical data on pregnancies are available for daptomycin. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Daptomycin should not be used du... |
Daptomycin 500mg Powder for Solution for Injection/ Infusion | Clinical particulars - Effects on ability to drive and use machines | Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
On the basis of reported adverse drug reactions, daptomycin is presumed to be unlikely to produce an effect on the ability to drive or use machinery.
4.8 |
Daptomycin 500mg Powder for Solution for Injection/ Infusion | Clinical particulars - Undesirable effects | Undesirable effects
Summary of the safety profile
In clinical studies, 2,011 adult subjects received daptomycin. Within these trials, 1,221 subjects received a daily dose of 4 mg/kg, of whom 1,108 were patients and 113 were healthy volunteers; 460 subjects received a daily dose of 6 mg/kg, of whom 304 were patients a... |
Daptomycin 500mg Powder for Solution for Injection/ Infusion | Clinical particulars - Overdose | Overdose
In the event of overdose, supportive care is advised. Daptomycin is slowly cleared from the body by haemodialysis (approximately 15% of the administered dose is removed over 4 hours) or by peritoneal dialysis (approximately 11% of the administered dose is removed over 48 hours).
5. Pharmacological properties
5... |
Daptomycin 500mg Powder for Solution for Injection/ Infusion | Pharmacodynamic properties - Pharmacodynamic properties | Pharmacokinetic properties
Daptomycin pharmacokinetics are generally linear and time-independent at doses of 4 to 12 mg/kg administered as a single daily dose by 30-minute intravenous infusion for up to 14 days in healthy adult volunteers. Steady-state concentrations are achieved by the third daily dose.
Daptomycin adm... |
Daptomycin 500mg Powder for Solution for Injection/ Infusion | Pharmacodynamic properties - Pharmacokinetic properties | Preclinical safety data
Daptomycin administration was associated with minimal to mild degenerative/regenerative changes in skeletal muscle in the rat and dog. Microscopic changes in skeletal muscle were minimal (approximately 0.05% of myofibres affected) and at the higher doses were accompanied by elevations in CPK. No... |
Daptomycin 500mg Powder for Solution for Injection/ Infusion | Pharmaceutical particulars - List of excipients | List of excipients
Sodium hydroxide
6.2 |
Daptomycin 500mg Powder for Solution for Injection/ Infusion | Pharmaceutical particulars - Incompatibilities | Incompatibilities
Daptomycin is not physically or chemically compatible with glucose-containing solutions. This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
6.3 |
Daptomycin 500mg Powder for Solution for Injection/ Infusion | Pharmaceutical particulars - Shelf life | Shelf life
3 years
After reconstitution:
Chemical and physical in-use stability of the reconstituted solution in the vial has been demonstrated for 12 hours at 25°C and up to 48 hours at 2°C – 8°C.
From a microbiological point of view the product should be used immediately. If not used immediately, in-use storage t... |
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