bhpardo/ema_en · Datasets at Hugging Face

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MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
6.
10.
241 The carton contains a package leaflet with the full instructions for use and handling.
EXP
Actrapid is for injection under the skin (subcutaneously).
Hallucinations
Store in a refrigerator (2°C - 8°C) Do not freeze Keep the cartridge in the outer carton in order to protect from light During use: do not refrigerate or store above 30°C
Check the expiry date on the pre-filled syringe label (EXP:).
General: in patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e. g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure.
Do not take a double dose to make up for a forgotten dose.
Polyvinyl alcohol Titanium dioxide (E171) Macrogols 3350 Talc Iron oxide yellow (E172)
However, if you take more Azomyr syrup than you were told to, contact your doctor or pharmacist.
3 ml (3.5 mg/ ml)
40 weeks after the end of the treatment period, the percentage of patients who were still non-smokers was 23% among those who had taken CHAMPIX, and 9% among those who had taken a placebo.
Magyarország GlaxoSmithKline Kft.
-1.84
EU/ 1/ 02/ 229/ 024
4.
6.1 List of excipients
EU/ 1/ 06/ 360/ 009 EU/ 1/ 06/ 360/ 010 EU/ 1/ 06/ 360/ 011
Intravenous use
In pre/ postnatal toxicity study in the rat, duloxetine induced adverse behavioural effects in the offspring at systemic exposures levels below maximum clinical exposure (AUC).
The potential risk for humans is unknown.
Keep the container in the outer carton, in order to protect from light.
Common:
ETV
84 years; range:
Haematochezia Breath odour
Abseamed has no influence on the ability to drive and use machines.
Avastin in combination with paclitaxel is indicated for first-line treatment of patients with metastatic breast cancer.
The marketing authorisation was renewed on 13 October 2005.
Possible side effects are listed below:
=
Withdraw the needle at the same angle as it was inserted.
Always keep your cartridge in the outer carton when you’ re not using it in order to protect it from light.
Factor VIII inhibitor assays performed after completion of continuous infusion and at study termination were negative.
EPAR summary for the public
Chronic renal failure patients
Children and adolescents There are no data available on the use of rosiglitazone in patients under 10 years of age.
EXP
• The mode of action suggests that the effects of L-dopa, dopaminergic agonists, and anticholinergics may be enhanced by concomitant treatment with NMDA-antagonists such as memantine.
not known
These reductions in HbA1c were generally observed at 12 weeks after initiation of treatment.
Excipients: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, glycine, polysorbate 80, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment), and water for injections
PHARMACEUTICAL FORM
LABELLING
General
1.
Actraphane 10 Penfill
11 6.6 Special precautions for disposal
Your doctor has given you Aranesp (an anti-anaemic) to treat your anaemia.
If the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), a dose reduction should be considered.
What Aerius orodispersible tablet looks like and contents of the pack
Read all of this leaflet carefully before you start using this medicine.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Sodium acetate, sodium chloride, acetic acid and water for injections.
Pharmacokinetics have to be assessed regularly in each patient and posology has to be adjusted accordingly.
When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started.
5.3 Preclinical safety data
Apidra
CANCIDAS will always be prepared and given to you by a doctor or another healthcare professional.
Clinically important adverse reactions occurring in less than 1% of adult patients receiving CELSENTRI in Phase 3 studies are presented below.
7.
5.
Package size
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Arthralgia, myalgia, muscle spasms, muscular weakness, musculoskeletal pain, musculoskeletal chest pain
What benefit has Avandamet shown during the studies?
Therefore medicinal products that are inducers, inhibitors or substrates of CYP3A4 must be used with caution when administered concurrently with Agenerase (see sections 4.3, 4.4 and 4.5).
14 Absorption:
Do not lay the syringe down or let the needle touch anything.
Accidental exposure to freezing temperatures does not adversely affect the stability of Biograstim.
As with any insulin therapy, injection site reactions may occur and include pain, itching, hives, swelling and inflammation.
Not all pack sizes may be marketed.
5 No development of resistance was observed during treatment with retapamulin in the clinical study programme and all clinical isolates were inhibited by retapamulin concentrations of < 2µg/ ml.
12.
2.
4.3 Contraindications
Tel: + 39 06 50 39 61
37 Patients scheduled for major elective orthopaedic surgery
România Astellas Pharma Internaţ ional Detalii de contact pentru România Ş oseaua Bucureş ti-Ploieş ti 42-44, Clă dire 1, Parter, 013696-Bucureş ti Tel: +40 (0)21 361 0495
This is given twice a week by injection into a vein.
In vitro studies indicate that varenicline is unlikely to alter the pharmacokinetics of compounds that are primarily metabolised by cytochrome P450 enzymes.
Димитър Манов бл.10 София 1408 Тел. + 359 2 953 10 34
Common
It should also not be used in people who have had an allergic reaction after being given hepatitis A or hepatitis B vaccines.
Powder in Type I glass vial.
Name and address of the manufacturer responsible for batch release
It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
- patients with unstable angina or angina occurring during sexual intercourse,
Therefore this combination is not recommended (see section 4.4).
For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition.
BOX OF 2, 4, 7, 10, 14, 20 MODIFIED-RELEASE TABLETS
51 PARTICULARS TO APPEAR ON THE OUTER PACKAKING CARTON WITH 14 SINGLE PACKS, PART OF A CARTON WITH 42 (3 x 14) SINGLE PACKS (INCLUDING BLUE BOX)
6.4 Special precautions for storage
WHAT ARIXTRA IS AND WHAT IT IS USED FOR
Alcohol should be avoided when taking ABILIFY.
4.
• Allergic reactions, including anaphylactic reaction, angioedema, skin rash and urticaria.

MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE

6.

10.

241 The carton contains a package leaflet with the full instructions for use and handling.

EXP

Actrapid is for injection under the skin (subcutaneously).

Hallucinations

Store in a refrigerator (2°C - 8°C) Do not freeze Keep the cartridge in the outer carton in order to protect from light During use: do not refrigerate or store above 30°C

Check the expiry date on the pre-filled syringe label (EXP:).

General: in patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e. g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure.

Do not take a double dose to make up for a forgotten dose.

Polyvinyl alcohol Titanium dioxide (E171) Macrogols 3350 Talc Iron oxide yellow (E172)

However, if you take more Azomyr syrup than you were told to, contact your doctor or pharmacist.

3 ml (3.5 mg/ ml)

40 weeks after the end of the treatment period, the percentage of patients who were still non-smokers was 23% among those who had taken CHAMPIX, and 9% among those who had taken a placebo.

Magyarország GlaxoSmithKline Kft.

-1.84

EU/ 1/ 02/ 229/ 024

4.

6.1 List of excipients

EU/ 1/ 06/ 360/ 009 EU/ 1/ 06/ 360/ 010 EU/ 1/ 06/ 360/ 011

Intravenous use

In pre/ postnatal toxicity study in the rat, duloxetine induced adverse behavioural effects in the offspring at systemic exposures levels below maximum clinical exposure (AUC).

The potential risk for humans is unknown.

Keep the container in the outer carton, in order to protect from light.

Common:

ETV

84 years; range:

Haematochezia Breath odour

Abseamed has no influence on the ability to drive and use machines.

Avastin in combination with paclitaxel is indicated for first-line treatment of patients with metastatic breast cancer.

The marketing authorisation was renewed on 13 October 2005.

Possible side effects are listed below:

=

Withdraw the needle at the same angle as it was inserted.

Always keep your cartridge in the outer carton when you’ re not using it in order to protect it from light.

Factor VIII inhibitor assays performed after completion of continuous infusion and at study termination were negative.

EPAR summary for the public

Chronic renal failure patients

Children and adolescents There are no data available on the use of rosiglitazone in patients under 10 years of age.

EXP

• The mode of action suggests that the effects of L-dopa, dopaminergic agonists, and anticholinergics may be enhanced by concomitant treatment with NMDA-antagonists such as memantine.

not known

These reductions in HbA1c were generally observed at 12 weeks after initiation of treatment.

Excipients: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, glycine, polysorbate 80, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment), and water for injections

PHARMACEUTICAL FORM

LABELLING

General

1.

Actraphane 10 Penfill

11 6.6 Special precautions for disposal

Your doctor has given you Aranesp (an anti-anaemic) to treat your anaemia.

If the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), a dose reduction should be considered.

What Aerius orodispersible tablet looks like and contents of the pack

Read all of this leaflet carefully before you start using this medicine.

Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/

Sodium acetate, sodium chloride, acetic acid and water for injections.

Pharmacokinetics have to be assessed regularly in each patient and posology has to be adjusted accordingly.

When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started.

5.3 Preclinical safety data

Apidra

CANCIDAS will always be prepared and given to you by a doctor or another healthcare professional.

Clinically important adverse reactions occurring in less than 1% of adult patients receiving CELSENTRI in Phase 3 studies are presented below.

7.

5.

Package size

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Arthralgia, myalgia, muscle spasms, muscular weakness, musculoskeletal pain, musculoskeletal chest pain

What benefit has Avandamet shown during the studies?

Therefore medicinal products that are inducers, inhibitors or substrates of CYP3A4 must be used with caution when administered concurrently with Agenerase (see sections 4.3, 4.4 and 4.5).

14 Absorption:

Do not lay the syringe down or let the needle touch anything.

Accidental exposure to freezing temperatures does not adversely affect the stability of Biograstim.

As with any insulin therapy, injection site reactions may occur and include pain, itching, hives, swelling and inflammation.

Not all pack sizes may be marketed.

5 No development of resistance was observed during treatment with retapamulin in the clinical study programme and all clinical isolates were inhibited by retapamulin concentrations of < 2µg/ ml.

12.

2.

4.3 Contraindications

Tel: + 39 06 50 39 61

37 Patients scheduled for major elective orthopaedic surgery

România Astellas Pharma Internaţ ional Detalii de contact pentru România Ş oseaua Bucureş ti-Ploieş ti 42-44, Clă dire 1, Parter, 013696-Bucureş ti Tel: +40 (0)21 361 0495

This is given twice a week by injection into a vein.

In vitro studies indicate that varenicline is unlikely to alter the pharmacokinetics of compounds that are primarily metabolised by cytochrome P450 enzymes.

Димитър Манов бл.10 София 1408 Тел. + 359 2 953 10 34

Common

It should also not be used in people who have had an allergic reaction after being given hepatitis A or hepatitis B vaccines.

Powder in Type I glass vial.

Name and address of the manufacturer responsible for batch release

It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

- patients with unstable angina or angina occurring during sexual intercourse,

Therefore this combination is not recommended (see section 4.4).

For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition.

BOX OF 2, 4, 7, 10, 14, 20 MODIFIED-RELEASE TABLETS

51 PARTICULARS TO APPEAR ON THE OUTER PACKAKING CARTON WITH 14 SINGLE PACKS, PART OF A CARTON WITH 42 (3 x 14) SINGLE PACKS (INCLUDING BLUE BOX)

6.4 Special precautions for storage

WHAT ARIXTRA IS AND WHAT IT IS USED FOR

Alcohol should be avoided when taking ABILIFY.

4.

• Allergic reactions, including anaphylactic reaction, angioedema, skin rash and urticaria.