bhpardo/ema_en · Datasets at Hugging Face

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tolbutamide (used to treat type 2 diabetes) as these medicines may increase the risk of side effects.
Insulin products should only be added to compounds with which it is known to be compatible.
Thus, aripiprazole is unlikely to cause clinically important medicinal product interactions mediated by these enzymes.
The proportion of patients with CMV viraemia/ syndrome was 13.5%.
Immunosuppressants, including Advagraf, reduce your body´s own defence mechanisms to stop you rejecting your transplanted organ.
INSTRUCTIONS ON USE
In most of these patients, antibodies to erythropoietins have been observed (see sections 4.3 and 4.4 – Pure Red Cell Aplasia)
OUTER CARTON
Suspension for injection
Ireland Gilead Sciences Ltd Tel: + 44 (0) 1223 897555
INSTRUCTIONS ON USE
LIST OF EXCIPIENTS
15.
Excipients
Potassium elevation has been reported in a few patients receiving Aranesp, though causality has not been established.
2.
Elderly:
3 Patients with cardiac disease, such as angina, congestive heart failure or arrhythmia, should be closely monitored for worsening of their clinical condition during treatment with AVONEX.
Infections and Infestations:
Elimination and excretion The elimination of caspofungin from plasma is slow with a clearance of 10-12 ml/ min.
Lot
39 4.7 Effects on ability to drive and use machines
Common
EU/ 1/ 03/ 258/ 015
15.
Darbepoetin alfa has five N-linked carbohydrate chains whereas the endogenous hormone and recombinant human erythropoietins (r-HuEPO) have three.
It should be handled with care.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
9.
3%
Risk factors that may predispose patients to severe complications include obesity and family history of diabetes.
Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/ dl (6.2 mmol/ l) to 12 g/ dl (7.5 mmol/ l).
ALT normalisation (≤ 1 times ULN)
Portugal BRISTOL-MYERS SQUIBB FARMACÊUTICA PORTUGUESA, S. A.
4.
Intravenous use
S R. O.
BATCH NUMBER
ABILIFY is indicated for the treatment of schizophrenia.
Erythropoietin receptors may be expressed on the surface of a variety of tumour cells.
Do not use ADVATE after the expiry date, which is stated on the label after EXP.
6.
Varenicline did not alter the pharmacokinetics of warfarin.
CARTON
≥ 50
Determine the number of vials to be reconstituted based on the individual patient's dosage regimen and remove the vials from the refrigerator.
Bonviva should be taken after an overnight fast (at least 6 hours) and 1 hour before the first food or drink (other than water) of the day (see section 4.5) or any other oral medicinal products or supplementation (including calcium).
Do not shake.
81 Using Betaferon with food and drink:
Tel.: + 36-1-2255300
CONDITIONS OF THE MARKETING AUTHORISATION
25.50 mg of lactose monohydrate per film-coated tablet.
Tadalafil is principally metabolised by CYP3A4.
PHARMACEUTICAL FORM AND CONTENTS
4.
Norge BRISTOL-MYERS SQUIBB NORWAY LTD Tlf: + 47 67 55 53 50
Premeal blood glucose concentrations were generally lower in patients taking insulin compared to BYETTA.
19 5.3 Preclinical safety data
Minervum 7061 NL-4817 ZK Breda The Netherlands
Uncommon:
See the advice in 4 What to do in an emergency.
You may need to read it again.
Actrapid NovoLet is designed to be used with NovoFine needles.
10.
Mix the measured dose with solid foods (such as mashed potatoes or apple sauce) or liquid foods (such as water, apple juice, orange juice or protein-free infant formulas) and take it immediately after mixing.
Aranesp is a sterile but unpreserved product.
As an increased incidence of thrombotic vascular events (TVEs) has been observed in cancer patients receiving erythropoiesis-stimulating agents (see section 4.8), this risk should be carefully weighed against the benefit to be derived from treatment (with epoetin alfa) particularly in cancer patients with an increased risk of thrombotic vascular events, such as obesity and patients with a prior history of TVEs (e. g. deep vein thrombosis or pulmonary embolism).
In clinical trials, an increased risk of death and serious cardiovascular events was observed when erythropoiesis stimulating agents (ESAs) were administered to target a haemoglobin of greater than 12 g/ dl (7.5 mmol/ l).
Κύπρος sanofi-aventis Cyprus Ltd.
Skin and subcutaneous tissue disorders
6.4 Special precautions for storage
2 x 15 ml) into 140 ml of glucose intravenous infusion 5%.
In rats, co-administration with vitamin E increased the bleeding effects of tipranavir (see section 5.3 Preclinical safety data).
Hepatobiliary disorders
METHOD AND ROUTE(S) OF ADMINISTRATION
Advagraf can also be used to treat organ rejection in adult patients when other immunosuppressive medicines are not effective.
Film-coated tablet
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Hb between 10 and 12 g/ dl (6.2 - 7.5 mmol/ l).
The marketing authorisation was renewed on 9 July 2008.
SPECIAL STORAGE CONDITIONS
Lot
Your eyeballs contain a clear, watery liquid which feeds the inside of the eye.
In cases where there is a medical need to shorten the lead time before surgery to less than three weeks, 300 IU/ kg epoetin alfa should be given daily for 10 consecutive days prior to surgery, on the day of surgery and for four days immediately thereafter.
Remove and discard the filter spike.
4.5 Interaction with other medicinal products and other forms of interaction
Correction Phase
Confusion, Anxiety, Emotional lability, Suicide attempt (see also section 4.4)
There are no data with intranasal fluticasone furoate in patients with hepatic impairment.
Long-term carcinogenicity studies have not been carried out.
4.
People who smoke become addicted to nicotine, a chemical in tobacco.
Keep the injection button pressed all the way in.
4
24 PACKAGE LEAFLET:
- if you are male and wish to father a child, as Arava can cause birth defects in new born infants.
5 (0.5) 10 (1.0) 28 (2.9) 26 (2.7) 22 (2.3) 9 (0.9)
MIC values for caspofungin should not be used to predict clinical outcome, since a correlation between MIC values and clinical outcome has not been established.
One of the active ingredients may impair the ability of elderly patients to perform tasks requiring mental alertness and/or physical coordination.
80 µg

