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Injektionsvätska/koncentrat till infusionsvätska, lösning 0,5 mg/ml
(Injektionsvätska, lösning och koncentrat till infusionsvätska)

Bronkdilaterande läkemedel

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ATC-kod: R03CC03
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Läkemedel från AstraZeneca omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?




Miljörisk: Användning av terbutalin har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning: Terbutalin är potentiellt persistent.
Bioackumulering: Terbutalin har låg potential att bioackumuleras.

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Detaljerad miljöinformation

PEC/PNEC = 0.0053/240 = 0.000022

PEC/PNEC = ≤ 0.1

EnvironmentalRisk Classification

Predicted Environmental Concentration (PEC)

The PEC is based on following data:

PEC (µg/L) = (A*109*(100-R))/(365*P*V*D*100)

PEC (µg/L) = 1.5*10-6*A*(100-R)

A (kg/year) = total sold amount API in Sweden year 2017, data from IQVIA (former IMS Health and Quintiles). 

R (%) = removal rate (due to loss by adsorption to sludge particles, by volatilization,

hydrolysis or biodegradation) = 0 if no data is available.

P = number of inhabitants in Sweden = 9 *106

V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (Ref.1)

D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Ref.1)

(Note: The factor 109 converts the quantity used from kg to μg).

A = 35.1 kg

R = 0

PEC = 1.5 * 10-6 *35.1 * (100-0) = 0.0053 µg/L 


Terbutaline is metabolised and excreted as the sulphate conjugate with no active metabolites being formed (Ref. 2). Note: Whilst terbutaline is metabolised in humans, little is known about the ecotoxicity of the metabolites. Hence, as a worst case, for the purpose of this calculation, it is assumed that 100% of excreted metabolites have the same ecotoxicity as parent terbutaline.

Ecotoxicity data



Common Name





ErC10 - Based on Growth Rate

Pseudokirchneriella subcapitata (formerly known as Selenastrum


Green Alga

OECD 201

72 h

300 mg/L 

Note 1


ErC50 - Based on Growth Rate

>500 mg/L 
Note 1

EC50 - Based on Immobilisation

Daphnia magna

Giant Water Flea

OECD 202

48 h

240 mg/L 

Note 1

LOEC - Based on Immobilisation

100 mg/L 

Note 1

NOEC - Based on Immobilisation

50 mg/L

Note 1

EC50 – Based on Mortality

Danio rerio (formerly known as Brachydanio rerio)

Zebra Fish

OECD 203

96 h

>1000 mg/L 
Note 1

NOEC - Based on Mortality

1000 mg/L 
Note 1

Note 1: Results are expressed as nominal concentrations.

PNEC (Predicted No Effect Concentration)

Short-term tests have been undertaken for species from three trophic levels, based on internationally accepted guidelines. Therefore, the PNEC is based on the acute toxicity (E/LC50) to the giant water flea (Daphnia magna), the most sensitive species, and an assessment factor of 1000 is applied, in accordance with ECHA guidance (Ref. 4).

PNEC = 240000/1000 µg/L = 240 µg/L

Environmental risk classification (PEC/PNEC ratio)

PEC/PNEC = 0.0053 μg/L /240 μg/L = 0.000022, PEC/PNEC = ≤ 0.1 which justifies the phrase ”Use of terbutaline sulphate has been considered to result in insignificant environmental risk.”

In Swedish: “Användning av terbutalin har bedömts medföra försumbar risk för miljöpåverkan.”

Environmental Fate Data



Test Substance Concentration




Partition Coefficient Octanol Water

Not specified



Log P = -1.8

Note 2


Percentage DOC Removal

ISO 7827-1984E

36 mg Carbon/L

28 d

5 %


Note 2: The reported Log P is a measured distribution coefficient.


Terbutaline sulphate is not readily degradable, and since no other biodegradation data is available, the substance has been assigned the phrase “Terbutaline sulphate is potentially persistent”.

In Swedish: “Terbutalin är potentiellt persistent” under the heading “Nedbrytning”.


Since Log P < 4, the phrase “Terbutaline sulphate has low potential for bioaccumulation” is assigned.

In Swedish: ”Terbutalin har låg potential att bioackumuleras” under the heading ”Bioackumulering”.

Physical Chemistry Data





Dissociation Constant

Not specified

pKa = 8.8


pKa = 10.1

pKa = 11.2

Water Solubility

252000 mg/L



  1. [ECHA] European Chemicals Agency. Guidance on Information Requirements and Chemical Safety Assessment. Chapter R.16: Environmental exposure assessment (Version 3.0). February 2016.

  2. Electronic Medicines Compendium, SmPC Bricanyl https://www.medicines.org.uk/emc/(accessed September 2019).

  3. Report No: SR99250-01 3/92. Environmental assessment of the pharmaceutical agent 'A003' from AB Astra. Toxicon. April 1992.

  4. Chemical Safety Assessment. Chapter R.10: Characterisation of dose [concentration]-response for environment. May 2008.

  5. Novel Core in Cup Bucco-adhesive Systems and Films of Terbutaline Sulphate and in vitro evaluation. Pramod Kumar T.M.; Shivakumar H.G. Asian Journal of Pharmaceutical Sciences 2006 v1 n3-4 p175-187.

  6. S1.03 Marketing, General Properties, Terbutaline Sulphate Drug Substance, Respiratory Use. AstraZeneca. Doc ID-000329236, Version 3.0.