Introduction
Materials and methods
Herbal medicinal product | Number and age of children evaluated | Dose | % (v/v) ethanol | Gram ethanol per doseb
| References | ADRa
|
---|---|---|---|---|---|---|
Bronchicum® Elixir, oral liquid |
n = 312 children (1–4 years) | 2.5 ml 6 × daily | 4.9 | 0.097 | 3 | |
n = 324 children (5–12 years) | 5.0 ml 6 × daily | 0.194 | ||||
Bronchicum® Elixir, oral liquid |
n = 111 children (1–4 years) | 2.5 ml 6 × daily | 4.9 | 0.097 | 0 | |
n = 109 children (5–12 years) | 5.0 ml 6 × daily | 0.194 | ||||
Bronchicum® Tropfen, oral liquid |
n = 110 school children (6–12 years ) | 25 drops 5 × daily | 27.7c
| 0.274 | 0 | |
Bronchicum® Elixir, oral liquid |
n = 474 children (1–4 years) | 2.5 ml 6 × daily | 4.9 | 0.097 | 3 | |
n = 365 children (5–12 years) | 5.0 ml 6 × daily | 0.194 | ||||
Bronchicum® Elixir, oral liquid |
n = 200 infants (6–12 months) | 1.0 ml 6 × daily | 4.9 | 0.039 | 1 | |
Contramutan® Tropfen, oral liquid |
n = 85 infants (6–12 months) | 2–3 drops 12 × daily | 33.4c
| 0.040 | [12] | 0 |
n = 95 children (1–6 years) | 3–5 drops 12 × daily | 0.066 | ||||
n = 90 school children (6–12 years) | 4–7 drops 12 × daily | 0.092 | ||||
Contramutan® Saft, oral liquid |
n = 174 infants (6–12 months) | 1.5–2.0 ml 12 × daily | 3.6 | 0.057 | 0 | |
n = 195 children (1–6 years) | 2.0–3.5 ml 12 × daily | 0.100 | ||||
n = 188 school children (6–12 years) | 3.0–5.0 ml 12 × daily | 0.142 | ||||
Contramutan® Saft, oral liquid |
n = 100 infants (6–12 months) | 2.0 ml 12 × daily | 3.6 | 0.057 | [22]d
| 0 |
n = 100 children (1–6 years) | 4.0 ml 12 × daily | 0.114 | ||||
n = 100 school children (7–12 years) | 5.0 ml 12 × daily | 0.142 | ||||
Iberogast®, oral liquid |
n = 642 infants (under 3 months) | 0.33 ml 3 × daily | 31.0c
| 0.081 | [23] | 0 |
n = 7709 infants (3 months–3 years) | 0.4 ml 3 × daily | 0.098 | ||||
n = 12,802 (4–6 years) | 0.5 ml 3 × daily | 0.122 | ||||
n = 19,808 (7–12 years) | 0.75 ml 3 × daily | 0.184 | ||||
Iberogast®, oral liquid |
n = 13 infants (under 3 months) | 0.33 ml 3 × daily | 31.0c
| 0.081 | [24] | 0 |
n = 286 infants (3 month–3 years) | 0.4 ml 3 × daily | 0.098 | ||||
n = 480 children (4–6 years) | 0.5 ml 3 × daily | 0.122 | ||||
n = 1571 school children (7–12 years) | 0.75 ml 3 × daily | 0.184 | ||||
Iberogast®, oral liquid |
n = 389 children (3–6 years) | 0.5 ml 3 × daily | 31.0c
| 0.122 | [25] | 4 |
n = 591 school children (7–14 years) | 0.75 ml 3 × daily | 0.184 | ||||
Monpax® Saft, oral liquid |
n = 118 infants (7–12 months) + infants (1–3 years) | 2.5 ml 3 × daily | 3.9 | 0.077 | [26] | 0 |
n = 119 children (4–7 years) | 2.5 ml 4 × daily | 0.077 | ||||
n = 113 school children (8–14 years) | 5.0 ml 3 × daily | 0.154 | ||||
Monapax® Tropfen, oral liquid |
n = 118 infants (7–12 months) + infants (1–3years) | 8 drops 3 × daily | 32.8c
| 0.104 | 0 | |
n = 115 children (4–7 years) | 10 drops 3 × daily | 0.130 | ||||
n = 115 school children (8–14 years) | 10 drops 4 × daily | 0.130 | ||||