tolbutamide (used to treat type 2 diabetes) as these medicines may increase the risk of side effects.

Insulin products should only be added to compounds with which it is known to be compatible.

Thus, aripiprazole is unlikely to cause clinically important medicinal product interactions mediated by these enzymes.

The proportion of patients with CMV viraemia/ syndrome was 13.5%.

Immunosuppressants, including Advagraf, reduce your body´s own defence mechanisms to stop you rejecting your transplanted organ.

INSTRUCTIONS ON USE

In most of these patients, antibodies to erythropoietins have been observed (see sections 4.3 and 4.4 – Pure Red Cell Aplasia)

OUTER CARTON

Suspension for injection

Ireland Gilead Sciences Ltd Tel: + 44 (0) 1223 897555

INSTRUCTIONS ON USE

LIST OF EXCIPIENTS

15.

Excipients

Potassium elevation has been reported in a few patients receiving Aranesp, though causality has not been established.

2.

Elderly:

3 Patients with cardiac disease, such as angina, congestive heart failure or arrhythmia, should be closely monitored for worsening of their clinical condition during treatment with AVONEX.

Infections and Infestations:

Elimination and excretion The elimination of caspofungin from plasma is slow with a clearance of 10-12 ml/ min.

Lot

39 4.7 Effects on ability to drive and use machines

Common

EU/ 1/ 03/ 258/ 015

15.

Darbepoetin alfa has five N-linked carbohydrate chains whereas the endogenous hormone and recombinant human erythropoietins (r-HuEPO) have three.

It should be handled with care.

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

9.

3%

Risk factors that may predispose patients to severe complications include obesity and family history of diabetes.

Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/ dl (6.2 mmol/ l) to 12 g/ dl (7.5 mmol/ l).

ALT normalisation (≤ 1 times ULN)

Portugal BRISTOL-MYERS SQUIBB FARMACÊUTICA PORTUGUESA, S. A.

4.

Intravenous use

S R. O.

BATCH NUMBER

ABILIFY is indicated for the treatment of schizophrenia.

