Paracetamol B.Braun – Medicinal Product Register of Latvia

Paracetamolum

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Medicinal product name

Paracetamol B.Braun 10 mg/ml solution for infusion

Pharmaceutical form

Solution for infusion

Strength

10 mg/ml

Information from the MAH on shortages

No information on expected shortages

Availability of medicinal product

Product No.	Package size	Wholesalers' stock state
12-0052-01	N10	Is available
12-0052-02	N10	Is available

Legal status

Rx Prescription (Pr.)

Package leaflet

13-09-2022

Summary of product characteristics

13-09-2022

ATC code

N02BE01 – Analgesics

Information for Marketing authorisation holders

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Product information leaflet and summary of product characteristics in MS Word format.

Package leaflet	13-09-2022
Summary of product characteristics	13-09-2022

Important notice

Additional information regarding the use for persons aged 75+

If used as "ANALGESICS"
Substance	Class	Comment
Paracetamolum	A	Suitable for older adults. Maximum dose in regular use 2-3 grams per day. Consider paracetamol in OTC drugs and combination products. Overdose is hepatotoxic. Over 2 gram can be used concurrently with warfarin if INR values are monitored.

Medicinal products (3)

Display only medicinal products with a declared price

Display only medicinal products available in wholesalers' stock

Availability of medicinal product	Wholesalers	Package size, content	Primary packaging	Maximum admissible pharmacy price (€ incl. VAT)	Product No.	Labelling
Is available (according to the information provided by wholesalers) (160 containers)	B. Braun Medical	N10 (500 mg/50 ml)	LDPE bottle	€ 16.60	12-0052-01	Labelling text Aug 11, 2016 Labelling text Aug 11, 2016
Is available (according to the information provided by wholesalers) (1171 containers)	Tamro, B. Braun Medical	N10 (1000 mg/100 ml)	LDPE bottle	€ 22.74	12-0052-02	Labelling text Aug 11, 2016 Labelling text Aug 11, 2016
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N20 (100 mg/10 ml)	LDPE ampoule		12-0052-03	Labelling text Aug 11, 2016 Labelling text Aug 11, 2016

Registration information

Marketing authorisation No.	12-0052
Date of authorisation	Mar 20, 2012
Marketing authorisation holder, country	B.Braun Melsungen AG, Germany

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Icon explanation

– Medicine is available
– Medicine is not available
– Distribution permitted for a limited time span
– Without a prescription
– Prescription medicine

– Medicine is listed on the Latvian National Health Service (NHS) list of state reimbursed medicines. (source of the information – the NHS)
– Reference medicine on the NHS List of state reimbursed medicines
– Lowest cost medicine within its therapeutic effectiveness class in cases where no reference medicine is available
- – Next lowest cost medicine after or (in ascending order)

Class A A (green): Suitable for the older persons. The medicinal substance can be used as in younger patients. Changes due to aging do not affect the dose or frequency of administration, and the adverse reaction profile is not different from that of younger patients.

Class B B (grey): There is little research evidence, practical experience or efficacy in older persons.

Class C C (yellow): Suitable for older persons, with specific cautions. The medicinal substance can be used by older persons, but the dose might either have to be reduced, or the frequency of administration decreased due to mild or moderate renal insufficiency or a significant risk of interactions or adverse reactions.

Class D D (red): Avoid use in older persons. Use is possible only in exceptional cases or on a one-off basis. Changes due to aging predispose older persons to adverse or dangerous reactions to the drug. The risk of adverse reactions typically exceeds the benefits.

Meds75+ data source is Finnish Medicines Agency Fimea (licensed under CC BY 4.0).
Data updated on May 10, 2024.