Phytohustil® Hustenreizstiller Sirup, oral liquid |
n = 100 children (under 3 years) | 2.5–3 ml 4 × daily | 1.1 | 0.026 | [27] | 0 |
n = 115 children (3–6 years) | 5 ml 4 × daily | 0.043 | ||||
n = 98 school children (6–12 years) | 5 ml 5 × daily | 0.043 | ||||
Phytohustil® Hustenreizstiller Sirup, oral liquid |
n = 61 infants (under 3 months) | 2.5 ml 4 × daily | 1.1 | 0.022 | [28]d
| 0 |
n = 128 infants (3 month to 2 years) | 3.4 ml 4 × daily | 0.030 | ||||
n = 188 children (3–5 years) | 4.3 ml 4 × daily | 0.037 | ||||
n = 222 school children (6–12 years) | 4.6 ml 5 × daily | 0.040 | ||||
Phytobronchin® Saft S Lösung, oral liquid |
n = 220 infants (under 1 year) | 2.5ml 3 × daily | 5.0–8.0 | 0.158 | [29] | 4 |
n = 267 children (1–2 years) | 3 m 3 ×daily | 0.190 | ||||
n = 352 children (3–5 years) | 5 ml 3 × daily | 0.316 | ||||
n = 401 school children (6–12 years) | 5 ml 3–4 × daily | 0.316 | ||||
Soledum® Hustensaft, oral liquid |
n = 18 infants (under 2 years) | 1.25 ml 3–4 × daily | 5.8 | 0.057 | – | 0 |
n = 105 children (2–6 years) | 2.5 ml 3–4 × daily | 0.115 | ||||
n = 19 school children (7–10 years) | 5 ml 3–4 × daily | 0.229 | ||||
Sum
|
n = 50,316 children (0–12 years)
| – | – | – | – |
15
|
Results
Data from clinical studies
Pharmacovigilance data and patient exposure
Herbal medicinal product | Period | Daily doses sold (n, million) | Corresponding number of patients (n, million) | ADRs attributable to ethanol |
---|---|---|---|---|
Allergo-loges® | 2003–2009 | 3.4 | 0.1 | None |
Bronchicum® Elixir | 2004–2009 | 19.3 | 1.6 | None |
Bronchicum® Tropfen | 2004–2009 | 47.8 | 4.0 | None |
Contramutan® N Saft | 2004–2009 | 4.8 | 0.4 | None |
Contramutan® Tropfen | 2004–2009 | 2.1 | 0.2 | None |
Diarrhoesan® | 2003–2009 | 4.4 | 0.6 | None |
Iberogast® | 1993–2009 | 636.9 | 22.7 | None |
Influex® | 1993–2009 | 15.5 | 1.5 | None |
Melrosum® Hustensirup | 2004–2009 | 2.1 | 0.2 | None |
Monapax® Saft | 2004–2009 | 7.2 | 0.6 | None |
Monapax® Tropfen | 2004–2009 | 1.5 | 0.1 | None |
Phytobronchin® Saft S Lösung | 1994–2009 | 3.4 | 0.4 | None |
Phytohustil® Hustenreizstiller Sirup | 2000–2009 | 11.4 | 1.4 | None |
Soledum® Hustensaft | 2004–2009 | 3.5 | 0.3 | None |
Soledum® Hustentropfen | 2004–2009 | 1.3 | 0.1 | None |
Total
| 764.6 | 34.3 | None |
Product | Sales figures total (million packages) 2005–9/2009 | Sales figures Rx (million packages) 2005–9/2009 |
---|---|---|
Bronchicum® Elixir | 8.23 | 2.22 |
Bronchicum® Tropfen | 5.81 | 0.58 |
Contramutan® Saft | 3.16 | 1.52 |
Contramutan® Tropfen | 0.90 | 0.18 |
Melrosum® Sirup | 0.74 | 0.40 |
Monapax® Saft | 2.69 | 1.51 |
Monapax® Tropfen | 0.31 | 0.13 |
Soledum® Hustensaft | 1.410 | 0.48 |
Soledum® Tropfen | 0.17 | 0.05 |
Diarrhoesan® | 1.04 | 0.58 |
Toxi-loges® Tropfen | 0.77 | 0.02 |
Alergo-loges® | 0.05 | 0.00 |
Iberogast® | 20.63 | 2.86 |
Phytohustil® Hustenreizstiller Sirup | 1.44 | 0.17 |
Phytobronchin® Saft S Lösung | 0.41 | 0.07 |
Phytodolor® | 0.29 | 0.09 |
Sum
|
48.09
|
10.85
|