Erythropoietin receptors may be expressed on the surface of a variety of tumour cells.

Do not use ADVATE after the expiry date, which is stated on the label after EXP.

6.

Varenicline did not alter the pharmacokinetics of warfarin.

CARTON

≥ 50

Determine the number of vials to be reconstituted based on the individual patient's dosage regimen and remove the vials from the refrigerator.

Bonviva should be taken after an overnight fast (at least 6 hours) and 1 hour before the first food or drink (other than water) of the day (see section 4.5) or any other oral medicinal products or supplementation (including calcium).

Do not shake.

81 Using Betaferon with food and drink:

Tel.: + 36-1-2255300

CONDITIONS OF THE MARKETING AUTHORISATION

25.50 mg of lactose monohydrate per film-coated tablet.

Tadalafil is principally metabolised by CYP3A4.

PHARMACEUTICAL FORM AND CONTENTS

4.

Norge BRISTOL-MYERS SQUIBB NORWAY LTD Tlf: + 47 67 55 53 50

Premeal blood glucose concentrations were generally lower in patients taking insulin compared to BYETTA.

19 5.3 Preclinical safety data

Minervum 7061 NL-4817 ZK Breda The Netherlands

Uncommon:

See the advice in 4 What to do in an emergency.

You may need to read it again.

Actrapid NovoLet is designed to be used with NovoFine needles.

10.

Mix the measured dose with solid foods (such as mashed potatoes or apple sauce) or liquid foods (such as water, apple juice, orange juice or protein-free infant formulas) and take it immediately after mixing.

Aranesp is a sterile but unpreserved product.

As an increased incidence of thrombotic vascular events (TVEs) has been observed in cancer patients receiving erythropoiesis-stimulating agents (see section 4.8), this risk should be carefully weighed against the benefit to be derived from treatment (with epoetin alfa) particularly in cancer patients with an increased risk of thrombotic vascular events, such as obesity and patients with a prior history of TVEs (e. g. deep vein thrombosis or pulmonary embolism).

In clinical trials, an increased risk of death and serious cardiovascular events was observed when erythropoiesis stimulating agents (ESAs) were administered to target a haemoglobin of greater than 12 g/ dl (7.5 mmol/ l).

Κύπρος sanofi-aventis Cyprus Ltd.

Skin and subcutaneous tissue disorders

6.4 Special precautions for storage

2 x 15 ml) into 140 ml of glucose intravenous infusion 5%.

In rats, co-administration with vitamin E increased the bleeding effects of tipranavir (see section 5.3 Preclinical safety data).

Hepatobiliary disorders

METHOD AND ROUTE(S) OF ADMINISTRATION

Advagraf can also be used to treat organ rejection in adult patients when other immunosuppressive medicines are not effective.

Film-coated tablet

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Hb between 10 and 12 g/ dl (6.2 - 7.5 mmol/ l).

The marketing authorisation was renewed on 9 July 2008.

SPECIAL STORAGE CONDITIONS

Lot

Your eyeballs contain a clear, watery liquid which feeds the inside of the eye.

In cases where there is a medical need to shorten the lead time before surgery to less than three weeks, 300 IU/ kg epoetin alfa should be given daily for 10 consecutive days prior to surgery, on the day of surgery and for four days immediately thereafter.

Remove and discard the filter spike.

4.5 Interaction with other medicinal products and other forms of interaction

Correction Phase

Confusion, Anxiety, Emotional lability, Suicide attempt (see also section 4.4)

There are no data with intranasal fluticasone furoate in patients with hepatic impairment.

Long-term carcinogenicity studies have not been carried out.

4.

People who smoke become addicted to nicotine, a chemical in tobacco.

Keep the injection button pressed all the way in.

4

24 PACKAGE LEAFLET:

- if you are male and wish to father a child, as Arava can cause birth defects in new born infants.

5 (0.5) 10 (1.0) 28 (2.9) 26 (2.7) 22 (2.3) 9 (0.9)

MIC values for caspofungin should not be used to predict clinical outcome, since a correlation between MIC values and clinical outcome has not been established.

One of the active ingredients may impair the ability of elderly patients to perform tasks requiring mental alertness and/or physical coordination.

80 µg