UFIS-SWE-IG
0.1.0 - ci-build

UFIS-SWE-IG, published by UNICOM. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/joofio/ufis-swe-ig/ and changes regularly. See the Directory of published versions

Example Bundle: Mydrane-InjSol-SE-AJ-MPD-BBDL

Mydrane 0,2 mg/ml + 3,1 mg/ml + 10 mg/ml Injektionsvätska, lösning

MPID: SE-100001677-00051088
EURDID: 10390

Full name: Mydrane 0,2 mg/ml + 3,1 mg/ml + 10 mg/ml Injektionsvätska, lösning

- Invented Name Part: Mydrane

- Strength part: 0,2 mg/ml + 3,1 mg/ml + 10 mg/ml

- Pharmaceutical dose form part: Injektionsvätska, lösning

Name usage: Swedish (Kingdom of Sweden)

Authorised dose form: Solution for injection

Legal status of supply: Medicinal product subject to medical prescription

Domain: Human use

Resource status: Current

Product classification:

  • 100000098543 tropicamide, combinations

Marketing Authorisation 1 of 1

Authorisation number: 51088

Region: Kingdom of Sweden

Marketing authorisation holder: Laboratoires THEA

Identifier:

  • LOC-100005605

Status: Valid (2016-03-31)

Package 1 of 2

PCID:

Description:
Ampull, 20 x 0,6 ml (Blister med en ampull och en filterkanyl.)

Marketing status:

  • Kingdom of Sweden: Marketed

Pack size:

  • 20 Ampoule

Package: 1 Box (Cardboard)

Containing:

Package: 20 Unit-dose blister (Paper) (PolyVinyl Chloride)

Containing:

Package: 1 Ampoule (Glass type I)

Containing: 0.6 millilitre(s)

Manufactured Item

Dose form: Solution for injection

Unit of presentation: Ampoule

Ingredient

Role: Active

Substance: Lidocaine hydrochloride

Concentration strength: 10 milligram(s) / 1 millilitre(s)

Reference strength:
Lidocaine 8.65 milligram(s) / 1 millilitre(s)

Ingredient

Role: Active

Substance: Phenylephrine hydrochloride ph. eur.

Concentration strength: 3.1 milligram(s) / 1 millilitre(s)

Reference strength:
Phenylephrine 2.54 milligram(s) / 1 millilitre(s)

Ingredient

Role: Active

Substance: Tropicamide

Concentration strength: 0.2 milligram(s) / 1 millilitre(s)

Reference strength:
Tropicamide 0.2 milligram(s) / 1 millilitre(s)

Package 2 of 2

PCID:

Description:
Ampull, 20 x 0,6 ml (Blister med en ampull. Filterkanyl i separat blister.)

Marketing status:

  • Kingdom of Sweden: Marketed

Pack size:

  • 20 Ampoule

Package: 1 Box (Cardboard)

Containing:

Package: 20 Unit-dose blister (Paper) (PolyVinyl Chloride)

Containing:

Package: 1 Ampoule (Glass type I)

Containing: 0.6 millilitre(s)

Manufactured Item

Dose form: Solution for injection

Unit of presentation: Ampoule

Ingredient

Role: Active

Substance: Lidocaine hydrochloride

Concentration strength: 10 milligram(s) / 1 millilitre(s)

Reference strength:
Lidocaine 8.65 milligram(s) / 1 millilitre(s)

Ingredient

Role: Active

Substance: Phenylephrine hydrochloride ph. eur.

Concentration strength: 3.1 milligram(s) / 1 millilitre(s)

Reference strength:
Phenylephrine 2.54 milligram(s) / 1 millilitre(s)

Ingredient

Role: Active

Substance: Tropicamide

Concentration strength: 0.2 milligram(s) / 1 millilitre(s)

Reference strength:
Tropicamide 0.2 milligram(s) / 1 millilitre(s)

Administrable Product (1 of 1)

Dose form: Solution for injection

Unit of presentation:

Route of administration:

  • Intracameral use

Ingredients:

Ingredient

Role: Active

Substance: Lidocaine hydrochloride

Concentration strength: 10 milligram(s) / 1 millilitre(s)

Reference strength:
Lidocaine 8.65 milligram(s) / 1 millilitre(s)

Ingredient

Role: Active

Substance: Phenylephrine hydrochloride ph. eur.

Concentration strength: 3.1 milligram(s) / 1 millilitre(s)

Reference strength:
Phenylephrine 2.54 milligram(s) / 1 millilitre(s)

Ingredient

Role: Active

Substance: Tropicamide

Concentration strength: 0.2 milligram(s) / 1 millilitre(s)

Reference strength:
Tropicamide 0.2 milligram(s) / 1 millilitre(s)